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Pages: 1 through 292
Place: Washington, DC
Date: March 8, 1999


Official Reporters

1220 L Street N.W., Suite 600
Washington, DC

(202) 628-4888

Third Floor
Waugh Auditorium
1800 M Street N.W.
Washington, D.C.
Monday, March 8, 1999

The meeting in the above-entitled matter commenced, pursuant to notice, at 9:10 a.m.




Year 2000 Dietary Guidelines Advisory Committee:

Vice Provost and Professor
Cornell University
Associate Director, Food and Nutrition Programme
United Nations University

Director, Institute of Human Nutrition
Columbia University College of Physicians and

Director, Frances Stern Nutrition Center
New England Medical Center
Professor of Medicine (Nutrition) and
Community Health
Tufts University School of Nutrition

Year 2000 Dietary Guidelines Advisory Committee:

Chair, Department of Clinical Nutrition
Director, Center for Human Nutrition
University of Texas Southwestern Medical Center
at Dallas

Associate Professor
Department of Nutritional Sciences
University of Vermont

Head and Professor, Department of Human Nutrition
and Dietetics
Professor of Epidemiology
University of Illinois at Chicago

Scientist I, USDA Human Nutrition
Research Center on Aging
Association Professor, School of Nutrition
Tufts University

Researcher, Cancer Research Center of Hawaii
University of Hawaii

Professor of Epidemiology and Nutrition
Harvard School of Public Health
Associate Professor of Medicine
Harvard Medical School

Chair and Professor, Departments of Nutrition
Sciences and Medicine
School of Medicine
University of Alabama-Birmingham

Co-Executive Secretaries:

(301) 734-5640

(202) 418-2312

(202) 401-0751

(202) 205-4872

Also Present:











CHAIRMAN GARZA: Good morning. I am Bert Garza. I have the privilege of chairing this group, and I want to take the opportunity to thank each of you for coming this morning. We have a full three days ahead of us and certainly appreciate the interest that your presence represents.

I want to also publicly thank the committee members who have been hard at work in getting ready for this meeting. There have been several comments about this being one of the hardest working committees in the history of the dietary guidelines, so that is a real testament to each of you because in fact certainly the other previous committees have worked very diligently as well.

Before moving on to hearing from those of you that have registered to testify this morning, and that is somehow too stringent a term; at least to comment and share your views with us, I think it is important for me to review with you the rules and procedures we are going to be following.

There is an electronic timer that you have by the microphone. The green light will go on as you speak. The yellow light will come on two and a half minutes into your presentation, and then at the red light there will be a gong, and then the floor will open from underneath.


CHAIRMAN GARZA: So I would advise that you step off that platform quickly. The consequences, I am told, are not pleasant. Shanthy has provided for the opening platform.

Through all of this, we have as a committee five broad objectives in mind for the next three days. The first is to hear from you and to have an opportunity to evaluate the information that will be presented from your oral and/or written presentations.

We also will be hearing from a number of invited guests today and tomorrow, and so the committee will be looking very carefully at the information that they bring us.

It also gives us an opportunity to update for each of the working groups that have been involved with various of the guidelines, since our last meeting, an opportunity to update the entire committee on the review of their work. It gives us an opportunity to assure the committee the opportunity to review various options that are under consideration that are based on information that has been reviewed by each of the working groups to date.

Thus, I want to stress that we are still in the information gathering stage of our deliberations. We still have at least two more meetings, possibly even three, but I do not think that three will be necessary. Nonetheless, we have at least two more before we reach any final recommendations.

Lastly, we would like by the end of the three days to reach a consensus regarding the format of our report to the Secretary and to begin the development of outlines that address each of the report's sections.

All of this process and achieving these aims and in the presentations we are about to hear, I would like to ask each of you to concentrate or focus your attention primarily on information that has been obtained since 1995.

To the extent that we need additional information from previous studies to help interpret that context, that is great, but our primary goal is to evaluate information that has come up since 1995, not necessarily to second-guess the scientific judgments that have gone before us.

Certainly if there is data that would cause us to relook at some of those judgments we ought to, but our principal focus should be assessing data that has been developed since the last guidelines were formulated.

With that very brief introduction, I would like to ask any of the committee members if they would like to add anything before we turn to the first organization that will be presenting?

If not, then let's begin. Again just to refresh everybody's mind in case the horror of it caused you to forget, you have three minutes. The orange light comes out at two and a half, and then the red light comes on at three.

Our first presenter is Ms. Kathryn Carroll. I would ask that you please state your name clearly, the organization that you are representing, because those individuals that are transcribing need to make that part of the record.

MS. CARROLL: Sure. Can you hear me? I am Kathy Carroll with the American Dietetic Association.

The American Dietetic Association commends USDA, HHS and the Dietary Guidelines Advisory Committee for their work on the Year 2000 Dietary Guidelines for Americans. We recognize the difficulty of adhering to the science while providing understandable and applicable messages in an increasingly complex and confusing environment.

We urge the committee to continue to base the guidelines on sound scientific evidence. We stand ready to assist in translating that science from the textbook to the table. Our written comments provide additional detail to augment these verbal ones.

ADA feels strongly that variety should remain the cornerstone of the guidelines. Because a variety of foods are needed for health, it is vital that the total diet be emphasized. We urge the committee to state that all the guidelines are important. One does not take precedence.

The guidelines should reinforce the importance of grain, vegetable and fruit consumption, but not to the exclusion of other nutrients and foods, such as non-fat and low-fat foods within the dairy and meat/meat alternative groups.

ADA feels strongly that optimal nutrition and physical activity can promote health and reduce chronic disease. Physical activity goes hand in hand with sound nutrition, and the guidelines should continue to reflect this interrelationship.

Advice on serving sizes should be strengthened and reinforced throughout. The guidelines should encourage achievement and maintenance of a healthy weight through expanded information on serving sizes and portion control in a variety of settings, including restaurants.

ADA feels strongly that eating well is more than nutrient selection. The importance of pleasure and emotional satisfaction should be acknowledged throughout as well.

ADA concurs with the 1995 guideline on alcohol, which includes a balance of positive and negative effects of drinking. We urge the committee to explore the risks and benefits of moderate alcohol consumption among those at higher risk for certain diseases.

ADA supports the language in the 1995 guidelines on supplements and recognizes some subpopulations may require supplementation to meet certain nutrient needs. Research continues to show that most Americans can lead healthy lives by eating a variety of foods and being physically active.

In addition, the current legislative and regulatory environment governing dietary supplements lacks sufficient controls. A separate guideline, regardless of the message, could prove very confusing to consumers and potentially unsafe if misunderstood and misapplied.

Given the scope of consumer concern about food safety, ADA urges the committee to consider adding food safety messages in an informative, but not alarming, way. In light of the need to keep the number of guidelines manageable, we do not support a separate food safety guideline, however.

ADA is ready to assist in developing scientifically based and consumer focused guidelines. We look forward to working with government agencies and other organizations such as the Dietary Guidelines Alliance inputting the dietary guidelines into practice.


Ms. Margo Wootan?

MS. LEIBMAN: I am Bonnie Leibman from Center for Science in the Public Interest.

The sugar guideline needs more strengthening than any other because the advice is weak, and intakes of sugar, added sugars, are going through the roof. Added sugars now comprise 16 percent of the average American's calories and 20 percent of the average teenager's calories.

The guideline should make a clear distinction between foods rich in added sugars versus fruits and low-fat dairy products which are rich in naturally occurring sugars, but are associated with a lower risk of disease.

In contrast, foods rich in added sugars displace healthy foods as illustrated by the steep rise in soft drink consumption and steady fall in milk consumption. Analyses of USDA's 1987-88 data indicate that adults age 25 to 50 who consume the most added sugars are less likely to get the RDA for iron, zinc, calcium, vitamins E, B6, B12, thiamine, riboflavin and niacin than those who consumer lower, moderate amounts of added sugars.

The high sugar consumers would probably also have fared worse for folate, Vitamin A and Vitamin C if that analysis had not lumped fruit sugars in with added sugars and if the analysis had used current sugar intakes, which are higher than they were in the 1980s.

Foods rich in added sugars also contribute to the nation's epidemic of obesity because they are typically calorie dense. Furthermore, recent studies suggest that people may not compensate for the calories in liquid foods like soft drinks as well as for the calories in solid foods.

An analysis of NHANES III found that overweight boys and girls consume a greater percentage of their calories from soft drinks than normal weight children. For years, the sugar industry has argued that high sugar consumers are skinnier, but that relationship is probably confounded by age.

Foods rich in added sugars also contribute to heart disease because they raise triglycerides more than other carbohydrates, at least in the growing fraction of the population that is insulin resistant.

The guidelines should tell the public how much added sugar is moderate. Like the food guide pyramid, it should urge people to "limit added sugars to six teaspoons a day if you eat about 1,600 calories, 12 teaspoons at 2,200 calories, or 18 teaspoons at 2,800 calories."

The sodium guidelines should elaborate on the evidence that salt raises blood pressure, especially the evidence from clinical trials. The guidelines should also point out that one out of two Americans age 60 or older has high blood pressure, and millions more have higher than optimal blood pressure, which raises the risk of heart disease and stroke.

The guidelines should also urge people to look for foods labeled healthy, like Healthy Choice and Campbell's Healthy Request soups. FDA allows healthy foods to contain no more than 480 milligrams per serving. That regulation has single-handedly given consumers an alternative to high salt soups, processed meats, frozen dinner and other foods. The success of these brands show that if it has to, the food industry can cut sodium levels and maintain taste.

We suggest changing the title of the fat guideline to choose a diet low in fats, especially saturated fat, transfat and cholesterol. The text should explain which foods contain transfat and also explain that ground beef is a major source of saturated fat in the average American's diet, and ground beef labeled 80 percent or 85 percent lean is still high in saturated fat.

Finally, the guidelines should address the extremely high levels of salt, sugar and sodium in restaurant foods. The tips in each guideline --

CHAIRMAN GARZA: I am afraid I have to interrupt.

MS. LEIBMAN: Okay. Well, anyway.


MS. LEIBMAN: That last sentence you can read. Thank you.

CHAIRMAN GARZA: That is much kinder than the platform opening beneath your feet.

MS. LEIBMAN: Okay. Thanks.

CHAIRMAN GARZA: Council for Responsible Nutrition?

MS. DICKINSON: This is a contest to see who can talk the fastest.

I am Annette Dickinson with the Council for Responsible Nutrition. CRN is a trade association of dietary supplement manufacturers whose members manufacture a large fraction of the dietary supplement products available to you in supermarkets, drugstores, discount department stores, health food stores, direct sales and mail order.

In 1998, we submitted extensive comments urging the Dietary Guidelines Committee to recognize nutritional supplements as an important tool in assuring desirable intakes of key nutrients. We provided copies of our publication, Optimal Nutrition for Good Health, Benefits of Nutritional Supplements.

Today we want to remind the committee of the importance of fairly recognizing the contribution of supplements and draw your attention to two new developments in this area. One is the formation of a national campaign on folic acid. The other is the recent development of a new food guide pyramid for seniors which features a pennant on top to flag the importance of supplementation of some specific nutrients.

The National Campaign on Folic Acid, under the leadership of the March of Dimes and the CDC, is launching a major campaign to make all women of childbearing age aware of the importance of folic acid in preventing neural tube birth defects. But, as we all know, awareness is only one part of the puzzle. The key is to change behavior.

Another goal of the National Campaign on Folic Acid is to create an environment in which taking a multivitamin with folic acid everyday becomes the community norm, along with improving dietary folate intake and using foods fortified with folic acid.

We have provided copies of the draft advertising copy and the brochure being developed by the National Campaign on Folic Acid, and we urge you to include language in the guidelines which are consistent with these messages.

The second development we wish to highlight briefly is the publication this month in the Journal of Nutrition of a new food guide pyramid for seniors developed by researchers at Tufts.

The guide is a departure from other pyramids in that it sits on a base of water, eight glasses a day recommended for everyone, but especially seniors, emphasizes whole grains over refined grains, focuses on richly colored vegetables rather than pale vegetables, and is topped by a pennant flagging the importance of several nutritional supplements for seniors, specifically calcium, Vitamin D and Vitamin B12.

We urge this committee to consider these advances as you think about dietary guidelines for the year 2000. As emphasized by both of these developments, nutritional supplements are achieving a level of acceptance which should make it easier for this Dietary Guidelines Committee to move forward with language in the year 2000 revision which specifically acknowledges supplements as an important source of nutrients which are difficult to obtain from diet alone.

Thank you.


The Dietary Guidelines Alliance?

MS. SOWA: Good morning. I am Jeanne Sowa, Group Director of Consumer and Marketing Services for the American Dietetic Association, but today I am here on behalf of the Dietary Guidelines Alliance to provide a consumer communications perspective to your deliberations.

Four years ago, 17 organizations from the food industry, the health community and the Federal Government joined forces to promote the Dietary Guidelines for Americans. The result is the Dietary Guidelines Alliance, a public/private partnership with the mission of supporting the guidelines by helping consumers incorporate them and making them actionable in their everyday lives.

We applaud the Advisory Committee's dedication to continue to base the guidelines on sound science and consensus. Many in this room agree that consumers are still confused about how to use the guidelines. Repeatedly we hear appeals to communicate the guidelines in meaningful and motivating ways.

Our experience working with the 1995 guidelines and conducting consumer research show that consumers need nutrition messages that are simple and practical. There is a large gap between what consumers say and what they do about eating and physical activity.

Consumers want more healthful lifestyles, but real or perceived obstacles of time, confusion, fear of giving up foods get in their way. We've also learned that consumers do not want to hear nutrition speak. They want empowering, useful messages and tips that resonate with their core values.

Based on this research, the Alliance launched a broad scale campaign for consumers called It's All About You. The campaign was designed for consumers by consumers, and they shaped the core messages, these being -- be realistic, be adventurous, be flexible, be sensible and be active. These messages are designed to motivate positive change.

For the past two years, the American Dietetic Association has made these messages the cornerstone of our National Nutrition Month campaigns, and soon we will see the messages and the food guide pyramid on the $2 food stamp coupon book. We are completely a nutrition education tool kit that includes a unique owner's manual for the body. Again, consumer research is shaping and evaluating the kit.

I wish to leave you with these thoughts as you review the Dietary Guidelines for Americans. First, the Alliance pledges to continue its support of the dietary guidelines, and, secondly, we urge the Advisory Committee and all of us in the nutrition and health communities to listen to what consumers are telling us. They say give us positive, simple and consistent dietary messages that we can understand and use throughout our lives.

Thank you for your interest.


Geiger & Associates?

MS. GEIGER: Good morning. It is a pleasure to be here. I am Constance Geiger, president of Geiger & Associates, a food labeling, health communications and government affairs consulting firm, and assistant research professor, Division of Foods and Nutrition, University of Utah.

I appreciate the opportunity to be here today to share the results of the Dietary Guidelines for Americans focus group study, which was funded by the International Life Sciences Institute's Human Nutrition Institute and upon which comments and advice was given to me by both USDA and the Department of Health and Human Services.

This research was a follow-up to the questions from the 1995 dietary guidelines, which I was asked to address at that time. One, what would be the effect of a two-tiered information approach on consumer attitudes and comprehension, and, two, how would consumers react to fewer dietary guidelines?

There was concern about consumer perception at that time. Therefore, this research examined consumers' reactions to and understanding of the bulleted headlines of the dietary guidelines as a whole and then each individual guideline. And then we also looked at consumers' reactions to potential changes in the guidelines and alternative wording for some of those, and, thirdly, consumers' reactions to three different formats for the dietary guidelines. The committee has a full copy of the report, which is being prepared for publication.

In terms of some of the selected results, consumers are confused by several of the guidelines' messages. First, the message to maintain or improve your weight does not make sense to them.

Second, to some focus group respondents the term balance with respect to high-fat foods conveys permission to balance high-fat foods with other high-fat foods instead of balancing -- that was quite of interest to us. Instead of balancing low-fat foods with high-fat foods.

Consumers are also frustrated because they think dietary advice should be restrictive, but they do not believe the advice is realistic or achievable, and they do not appear to understand how to apply the dietary guidelines to an eating pattern. Respondents are also receptive to changes in the guidelines as long as they are supported by research, so you can make changes.

The respondents reacted to three different formats for the guidelines based on the deliberations of the previous Dietary Guidelines Committee. Again, I was asked to address those in 1996.

Most respondents do not care for the current format; that is the list of the seven statements -- you have those formats in the handout I just passed around -- because it provides too much information. It cannot be read quickly and does not hold their interest.

The two-tiered format is considered easier to read. People like the grouping by importance. The final format is the most preferred. Short, and easy to follow are most important. It contains the most important information. Almost all of the guidelines could be better communicated to the public, and the format of the guidelines could be changed to make them more useful to consumers.

Thank you for considering our comments today.


International Food Information Council?

MS. BORRA: Good morning. I am Susan Borra from International Food Information Council. We are a nonprofit organization based here in Washington, and our mission is to communicate science-based food safety and nutrition information. Our programs are supported by the broad based food and beverage industry.

We do support the Dietary Guidelines for Americans, but when we look at government data, that data shows us that only one percent of Americans are eating according to food guide pyramid recommendations. Therefore, that tells us that we all must work together to make the science-based recommendations much more useable for consumers so that they can improve their diets and ultimately their health.

At IFIC, we conduct both quantitative and qualitative research, consumer research, in order to assist in understanding their concerns and behaviors regarding food nutrition and food safety. Last August, IFIC conducted consumer focus groups with adult women about dietary guidance messages. We were especially interested in their perceptions about dietary fats. We discovered the following.

While we knew consumers would tell us if they were confused, which they did, we were amazed at the extreme guilt, worry and fear evoked about their diets and those of their families. Guilt about eating habits results from feelings that they are not doing what is expected of them or what is right. Worry and fear emerge from thinking about the effects of not eating a healthy diet. Other feelings include helplessness, anger, deprivation and frustration. That is what they told us.

Next we shared the dietary guidelines' message, choose a diet low in fat, saturated fat and cholesterol. Consumers interpreted this message as no fat, no taste, no enjoyment and not attainable. Most felt this meant a diet with as little fat as possible, which was an unrealistic prospect for them.

Now, by simply substituting the word moderate, as in choose a diet moderate in fat, saturated fat and cholesterol, this promoted common sense and responsible choice. These consumers believed that a moderate-fat diet was motivational and doable, while a low-fat diet was not achievable.

By encouraging a moderate rather than a low-fat diet, we may be more effective in building consumer confidence that they can indeed achieve a healthful diet. Moderation works with consumers.

Similarly, consumer research on sugars found that adults believe that a healthy diet can include sugar- containing foods in moderation, a concept that reflects current dietary advice.

Looking toward the future, consumers want information about how foods can promote optimal health. The committee really has an opportunity to help Americans understand functional foods, foods that promote health benefits beyond basic nutrition. This will provide consumers with additional choices to meet dietary goals.

The committee is also considering including food safety in the guidelines. Our research shows that consumers want diet and health messages that incorporate safe food handling. With escalating interest in food safety fundamentals, along with nutrition, the committee can provide leadership to empower consumers to handle food properly via the guidelines and other nutrition education vehicles.

I thank you for the opportunity this morning.



(No response.)

CHAIRMAN GARZA: National Food Processors Association?

MS. APPLEBAUM: Good morning. I am Rhona Applebaum with the National Food Processors Association. NFPA is the principal scientific and technical trade association representing the food-processing industry.

As a scientific trade association, NFPA strongly supports the need for scientifically based dietary guidelines designed to promote the health and well-being of Americans. The dietary guidelines must be based on the best current science, and I underscore current science. If not, they run the risk of being nothing more than folktales.

These guidelines are too important to the health of our nation to be based on anything less than the best current science available, and we applaud the Chair in his direction to the committee to focus on information 1995 and on.

In addition to the guidelines being science-based, NFPA considers it essential that the guidelines be easily understood, easily managed and motivational. Until consumers understand the advice, are convinced of the benefits the guidelines can deliver and incorporate them into their daily lives, the guidelines will continue to be ineffective. Consequently, it is imperative the guidelines trigger action by consumers.

The question before us is how can the guidelines evolve from mere recommendations to motivational tools? NFPA recommends strongly that the committee request the government agencies to review the literature for any research that enumerates criteria needed to produce behavioral change in consumers.

This information, if it exists, should be combined with findings from the work of the Dietary Guidelines Alliance, as well as others, in order to prompt behavioral changes in consumers. In the absence of such research, we strongly urge it be undertaken as soon as possible.

In addition, the guidelines in their current form do not adequately provide Americans with a priority listing of targeted recommendations to serve as a foundation for a healthful diet and lifestyle. The laundry list of recommendations is simply too unwieldy, too difficult for consumers to manage as part of their busy and hectic lives.

To facilitate acceptance and internalization of these recommendations by consumers, NFPA urges the committee to employ a two-tiered approach to presenting the dietary guidelines. The first tier, the foundation, would include those guidelines judged most important. The second tier will include those less critical.

In our view, the first tier would consist of three guidelines, those being -- eat a variety of foods, engage in physical activity to maintain or improve weight, and choose a diet with plenty of grain products, fruits and vegetables. These three guidelines set the foundation for consumers who can then advance to the second tier of guidelines.

Time constraints permit me to focus on only one other guideline, the guideline on salt and sodium. In brief, NFPA believes this should be removed. Current science does not support a policy of universal sodium restriction for healthy, normotensive Americans to prevent hypertension and reduce the risk of cardiovascular disease.

In conclusion, NFPA believes the dietary guidelines provide important public health messages to consumers. We believe they should be scientifically based, easily understood, easily managed and trigger behavioral change.

To sum up, they should be short, sweet -- yes, we also have issues with the guideline on sugar, but that is commentary for another day -- and, most important, motivational action items.

Thank you for this opportunity to address these important issues. We will provide more substantial input on these issues in our written comments. Thank you.


The Nebraska Association of Family and Consumer Sciences?

(No response.)

CHAIRMAN GARZA: Physicians Committee for Responsible Medicine?

(No response.)

CHAIRMAN GARZA: Society for Nutrition Education?

MS. PENNINGTON: Good morning. My name is Jean Pennington. I am president of the Society for Nutrition Education. The Society is pleased to address the Dietary Guidelines Advisory Committee, and we are proud to have three SNE members among you.

The mission of SNE is to promote healthy, sustainable food choices. The vision is healthy people and healthy communities. We provide forums for nutrition educators to exchange and share innovative ideas, disseminate research findings and advocate for public policy concerning nutrition education programs and food service programs.

SNE members are a diverse group, holding positions in academia, government and private industry in the U.S. and other countries. We translate the science of nutrition into practical messages and communicate those messages to target audiences, including students, patients, clients, parents, families, other educators, and policymakers.

Our members are effective in encouraging behavior change so that nutrition messages become incorporated into healthier lifestyles. Because of the diverse views of SNE members, we will not make comments on individual guidelines, but wish to make general comments regarding the communication of nutrition messages to the public.

First, we recognize that the dietary guidelines must be based on sound science and understand that science evolves and changes. We urge the committee to be willing to adapt the guidelines' messages to match the evolving science and to have the message tested on audiences diverse in age, ethnic group and educational level to determine if the intended meanings are correctly interpreted.

Second, we encourage the committee to review not only nutrition science research, but nutrition education research, such as the papers published in the Journal of Nutrition Education, to have a better understanding of how population groups understand and interpret nutrition information.

Third, we know well that imparting information is not sufficient to change patterns or behavior related to eating or physical activity. We request that the committee design the guidelines for people at varying stages of readiness to make behavior change and to address the environmental as well as the personal supports for behavior change.

Fourth, we ask that you look at the nutrition education tools that have been developed and tested by nutrition educators to determine what works and identify potential barriers to behavior change. Lastly, we ask that you focus on messages that are active, practical and positive.

SNE members rely on the dietary guidelines as a primary educational tool to convey nutrition information to the public. We offer two items for your use. One, we have prepared a list of papers published in the Journal of Nutrition Education and other journals over the past five years that relate to message interpretation, behavioral modification and educational tools.

Secondly, we have a list to obtain quick response from our members. We would be pleased to put any questions or requests that the committee might have and provide timely responses from a wide range of nutrition educators.

We thank you for considering our comments and wish you well in your deliberations.


Dairy Management, Inc., the National Dairy Council?

MS. CRAIG: Good morning. My name is Suzanne Craig. I am a registered dietician responsible for nutrition and health promotion for the National Dairy Council.

Since its founding in 1915 by the nation's dairy farmers, the National Dairy Council has funded nutrition education and nutrition research projects and provided health professionals with nutrition information based on sound sciences. References for all my remarks are found in the written version of our comments.

Ladies and gentlemen, our nation is in a calcium crisis. As many as seven out of ten pre-teen and teen girls and six out of ten preteen and teen boys in the United States are not drinking their milk. As many as nine out of ten adult women in their childbearing years are not getting enough calcium.

Many of us have experienced teenagers growing seemingly overnight. Children put on 15 percent of their adult height during their teen years. That could be nine to ten inches. What is not so visible is that 45 percent of their bone density mass is forming as well. Bone density formation continues until about 35, provided there is adequate calcium in the diet.

Recognizing the critical need for calcium during the growth years, a National Institutes of Health expert panel a few years ago recommended that calcium consumption be increased. The National Academy of Sciences increased their recommendations for calcium two years ago.

Calcium is also essential in disease prevention. Osteoporosis is a painful and crippling disease that affects 25,000,000 Americans, and it is not just a woman's disease. We are finding that one out of five men will also get osteoporosis.

Higher intakes of milk and other dairy foods during childhood are linked with greater bone density and a reduced risk of hip fractures and osteoporosis in later years, and recent research is also showing that milk and calcium helps in reducing hypertension. It has been found that a diet rich in low-fat dairy foods and fruits and vegetables may be an alternative to drug therapy for some people with hypertension.

Other research indicates dairy foods may prevent colon cancer, kidney stones and lead intoxication. Milk and other dairy foods are rich sources of calcium, along with other essential nutrients, including vitamin D essential for nutrition for calcium absorption.

Use of supplements to meet calcium needs is a pharmacological rather than a natural dietary approach. Many calcium supplements do not contain vitamin D. Diets with adequate amounts of dairy foods also provide significant amounts of riboflavin, complete protein, zinc, potassium, vitamin A, magnesium and vitamin B6. Milk and dairy foods are readily available in all communities.

On behalf of the National Dairy Council, thank you for this opportunity to provide comments today.


The Egg Nutrition Center?

MR. MCNAMARA: Good morning. I am Donald McNamara, the Executive Director of the Egg Nutrition Center. I thank the committee for the opportunity to address the role of dietary cholesterol and heart disease risk.

Clinical studies show that dietary cholesterol really has only a small effect on plasma cholesterol levels in most people. In 166 cholesterol feeding trials in 3,498 subjects, the average plasma cholesterol response was a 2.3 milligram per deciliter change in plasma cholesterol for 100 milligram change in dietary cholesterol. This response is shown to be independent of dietary fat type and amount and of the patient's baseline plasma cholesterol level.

However, we recognize there are individuals who are sensitive to dietary cholesterol. It is estimated that 15 to 25 percent of the population has the inability to compensate for a dietary cholesterol challenge. That would indicate that 100 milligrams per day of dietary cholesterol changes plasma cholesterol by four milligrams per deciliter in that 20 percent of the population who is sensitive, but only 1.5 milligrams per deciliter in the 80 percent of the population who is insensitive.

It has been suggested that dietary cholesterol contributes to heart disease risk independent of its effects on plasma cholesterol. Recent reports from the seven country studies, the Framingham heart trial, Mr. Fidd and the Lipid Research Clinic's prevalence trial, all support no significant relationship between dietary cholesterol and plasma cholesterol levels or heart disease incidents.

Analysis of the nurses' health study, the health professionals' follow-up study, the alpha-tocopherol, beta- carotene cancer study also report no significant relationship between dietary cholesterol and cardiovascular incidence. There is no consistent evidence supporting an independent effect of dietary cholesterol.

The question is whether dietary cholesterol restrictions are needed for the general population since half the population has cholesterol levels below 200, and 75 percent of those with cholesterol levels above 200 are insensitive to dietary cholesterol.

While dietary cholesterol does have a statistically significant effect on blood cholesterol levels, the epidemiologic data indicate that this has little biological importance. This is the conclusion drawn in 17 of 27 dietary guidelines from other industrialized countries, which do not include dietary cholesterol restrictions.

An emphasis on dietary cholesterol diverts attention away from effective dietary changes, while limiting the contribution of low-fat, high-cholesterol products such as eggs to the nutrient value of the diet.

With regard to eggs, international data of cardiovascular mortality and per capita egg consumption indicate a significant, but negative, relationship. NHANES III shows that eggs provide more nutrition than calories with high-quality protein and 22 different vitamins and minerals.

Exclusion of eggs from the diets from growing children, the elderly and low-income families can negatively impact the nutrition well-being of these subgroups. I believe the evidence shows that undue restrictions of dietary cholesterol, and indirectly eggs, have little benefit and potential concerns.

Thank you.


National Cattlemen's Beef Association?

MS. YOUNG: Good morning. My name is Mary Young. On behalf of the National Cattlemen's Beef Association, it is a privilege to participate in today's discussion. I will highlight the nutrient contributions of red meats to the diet of today's consumers.

Red meats are one of nature's most nutrient dense foods. A three-ounce serving of beef contributes less than 10 percent of calories to a 2,000 calorie diet. Yet it supplies more than 10 percent of the RDAs for protein, iron, zinc, niacin, vitamins B6 and B12, and does so in a highly absorbable form.

Of red meat's nutrient contributions, iron often is most trumpeted, perhaps because iron deficiency is the most common nutritional deficiency in the United States, affecting 7.8 adolescent girls and women of childbearing age and 700,000 children who are one to two years old.

In a CDC report on preventing iron deficiency, scientists wrote, "In children, iron deficiency causes developmental delays and behavioral disturbances, and in pregnant women it increases the risk for pre-term deliveries and delivering low birth weight babies."

Hemiron, found only in the meat group, is two to three times more absorbable that non-hemiron found in plant- based foods, and hemiron in cooked red meat can be as high as 70 percent, while white meat is less than 25 percent.

Deficiencies in zinc are equally prevalent. According to USDA's 1995 CSFII, only 26.7 percent of Americans are meeting the dietary requirement for zinc. Deficiencies can delay cognitive and physical development and decrease immunity, among other things. Since nearly half of the most highly available zinc in the food supply comes from the meat group, it is not surprising that studies have linked deficiencies to meatless diets.

Red meats also are a significant source of vitamin B12, contributing 62 percent of this nutrient to the food supply, while plant sources, including soy, contribute very little physiologically active B12, and B12 deficiencies can be extremely serious.

The Bogalusa heart study shows red meats enhance diet quality. The percentage of individuals meeting at least two-thirds of the RDA for key nutrients was greatest among those in the upper quartile of meat consumption.

There is a perception that Americans over-consume meat. However, few people actually meet minimum needs. Data from CSFII reports that on average, Americans eat 2.6 ounces or red meat daily. It is often what is missing from the diet that has long-term health implications.

The meat industry agrees Americans need to consume more whole grains, fruits and vegetables, but not at the expense of foods like red meat that provide key nutrients deficient in American's diet.

It is also important to note that red meat contributes functional components such as selenium and conjugated linoleic acid to the diet. According to the Journal of the American Dietetic Association, beef is the number one source of protein, B12 and zinc in the diet.

In conclusion, in a very small package, red meat plays a major role in meeting the nutrient needs of Americans, which demonstrates the essential nature of including red meat in a varied diet.

Thank you.


National Pork Producers Council?

MR. HENTGES: Eric Hentges, National Pork Producers Council.

Fat, saturated fat and cholesterol are integral components of all meat and meat products. Nature put them there. Currently, 25 percent of total caloric intake comes from the discretionary fat at the pyramid tip. Meat and poultry fat contribute 9 percent of the total caloric intake.

It is common, even in scientific circles, to hear saturated fats are animal fats. However, the predominant fatty acid class in meat is monounsaturated, accounting for half of the fatty acid composition. Furthermore, one-third of meat's saturated fatty acid content is stearic acid. This is important because stearic acid does not elevate serum cholesterol.

The December 1994 supplement of the American Journal of Clinical Nutrition on stearic acid documents the lack of effect stearic acid has on serum LDL cholesterol concentration. The review also suggests a lack of effect of stearic acid upon thrombosis and coagulation factors. Despite this evidence, for regulatory purposes stearic acid is still classified with saturated fatty acids known to elevate serum cholesterol.

The meat industry has supported numerous research projects since the mid 1980s that look at meat's inclusion in an NCEP step one diet. Most recently, abstracts from the latest studies have been published in the Journal of the American College of Nutrition, October 1995, American Journal of Clinical Nutrition, July, 1997, and Circulation, October, 1998.

Like the many studies before them, these recent studies document that a step one diet plan containing lean beef and pork in servings consistent with the food guide pyramid can be effective in lowering serum lipids. Current research also is discovering that meats, not just plant foods, contain functional properties.

I am referring to conjugated linoleic acid or CLA, a natural derivative of the fatty acid, linoleic acid. Initial interest in CLA was in CLA's anticarcinogenic effects. In animal studies, as little as .1 percent CLA in the diet was sufficient to cause significant reduction in mammary tumors. Recent interests have turned to CLA's influence on body fat accretion. Studies with mice, rats, chicks and pigs have shown decrease in body fat accretion and increase in lean muscle.

Finally, with feeding, breeding and fabrication, the industry has reduced the amount of fat in the fresh meat case by 31 percent for pork and 27 percent for beef. Currently, 24 percent of lunchmeat purchases are low-fat products. These changes resulted in complete overhauls of USDA's nutrient database for these products.

In conclusion, these data do not support any substantial change to the fat intake guideline, significant changes to the content or quantification of the guideline. The recommendations --

CHAIRMAN GARZA: I am afraid I have to interrupt.

MR. HENTGES: -- are not scientifically justified. Thank you.

CHAIRMAN GARZA: Physicians Committee for Responsible Medicine?

DR. BARNARD: Good morning. Please review our letters of support from the Congressional Black Caucus, former Surgeons General Joycelyn Elders and C. Everett Coop, Martin Luther King, III, Jesse Jackson, Jr., --

CHAIRMAN GARZA: Please identify yourself.

DR. BARNARD: I am sorry. I am Dr. Neal Barnard, as listed in the program.

-- Mohammed Ali, Alice Walker, leading physicians and many minority health organizations.

Since 1916, federal food guides have promoted dairy products, but in the 1960s and 1970s research established that most members of racial minorities are unable to digest the milk sugar, lactose.

Lactose intolerance occurs in more than 50 percent of Hispanic Americans, 70 percent of African Americans and Native Americans, and 95 percent of Asian Americans, but in only about 15 percent of Caucasians. African Americans are not only much more likely than whites to have lactose intolerance. When it occurs, they are much more likely than affected whites to have pain, diarrhea and bloating.

Dairy industry research studies suggest that spacing out dairy products during the day and consuming them with other foods can reduce the problem, but what they avoid pointing out is that many people still have serious symptoms.

Nearly half of their research participants have dropped out, presumably due to symptoms, and their research has largely excluded African Americans. Indeed, African Americans have also been excluded from nearly every calcium and milk study due to better bone density and lower rates of osteoporosis.

Milk consumption is in fact poor protection against osteoporosis. In the Harvard nurses' health study of 78,000 women followed prospectively for 12 years, those who got the most calcium from dairy products had slightly, but significantly, more fractures compared to those who drank little or no milk, even after adjustments for weight, menopausal status, smoking and alcohol use.

A 1995 study of 10,000 elderly women reached similar results, as have other studies. Studies suggesting any benefit of milk have often been confounded by vitamin D supplemented to milk.

Dairy products should be considered optional and in no way superior to other calcium sources, such as green, leafy vegetables, beans and other legumes or fortified fruit juices for those who may choose them.

Our second key point is that diet related diseases take a disproportionate toll among minorities, despite the fact that nutrient intakes are similar. Diabetes prevalence is high among minorities. Prostate cancer is especially common among African Americans, yet the current guidelines promote the very meat and dairy diets that increase the risk of these problems in the first place.

Stronger dietary guidelines are essential. For example, ischemic heart disease rates are high among middle- aged African Americans and Hispanic women. Diets adhering to the guidelines clearly foster heart disease progression, while vegetarian diets promote disease reversal. Hypertension also takes a disproportionate toll, yet African Americans who switch to a vegetarian diet cut their risk in half.

Those who may wish to reduce their risk of disease by increasing their use of vegetables, fruits, whole grains and legumes or by reducing or eliminating the use of meats, dairy products and fatty foods should be encouraged to do so by the federal dietary guidelines. The guidelines have unintentionally --

CHAIRMAN GARZA: I have to interrupt.

DR. BARNARD: Thank you very much.


Before moving on to the next speaker, I have a brief question to staff. Have we had anyone register that wants to make a presentation, Shanthy, to the committee that was not pre-registered? I am trying to look at time and see how we are going to be.

DR. BOWMAN: I don't think there's any one else.

CHAIRMAN GARZA: No one that you are aware of?

DR. DWYER: Dr. Garza, I had been contacted from Dr. William Grant earlier, who is not listed here.

CHAIRMAN GARZA: So we only have one then. Okay.

Looking at how we have been using time, I am going to stop just for a few minutes to ask the committee if they have any questions of anyone that has spoken previously?

I will be taking questions after every five presenters because I think we are going to have the flexibility in time.


DR. DWYER: I had a question for Donna Leibman.

CHAIRMAN GARZA: She just left.

DR. DWYER: The question was simply if corn syrup is what has gone up, then why talk about teaspoons because that is not how we eat or drink corn syrup?

CHAIRMAN GARZA: Okay. Are there any other questions?

Shanthy? Shiriki?

DR. KUMANYIKA: The presentation from the consumer research of the Alliance, I want to clarify whether the responses of consumers are to the pyramid or to the guidelines themselves because I think there is confusion about how to interpret some of the things on the pyramid, but that's not actually our domain so I would just ask people to clarify that whenever it is appropriate.

FEMALE VOICE: Yes. The clarification is what is on the guidelines.

DR. KUMANYIKA: On the guidelines? Okay.


DR. KUMANYIKA: Thank you.

CHAIRMAN GARZA: Dr. Lichtenstein?

DR. LICHTENSTEIN: With respect to the comments from the Council for Responsible Nutrition, I would like to point out that written in the text for that pyramid that was recommended for older individuals with the flag on the top for supplements, that was clearly stated as optional and that one needs to consider various conditions that are more prevalent in the elderly like achlorhydria and the impact on B12 absorption, so it was not recommended for everyone.

CHAIRMAN GARZA: Any other comments or questions?

If not, everyone understood Dr. Shiriki's comment about distinguishing between the pyramids and the guidelines. It is the purview of this committee to make recommendations to both departments related to the guidelines, but in fact we do not formulate the pyramid.

The pyramid is based on the guidelines, but it is totally in the purview of the Federal Government. They do not rely on us theoretically at least on advice for the construction of the pyramid itself. It is the teaching tool for the guidelines.

I think I have that correct. I will turn to both agencies to make sure.

DR. KENNEDY: Do you want a response on that?

CHAIRMAN GARZA: Yes. I think that needs to be clarified.

DR. KENNEDY: I always present it as there are three parts to how the pyramid is developed. Number one, Dr. Garza is absolutely right. It is the most recent Dietary Guidelines for Americans.

Secondly, it is also the nutrient needs, and, thirdly, it is looking at current consumption patterns, trying to deviate in the least possible way in meeting nutrient needs in dietary guidelines.

I bring that out because as we talk in global forum, I mean clearly there are an infinite number of combination of foods that could be used to meet both our dietary guidelines and nutrient needs, but it is anchored to the current consumption patterns of Americans.


We will move on. USDA Human Nutrition Center for Aging at Tufts University?

MR. BLUMBERG: Good morning. I am Jeffrey Blumberg, a professor in the School of Nutrition, Science and Policy and a researcher at the John Meiere USDA Human Nutrition Research Center on Aging at Tufts University.

In addition, since last year I have served as a member of the Scientific Advisory Board of the Egg Nutrition Center, a resource for scientifically accurate information on egg nutrition supported by a cooperative agreement between the American Egg Board and the United Egg Producers.

Among older Americans, there is an increased risk of malnutrition and evidence of subclinical deficiencies with a direct impact on physiologic function. Critical risk factors of malnutrition among older adults are their declining need for energy due to a reduction in the amount of lean body mass and a more sedentary lifestyle.

Decreasing energy intake with advancing age has important implications for the diet in terms of protein and micronutrients. There is a substantial gap between nutrient consumption common among older adults and the recommended intakes from diets associated with health promotion and the prevention of chronic disease.

New dietary guidelines sensitive to the needs of the elderly should emphasize the value of high-quality nutrient dense foods. Eggs are a nutrient dense food. A single egg can provide 10 percent of the requirement for protein and serve as a rich source of several vitamins, for example, providing 15 percent of the riboflavin, 8 percent of the vitamin B12 and 6 percent of the vitamin D and folate required by older adults, all in about 70 calories.

Eggs are also a good source of bio-available lutein and zeaxanthin, two carotenoids associated in recent research with a lower risk for age-related macular degeneration.

Eggs also present a number of features which make them a sound part of a balanced diet for most older adults. They are lower in cost than most other animal protein foods and so can be served occasionally as an alternative to meat, poultry or fish to keep a food budget affordable.

The single serving packaging of eggs makes them convenient to store and prepare, especially for older people who live alone. Eggs are also easy to chew so that older adults with dental problems and/or dysphasia will experience less problems eating them than meat or poultry. Importantly, eggs are perceived by many older adults as a welcome part of a traditional American diet and thus not a food choice where compliance with recommendations is difficult.

Eggs are a significant source of dietary cholesterol, and the impact of egg consumption must be considered by those with levels of serum cholesterol which place them at risk for heart disease. However, it is important to recognize that people who eat eggs are consuming a complex food, one that has high-quality protein, various mono and polyunsaturated fatty acids, micronutrients and carotenoids.

Specifically restricting only one food, that is eggs, in the Dietary Guidelines for Americans would discourage people from any consumption despite their value as a nutrient dense food.

The reputation of eggs as a significant factor for heart disease for all Americans is not founded in scientific fact, and recommendations that they be avoided by everyone are misguided. Eggs can readily be incorporated into a healthful diet and help increase the nutrient density of the diet.

Thank you.


American Obesity Association?

MR. DOWNEY: Good morning. I am Morgan Downey, and I am the Executive Director of the American Obesity Association. It is a pleasure to be here today and hopefully help you with your work.

The American Obesity Association was founded in 1995 to advocate for the interests of persons suffering with obesity. By today's date, we have nearly 22 percent of the adult American population is obese. Over half is overweight and incurs the risk of obesity. Twelve to 14 percent of children suffer with obesity.

I appear before you today much like Mark Twain might have observed that everybody talks about obesity, but nobody does anything about it. That is certainly the case in Washington.

Obesity is second only to tobacco as the leading cause of preventable deaths in the United States, and it is responsible for over 300,000 to 500,000 preventable deaths each year.

It is also a major contributor to nearly 30 chronic diseases. Those include osteoarthritis of the knee and hip, rheumatoid arthritis, birth defects, breast cancer, cancer of the esophagus and gastric cardia, colorectal cancer, endometrial cancer, renal cell cancer, cardiovascular disease, carpal tunnel syndrome, chronic venous insufficiency, daytime sleepiness, end stage renal disease, gallbladder disease, gout, heat disorders, hypertension, impaired immune response, etc., down to Type II diabetes.

The full complement and description of the current medical literature is in your materials of statements we have provided.

We have several recommendations. One, we believe the dietary guidelines should recognize that obesity is the overwhelming dietary influence on major chronic disease. Two, the dietary guidelines should prioritize their recommendations to Americans to correct what we see as a false equality among all recommendations.

We also believe that the literature would support our belief that obesity is the major contributor to chronic disease in America and thus should receive major attention in a prioritization of the guidelines.

We believe that the section on weight should be retitled Achieve a Healthy Weight. The current title, Balance the Foods You Eat With Physical Activity, Maintain or Improve Your Weight, is unclear, awkward, and I believe does not directly affect the primary issue for some 22 percent of Americans, which is that they need to lose weight.

Finally, we believe that the dietary guidelines should be identified as being for adult Americans, and a separate dietary guideline should be established for children.

We believe that the recommendations should include a body mass index chart, not the current height and weight chart in the guidelines. That would be preferable, but not entirely adequate. We would recommend proceeding further to develop a profile based on a further consideration of the effects of weight.

Thank you.


Georgetown University Center for Food and Nutrition Policy?

MS. STOREY: Good morning. My name is Maureen Storey. I am a faculty fellow with the Georgetown University Center for Food and Nutrition Policy.

The key point I would like to make before this committee is also provided in written testimony submitted to you by me and several of my colleagues, namely Drs. Robin Wu and Richard Forshi. I would also like to acknowledge my graduate student, Alexis Weaver, without whom we would not have these data.

Over the last several months, a great deal of media attention has been turned to the issues of obesity among children and carbohydrates as a chief villain in keeping our children and adults from having a healthier body weight. While this is a great media story, our data suggest that that is exactly what it is, a story, a fairy tale.

To get to the point, we recently examined the association between several dietary components and other variables on the body mass index of children ages six to 11 years. In our study, we used the Continuing Survey of Food Intakes by Individuals, CSFII, and performed bivariate and multivariate regression analyses to determine the association between children's BMI and these independent variables. There were 1,230 records from the children in the study.

These independent variables may also be categorized as those that are not modifiable and those that are modifiable. The nonmodifiable variables included gender, age and race. The modifiable independent variables included total energy intake, total fat, carbohydrate and protein intake, added sugars intake, servings of milk and television hours watched.

The bivariate regression analysis showed that children's BMI was not correlated with total energy intake, total carbohydrate intake or added sugars intake. We found a very small, but significant, correlation between children's BMI and total fat intake and hours of TV watched. However, only .4 percent of the variation in the children's BMI was predicted by total fat intake, and only 1.4 percent of the variation in BMI was attributable to TV hours watched.

The multivariate regression analysis showed that combining seven variables, including three dietary components, total energy, total fat and added sugars, with age, race, gender and TV hours explained only 6 percent of the variation in children's BMI.

In the multivariate model, BMI was positively correlated with age. This is no surprise. African American children had higher BMIs than other children. BMI increased by two-tenths of a BMI unit as TV hours watched increased.

To conclude, these data show that no single dietary component, including total energy, total carbohydrate and added sugars intake, contributes to increased BMI among children.

Based on our study, the Georgetown University Center recommends that the language regarding the importance of physical activity be strengthened.

CHAIRMAN GARZA: I apologize. I have to interrupt.

MS. STOREY: Thank you.

CHAIRMAN GARZA: National Coalition for Promoting Physical Activity?

MR. DAVIS: Good morning. I am Mike Davis, Executive Vice-President of the American Alliance for Health, Physical Education, Recreation and Dance, which represents over 60,000 educators.

I am pleased to be here today to represent the interests of the National Coalition for Promoting Physical Activity. NCPPA combines the force of more than 154 organizations in our efforts to inspire Americans to lead physically active lifestyles that enhance their health and quality of life.

Eight leading national organizations serve on NCPPA's board of directors, including my organization, the American College of Sports Medicine, the American Cancer Society and the American Heart Association. Together we are dedicated to addressing the need to increase the physical activity of all Americans in response to the 1996 Surgeon General's report on physical activity and health.

As the committee members know, this landmark report of the Surgeon General was issued since the last review of the U.S. dietary guidelines. We applaud the 1995 advisory committee for recognizing the importance of physical activity and weight maintenance and for including a guideline addressing the need to balance the food we eat with physical activity.

We look forward to the current committee's review and strengthening of these physical activity recommendations in light of the Surgeon General's report, the National Institutes of Health consensus development conference on physical activity and health, and the National Institutes of Health clinical guidelines on the identification, evaluation and treatment of overweight and obesity in adults.

We encourage the committee to craft recommendations that more strongly convey the role of physical activity in preventing obesity, assisting in weight maintenance and reducing chronic disease risk.

We know physical inactivity to be a major national public health problem. The Surgeon General's report established that nearly half of Americans 12 to 21 years of age are not vigorously active on a regular basis. More than 60 percent of American adults are not regularly physically active, and 25 percent are sedentary. Yet, as the Surgeon General also points out, physical activity reduces the risk of premature mortality, mortality in general and of coronary heart disease, hypertension, colon cancer and diabetes in particular.

Therefore, the Surgeon General recommends that all Americans include a moderate amount of physical activity on most, if not all, days of the week. The NIH consensus development conference reinforced these findings.

We encourage the Dietary Guidelines Advisory Committee to consider including this recommendation in the revised guidelines. Clearly, when an estimated 97,000,000 adults --

CHAIRMAN GARZA: Excuse me. I apologize. I have to interrupt.

MR. DAVIS: Thank you.

CHAIRMAN GARZA: Rutgers University, The Nutraceuticals Institute?

MR. LACHANCE: Thank you. I am Paul LaChance, professor of Food Science and Nutrition at Rutgers. I happen to be the Executive Director of the Nutraceuticals Institute also.

I have a couple of points I just want to get across which are I think important, and that is that I think that we need to reduce the number of dietary guidelines down to probably five or do a two-tier thing.

I am suggesting daily nutrient dense foods, particularly fruits, vegetables, legumes, seeds and nuts, along with basic cereal grain products. Look for fortified foods, especially if dieting, skipping meals or experiencing changing nutrient requirements.

Control body weight through proper selection of foods and daily activity, minimally walking briskly two miles a day. I think we should push details. Choose desserts and snack foods that are moderate in saturated fat, sugars or salt, and, if you drink alcohol, do so in moderation.

One of the reasons I am hoping that would come out and emerge out of this is that when the pyramid is evolved that the new base would be fruits, vegetables, legumes, nuts, because that is where all the phytochemicals are. That is where all the immunological data is telling us that we have a lot to gain from.

I mean, we are talking about hundreds of studies showing decreased heart disease, decreased cancer if people consume fruits and vegetables, legumes and cereal grains, so I think we should put the emphasis there because that is where the data is.

The other point I would like to point out to you is that obesity correlates almost perfectly with the amount of dollars spent eating away from home. The USDA has just recently released some data showing that there is a 6 percent increase in percent calories from fat looking at what they do at home relative to what they do when they eat out.

When we eat out, our value system is we want value for our dollar. When we are at home, we may have a healthy guideline kind of idea in our head, but we disinhibit our inhibition, if you will, with that concept.

Another point that I think I would like to keep reinforcing in the document is in addition to food fortified, that vitamin supplements serve and provide an advantage in thwarting morbidity and mortality of chronic disease. I have always been an advocate of that, so I am not changing my tune. I really think that that is important to do.

In the long run, I think what we are talking about is what C. Everett Coop has pointed out with his colleagues, that as much as 70 percent of disease and associated cost can be modified by dietary means. I think we ought to start moving down that road as soon as we can with very direct approaches. Be daring.

Thank you.


Are there any questions or comments from the group to any of the last five speakers?

DR. GRUNDY: I have one --


DR. GRUNDY: -- question of the last speaker.

You said there have been hundreds of studies showing the benefit or epidemiologic association with fruits and vegetables. Could you provide us with that list of those studies? Do you have those references?

MR. LACHANCE: I have those references. They are available. A couple of different books have tabulated them. We can send that to you.

DR. GRUNDY: What would you say is the single best study to prove that of the hundreds?

MR. LACHANCE: The single best would be a difficult thing to point to. There are so many of these devoted to overseas, multicountry studies. There are several country studies. There are regional prospective studies.

You know, every type of study is giving us this positive stuff. I mean, there are a few exceptions. Obviously we are talking about, you know, 130 positive and maybe ten or 20 more that do not show anything, but I still think that is a very powerful direction in terms of the delivery of it says fruits and vegetables.

I think it is phytochemicals and micronutrients myself, but we do not have the data to support that since we translated it by tunnel vision back to vitamin A or, you know, some nutrient that we were aware of at the time.

CHAIRMAN GARZA: Okay. Any other comments or questions from the group?

All right. The American Bakers Association?

MR. LINEBACK: I am David Lineback presenting testimony on behalf of the American Bakers Association, which is a national trade association representing the wholesale baking industry.

I encourage you to look at the written comments because we will not have time to develop many of those this morning. Based upon data, it has been recognized in our recommendations on dietary guidelines that the foods consumers need in the greatest number, the grain foods, should be the base of a healthy diet.

However, the USDA's healthy eating index for 1994 to 1996 indicated Americans are barely eating the recommended number of servings of grains, averaging a little over six servings per day. Recommendations to consume six to 11 servings from the grains group is well supported. Data used in developing the guidelines emphasizes the contribution grain foods have to total nutrient intake.

Grain products such as enriched white breads and rolls are nutritionally fundamental. They are recognized as sources of B vitamins and other antioxidant nutrients, folate, potassium, calcium, iron, protein and magnesium.

In addition, enriched grain products such as breads, rolls, bagels and crackers, including whole grain crackers or daily staples that contain fortification, are emphasized by dieticians and nutritionists as a healthy, low-calorie, low-fat sources of essential vitamins, nutrients and dietary fiber.

Recent studies have indicated that bread products provide an important component of fiber in the diet of many Americans, and, of course, other grain bases add to that. Some recent studies indicate that yeast bread is the single largest contributor, about 14 percent, of fiber in the diets of children ages two to 18. The folic acid found in enriched grain products protects against neural tube birth defects, as we know. It may help protect against some heart disease and certain cancers.

Data has indicated that fortification of grain products, such as breads, cereals and flour, will enable nearly 50 percent -- some will say as high as 70 percent -- of women ages 11 to 50 years old to ingest a minimum of 400 micrograms of folic acid per day.

Grain products since World War II have been responsible for most of the increases in key nutrients, such as thiamine, riboflavin, iron and niacin in the diet, and, after dairy products, grain-based foods are the second best source of calcium in the diet.

Unfortunately, there are many who would like to recommend against the consumption of enriched grain products. This would be unfortunate. It sends a mixed message to consumers and adds to the confusion about good nutrition. Research data indicate that the grain-based foods play major roles in our diet, and there is no evidence that there is any negative aspects to the consumption of such products.

On behalf of the American Bakers Association, I would like to point out for all of us who work in the field that the grain-based foods offer consumers a wide range of convenient, affordable and enjoyable food products which we eat.

Therefore, I encourage the committee to maintain the current dietary recommendation of six to 11 servings of bread and other grain-based foods per day as a foundation of a healthy diet. I think we can realize that grain-based foods play a major role.

Thank you.

CHAIRMAN GARZA: Chilean Fresh Fruit Association?

MR. GRANGER: Thank you for the opportunity to give testimony. I am Curtis Granger, Executive

Vice-President, Chilean Fresh Fruit Association. I oversee the strategic marketing of all imported fruit to the United States from Chile.

Chile has been providing the United States with fresh fruit for more than 30 years. Chile is the primary winter source of fresh table grapes, peaches, plums, nectarines, pears, raspberries, apricots and cherries. It is North America's largest summer provider of kiwi fruit, as well as a major supplier of apples, blueberries and blackberries.

In reference to the dietary guidelines for fruit consumption, my purpose here today is twofold. First, to present some of the research showing that the overall fruit consumption is low and seasonally lower in winter. Secondly, this research will highlight the need to strengthen the dietary guidelines, focusing on effective communication messages to educate the public and achieve the current pyramid recommendations.

The first research as shown here is the healthy eating index. It is a summary measurement of how well Americans conform to the dietary guidelines. It is the real scorecard on food consumption measured against the dietary guideline recommendations.

Of the ten diet components measured in the healthy eating index, the lowest score is fruit at 3.9 out of ten points. Eighty-three percent of Americans are not meeting the USDA's recommended of two to four servings per day. Fruit consumption annually is at one and a half servings, half the recommendation.

Chile conducted the further analysis of the latest CSFII 1994-1996 data to determine fruit intake by age, sex group, and by season of the year. For females, each group is broken down into recommended servings, annual average and by quarter.

The chart shows no single age group meeting the minimum fruit recommendation in any season of the year. In fact, fruit consumption is lowest in the winter months. The male fruit consumption shows the same results. There is not a single age group meeting the recommendation, children included, in any season.

These findings present an opportunity to strengthen the dietary guidelines for the year 2000. The 1995 committee challenged future committees to be more effective in communicating current scientific thought and to insure that dietary guidelines respond to current consumption issues.

The current guidelines should be updated to address the current problems found in consumption data. The guidelines should inform Americans of the healthy eating index. Knowing the score is the first step in implementing changes in the diet.

In conclusion, we urge the committee to include the healthy eating index in the year 2000 guidelines. This scorecard should be used in conjunction with recommendations as a performance measure. It will serve as an effective communication measure to educate the public and to achieve behavior modification.

Finally, in response to the extreme lack of fruit consumption, the dietary guidelines should urge Americans to double -- and I repeat, double -- their current fruit consumption.

Thank you for your time and consideration.


Dole Food Company?

MS. DISOGRA: Good morning. My name is Lorelei DiSogra, and I am Director of Nutrition and Health for Dole Food Company. For the last 20 years, I have been professionally involved in the area of nutrition and cancer prevention and one of the principals in creating the Five a Day for Better Health Program.

Dole Food Company is one of the founding members of the national Five a Day for Better Health Program, and we are committed to developing effective technology-based nutrition education programs to encourage children to eat five to nine servings of fruits and vegetables a day. Our educational programs are used in more than 50 percent of all elementary schools in the United States today.

Today, I am here to recommend a stronger and more prominent guideline on fruits and vegetables, a guideline that emphasizes the overwhelming scientific evidence that eating five to nine servings of fruits and vegetables a day improves health and reduces the risk of chronic diseases.

Dr. Elizabeth Pivonka, who will speak to you very shortly, will provide the overwhelming scientific research in this area.

We just completed an analysis of the 1997 MRCA survey of children's eating habits. What children ages six to 12 eat is appalling and clearly not conducive to good health in this country.

This chart illustrates children's eating patterns compared to the USDA food guide pyramid. Children are only eating 2.4 servings of fruits and vegetables a day, less than half of the five that are recommended. These results are consistent with USDA's 1996 CSFII data if remove the french fries and potato chips from the USDA data from the vegetable category.

Allow me to share some alarming statistics from this recent survey with you. At breakfast, less than half of all children drink 100 percent fruit juice. At lunch, children are twice as likely to eat french fries than any other vegetable.

Children hardly eat any nutrient dense, dark green leafy or yellow/orange vegetables. Potatoes are one-third of all vegetables consumed by children at dinner. Children seldom eat fruit for dessert, and they eat very few fruit and vegetable snacks.

You will also notice from this chart that children's diets are exploding with fat and sugar. For the health of all Americans, both children and adults, fruits and vegetables should be at least one-third of the total food eaten on a daily basis.

I am recommending that the Dietary Guidelines Committee first position fruits and vegetables as the foundation of a healthy diet by creating a separate guideline for fruits and vegetables. Please separate us from grains. This guideline should be prominent and emphasize the unique nutrient contribution that only fruits and vegetables make to a healthy diet.

Second, emphasize that Americans make fruits and vegetables, in addition to other plant-based foods, the center of their plate. Some foods, such as fruits and vegetables, are in fact more healthy than others. This must be communicated clearly. Guidelines recommending variety, balance and moderation are just not specific enough anymore and do not communicate anything to the American public.

Third, recommend that all federal food and nutrition policies --

CHAIRMAN GARZA: I apologize for having to interrupt. You are out of time.

MS. DISOGRA: Thank you very much.


Farm Animal Reform Movement?

MR. HERSHAFT: Good morning. My name is Alex Hershaft, and I am the president of FARM, a national public interest organization promoting plant-based eating.

According to the latest figures from the Centers for Disease Control and Prevention, 2,314,690 Americans died in 1996. Nearly 60 percent, or approximately 1,376,000, of these deaths were attributed to diseases linked conclusively to consumption of meat and other animal products. Not one death in America has been linked to consumption of grains, vegetables and fruits.

The current edition of Dietary Guidelines for Americans devotes four pages to touting a diet with plenty of grain products, vegetables and fruits, and seven pages to a diet low in fat, saturated fat and cholesterol, yet the document fails to recommend the vegan diet, which abides zealously by these recommendations. In fact, it cautions vegan consumers to get proper amounts of iron, zinc, calcium and vitamins B and D.

Ladies and gentlemen, let me ask you. How many vegans die each year in America from shortages of these nutrients, and where are the warnings in the guidelines to consumers of meat and other animal products about proper amounts of saturated fat, cholesterol, hormones, nitrites, dioxin, benzopyrene, benzaldehyde, methylcholanthrene, E. coli, salmonella, campylobacter, listeria, clostridium and staphylococcus?

My personal guess is that the current guidelines are guided less by science than by the politics of fear instigated by the swift retribution visited by the meat industry on the U.S. Senate Select Committee on Nutrition and Human Needs in 1977. The committee's guidelines call for Americans there to recommend reduced meat consumption.

This distinguished committee has an opportunity to redeem this sorry record. As we enter the new millennium, Dietary Guidelines for Americans 2000 should reflect the science rather than the politics of nutrition. The guidelines should recommend a gradual, but steadfast, transition to a vegan diet with no qualifications, no apologies.

Thank you.


Great American Meatout 1999?

MR. PRYOR: Good morning. My name is David Pryor. I am the National Director of America's largest annual grassroots diet education campaign, the Great American Meatout, now in its fifteenth year.

Culminating on the first day of spring, the Great American Meatout campaign brings together thousands of caring people across this nation to stage over 2,000 educational events focused on helping friends and neighbors quit the meat habit for at least one day and explore a more wholesome and less violent plant-based diet.

Meatout draws massive support from consumer, environment and animal protection advocates, as well as health providers, meatless food manufacturers and educators. They believe the consumer is entitled to a one-day respite from the relentless barrage of meat industry propaganda in schools, in the media and in the streets.

While it is estimated that only five or six percent of the population is currently vegetarian, growth estimates for new vegetarians are in the 100,000 per month range. This trend is particularly prevalent among teens. The acceptance and growth of demand for vegetarian products among mainstream public can probably best be reflected in the 50 to 150 percent growth rates of manufacturers who produce these products.

A major strategy for this year's Great American Meatout campaign is to encourage mainstream supermarket chains to step up their introduction of nonanimal-based product selections in all appropriate areas of the store. That includes a greater selection of meat alternatives,

nondairy/nonegg-based pastas, breads, cereals, baking supplies, etc., and nonanimal ingredient personal and health care products.

Reports from our coordinators in the field suggest that American consumers are confused about nutritional advice. It is time for the health communities and the government to stop kowtowing to economic/political interests of the meat industry and start speaking in one clear, unambiguous voice.

We ask this committee to strengthen its commitment to get Americans off the meat habit and on a more wholesome plant-based diet.

Thank you.

CHAIRMAN GARZA: Are there any questions or comments related to any of the five previous speakers? Dr. Lichtenstein?

DR. LICHTENSTEIN: This is for the gentleman from the Chilean Fresh Fruit Association.

Is it safe to assume the data that you gave to us was limited to fresh fruit consumption and not to all fruit consumption?

FEMALE VOICE: No. It is all fruit consumption as was listed in the pyramid grouping for fruit.

DR. LICHTENSTEIN: So that is canned, frozen, dried?


FEMALE VOICE: All types.



DR. DWYER: On that same analysis, do those differences by season reflect price?

FEMALE VOICE: Price? No, it didn't reflect price.

DR. DWYER: I am just wondering if --


DR. DWYER: -- the reasoning was --

FEMALE VOICE: It is year-around availability of fruit.

DR. DWYER: Thank you.

CHAIRMAN GARZA: Dr. Murphy? I looked everywhere but to my right and to my left.

DR. MURPHY: I would like to ask Dr. DiSogra about the one-third of the children's diets from fruits and vegetables. Do you mean by calories or by grams? How are you calculating that?

MS. DISOGRA: Well, we just did something. We looked at the pyramid, and if you take away the top, which is the fats and oils used sparingly, and you just look at the number of servings, so assuming kids, okay, so we took the low ends of the servings, six servings of grains, five servings of fruits and vegetables, two or three dairy, two or three meat.

You get a total of 15 servings of healthy foods you are supposed to eat everyday. One-third, five out of 15, is fruits and vegetables. That is how. Very simple.

DR. MURPHY: So it is servings?

MS. DISOGRA: Servings.

DR. MURPHY: Thank you.

MS. DISOGRA: The pyramid is supposed to represent a healthy diet, is it not?

DR. MURPHY: Right.

CHAIRMAN GARZA: Are there any other questions or comments?

I am going to ask is it Ms. Finalli?

MS. FINALLI: Finalli.

CHAIRMAN GARZA: We are going to take a break now, and we will reconvene -- you have a generous Chair -- in 20 minutes instead of the 15 that we were allotted.

I hope this does not represent the triumph of optimism over experience once again, but let's try and reconvene at 11:00 a.m.

(Whereupon, a short recess was taken.)

CHAIRMAN GARZA: We had a light exchange with Dr. Grundy. He led a minimutiny at the break. He said we were promised 30 minutes. What did you do with our other ten? I said all right. I must have misread the agenda. I just got back and realized I was tricked.


CHAIRMAN GARZA: He is from Texas, and I am from Texas, so between two Texans it is all right. We will just mark this one down for our next exchange.

DR. DECKELBAUM: Lunch is four hours.


CHAIRMAN GARZA: See what happens when you set a bad example for a New Yorker?

DR. DECKELBAUM: I am from French Quebec.

CHAIRMAN GARZA: Well, to a Texan it's up north.

All right. Let's continue then with that to the Humane Society of the United States.

MS. FINALLI: Hello. I am Mary Finalli, senior researcher in the Farm Animals and Sustainable Agriculture Section of the Humane Society of the United States.

Americans eat far too much fat, saturated fat, cholesterol and protein, the majority of which, and in the case of cholesterol all of which, come from animal products in the form of meat, including poultry and fish, dairy products and eggs.

These substances are closely associated with the leading causes of death and disease in the United States, including heart disease, cancer and stroke. Additionally, animal products are the primary sources of acute foodborne disease and death from bacterial contamination.

The medical dollar cost of meat consumption alone is conservatively estimated to be as much as $60 billion annually in direct health care costs and hundreds of billions of dollars in indirect costs such as lost work time.

We are glad that vegetarian and vegan diets were acknowledged as being diets suitable to good health in the last revision of the federal dietary guidelines. However, if the government is sincere in its intent to provide sound and current dietary guidance to consumers, it needs to more than acknowledge the suitability of vegetarian and vegan diets. It needs to advocate their adoption.

For example, according to the Food and Drug Administration, 25 grams of soy protein a day may reduce the risk of heart disease. Twenty percent of the American population is said to have elevated cholesterol levels. Over 50,000,000 people in the U.S. could benefit from increased soy consumption. This is an excellent example of the positive and meaningful guidance the federal dietary guidelines should include.

According to the American Dietetic Association's position on vegetarian diets, scientific data suggests positive relationships between a vegetarian diet and reduced risk for several chronic degenerative diseases and conditions, including obesity, coronary artery disease, hypertension, diabetes mellitus and some types of cancer.

Studies indicate that vegetarians often have lower morbidity and mortality rates from several chronic degenerative diseases than do nonvegetarians. Vegetarian diets have been successful in arresting coronary artery disease, and vegetarians tend to have a lower instance of hypertension than nonvegetarians.

Type II diabetes mellitus is much less likely to be a cause of death in vegetarians, and the incidence of lung and colorectal cancer is lower in vegetarians. A vegetarian diet may be useful in the prevention and treatment of renal disease, and breast cancer rates are lower in populations that consume plant-based diets.

The American Dietetic Association states that vegan diets are appropriate for all stages of life, including during pregnancy and lactation. They satisfy nutritional needs of infants, children and adolescents and promote normal growth. Vegetarian diets can also meet the needs of competitive athletes.

The American public should be advised to reduce their dietary consumption of animal products. The federal dietary guidelines can help accomplish this by stating more effectively the hazards of animal products and by revising its position on vegetarian and vegan diets from that of mere acknowledgement of their suitability to promotion of their healthful advantages.

Thank you very much.


National Pasta Association?

MS. MCMAHON: Good morning. I am Kathy McMahon with Edelman Public Relations, and I would like to thank the committee for the opportunity to testify this morning on behalf of my client, the National Pasta Association.

The NPA is the trade organization for the U.S. pasta industry composed of manufacturing, industry supplier and allied industry representatives. It is involved in a number of activities that serve to promote the use and benefits of American-made dry pasta providing leadership in the development of public policy, collecting data and information on pasta production and disseminating information concerning the value, nutrition and quality of pasta.

At this time we would like to share our perspective on the grain foods and carbohydrate issues raised at the open meeting of the committee last September. Our comments stress the importance of placing evolving sound science into practical context.

We hope that you will carefully scrutinize the totality of the body of evidence and consider the implications that changes in the dietary guidelines might bring to messages that are targeted to an already confused consumer.

Our comments fall under two categories, the current consumer environment and the state of misinformation on the role carbohydrates and grain foods play in healthful eating and the limited body of evidence that is driving this consumer misinformation.

When we look at the current state of the consumer environment, we hope that you will keep in mind consumers' knowledge and attitudes to provide the appropriate context especially in this area. According to the 1997 Wheat Foods Council survey, while 75 percent of consumers agree that complex carbohydrates are good for you, another 45 percent also agree high protein/high carbohydrates diets can help them lose weight.

In the 1997 American pasta report, close to 50 percent of those who hear about high-protein diets have changed their behavior, and really only 10 percent polled knew the current recommendations for what they should be consuming for grain foods.

Consumers are swayed by books like The Zone Diet Sugarbusters. These popular diet books have captured headlines for overextending the limited research base and taking the science too far. We are concerned that the discussion here and the outcomes from the committee could inadvertently fuel the fire where the science has become pseudoscience in the lay press.

Under a limited body of evidence, dietary recommendations to keep dietary guidelines of carbohydrate at 55 percent of total calories have been revisited and not changed by the most recent report of the joint FAO/WHO committee.

As a specific example, we would like the committee to take a serious look at the science behind the glycemic index as a rating for carbohydrate foods. It appears that a carbohydrate like pasta is predominantly resistant starch and does not act like other grain foods.

What does this mean? Is it possible that although it is refined it acts like a grain food? We ask the committee to consider these kinds of things in considering what the implications are going to be for guidelines for consumers.

Thank you.


People for the Ethical Treatment of Animals?

MS. PARK: Good morning. My name is LeeAnn Park. I am with People for the Ethical Treatment of Animals.

There is no credible doubt any more that vegetarianism is the healthiest dietary choice. America's top three killers, heart disease, cancer and stroke, have been conclusively linked to meat consumption, as have a variety of other illnesses, including diabetes, osteoporosis and obesity.

Sadly, it is the children who are paying the biggest price for our nation's addiction to chicken nuggets and high-fat hamburgers. For their sake, we urge the committee to strongly recommend vegetarianism in the new dietary guidelines.

Almost any five year old can master the basics of good nutrition. Eat a variety of fresh fruits and vegetables, beans and whole grains. Unfortunately, the government has not done nearly enough to educate consumers about the health benefits of a plant-based diet.

In the current dietary guidelines, which promote the consumption of meat, dairy products and eggs, foods known to be high in saturated fat and cholesterol and which contain absolutely no fiber, undermine the healthful vegetarian message altogether.

Unfortunately, companies like McDonalds and Oscar Mayer, the Joe Camels of the food industry, have no qualms about selling our children down the river by promoting their artery-clogging animal products. The average American child is bombarded by 10,000 food commercials every year. These ads are not promoting apples or broccoli, but rather a nutritionist's worst nightmare -- fast food, sugary cereals, soft drinks and candy.

By the time they are two years old, kids know who Ronald McDonald is, and more of them can recognize the golden arches than the Christian cross. It is little wonder then that 41 percent of schoolchildren in America have elevated blood cholesterol levels or that in the last three decades the number of children who are overweight has more than doubled.

In fact, one-quarter of American kids are clinically obese, weighing 20 percent or more than their ideal body weight. These extra pounds put children at risk for diseases typically associated with adults, everything from heart disease to Type II diabetes and arthritis.

According to research cited by Dr. Neal Barnard, author of Food for Life, vegetarians are on average 10 percent leaner than the typical meat eater. Studies published in the Journal of the American Dietetic Association have shown that the main sources of fat in children's diets are meat and dairy products. All that unhealthy food leaves little room for healthful fare like fruits and vegetables.

A National Cancer Institute study found that 30 percent of children eat less than one serving of vegetables a day and that 50 percent eat less than one serving of fruit. Of course, most children would never eat meat in the first place if adults did not concoct myths about where animal foods come from.

In a Rocky Mountain News article, one nine-year-old boy told a reporter, "I thought meat was made out of something else. I didn't know about the cow." That is hardly surprising. Ronald McDonald tells kids that hamburgers grow in hamburger patches.

Other companies also hide from children the horrific suffering and abuse animals endure on today's factory farms. Oscar Mayer, for example, sends its colorful Weinermobile car across the country to convince kids that eating pigs is fun and that singing about ham and sausages can make you rich and famous. Were children to see where hotdogs really come from, they would be deeply traumatized and never touch meat.


MS. PARK: Thank you.

CHAIRMAN GARZA: Produce Marketing Association?

MR. SILBERMAN: Good morning, Mr. Chairman, members of the committee. My name is Bryan Silberman, and I am the president of the Produce Marketing Association. I would like to thank you very much for the opportunity to be here this morning.

PMA is the largest worldwide, not-for-profit trade association representing more than 2,000 organizations that market fresh fruits and vegetables from seed to supermarket. I am delighted to have some of those members with me today.

Also having been present at the birth of the national Five a Day for Better Health program, I have a personal interest in seeing an ongoing improvement in the diet of American consumers.

PMA agrees with the advice on fruit and vegetable consumption that has been part of previous versions of the dietary guidelines. Now we believe we have to look to your leadership for even stronger counsel about the health benefits of fruits and vegetables in the Year 2000 Dietary Guidelines for Americans.

Our interest in this issue is very strong because we believe fruits and vegetables should be the mainstay of the American diet. We know from scientific studies and the recommendations of many credible health authorities that you will hear about more later that greater consumption of fruits and vegetables does help consumers reduce the risk of many diseases, such as cancer, heart disease, diabetes, obesity and more.

There are four simple requests I have for you today. First, we seek your unequivocal endorsement that for healthy consumers, including children, eating whole foods is the best way to get the nutrients needed to maintain health. Popping pills is no substitute for a proper diet.

Secondly, we ask you to strengthen your dietary guidance by increasing the prominence of fruit and vegetables. Eating five servings of fruit and vegetables a day is a laudable but only a minimal start. We ask that you strengthen or preferably separate the advice about increasing fruit and vegetable consumption from that currently linked with grains.

Making fruits and vegetables the food of choice can help consumers implement most of the guidelines you present. Therefore, our third request is that in each guideline, where appropriate, you specifically mention how fruit and vegetables can help consumers achieve that specific objective.

Fourth, we ask your support in making your guidelines the rule for government feeding programs. The benefits of such action will continue to be felt for generations as children learn to make good food choices, and the less fortunate among us gain greater access to fresh produce. Why should our government's feeding programs not follow our government's dietary advice?

Ladies and gentlemen of the committee, the scientific evidence is in. The time for action is now. Simply put, it is time to move fruit and vegetables from the side of the plate to the center.

We applaud your efforts. We thank you for this opportunity. Thank you.


Produce for Better Health Foundation?

MS. PIVONKA: Good morning. My name is Elizabeth Pivonka, and I am the president of the Produce for Better Health Foundation, a national nonprofit organization devoted to increasing the consumptions of fruits, vegetables, fresh, canned, frozen, dried and 100 percent juice among Americans for their better health. We work in partnership with the National Cancer Institute on the Five a Day program.

As a starting point, regarding the guideline that states choose a diet with plenty of grain products, vegetables and fruits, we ask you to consider a new guideline for just fruits and vegetables. Americans are much better at including more grains in their diets than fruits and vegetables.

Grouping grains, fruits and vegetables almost makes them sound interchangeable, and we know that they are not. By separating fruits and vegetables, we can emphasize their importance in and of themselves. However, in addition to a separate guideline for fruits and vegetables, we ask that the committee consider placing fruits and vegetables and other plant-based foods at the core of the dietary guidelines. We are not alone in this request.

I would like to present to you, the Advisory Committee, this petition. This petition is signed by hundreds of researchers and health organizations across the country, including the American Cancer Society, the American Diabetes Association, the Boys and Girls Clubs of American, the American Institute for Cancer Research, AARP, the American Public Health Association, the Center for Science in the Public Interest, Shape up America, schools of medicine, cancer research centers, state and local departments of health and many others.

It reads, "An overwhelming body of evidence strongly supports increased consumption of fruits and vegetables to reduce the risk of chronic diseases, including, but not limited to, many types of cancer, heart disease and stroke.

"The Year 2000 Dietary Guidelines will determine the direction of nutrition education for the next century. As such, the revised guidelines should reflect the established and ever increasing research behind the key role that fruits and vegetables play in the diet.

"We, the undersigned, strongly urge the Year 2000 Dietary Guidelines Advisory Committee to position fruits and vegetables, in addition to other plant-based foods, as the core of America's diet and facilitate educating Americans to make fruits and vegetables the center of their plate."

A copy of the petition with all supporting signatures is attached to our written comments, along with a summary document outlining the latest research that has accumulated on fruits and vegetables and their importance in the reduced risk of disease. That document is in your folder, and I encourage you to take a look at that. It is literature searched through the month of January of this year.

Placing fruits and vegetables at the core of the guidelines can help the public understand how easily other elements of the guidelines can fall into place. With this in mind, the Foundation has additional requests which are outlined in our written comments.

I would also like to say that as nutrition communicators, we have done a great job with the message, "All foods can fit." Unfortunately, we have not adequately communicated the more important fact that some foods are clearly more healthful than others. The new guidelines should refine the variety message to emphasize the most healthful, nutrient dense foods.

We believe the new guidelines will greatly help improve the health status of Americans in the next century if, and only if, they reflect the science-based evidence of the health value of nutrient rich foods like fruits and vegetables in a clear, dramatic form.

Thank you.


Are there any questions or comments the group might have for any of the five speakers?

Okay. Let's move on then to United Poultry Concerns, Inc.

MS. DAVIS: My name is Karen Davis. I am delighted to be here today. My name is Karen Davis again, United Poultry Concerns president, and I am here to offer the following comments in regard to the proposed revised guidelines, Dietary Guidelines for Americans.

The revised guidelines should recommend a plant- based, nonanimal-based vegan or vegetarian diet. The guidelines should promote the positive health benefits of a vegan diet.

The conservative annual cost estimate of human illness caused by the seven best known, most prevalent

foodborne pathogens is anywhere between $5 billion and $10 billion or more per year. The USDA Economic Research Service has in its own studies identified meat and poultry as the primary sources of these pathogens and has said that they are in fact the result of consumption of meat, poultry, seafood, dairy products and eggs.

Regarding antibiotics, which have not really been brought out here today, but should be, a University of Maryland study that was reported by the British journal, Lancet, and summarized in The New York Times on February 26 of this year, states that bacteria are resistant to the most powerful antibiotics used to treat infections in people and that they have been found in chicken feed, raising concerns about the threat to human health from the overuse of antibiotics in humans and in animal agriculture.

Ironically, the overuse of antibiotics such as fluroquinolones in humans is in large part an effort to treat food poisoning, such as campylobacteriosis and salmonellosis and E. coli infections derived from the consumption of animal products, including poultry, beef, dairy, and eggs.

The overuse of antibiotics in animal agriculture is an effort to compensate for the overcrowding, filth and overstressed immune response imposed on animals who are forced to live in systems that are making them sick.

The use of antibiotics as growth promoters in these animals predisposes these animals to metabolic diseases that in turn require the use of more antibiotics, and a vegan diet would eliminate this pathogenic recycling of disease organisms and overuse of antibiotics to cope with them, unsuccessfully I should add.

The revised Dietary Guidelines for Americans should promote a vegan diet. A vegan diet will reduce human illness and human health care costs. It will eliminate the animal waste management problem that we are faced with. It will eliminate the unwholesome and unethical confinement of animals, itself a major cause of diseases in humans and

nonhumans, including both wild and domestic animals.

It will encourage the manufacture and development of nutritional plant-based foods and promote human culinary and food processing creativity, as well as human health. This is an opportunity for us.

I should say in conclusion that anybody who really would visit an egg factory or a poultry house and saw the absolutely filth --

CHAIRMAN GARZA: I apologize. You are --

MS. DAVIS: -- that these animals live in, would not even consider these things as a healthy diet.

Thank you.


The next group is the Vegetarian Nutrition Dietetic Practice Group of the American Dietetic Association.

MS. REESER: Good morning. My name is Cyndi Reeser, and I am the past Chair of the Vegetarian Nutrition Dietetic Practice Group of the American Dietetic Association, hereafter referred to as the VNDPG.

The VNDPG views the fifth edition of the U.S. Dietary Guidelines for Americans as a unique and historic opportunity to strengthen our national commitment to promote health and prevent disease. The dietary guidelines can and must reach for higher outcomes than have been achieved in the past.

Government surveys indicate that the prevalence of overweight has increased for nearly all age, ethnic and gender groups since 1980. This may be explained in part by the exceedingly large portions served in restaurants.

We also know that fat and saturated fat intake both declined only one percent from 1989 to 1996. Only 33 percent of the population over two currently meets goals for fat intake, and only 36 percent of the same population meets the goal of five or more servings of fruits and vegetables per day. Vegetarian eating patterns tend to be lower in caloric density and fat and higher in fruits and vegetables and fiber.

The VNDPG are just a committee to revise and strengthen dietary guidelines so as to make it an even more effective and powerful tool for health promotion in the hands of the consumer. We make the following recommendations:

Strengthen guidelines for achievement and maintenance of healthy weight by clarifying and expanding information on serving sizes of foods and portion control, especially for restaurant and take-home meals.

Update and expand information on the well-documented protective benefits of a vegetarian diet, including phytochemicals and antioxidants. The VNDPG stands ready to assist the committee by providing this documentation from the scientific research as needed.

Provide information on alternative sources of calcium for those who avoid consumption of dairy products. Provide information on plant sources of protein for those who avoid consumption of animal foods. Finally, expand emphasis on ethnic and cultural diversity in the food supply.

Thank you for the opportunity to testify today.


The Vegetarian Society of the District of Columbia?

MR. BALCOMBE: Members of the panel, thank you for the opportunity to comment. I did bring a helper today.

My name is Jonathan Balcombe. I am a biologist with a Ph.D. in Animal Behavior. I have been a vegetarian for 20 years and practically vegan for the past ten. I come representing the Vegetarian Society of the District of Columbia, a fast-growing group whose members have doubled to about 800 members in the last few years.

I am also accompanied by my four-year-old daughter whose hand I just stepped on -- my apologies, Emily -- who has been a vegetarian and practically vegan since her birth.

I would like to comment briefly on two relevant issues, both from the perspective of a parent. I apologize that I may be flogging a dead carrot, because several of these issues have been brought up with the past few speakers.

First as a general comment, I urge you to recommend that the dietary guidelines under your purview go beyond the current acknowledgement that vegetarian diet is adequate to meet the nutritional needs of Americans. These guidelines ought to strenuously urge Americans to replace meat-derived protein in their diets with plant-based protein.

Not only does a vegetarian diet provide more than adequate nutrition, it provides numerous benefits to the traditional meat-based diet most Americans consume today. Vegetarians are markedly less likely to suffer from heart disease, cancer, and stroke than their meat-eating counterparts. Vegetarians are also much less prone to obesity, as you have already heard, and tend to live years longer.

It is also worth mentioning from an economic standpoint that the above diseases of affluence not only take a huge toll on American lives, but a huge economic toll as well due to the cost of treatment, which amounts to tens of billions of dollars annually.

Second, I wish to comment briefly on the national school lunch program. The national school lunch program is generous in principle, but unhealthy in practice. A 1993 survey by the USDA found that national school lunch program meals averaged 38 percent of calories from fat. This is eight percentage points higher than the government's maximum recommended dietary daily intake of fat, which, in the view of many medical experts, is already much higher than it ought to be.

A 1991 analysis found that 90 percent of the foods the USDA bought from industry for the national school lunch program were butter, cheese, whole milk, beef, pork, and eggs. All of these foods are loaded with fat, cholesterol and sodium.

Being a middle-class child, my daughter will probably not likely need to resort to the national school lunch program for the support that it provides, but, for the sake of those who do, please recommend an overhaul of the national school lunch program to emphasize plant-based protein in the place of the high-fat/low-fiber fare that currently dominates it.

Emily, do you want to make a comment? No.

Thank you for the opportunity to comment.


The Wheat Foods Council?

MS. SLAVIN: Hi. My name is Joanne Slavin. I am a professor at the University of Minnesota, but here I am speaking on behalf of the Wheat Foods Council, which is a nonprofit organization formed in 1972 to help increase public awareness of grains, complex carbohydrates and fiber as essential components of a healthful diet. The Council is supported voluntarily by wheat producers, millers, bakers and related industries.

The U.S. dietary guidelines are well recognized as dietary recommendations based on scientific evidence and serve as a valuable educational tool in helping consumers understand how to enjoy a variety of foods in moderation as part of a healthy diet.

I would like to discuss the third recommendation today. Choose a diet with plenty of grain products, vegetables, and fruit. Grains are the base of our diet because they provide complex carbohydrates, fiber, protein, phytochemicals, vitamins, and minerals.

The current recommendation that Americans consume six to 11 servings from this group is supported by the fact that grains provide a range of nutrients, are well liked, and offer convenient products that people find enjoyable.

As certain segments of the population may need more calories and nutrients, such as athletes, growing children, childbearing women and low-income families, it makes sense that additional calories will come from this grain group.

Therefore, it is important to maintain the current dietary recommendations at six to 11 servings of grain foods a day with at least three of these servings coming from whole grains. Currently American are barely meeting the recommended grain servings, consuming about six and

two-thirds servings per day. Daily intake of whole grains is much less, less than one serving per day.

In addition to fiber and B vitamins, whole grains contain a wide range of phytochemicals that help protect against heart disease, as well as colorectal and breast cancer.

Therefore, we support the American Dietetic Association's recommendation that consumers include at least three servings of whole grains per day as part of the six to 11 recommended grain servings.

Please note that I said as part of the recommended grain servings. It is important to underscore the point that by encouraging the public to consume more whole grains, we should not discourage them from consuming adequate amounts of enriched and fortified grain products. While studies have shown positive effects from consuming whole grains, there is no scientific evidence that indicates consumption of enriched and fortified grain products has deleterious health effects.

We urge you to recognize that enriched grain products play a key role in helping consumers include recommended amounts of folic acid, iron, and fiber in the diet.

In the October issue of Pediatrics this year, researchers found that yeast bread was the single largest contributor to fiber in the diets of children. In addition, the researchers reported that ready-to-eat cereals were the top contributors of folate in children's diets.

In a January 1999 Journal of the American Dietetic Association study looking at folic intake from fortified grain products in low-income women, the researcher concluded that most subjects would be able to get the goal of 400 micrograms of folic acid exclusively through intake of fortified enriched grain products.

Finally, the committee should consider the importance of taste in consumers' food selection and consumption needs. Taste is a major reason people give when choosing a food, and taste affects their attitudes about eating healthfully.

People enjoy eating enriched grain products. Additionally, as a mother of three school-aged children, I appreciate the convenience of these products. We need to --

CHAIRMAN GARZA: I apologize for interrupting, but your time is up.

MS. SLAVIN: Thank you.

CHAIRMAN GARZA: Sugar Association?

MR. KEELOR: I am Richard Keelor, president of the Sugar Association, and pleased to be here on behalf of this country's sugar cane growers and refiners, sugar beet growers and producers.

We believe the current science supports the moderate use of sugar and other nutrient sweeteners as part of a healthful diet, and we recommend that revised guidelines continue and extend the focus on total diet that was established in 1995. Sugars are not stand-alone foods. They should not be in a separate guideline.

As you know, the science pertaining to sugars has not changed significantly since the 1995 guidelines advised choosing a diet moderate in sugars. More recently, the report referred to earlier, the FAO/WHO report on carbohydrates, reconfirmed the scientific consensus on sugars finding no evidence of a direct involvement of sugars in the etiology of lifestyle-related diseases.

A basic issue involving sugar and other sweeteners is the overall nutritional quality of the diet. Much attention has been paid to the theory that if you eat a lot of added sugars you might not get the necessary micronutrients. I emphasize that is just a theory because there is no validated evidence that the intake of added sugars actually reduces the nutrient adequacy of the American diet.

We ask you to remember one important truth. People do not eat sugars. They eat foods. It is impossible to separate the sugars from the foods that contain them. Some sugar-containing foods are nutrient dense. Others are not. We believe it is far more meaningful to advise Americans to evaluate foods and diets on their nutrient profile and not on their sugar content.

The Department of Agriculture currently has a mechanism for measuring diet quality that does exactly that, the healthy eating index. As you know, its components are total fat, saturated fat, cholesterol, sodium and variety and, of course, the five pyramid food groups. Sugar intake is not a criteria, apparently on the realization that if a diet meets these ten important measures, the amount of sugar in the diet will not be disproportionate.

This is exactly the approach the dietary guidelines should follow with respect to sugars. Current sugar science supports dietary guidelines emphasizing total diet without singling out a specific ingredient, such as sugars.

As the healthy eating index illustrates, the amount of sugars in the diet is secondary to observing more important priorities. Moreover, focusing on core advice would make the dietary guidelines memorable to consumers and enhance the likelihood that Americans will actually understand and use them.

Thank you.

CHAIRMAN GARZA: Are there any comments or questions of the five previous speakers? Dr. Dwyer?

DR. DWYER: Several of the speakers mentioned $5 to $10 billion in foodborne pathogens.

MS. DAVIS: Yes. I believe that was me.

DR. DWYER: Have you thought at all about recommending safer handling of these items rather than outright elimination?

FEMALE VOICE: Are you speaking to me? I am the one who cited those figures --


MS. DAVIS: -- from the USDA Economic Research Service study that was published in 1995.

Safer handling can only, you know, deal with a problem that preexists and goes back to the deplorable conditions in which the animals are actually living -- .

You can clean up a mess that began back here, but we are saying clean it up back here by, you know, eliminating the raising of animals period for nutrients that we do not need animals in order to obtain and be healthy.

CHAIRMAN GARZA: Any other comments or questions to any of them?

All right. Our next speaker is from the University of Toronto, Faculty of Medicine.

MR. ANDERSON: Hi. I am Harvey Anderson. I am a professor at the University of Toronto in nutritional sciences. I apologize to the committee. I have only given you ten copies of handouts with tables backing up the one-page statement that I provided on sugars intake and dietary guidelines.

I would just like to make a couple of points. One is, of course, that since dietary guidelines came into effect, we have increased carbohydrate intakes substantially from 43 percent to 51 percent. The interesting thing is that total sugars intake is increasing more slowly than total carbohydrates.

Now, the problem that I want you to focus on is the estimates of added sugars. The added sugars, based on the USDA report, 1986, defines added sugars as mono and disaccharides, which is the precise definition of sugars.

If you use the USDA database for the NHANES III, which we have done, and I would like to thank Deborah Keist and Huang Swang at Michigan State for doing the number crunching and ILSI Human Nutrition Institute for providing the money.

You will see that substantially higher estimates of added sugar intake are made. The problem is one of definition. The USDA teaspoon estimates and serving size is based on sweeteners, and many sweeteners contain polymers of glucose, not mono and disaccharides. That is a fundamental difference, and right at the moment it is very hard to define precisely added sugars by the right definition of mono and disaccharides.

Thank you.

CHAIRMAN GARZA: Salt Institute?

MR. HANNEMAN: Good morning. My name is Dick Hanneman. I am president of the Salt Institute. We represent salt manufacturers and are here to testify in favor of a scientifically based set of guidelines and to remind you that there is a lot of new science with regard to salt over the last five years.

In fact, I was reading a book and got a great quote from John Locke I thought maybe you would find interesting. "It is ambition enough to be employed as an under laborer in clearing the ground a little and removing some of the rubbish that lies in the way of knowledge." I would like to try to do that in the short minutes I have with me.

For the last 20 years, healthy Americans have been trying to improve their diets using Federal Dietary Guidelines for Americans, and they have been told that one of seven key behaviors is choosing a diet moderate in salt and sodium.

The claim purpose has been to curb excess sodium consumption and reduce the risk of cardiovascular events. The current strategy fails on both counts and should be abandoned. Better targets and strategies are available, and persisting in a focus on sodium prevents effective pursuit of more effective approaches.

I am sorry that you will not be hearing from the experts who you discussed last time as coming before you. I think it is good that your subcommittee did attend an NHLBI workshop on salt and sodium, which gathered and discussed a lot of the science.

I would like to make three points in my remaining time. One is that Americans are consuming an average amount of sodium in the world and that that is an amount which has remained unchanged for probably the entire century.

Second point is that studies have now examined the motivating assumption that lowering dietary sodium will reduce the incidence of heart attack and stroke and cardiovascular disease. All the studies have concluded that there is no benefit of reducing dietary sodium. Some have found increased risks. Some have not found increased risks, but none of them have found a health benefit of reducing dietary sodium.

Finally, there was reference earlier to the DASH diet, Dietary Approaches to Stop Hypertension, a program developed by the National Heart, Lung and Blood Institute, which emphasizes the fruit and vegetable diet which has been much discussed this morning, but more than double the benefit in blood pressure lowering was achieved by adding low-fat dairy products to that diet. We strongly recommend that to you.

I have handed out a copy of a chart which very briefly shows that a salt reduction diet, the far left column, will reduce systolic blood pressure by six-tenths of one millimeter.

Compare that going across with the various groups so that the yellow chart, fruits and vegetables, is 2.8, about four times, and then you get to 5.5 or double the fruits and vegetables when you have the addition of low-fat dairy, and then for the subgroups of African Americans who are at particular risk for hypertension, 6.8, and hypertensive at 11.4.

A separate guideline for salt and sodium should be eliminated --

CHAIRMAN GARZA: Mr. Hanneman, I am afraid your time is over.

MR. HANNEMAN: Thank you very much for your attention.

CHAIRMAN GARZA: The American Institute of Wine & Food?

MR. BEAUCHAMP: Thank you. My name is Gary Beauchamp. I am the Director of the Monall Chemical Census Center in Philadelphia, the first institute devoted to basic research in smell and taste, and I am also a board member of the American Institute of Wine & Food, for whom I am speaking today.

I want to talk to you briefly about an issue that has been mentioned, as far as I know, only once today, and that is that food gives us pleasure. That is something we have to concern ourselves with.

We want to recommend that the importance of taste and flavor and pleasure in diet and eating be included in the text guideline explaining eat a variety of foods. This recommendation is also supported by the Food and Culinary Professionals, a dietetic practice group of the American Dietetic Association.

The flavor of foods and beverages is important in considering health recommendations for the American diet for two reasons. First, it has been demonstrated in a large number of studies that the primary attribute which consumers choose a food is its taste or flavor. This is the case even in health oriented individuals.

A recent study of 3,000 individuals showed that even among people who do not smoke, do not drink beyond moderation, exercise routinely, eat a healthful diet, watch their weight, they still rate taste as the most important determining factor in the foods they consume.

Foods and beverages that are not palatable or do not taste good might be consumed once or a few times for reasons of health or advertising, but over the long run if they are unpalatable they will fall from the diet. Foods that taste good and provide enjoyment become a part of an individual's regular diet, and frequently eaten foods have the greatest impact on health and well-being.

There is a second important reason that foods and beverages should be flavorful. Flavor has been demonstrated to stimulate a cascade of enzymes involved in absorption and utilization of nutrients. For example, flavors are involved in the stimulation of exocrine and endocrine pancreas secretions, the best example of this being insulin.

These neurally based or cephalic phase effects are thought to optimize digestion and absorption of foods and beverages. Indeed, recent studies have shown that flavor can improve nutrient metabolism in humans.

In summary, it is imperative for those who wish to insure that our diets are nutritious that they also consider that they be flavorful. Other countries acknowledge this. We know the French are particularly concerned with taste. Indeed, they teach the importance of taste in formal courses in primary school. Other countries such as England, Japan, Vietnam and Thailand include the importance of taste in their guidelines. The United Kingdom's first guideline is enjoy your food.

No food, no matter how healthful, will provide benefit if it is unpalatable and thus unconsumed. Palatability and taste guide food and beverage selection, intake and utilization. Consumers have told us loudly and clearly that flavor is paramount in the enjoyment of food. As such, its importance should have a prominent place in our recommendations for a healthy diet.

Thank you.


Center for Science in the Public Interest?

MR. HACKER: Good morning. I am going to address alcoholic beverages. I am only going to make a couple of very -- excuse me?

CHAIRMAN GARZA: Identify yourself.

MR. HACKER: My name is George Hacker, and I direct the alcohol policies project at Center for Science in the Public Interest.

I am going to address the alcoholic beverage portion of the dietary guidelines and only make a couple of points and allow the committee to look at our submitted comments for the remainder of those points.

Principal in terms of the caution I would like to bring to the committee today is that the dietary guidelines should not be permitted to be exploited to encourage alcohol consumption or the initiation of consumption.

The fact that the Bureau of Alcohol, Tobacco and Firearms just three weeks ago approved a label that talks generally about the health effects of wine consumption has been so distorted in the media to suggest that that label actually provides consumers information about the potential benefits of moderate alcohol consumption should be a warning to this committee that any language that suggests benefits for alcoholic beverages can be and will be distorted for commercial purposes. It has been done in the past, and I think it is inherent upon this committee to ensure that it not occur in the future.

Secondly, I would like to point out that even providing this committee with hundreds of research reports, all the evidence in the world about the benefits of moderate alcohol consumption will not change the fact that alcohol is America's leading and most destructive drug. It is addictive to eight to 10 percent of its users and causes untold problems, more than 100,000 deaths each year and $160 billion of economic damage.

As you will note in our written submission, we question the use of the word moderate and moderation in defining how people should use alcohol principally because most people will not get copies of this document and will not have the definition that is provided. We suggest a specific quantity be referred to where moderation is now currently used, particularly in the Advice for Today.

Lastly, we believe that it is time to get rid of the gratuitous rhetoric in one sentence of the guideline that suggests that alcohol beverages have been used to enhance the enjoyment of meals by many societies throughout human history. We question why that same language does not appear in the salt section, the fat section and the sugar section because certainly those consumables have enhanced the enjoyment of meals for many centuries as well, probably longer even than alcohol.

We also question, and we think that it might be appropriate if one suggests the enhancement of meals, that alcoholic beverages have also been used for centuries to enhance inebriation, the prospects for sex --

CHAIRMAN GARZA: Mr. Hacker, I apologize, but your time is over.

MR. HACKER: Okay. Thank you.

CHAIRMAN GARZA: Multinational Business Services, Inc.?

MR. FROMM: Good morning. My name is Charles Fromm. I am with Multinational Business Services, and I am here on behalf of the Miller Brewing Company.

I am not going to address the somewhat controversial issue of health benefits for alcohol. However, I would like to discuss the very important issue of measurement, specifically the definition of one drink, which is currently stated in the guidelines as a 12-ounce beer, a five-ounce glass of wine or 1.5 ounces of 80 proof distilled spirits. We believe that that definition is both misleading, and it is inaccurate. Therefore, it needs to be significantly revised or stricken altogether.

First of all, it is misleading. If you look at it, and I have attached a list of some 30 specific drinks that contain more than 1.5 ounces, and I think that common experience bears this out that the amount of hard liquor in a mixed drink is quite variable, and in many cases, if not most cases, it contains more alcohol than the 12-ounce beer, which I will get to in a minute.

That list contains very common drinks -- gin and tonic, margarita, martini, screwdriver, whiskey sour, on and on -- that contain well over 1.5 ounces, so we are already skewing the one-drink term in favor of the distilled spirits component.

Secondly, and that is this thing, there are on the market now a number of "single serve" drink beverages. I purchased this one about two blocks away standing right between a beer and I think a wine cooler. Twenty-one percent alcohol. This is a 6.8 ounce bottle, so you can see how that translates.

By saying that we have one drink, if we are recommending one drink or two drinks, when we have products on the market like this that does not reflect reality if that is what we are recommending in the guidelines.

So what do we do? We would suggest that a statistical survey be commissioned either by USDA or HHS to take a look at the many different products and come up with a different matrix. Rather than simply call them one drink, let's look at what is in one of these versus some of the other drinks and not just limit the definition of one drink to beer, wine, and all distilled spirits.

Failing that, as the previous speaker suggested, let's come up with a specific number. We address nutritional guidelines with respect to salt, with respect to fat, in terms of grams. Why are we not doing the same thing with respect to alcohol? Instead we have this gross surrogate, which, as I said, is inaccurate and misleading, and we attempt to say that that is what we are recommending. If it is 15 to 30 grams, let's say 15 to 30 grams.

Lastly, it is inaccurate even as stated. Even if it is not changed, it is inaccurate now because the math is wrong if you do it. If you do the math, you are implying that .6 ounces is what is recommended as one drink. That necessarily implies that the beer is a 5 percent beer, which is not the U.S. norm. Therefore, we would recommend if nothing else that you change the distilled spirits component to 1.5 ounce.

Thank you very much.

CHAIRMAN GARZA: Are there any comments or any questions to any of our speakers? Dr. Weinsier?

DR. WEINSIER: I have one. Was it Dr. Beauchamp who spoke from the American Institute of Wine and Food?


DR. WEINSIER: Help me. I think I appreciate your comments about the importance of flavor of food and enjoyment of food by the consumer, but for the Dietary Guidelines Committee help me understand.

Are you implying that flavor is an innate characteristic of a food such that our committee can consider development of a guideline around the flavor of food? What are you trying to leave us with in that regard?

MR. BEAUCHAMP: If I had an hour, I could answer that question.

Basically what I am suggesting is that from

whatever defines what is a good flavor, and that is a very complicated issue which I and many people have written much about, but if the flavor is not good, people will not consume it. No matter how healthy you think it is, if it does not taste good --

DR. WEINSIER: I understand that, but from the standpoint of our trying to develop guidelines around individual foods, how do we use this information to alter the guidelines? What is your suggestion?

MR. BEAUCHAMP: Our suggestion is that in the section where it says eat a variety of foods, you include a statement that amongst the variety it has to be foods that are flavorful. That I think will stimulate industry to develop --

DR. WEINSIER: But that gets back to my question of is flavor an innate characteristic of foods so we can say eat foods that are flavorful?

MR. BEAUCHAMP: There are some aspects of flavor that are innate characteristics.

CHAIRMAN GARZA: Dr. Lichtenstein?

DR. LICHTENSTEIN: I have a question for the gentleman from the Salt Institute. You indicated that the addition of fruits and vegetables and I guess it is low-fat dairy products resulted in a decrease in blood pressure.

Are you sure that it is actually the addition of those foods that result in the decrease in blood pressure, or could it be the displacement of other foods? When you add foods to the diet because of energy levels, you have to sort of displace other things.

MR. HANNEMAN: It was a feeding study.

DR. LICHTENSTEIN: I understand the study. I am familiar with the work. I am just saying do you know it was the addition of those components, as opposed to the displacement? By necessity, they had to displace other foods from the diet.

MR. HANNEMAN: A diet high in fruits, vegetables, and low-fat dairy produced the results.


MR. HANNEMAN: I would add that the DASH diet was not sodium restrictive, so the sodium does not explain the --


DR. DWYER: Just to follow up on that, what was the average amount in the DASH diet because it was fed?

MR. HANNEMAN: In sodium?


MR. HANNEMAN: Between 3,000 and 3,100 milligrams.

DR. DWYER: So it was fairly low sodium?

MR. HANNEMAN: 3,500 is what we consider the normal diet, so it is low average.

DR. DWYER: Thank you.

CHAIRMAN GARZA: Dr. Dwyer, and then we will go to Dr. Kumanyika. Go ahead.

DR. DWYER: I wanted to get back to this handout from Dr. Anderson. I am not sure I got your point.

I gather what you are saying is that the teaspoon business is difficult because of the fact of mono and disaccharides? You are dealing with stuff that is in water or syrup?

MR. ANDERSON: Yes. On the last page of your handout you have the definition. The point that I am trying to make is that we cannot estimate at the moment with any sense of accuracy added sugars intake using any of these database because we do not have the database that will let us do it.

We tried to do it using the USDA food pyramid serving size approach for which they have -- . The problem with that, it is often recipe based so if you take bread there is a lot of sugar going into bread. It is assumed it is consumed.

Of course, we know that yeast shoots out the sugar that is in the bread, so by the time it is consumed, and if you start doing comparisons about the estimated USDA sugars in food compared with the analytical, you will often find that the added sugars by their estimation exceeds the total carbohydrates in some foods or the total sugars in some foods, so there is something fundamentally wrong that we cannot use that database until we get it sorted out.

My point is that at the moment, estimates of added sugar, true estimates of added sugar consumption, are difficult to obtain. We have to do a lot more work to go back and determine whether there has been a change since the 1978 national food consumption survey, of which FDA then did all the hard work to find the sugar content of foods, and then they tested it based on the definition of mono and disaccharides.

When you get to sugars as syrups -- from syrups -- or sweeteners from syrups, I remind you that many of those that added the sugars -- as sweeteners, but for their functional properties, for example -- as soup, dried soup mix, is there because it contains the polymers of glucose, which are hygroscopic. That is not sugar consumption.

DR. DWYER: Tell me, though, how big are the errors? Are they like 10 percent?

MR. ANDERSON: Well, if you do the comparisons, as you will see in the table, if you use the USDA approach versus you can go back to the mono and disaccharides, you get an estimated average for consumption of added sugars of 12 percent versus 16 percent.

I would say that that difference from 12 to 16 percent is due to definitions, not due to consumption of mono and disaccharides or sugars. That is what we have to sort out before you can make any judgment about where we are in sugars, added sugars.

CHAIRMAN GARZA: Okay. Dr. Kumanyika?

DR. KUMANYIKA: My question is also on the salt slide. I am assuming that the first four bars come from DASH, which was a feeding study, so the question is whether --

MR. HANNEMAN: No. I am sorry?

DR. KUMANYIKA: I am sorry. The last four.

MR. HANNEMAN: Yes, the last four.

DR. KUMANYIKA: Right. The question is are you then comparing weight reduction and sodium restriction also from feeding studies?

MR. HANNEMAN: The first two bars, which are the trials of hypertension prevention.


MR. HANNEMAN: These two.

DR. KUMANYIKA: So these data are not actually comparable? I mean, you would have to take a feeding study to look at the effect size for sodium?

MR. HANNEMAN: In essence, they are separate studies. The trials of hypertension prevention, as I know you well know, over three years examined the intervention of a low-salt diet and a weight reduction diet, a combination of those diets.

DR. KUMANYIKA: No, I did not know. The point is that I mean usually you compare data from similar types of studies, and the DASH where they gave people all the food and they got a certain effect is different from a study in a free living population. If that is what you are doing, it affects your effect sizes.

MR. HANNEMAN: I certainly concede that point. That is correct.



DR. GRUNDY: I wanted to ask Harvey one more question.

Your points are well taken and very interesting, but what does that have to do with us here? I did not quite get the point.

MR. ANDERSON: Well, the issue is I think someone referred to earlier -- a comment on added sugars in dietary guidelines at all, and that is where I got into this years ago with the Canadian one. Why have a guideline unless you have the support in terms of data that -- ?

That is the background, and then with the new data I thought well, it would be interesting to see whether consumption has in fact changed over the past ten years because there is an assumption that it has. Let's get the data.

That is why we turned to the USDA serving size, and then it started to look like there was something wrong in terms of those estimates. That is where I am with it now, but I think, you know, if it has increased then there is a judgment that there is a problem, but if you look at those tables I can show you data where BMIs are associated, elevated BMIs, with the higher fat diet or BMIs with the higher carbohydrate and total sugars and also the added sugars, but I still say you have to be careful with that added sugars data.

DR. GRUNDY: So you think that term, added sugars, is inappropriate or unnecessary?

MR. ANDERSON: That is the message at the moment.


DR. JOHNSON: I just wanted to be crystal clear, Dr. Anderson. Are you arguing that added sugar intake has not increased?


DR. JOHNSON: Okay. I am wondering how you --

MR. ANDERSON: Well, let me just say that --

DR. JOHNSON: --jibe that with --

MR. ANDERSON: Let me just go back. I would argue that you cannot use the existing data and use the USDA food serving size in teaspoons to determine whether added sugar intake has increased in 20 years or not. That is our problem right now, and we are trying to take a look at that.

DR. JOHNSON: Okay. Can we use the data that says that the number one source of added sugar for all age and gender groups is carbonated beverages and that carbonated beverage consumption and production has increased dramatically over the last decade?

MR. ANDERSON: You can rank sources of added sugars. Again, in that case, yes. I mean, that is reasonable. That is where the source is.

DR. JOHNSON: Okay. Thanks.

MR. ANDERSON: But for other food products, it would not be perhaps -- in terms of the quantities.

DR. LICHTENSTEIN: Dr. Anderson again. Are you saying that the percent of calories from added sugar has not increased over time, using whichever system you used to estimate it, or the number of grams of sugar has not increased with time?

MR. ANDERSON: Now we get into whether you can really estimate total quantities. I guess I have a little more faith in percentages.

Again, as you look at the NHANES data and you do use the USDA database, you find an increase in nutrient intake with an increase in quantity of servings. When you take it on a percentage basis and look at nutrients, you sort of get a U-shape curve, which all just keeps telling us moderation and variety in both ends puts you in the middle where you have a healthier diet.

Again, I hesitate to say how much the true added sugars by the same definition as the FDA used in the 1986 report, how much that change has occurred. I suspect it is quite small, but that is my opinion until we get some more quantitative data.

CHAIRMAN GARZA: Are there any other questions or comments?

All right. Let's move on. National Council on Alcohol and Drug Dependence?

MS. KAYSON: Good morning. I am Sarah Kayson. I am the Director for Public Policy at the National Council on Alcoholism and Drug Dependence. NCADD was founded in 1944, and our mission is to reduce the incidence and prevalence of alcoholism and other alcohol related problems.

NCADD has used the current dietary guidelines in many different ways, and we look forward to using revised guidelines that are based on the latest scientific research and that are as specific as possible about both the risks and potential health benefits about drinking at moderate and heavier than moderate levels.

We strongly urge you to develop a guideline that, based on science, is not used as permission to drink. There are two sentences in the current guidelines that give us pause and that we strongly urge you to address.

We hope that you will eliminate the reference to alcoholic beverages enhancing the enjoyment of meals for a couple reasons. One, basically it is rhetoric, and it is not based on science. I think if you asked the children of a heavy drinker or an alcoholic if the alcohol that is being consumed at their meal is enhancing it, I think the answer would be no. Also, as has been pointed out, that kind of language is not included in any other section of the guidelines.

We also would ask you to be more specific about the sentence that describes moderate drinking as being associated with lower coronary heart disease. The revised guidelines must eliminate the term "some individuals" and be much more specific about which populations according to scientific research might benefit from moderate drinking.

Unfortunately, alcoholics and other heavy drinkers, of whom there are over 14,000,000 in the United States, are most likely to be misled by that kind of information that suggests that drinking might be good for them.

We also support the inclusion of a definition of moderate drinking and the list of the five groups of people who should not drink under any circumstances. There should be, in addition to some others, but specifically two additions.

One, the National Institute on Alcohol Abuse and Alcoholism recently came out with research that demonstrated that the early use of alcohol in the adolescent and teen years greatly increases the chance of alcoholism or other alcohol related problems in life and also that to change the moderate drinking definition for men over the age of 65 because of changes in body composition. Moderate drinking should be lowered.

We would also just like to add that NCADD's Medical Scientific Committee, along with the American Society of Addiction Medicine, encourages language that they came up with a couple years ago that says that no alcoholic should be encouraged to drink, and alcoholics by definition cannot drink moderately.

It is critical that the revised version of the dietary guidelines not be a document that can be used as an endorsement to drink alcohol for health benefits. Alcohol consumption is still the third leading cause of preventable death in the United States, and for most people the risks far outweigh any potential benefits.

Thank you.


Wine Institute?

MR. ELLISON: I am Curtis Ellison, a professor at Boston University. While I was asked by the Wine Institute to comment, my comments are my own and do not necessarily reflect the Wine Institute, Boston University or National Institutes of Health that supports me mainly.

Four points. There is no question of the importance of alcohol in preventing coronary disease and stroke, partly through an increase in HDL cholesterol. In a new population based report, which we will be giving shortly, later this month, we found that alcohol consumption is by far the main lifestyle factor affecting HDL cholesterol, which protects against heart disease.

The second point is that there is growing evidence that moderate alcohol consumption may enhance other aspects of a healthy lifestyle, including vitamins and other components of the diet. In the handout that you are getting, Figure 1 is from the nurses' health study showing that higher levels of folate are associated with lower coronary heart disease deaths.

However, the protection was many times greater among drinkers, about 80 percent, than among abstainers where there is only 15 percent. The Leon Diet heart study similarly showed that vitamin E levels in the plasma relate better to wine consumption than to vitamin E intake.

I will not dwell on the adverse effects. I do include in the handout the results of my recent study of Framingham women looking at the effects on breast cancer. The adjusted risk ratios, as you will see in Table 1, are less than one for each category.

These are light drinkers. Most of them average less than a drink a day, but in many studies, including the nurses' health study, at a level of one drink a day we do not see an increase, and if there is any increase at one drink a day it is sure minimal.

The last point is total mortality. We can talk about effects on various diseases and states, but as epidemiologists we are pretty good at determining whether someone is dead or not, and we can count the live and the dead bodies, and we can see that people who in the U.S. it seems about 21 percent lower mortality rates for moderate drinkers than it is for people who do not drink.

The Figure 2 of your handout is from the Copenhagen heart study where they found that individuals consuming one to six drinks per week had the lowest death rates. The bars in that figure show the number of excess deaths attributable to alcohol consumption. In other words, those are more deaths in each of the categories that would not have occurred if these people were drinking at one to six drinks per week supposedly.

You will notice that the number of deaths attributable to too much alcohol are considerably less than the number of deaths attributable to not drinking, presumably increased deaths, on the basis of coronary heart disease.

I include in Tables 2 and 3 of your handout some calculations we are doing to apply such data to the U.S. population, and you will see from that that individuals who consume alcohol moderately do have a longer life expectancy. It has been shown in the U.S. about a three percent longer expectancy than nondrinkers.

I trust that future dietary guidelines will be based on sound scientific data.

CHAIRMAN GARZA: I apologize for having to interrupt you, but --


CHAIRMAN GARZA: -- your time is over.

MR. ELLISON: Thank you. I hope that your guidelines will be balanced and give information that will give us both the adverse and beneficial effects.

Thank you.


(No response.)

CHAIRMAN GARZA: Nebraska Association of Family and Consumer Science?

(No response.)

CHAIRMAN GARZA: Physicians Committee for Responsible Medicine?

MR. MILLS: My name is Dr. Milton Mills. I apologize for not being here when my name was initially called, but I spent the night working the coronary care unit over at Fairfax Hospital taking care of the business end of our dietary guidelines.

What I want to talk to you about today is racial bias in U.S. dietary guidelines. Every national health survey for the last 30 years has shown that minority groups in this country consistently fare worse in terms of both prevalence of chronic diseases and their death rate from it.

When you look at the traditional diets consumed by the minority groups that make up our nation's population, African Americans, New World Hispanics, Asians and Native Americans, they are all consistently plant-based diets with low levels of fat and animals foods, yet when you look at studies done within these groups as they consume a western diet, again you see that they consistently have more disease.

It turns out that African Americans have higher levels of LP delay. We know that Pima Indians have the

so-called thrifty genes, and we also know from migrant studies that as Asian populations begin to consume a western diet, their level of chronic disease skyrockets.

What this suggests is that these groups have genetically adapted to a plant-based, low-fat, low-animal- food diet. When these groups revert back to their traditional diets, again their levels of chronic disease fall. Their levels of high blood pressure, etc., also decrease.

I want to suggest to you that for the Dietary Guidelines Committee to continue to encourage the consumption of large amounts of animal foods and a fairly high-fat diet in these groups constitutes nothing short of racism.

You do not have to drag a person behind a pickup truck to kill them through racism. Both the person who dies from a lynching and the one who dies from premature chronic disease are equally dead. I urge you to please change these guidelines to reflect what we know from good science.

I just cannot help but also note that it seems that the under represented minority groups in this country are also under represented on this committee.

Thank you.

CHAIRMAN GARZA: Mr. William Grant?

(No response.)

CHAIRMAN GARZA: The American School Food Service Association?

MS. RIGBY: Good afternoon. I am Suzanne Rigby. I am with the American School Food Service Association. I am the Director of Nutrition and Education. Thank you for letting me be an add on this morning.

A little bit about ourselves. We are a membership association. We represent 60,000 people who work for child nutrition programs. We are primarily interested in the national school lunch program and the school breakfast program. A little statistics. Nationwide, the national school lunch program feeds 26,500,000 lunches; the breakfast program, 7,000,000 breakfasts.

Another fact. We are the only consumer feeding program that has been federally mandated to follow the Dietary Guidelines for Americans. That is one of our standards that we do menu planning for, and it is because of this that we are here to ask that when doing any altering of the current dietary guidelines that you do consider and make them practical, obtainable and user friendly.

We are very proud to be able to use the standard in doing our programs, but we have a little problem. While the standard has been mandated for us to use, you cannot mandate students' preferences. While you can lead a horse to drink, you cannot force it to drink.

What we are finding, as has been testified here to you, there is this gap between what we should be doing, what we know is good, and what preferences are. Real world today, students are coming to us with choices. They are not the captive audience that we used to have. Those choices today include whether to take that offering and eat that offering or whether to wait until school is dismissed and hit the other things that come closer to their preferences.

For this reason, we are asking that we -- you -- make sure that the dietary guidelines are attainable for us to be able to truly meet this standard.

Thank you.


Are there any comments or questions of any of the previous four speakers? Dr. Meir?

DR. STAMPFER: Yes. I had a question for the National Council on Alcohol presenter.

One of the recommendations you made was to lower the definition of moderate for older men. I wonder if you could give us any citation with clinical end points that that should happen?

MS. KAYSON: I cannot, but Dr. Gordis, I believe, from NIAAA later can.

CHAIRMAN GARZA: We will reserve the question for Dr. Enoch then.

DR. STAMPFER: Okay. My second question was you ended saying that the risks outweigh the benefits. Were you referring to all alcohol or just moderate as defined by the guidelines?

MS. KAYSON: All drinking. That overall that the risks outweigh the benefits of drinking.


DR. KUMANYIKA: My question is for the School Food Service Association.

The issue of preferences of children, is it the inability within the school food service to create the kind of foods that children will prefer, or is it the actual composition of the guidelines?

In other words, are you saying that the type of foods children prefer will always be out of line with the guidelines or that within your resources you are not able to prepare foods that children will prefer that meet the guidelines?

MS. RIGBY: The first path is probably the more real one. Until we are able to, through nutrition education, experience or whatever, be able to alter those taste preferences for things that are more healthful, there will be this disparity.

Students come to us already molded. Their environment outside of school is helping to reinforce whatever their preferences are, so it is more that the second path.

We are working very hard with tools that USDA is providing for us to alter prep methods and whatnot, the purchasing of foods. We are working a great deal with industry to improve, to help reduce fat without loosing too much of the flavor, but really the first factor that we have this little package of food preferences coming to us, and until that is over that is where the problem is.

DR. KUMANYIKA: Thank you.

CHAIRMAN GARZA: Any other questions or comments? Dr. Grundy?

DR. GRUNDY: Dr. Ellison said something about there is a 22 percent reduction in total mortality in people that drink a couple of drinks a day. Is that right?

MR. ELLISON: This was the article by -- the American Cancer Society study of about 500,000 Americans. The total mortality found in --

DR. GRUNDY: That is hard to believe. Even our best drugs for treating coronary heart disease and all cannot do that. That sounds like that would be a powerful drug. Is that possible?

MR. ELLISON: It is possible.

DR. GRUNDY: How? How is that possible?

MR. ELLISON: Well, I think recent studies on strokes show up to a 50 percent reduction in stroke with moderate drinkers versus nondrinkers. I am just reporting the data. The reason that --

DR. GRUNDY: What might be the mechanism? I mean, we do not have any plausible mechanism to explain such an approach.

MR. ELLISON: Not yet.

DR. GRUNDY: I realize what you are saying, but I mean, what would be the bottom line? --

MR. ELLISON: -- heart disease and stroke --

DR. GRUNDY: Then you would have to have an enormous reduction in morbidity -- . Is that possible?

CHAIRMAN GARZA: I think Dr. Grundy is referring to is it platelet aggregation that is affected? Can you give us a biological mechanism through which morbidity would be affected and, therefore, mortality?

MR. ELLISON: In most studies diabetes is reduced. Heart disease is reduced -- cholesterol, platelet aggregation, -- effects, so there are many, many effects. I think that this is an observation, not a -- . -- moderate drinkers in comparison -- .

CHAIRMAN GARZA: So that a 20 percent reduction, the comparison for that were nondrinkers?


CHAIRMAN GARZA: Not the general population. Okay.

DR. LICHTENSTEIN: Around that same point, a question for Dr. Ellison.

That figure that you pointed out to us, Figure 2, is quite compelling where there is it looks like a 2.75 percent higher risk in women that do not drink any alcohol at all of mortality related to those who drink one to six drinks.

Not having read that specific paper, are there any other characteristics of the individuals that do not drink versus the ones that were moderate drinkers that might also contribute to something as dramatic like that? I think that that also might get Dr. Grundy's question.

MR. ELLISON: The usual comparison has been

nondrinkers, and it has been pointed out that nondrinkers may include ex-drinkers who have higher mortality, but it is in essentially every study between Great Britain and the United States.

If you limit it to only lifetime nondrinkers, and we have done this in Birmingham, you still see a slight -- of higher mortality.

DR. LICHTENSTEIN: But is there any relationship between other health related behaviors that might also contribute?

MR. ELLISON: Yes. Yes. This is --

DR. LICHTENSTEIN: Like which ones?

MR. ELLISON: It said in particular that moderate drinkers probably exercise more and eat a healthier diet and many other things, but this is what causes gray hair for an epidemiologist is trying to adjust for the other lifestyle factors as best you can.

It seems that the findings are so consistent throughout the world in many different cultures that light to moderate drinking does have a health benefit in terms of total mortality.


DR. GRUNDY: I guess the question there is cause and effect. I mean, if it is associated, it would not justify a recommendation. If it is a causal factor, then it would.

I guess that is the question I am asking. Is there a causal relation, or is it just an association?

MR. ELLISON: I think the mechanism by which alcohol affects coronary disease, that has been worked out very well. The -- is one of the most important things we can do to lower our coronary risk, if you will.

DR. GRUNDY: I do not know that, actually. I wish I did, but I do not.

CHAIRMAN GARZA: Dr. Deckelbaum? You are standing up.

DR. DECKELBAUM: Most of the statistics we have heard this morning are on people beginning in their forties and up. Is there data available on the effects of moderate alcohol intake in adolescents and in the twenties on morbidity outcomes?

MR. ELLISON: There are many studies, as I am sure you will hear from other speakers, of adolescents and the mortality -- and so forth. I am talking of diseases related in mature individuals.

This is not referring, although a recent study by Siekto of strokes in Manhattan found that -- he found the same 40 to 50 percent reduction in stroke rates for people between 35 and 64, and other studies have shown that you do see some beneficial effect from the earliest effects.

At any age you see some effects against the chronic diseases. These are not diseases that affect adolescents obviously.

DR. DECKELBAUM: Again, at a young age, adolescents and twenties and early thirties, do the risks from accidents, which I was not including in my question initially, but I will include now, I would presume, and correct me if I am wrong, far outweigh any potential benefits?

MR. ELLISON: Absolutely. Yes.

CHAIRMAN GARZA: Dr. Ellison, are the putative benefits of alcohol that you described cumulative over a lifetime?

Does one have to start drinking at an early age in order to be able to accrue those benefits, or are they more acute so that in fact if you had a drink this week and you have an MI, you are more likely to survive it?

MR. ELLISON: Some of the effects of alcohol are quite transitory. The effects on platelet aggregation -- probably only last 24 to 36 hours. We think that is the explanation that some in Europe, the French, for example, consume alcohol on a regular basis, but they do not have these long periods -- .

It may be that most Americans drink on the weekends. They do not drink on Sunday and Monday, which the leading time for heart attacks is Monday morning, which may be the rebound phenomenon of heavy drinking on the weekend.

Studies from Harvard and Stanford show that consumption of a single amount of alcohol spread out across the week is by far the healthiest.

CHAIRMAN GARZA: Other comments or questions?

If not, I would like to thank all of the speakers for not rebelling too loudly as you were gaveled off the podium.

We are going to reconvene at 2:00 p.m. where we will have two invited experts to come speak to us. Thank you again.

(Whereupon, at 12:30 p.m. the meeting was recessed, to reconvene at 2:00 p.m. this same day, Monday, March 8, 1999.)



2:03 p.m.

CHAIRMAN GARZA: Good afternoon. Welcome to the afternoon session. We have two guests which have been invited to make two separate presentations to us this afternoon.

The first is on issues related to alcohol and health, and we are very fortunate that Dr. Enoch Gordis, the Director of the National Institute on Alcohol Abuse and Alcoholism of the NIH, was able to join us this afternoon. We will have approximately 20 minutes and then ten minutes for questions from committee members.

I will remind members of the audience that you are welcome to listen, but unless asked to address a specific issue by one of the committee members, we are unable to entertain discussion from other than individuals on the committee.

Dr. Gordis?

DR. GORDIS: Thank you very much, and thank you, Dr. Garza and Dr. Stampfer, for the invitation to join you today on a topic which is of great interest. I want to talk about the scientific issues which underlie the discussion on incorporating the topic of alcohol health benefits in the dietary guidelines.

We start with three things: A large epidemiological literature relating moderate drinking to reduced coronary mortality and, to a lesser extent, coronary morbidity; two, a group of biological mechanisms which are proposed to explain the alleged protective effect; and, three, the concept that encouraging the American population to drink moderately for the alleged health benefits would be in the interest of public health.

These are the three main things we are beginning with, and on those I want to touch. I will suggest that the evidence for them is in many instances incomplete and contradictory, that important topics other than mortality are hardly discussed, and that a recommendation whose effect, if any, is likely to be increase in per capita consumption has major risk for our society. That is going to be the bottom line.

I am not asserting that all claims about benefits and their explanations are wrong. What I am asserting is they all contain serious problems and opposing evidence which make them a poor foundation for an important public policy shift.

We begin with the first item, the epidemiological literature. The French paradox, as you all know, was the paradox which involved a low ischemic heart disease death rate combined with a high intake of saturated fats and other things that are not good for you. This is one of the things which got this whole field rolling.

Let me point out some ambiguities in the French paradox. I will just highlight them because I just have a few minutes. The first is that in the 20-year period between the 1960s and 1980s, the per capita of consumption of alcohol went down, and so did the coronary death rate in France. Furthermore, a recent analysis indicated that alcohol related deaths almost compensated for the ischemic deaths, which were allegedly averted.

Now, this whole issue of the tradeoff calculation I will address in another context at the end of my talk, but I think it is important that despite the fact that the low ischemic death rate in France is undoubtedly correct that there are some issues here which make the waters a little bit muddier.

On issues of cross-sectional analysis, you have probably heard before there are no longitudinal studies, as far as I know, over a variable in time. We do not know about the life histories of the individuals and the country- by-country comparisons. We essentially have population generalizations, not knowing which segment of the population is the one affected by the drinking.

Finally, another thing which is heavily missing in all this data is the issue of patterns of drinking because even if one describes somebody as having 14 drinks a week, which is a common way of talking about it, it makes a hell of a lot of difference as far as many of the social and medical consequences whether those are two drinks a day or seven on a Saturday night in a period of two hours. That is true also for drinking during pregnancy. These average numbers can see a lot of problems.

Another problem about the epidemiology is that all segments of society, even if the benefit is there, are not equally benefitted. For example, the young people are in the highest danger from deaths from violence, trauma and highway accidents. They are not in danger of dying of coronary artery disease.

Older folks are less tolerant of alcohol. They are taking many medications, and a fall for them is disastrous, propelling them frequently into a nursing home, which is their last stop. Furthermore, it is not clear that those without risk factors gain anything even from the alleged protective effect of alcohol.

The whole issue of longevity is not usually discussed, but apparently it is a very minor increment, if at all, even if aside from the alcohol issue coronary artery disease was eliminated completely.

Another very serious issue in the epidemiology of this issue is the issue of confounders. That is, is the alcohol a surrogate for something else, but not accounting for the phenomenon in itself?

Now, much of this large literature has not addressed these issues at all. However, the better papers have, but not uniformly so. Smoking is the commonest well-done analysis of a confounder; exercise much less so. Diet and saturated fats and vegetables and omega 3 fatty acids are generally poorly done. In fact, one can see accidental confounders tabulated in papers whose goal was really not that, but yet it illustrates the problem.

Issues of socioeconomic status are sometimes analyzed and sometimes they are not. So there is a variety of things which have been analyzed with various degrees of quality, but not uniformly so, which again makes the whole issue somewhat less certain than some of the spokesmen for the matter have addressed.

As far as wine is concerned, aside from wine as a specific beverage as against the other two, a question which has been raised seriously in several reports is, is it the wine itself or who it is that is drinking the wine?

That is, people who drink wine generally tend to be those of a better educated, higher socioeconomic level. They are working out in health clubs and eating tofu and all that, and so is wine simply the wine which is doing the trick, or is it a surrogate for the educated, healthier lifestyle? There is some reason to think that that is part of the answer. This question of a lifestyle for which alcohol or wine is a surrogate is much less pertinent to beer and spirits.

Now the issue of the so-called J-curve and who are the abstainers. I guess you have heard all about the J-curve in these discussions. Is that correct, Dr. Stampfer? It has been discussed, the idea that the abstainers, if you draw a J -- imagine drawing a J here -- of mortality here versus dose, the lowest dose and mortality is at one or two drinks a day, say. It is actually a good deal lower, but the abstainers have a somewhat higher mortality, hence the name J curve.

Most studies have shown this. Some have not, but a lot hinges on this J, and I should point out that in some of the better papers the protective effect, if it is attributable to alcohol, occurs at far less than the recommended so-called moderate drinking dose. It is something like two or three drinks a week, not two drinks a day.

Getting away from this, a lot hinges on this J because if the J is not correct and the abstainers really have a lower death rate than the people drinking moderately, a lot of this topic would probably not even be discussed at all.

Now, one of the criticisms with the J, which I think the researchers have disposed of well, is the issue of the sick quitters. Those who believe that the J is essentially sort of fraudulent say that the abstainers really include groups of people who either stopped drinking because they were alcoholic or had to stop drinking for medical reasons, so they were destined for an earlier or higher rate of mortality. Therefore, the abstainers are a self-selected group of people who were sicker.

This so-called sick quitter thing, however, I think has been addressed fairly by the researchers who were maintaining the protective effects of alcohol, so I think we can dismiss that as a criticism which has been laid to rest.

New questions have been raised about the abstainer group. For example, aside from the so-called sick quitters, abstainers -- by the way, 30 percent of American adults are abstainers. I think many people do not realize that.

The abstainers include two categories. One we might call religious or ideological abstainers, those who do not want to do it for reasons which have to do with their beliefs and what life is all about, and the other group of abstainers are those who generally tend to be loners, do not have firm social networks and so on.

In general, people who have extensive networks of friends and social relationships tend to be protective against all sorts of mortality. A few papers have looked at this; not many.

Therefore, I would say as far as the epidemiological data goes, the association between mortality and alcohol I think is clearly there, but its explanation is not clearly there, and there is even some question about the J curve as far as the abstainers are concerned.

Let me move on to the second point; that is, the proposed biological mechanisms. I am going to discuss four. The first is the higher level of high-density lipoproteins which is seen in chronic drinkers. Now, if high density lipoproteins were the cause of atherosclerosis, then probably if we are going to get the benefit of this effect we would have to be drinking for many years, including the young years when people are at risk for deaths other than coronary artery disease.

Even now in the face of increasing new kinds of research on atherosclerosis involving cytokines and reactive oxygen species and all sorts of genetic things, it is not even clear that HDL is responsible for coronary artery disease, but rather it is a parallel event which is going on along with it. In any case, if it is not causative then we are piling one uncertain effect on top of another.

The second arena in which biological explanations have been suggested are those in coagulation mechanisms, blood clotting. The general theory is that alcohol reduces the tendency to clot. Therefore, the thrombotic event, which is the one previous -- just antecedent -- to the myocardial infarction, is being reduced.

Much of the animal data here -- by the way, you should look at the papers carefully -- is in very high continual doses of alcohol. However, one area where there is some decent evidence, I think, is in the issue of platelet aggregation, which is an event which is in hours before the infarction, not over a period of years.

When the platelets aggregate, that sets off in motion the whole clotting apparatus. The data is not uniform here either, but I will say that most of the studies -- most, but not all -- indicate a reduced platelet aggregation from alcohol.

Another area in which Dr. Stampfer has contributed is the issue of tissue plasminogen activator and fibrinolysis. TPA is what is given to coronary patients within hours of their infarction to thin the blood so they do not go on to extensive damage, but it is a naturally occurring substance, and it is responsible for breaking down some of the materials that ultimately become part of a blood clot.

Now, much of the epidemiological evidence, but not all, indicates that TPA level, which is considered a good thing -- from the point of view of myocardial infarction, is higher in people who are drinking. It may be that this depends on some aspect of hepatic malfunction because liver disease shows this as well, and it is possible that clinical measures of hepatic malfunction do not reveal a small level of malfunction as responsible for the increase in TPA.

What is more important than that is the issue of the parallel compound, which is called tissue plasminogen activator inhibitor, another substance in the blood which essentially counteracts the action of TPA. Here we have a very mixed story indeed wherein some studies, especially epidemiological ones, the TPA goes up and the other one goes down, but even that is not uniform.

In certain studies where individuals rather than whole clusters of people have been studied before and after alcoholization over a period of time, the TPA and the inhibitor of the TPA have gone up in parallel, so the evidence on the TPA thing, in my judgment, is mixed.

Now, there is another area of great importance called reprofusion injury. It is known that after a period in which the heart muscle has been deprived of blood even for a short time, and that is so-called ischemia, when it is reprofused, the blood starts rushing back again either accidentally in nature or because of some intervention by man, that the heart muscle is in danger of injury because of that rapid reprofusion.

There are some excellent results on this. We know a lot about the adenosine receptors and protein -- AC. We do not know how much of the effect on total mortality this mechanism would account for, but it probably is genuine. However, it is not clear at which dose this effect is happening.

A recent excellent paper in PNAS, for example, I think is doing a little hand waving on the dose. In my calculation, if you took a 175-pound man and gave the same caloric value of alcohol that they did in the animals, and the authors extrapolate to a different kind of a person, it turns out this would be almost five standard drinks, not two.

I will continue now with the antioxidant issue as the last aspect of the biological explanations, and this applies, of course, mostly to wine. Now, most of the evidence indicates that wine has no special advantage compared to other beverages as far as the alleged protective effect. However, there is some evidence which claims the contrary and why I raised the issue of wine being a surrogate for various social and educational factors. In some studies, some non-alcoholic grape components seem effective as antioxidants.

The whole question of absorption here is very muddy. By absorption, I am talking about the ability of a person to duplicate in vivo, that is in the whole person, to arrive at a concentration of these alleged antioxidants that duplicate the concentrations which in laboratory experiments in vitro show an antioxidant effect. The absorption various tremendously among the antioxidant group. Therefore, I consider this issue really up in the air and very much mixed up.

The third and final point I want to discuss with you is the possible consequences of increasing per capita consumption by expansion of recommendations about moderate drinking. Let me talk about moderate drinking itself now, which for the sake of discussion, though I know you were talking about it this morning, I heard, will be two standard drinks, 13 grams of alcohol per drink essentially per day for most men, except for the elderly, and one for women.

The areas where I think nobody disagrees or at least few do is that there should be no drinking in pregnancy. The threshold for some sort of effect has been dropping. We do not know where, if it exists at all.

Medication interaction I think is an important thing, especially in the elderly, because alcohol interacts with at least 150 medications, and the elderly really cannot take an accidental overdose.

Breast feeding is another area. There used to be an idea that women who were nursing ought to take some alcohol. It loosens up the lactation and so on. The fact of the matter is that the evidence is entirely to the contrary as shown by Julie Manola at Manola and others that it interferes with nursing, and the babies do not sleep as well. Therefore, alcohol and breast milk is bad news. As you know, alcohol distributes to all body water, and that includes breast milk.

There is another issue which is somewhat subtler, and that is whether we really want the whole country alcoholized with two drinks a night, even if that was the dose, throughout their lifetime.

We do not talk about this very much, but if you are a young person trying to make their way in a career or trying to study for a graduate degree or become a super athlete or something, is it really something that our nation really wants to have everybody alcoholized at two drinks a night. I do not know the answer. I am just raising it.

Having listed all these things, I think you either agree to them or they are minor, but the really important issue is the risk of escalation once somebody who is not drinking then embarks on a course of moderate drinking.

About 10 percent of those who start drinking -- and all of them go through some phase of moderate drinking; they do not drink a quart of vodka the day after they have their first drink -- about 10 percent of people who start drinking go on to severe problems. That is, severe problems. That is, they fit the diagnostic category of DSM, alcohol abuse or alcoholism. Ten percent.

There is a much larger group, or at least a larger group, who do not fit these diagnostic categories, but who still cause many of the social complications and medical complications, the highway deaths, family violence and so on.

We are not as clear how the rate of alcoholism varies with age; that is, if you are a starter at 50 compared to 30. I do not think we have any data on that. I can tell you, though, as far as the adolescents goes that the odds of becoming alcoholic -- I am not talking about just troubles, but diagnosable alcoholism -- are 40 percent of kids who start below the age of 13, and it drops down to about the 10 percent that I just mentioned by the time they get to be about 18 or 20. In that sense, we have a considerable worry among the adolescents.

One issue that is not discussed very often in these discussions is issues other than mortality. Now, that is the so-called disability-adjusted life years, a term which was introduced into the recent Harvard WHO studies on the burden of disease.

Now, this disability-adjusted life years accounts for two things, life with disability and premature death because premature death means that valuable years of life have been lost, which is obviously much more important for a young person than it is for an older one as far as the calculation goes.

If you ask an old person like me if my life counts, I would have to say it is very important. Still in all, when you look at epidemiology a person who dies at 30 is a greater tragedy for society than a person that dies at 68. Alcohol is the fourth leading cause of disability-adjusted life years in the world. In the world. Now, this is from the burden of disease study.

Let's talk about that problem I referred to in the tradeoff in France where one group of researchers concluded that the alcohol-related deaths almost compensated for the lives allegedly averted from ischemia heart disease death. The Harvard WHO study concluded that 750,000 more deaths were caused by alcohol in the world, more than those allegedly averted by drinking. Eighty percent of this excess was in the developed countries.

Now, I am not claiming that this number is holy and opposite numbers are trash. No, I am not saying that at all. My point here is that this issue is not proven. That is all.

Let me say something else now about the pattern of distribution in society. In general, the higher the mean or median level of drinking in society, the more heavier drinkers there are and the more the social and medical consequences that ensue.

Now, we only have cross-country comparisons here. I have inquired, and nobody can tell me of a single country where the kind of normal distribution has been compared after social policy changes. We do have country-by-country comparisons. Furthermore, we have case after case where the access to alcohol has been loosened or tightened in various cycles, and almost invariably the extent of drinking and the consequences of drinking have gone up every time there has been an increase in the per capita consumption.

Now, what is the effect of the escalation of drinking on others around the drinkers and the whole society? We have been talking about the drinkers themselves. The current cost of alcohol misuse to our society is about $165 billion a year. This is the result of a study that we and IDA funded together.

Interpersonal relations, parenting, family violence. These are things that may extend beyond the drinker himself or herself. The ability to do well in one's education, new health care costs to one's self and to others, productivity costs to industry and the cost to social welfare and so on and so forth.

What I am saying here is that by raising the mean level of drinking and the per capita consumption, some people who start drinking in order to achieve these

so-called benefits of moderate drinking are going to escalate to higher doses, and it is going to end up costing society more in health and in medical cost.

In conclusion, the last few years have seen critical examination of all the premises in this matter. As I said before, I am not saying that all the claims are wrong. What I am saying is that important ambiguities and contradictions exist now in the protective effect itself and the purported biological mechanisms to explain it.

Measures whose effect are to increase per capita consumption lead us into risky territory where the dangers of doing harm are at least as likely as the odds of doing good. There is an old medical aphorism: In primis non nosere. (First do no harm).

One of our nonscientist senior people had a very nice phrase while discussing the pros and cons of this discussion. He said, what you are trying to say is a little bit of not so fast. That is it.

CHAIRMAN GARZA: Thank you very much.

Are there any questions or comments from any of the members on the committee? Dr. Stampfer?

DR. STAMPFER: Yes, a couple questions. In your last comment you emphasized the importance of not increasing per capita consumption, but is there any reason to believe that a recommendation for moderate consumption would do that?

DR. GORDIS: Yes, I think so. Yes. I mean, the only way a recommendation of that sort is going to make any dent is if people who are not drinking are going to start drinking. The heavier drinkers are not going to go down to two drinks a day by virtue of whatever guidelines you write.

Therefore, all we can see is either no effect because nobody reads the dietary guidelines or --

MALE VOICE: There is some evidence for that.


DR. GORDIS: Or an effect to increase drinking. Of those who start drinking from zero to two, there is going to be a batch of them who drink more. No way of escaping that, I do not think.

CHAIRMAN GARZA: Do you want to follow up on that?

DR. STAMPFER: Yes. I want to put you on the spot, if that is okay, --


DR. STAMPFER: -- and ask if you have any specific recommendations on the current guidelines and how they might be changed?

DR. GORDIS: I think I will stay out of that, Meir. That is your job, and we will comment on it when asked.

DR. STAMPFER: Remember, you had your chance.



DR. GRUNDY: My question is a little bit along the same lines. Just in general, how do you deal with that?

I mean, we have had a struggle with that for years with recommendations of different types where you say nothing about alcohol, comment on it at all or just leave it out of any kind of guidelines. What is your policy or your view on that?

DR. GORDIS: Well, I do not argue too much with what was in the last ones.


DR. JOHNSON: May I address a question to someone in the audience related to consumer information and alcohol?

CHAIRMAN GARZA: Can we do that at the end, right at the end of this presentation?



DR. DWYER: Dr. Gordis, I wonder if you would be kind enough to share your views on the evidence or lack of evidence associating the breast cancer with alcohol consumption? I know there is a putative mechanism, and I wonder if you would be willing to --

DR. GORDIS: There is a putative relationship. I do not think there is a putative mechanism.

I think at best the relationship was very weak. If you looked at the papers which supported a relation between alcohol and breast cancer, the risk ratio is probably not much more than 1.2, but a recent study I think from Framingham did not find anything, so I would say that that is a nonevent in this discussion.

CHAIRMAN GARZA: Dr. Kumanyika?

DR. KUMANYIKA: Could you elaborate on the idea that people who are heavier drinkers will not reduce their consumption? Is there no evidence that people can moderate their alcohol consumption and might be advised with the moderation?

DR. GORDIS: Sure, but I think you have to make a specific attempt to do that. Simply putting out dietary guidelines on the alleged safety or benefits of two drinks a day will not do it, I do not think.

DR. DWYER: How do you feel about the standard drink? We have heard some testimony earlier.

DR. GORDIS: Yes. Yes. You know, I know that came up this morning.

You know, it came up in our own discussions back in NIAAA last week because I heard that some people think that it was pulled out of whole cloth, you know, that it was just made up. The heavens opened, and the angels said two drinks a day, and that is the way it became sacred.

That is not really what happened. Actually, I called Charlie Leber in New York, who is professor at Sinai, because he has been on the history of this early on. I said, Charlie, how did this start?

The story he gave me was -- and it is quite reasonable, by the way, I believe -- that they looked at the data from France by Pequeno, and it turned out that they were looking at it to see where inflections occurred in various consequences of drinking and the curve of dose versus consequence.

It turns out that even for cirrhosis, which may be surprising, the inflection is at about two drinks a day. By the time you got to three drinks a day in the Pequeno data, the risk for cirrhosis started to climb. Now, actually it is not very high there. You have to drink a heck of a lot more than that to be pretty sure of getting it if you are going to get it because not everybody who drinks even heavily gets it.

It was based on looking at this kind of inflection point, and the difference with women is based on the not unreasonable idea that because of their lower lean body mass and the fact that there is some question about the gastric alcohol dehydrogenase being less efficient there, they are likely to get a somewhat higher blood level from drinking the same amount per unit of body mass. For the elderly, likewise, I think.

This is not, you know, absolutely tight, but I think it is very reasonable. It is not just pulled out of whole cloth.

CHAIRMAN GARZA: Would you please use a mike? Concern has been expressed that the committee's comments will not be preserved for posterity. We do not want that.

DR. STAMPFER: One last question on the elderly. You had mentioned that perhaps the recommendation for limit for moderation might be reduced, and I was wondering if there is any data based on clinical end points to support that?

DR. GORDIS: Well, we are dealing with a bunch of clinical observations. You know, alcohol has subtle effects on cognition, and the elderly may have some subtle ones, but in the animal literature there is evidence that the elderly animal is less tolerant to the acute effects of alcohol also.

CHAIRMAN GARZA: We heard some testimony this morning suggesting that in a large metanalysis, a decrease in mortality of 22 percent was found and that in fact because this occurred across many cultures that one could discount concerns regarding confounders.

DR. GORDIS: Well, you know --

DR. STAMPFER: Can I just clarify? That was a single study. It was not a metanalysis.

CHAIRMAN GARZA: All right. I am sorry.

DR. GORDIS: I do not agree.

CHAIRMAN GARZA: If you know the study, can you give us its strengths and weaknesses?

DR. GORDIS: Let me just say my view on

metanalysis is that when you analyze junk, you get


CHAIRMAN GARZA: Well, apparently this was not a metanalysis. It was a single study is what I was told.

DR. GORDIS: So many of the studies are riddled with the kind of limitations I have talked about that I do not think you can look at this global evidence with any great confidence. I think you have to look at the details of the individual studies, and that is what I think the committee ought to do.

CHAIRMAN GARZA: Any other comments?

FEMALE VOICE: You may have alluded to this with the older animals, but is there any evidence that as individuals age they have less of a capacity to metabolize a given amount of alcohol in a given period of time?

DR. GORDIS: No. The metabolism does not seem to be changed.

DR. STAMPFER: Just a point of clarification on that study with the 22 percent. What is being referred to is the Thun study, T-H-U-N. It was published in December of 1997 in the New England Journal.

It was based on the American Cancer Society cohort where they did adjust for smoking and several of the other factors. They looked at lifelong nondrinkers as the referent category, so I think it would qualify as one of the better studies in the area.

DR. GORDIS: Thank you.

CHAIRMAN GARZA: Any other comments or questions?

Thank you very much, Dr. Gordis.

I have one question for Dr. Grundy. Are you at all familiar with the evidence Dr. Gordis related regarding the HDLs and its possible role or nonrole in protecting against cardiovascular disease?

DR. GRUNDY: There is a strong association between HDL and risk for coronary disease. That is well recognized and duplicated in many studies. The question again is what is the nature of that relation. Is it a direct protective effect of the HDL on the artery wall, or is it an association?

I think the answer is probably it is multiple factors. It is associated, and it has maybe some direct effect from studies in -- animals and such where they raise just one factor like apo-A1. That does seem to protect.

However, there is a strong association between other atherogenic lipoproteins. When you have high remnants, you have low HDLs, so that is another factor. There is some confounding there. It is also confounded by the fact that low HDL is part of the insulin resistance syndrome and the other components of that metabolic syndrome like hypertension and other atherogenic lipoproteins and pro-coagulant state and glucose intolerance. They all go along with low HDL.

I think it is both an association and possibly a direct effect, but there are no strong studies. Well, we do not have a means in humans to raise HDL specifically, so we do not know that raising HDL per se would protect. I think that is why there is expressed some uncertainty before that we know that the alcohol effect working on HDL is a protective effect. We just do not know that.

CHAIRMAN GARZA: Rachel, you had a question of someone in the audience?

DR. JOHNSON: Yes. I just wanted to ask Dr. Geiger, who did the consumer focus group studies, about --

CHAIRMAN GARZA: Is Dr. Geiger still here?

DR. JOHNSON: -- if you had any data on the perception of the consumer with the alcohol guideline and whether it is sort of a permission to drink or whether it is, you know, if you do drink, drink in moderation.

DR. GEIGER: Two things arose out of that discussion. It was consistently ranked last in importance, and what they really wanted was a definition of moderation. They had heard that a glass of wine a day might help reduce the risk of heart disease.

DR. JOHNSON: But they were not clear what the definition of moderation was?

DR. GEIGER: They all had their own definition of moderation for themselves, but they did not know if everybody would interpret that correctly.

CHAIRMAN GARZA: That was specific for the alcohol guidelines?

DR. GEIGER: Yes, it was, although moderation meant different things for different guidelines, but for that particular --


DR. JOHNSON: Thank you.

CHAIRMAN GARZA: Dr. Lichtenstein?

DR. LICHTENSTEIN: I also have a question for Dr. Geiger.

Did any issue come up around that guideline regarding the appropriate age to start or who that exactly applied to? Did that apply to anyone over the age of 21, or was it supposed to be something that was phased in or any issues around that?

DR. GEIGER: That is a question I do not believe came up directly. The dietary guidelines were defined to them at the beginning of the focus groups for people aged two years and older, so I think some of them questioned if that would be appropriate for school-aged children.

CHAIRMAN GARZA: Any other comments or questions?

Dr. Kumanyika?

DR. KUMANYIKA: I am just wondering, and maybe this is a question for Dr. Gordis, if we were to try to harmonize an alcohol guideline in the dietary guidelines with other guidelines for alcohol consumption, what are the guidelines that are put forth by other agencies for alcohol consumption without thinking about the dietary aspect?

DR. GORDIS: I do not know of any others except the ones that we have stated, which I have mentioned. You do not drink until you are 21. You do not drink during pregnancy and stuff like that. Two drinks of the standard nature that I described to you for men and one for women and one for the elderly.

CHAIRMAN GARZA: So the American Heart Association, for example, does not comment on alcohol and the role in cardiovascular disease that you are aware of?

DR. GORDIS: They may. I just do not know.

DR. GRUNDY: I do not think the American Heart Association has advocated -- certainly they have not advocated its use for preventing. It is pretty much the same as in this guideline here.

CHAIRMAN GARZA: Shiriki, did you have any

other --

DR. KUMANYIKA: I was just thinking that the main arguments that we have heard against alcohol consumption have to do with vehicle injuries and issues that really are not dietary.

It seems odd in a way that the major coherent guidance for the public comes under a dietary context where it seems like it would imbalance in terms of the issues, so I was just trying to see what would the guideline be if diet were only one of many considerations and you looked at it that way.

DR. LICHTENSTEIN: Just for the record, there is a statement from the Nutrition Committee of the Heart Association on alcohol that is published in Circulation. Unfortunately, I do not remember the details of it, but that could be ferreted out relatively easily. I think the author is Tom Pearson.


DR. STAMPFER: Another question for Dr. Gordis. There was a recent paper from NIAAA which very nicely showed that the younger people started to drink, the more likely they were to run into problems later in life. I think if I remember right, the data stopped around the mid-twenties.

I am wondering if you can give us either some data or, if there are no data, some conjectures about what might happen if there were a recommendation to drink, say, starting at age 50 or something.

DR. GORDIS: I think I mentioned in my remarks that I do not know whether the -- I think you're going to find that the age, if you're going to do moderate drinking, is a little bit lower. We do know that there is less drinking among the elderly. There are a variety of problem drinkers who start their drinking in the fifties, but it is probably a minority compared to the ones who have been drinking their whole life.

It might be lower than 10 percent, but most people who do get in trouble with alcohol start at a relatively younger age. Ten percent is probably close.


DR. DWYER: I remember years ago one of the French premiers, I think it was Pierre Mendes-France, suggested that French youth, specifically little children, should not drink wine. They should drink milk. I believe he encountered severe criticism because of that. Now, I am not sure.

Do you know if they did start drinking milk instead of wine and if there were lesser problems --

DR. GORDIS: I remember that.

DR. DWYER: -- with the milk than with the wine?

DR. GORDIS: He was sort of laughed at and so on and so forth. Let's remember that France has one of the highest cirrhosis death rates in the world.

CHAIRMAN GARZA: Getting back to Dr. Dwyer's question, I thought I had understood you to say that limiting a recommendation to older age groups, even if the 10 percent figure did not apply and it was substantially lower, might be problematic because of the motor function issues --


CHAIRMAN GARZA: -- and also because of the

drug --

DR. GORDIS: -- medications.

CHAIRMAN GARZA: Medications. Do I understand you correctly then?

DR. GORDIS: That is right.


DR. DECKELBAUM: We heard this morning and now sort of differences between the age groups. When we look at the current guidelines, we can see at different points under the different guidelines a section relating to children, adolescents or special populations.

I would just like to bring up a general point to the committee that as we go through the deliberations in terms of considering whether this should be a special guideline for children, that is a possible option, but I would think more that somewhere in the text rather than children having to go through four or five places to find out what they should do, there could be a summary of what the guidelines do recommend and the different categories for children.

CHAIRMAN GARZA: Okay. We have promised Dr. Gordis on numerous occasions that this would be the last question, but this will really be the last opportunity for the committee at least.

Are there any others? I was about to offer the last opportunity. Richard?

DR. WEINSIER: It is stated in the 1995 guidelines, Dr. Gordis, that if you drink alcoholic beverages, do so in moderation with meals. Other than presumably decreasing the risk of inebriation, are there any health benefits to taking it with meals?


DR. WEINSIER: So am I correct the reason to take it with meals is simply to --

DR. GORDIS: Slow it down.

DR. WEINSIER: -- slow down the rate of absorption and inebriation, and the risks associated gets beyond the dietary guidelines per se.

CHAIRMAN GARZA: Thank you very much.

We will move on then to the next item. We are very fortunate again to have Dr. Catherine Woteki, the Under Secretary for Food Safety in the Department of Agriculture, come speak with us this afternoon to address the issue of food safety and to help the committee in its deliberations as to whether or not there should be greater inclusion of food safety issues in the current guidelines in one form or another.

DR. WOTEKI: Thank you very much, Dr. Garza.

While we are getting set up here, I would first of all like to introduce to you Sandy Facinoli, who is going to help me this morning or this afternoon with these overheads. Sandy is currently the acting head of our Office of Education and is looking forward to working with the committee as you continue your discussions of whether to include a guideline on food safety or how to address food safety within the context of the guidelines.

Also while they are still fiddling here with the projector, I have a couple of slides that are very busy, so I have made copies for the committee of those data slides so that you can have your own and will pass those out.

Thank you very much for the invitation to talk with you about food safety in the dietary guidelines. I had the opportunity last week to give the Enderson lecture at the University of Massachusetts to food science students, and I talked about during that speech the rare occasions when either an individual is in the right place at the right time or a group of people are in the right place at the right time where you can make a great leap in public health policy. I think in many ways this committee is situated at the right place at the right time to do that with respect to the dietary guidelines in food safety.

The dietary guidelines are an example really of a policy decision that was made quite some time ago that has had a great impact on the health of Americans from two different perspectives. One is the educational message to the public. Clearly through the millions and millions of copies of the dietary guidelines that have been distributed to the public and that have served as the basis of educational messages that are being taught in classes and being delivered, the guidelines have had an enormous impact.

The second impact has been the policy implications of the guidelines because they are viewed by the Department of Health and Human Services and by the Department of Agriculture as being the articulation of our policy as it relates to food and health.

The dietary guidelines have I think really been very much a success story because they are relevant. They are relevant to people's lives. They have been kept up to date by expert review such as the one that you are engaged in right now, and they are looked at by health educators, nutritionists and food educators as being a key document for their use.

Today what I would like is to encourage you to seize the opportunity to make them even more relevant to today's needs by supporting the view that the time has come for the dietary guidelines to address food safety.

Now, in preparing for this I went back, and I looked over some of the early documents that preceded the first dietary guidelines. The reason for doing that was to kind of look at what the original intent was underlying the dietary guidelines.

The three documents were all published in the 1970s, and they really helped to set the stage for the dietary guidelines. The first was the report of the Senate Select Committee on Nutrition and Human Needs, Dietary Goals for the United States, and it actually was the culmination of a whole series of different studies that that committee had undertaken.

In Dietary Goals, Senator McGovern, who chaired the Select Committee, said, and I quote, that "If we as a government want to reduce health costs and maximize the quality of life for all Americans, we have an obligation to provide practical guides to the individual consumer, as well as set national dietary goals for the country as a whole."

Now, the publication of the dietary goals drew attention to the need for new guidance on diet and health. I think the real emphasis at that point was on new guidance, what was new in the scientific community that would change the basic message of food and its role in health for the public.

Now, the publication of the dietary goals caused an enormous amount of controversy, and Surgeon General Julie Richman, who was then Surgeon General, asked that the American Society for Clinical Nutrition review the literature on the effect of nutrition and health outcomes. The result of that was actually a special publication in the American Journal of Clinical Nutrition that was entitled "Dietary Factors Relating to the Nation's Health." Then in 1979, the first edition of Healthy People was released, and some general dietary guidelines were included in that, calling attention to the role of the individual in maintaining his or her own good health.

Now, I think these three documents together really helped to focus the scientific and the educational community and the country at large to recast our health strategy to emphasize the prevention of disease and the role that food can play in the prevention of disease. They gave rise to the Dietary Guidelines for Americans.

As I was thinking back about it, it was actually the controversy about the dietary goals that actually gave rise later to the dietary guidelines, which were and still are designed to help Americans choose diets that will meet nutrient requirements, that will promote health, that will support active lives and reduce chronic disease risks.

That first dietary guideline is, as all of the subsequent reviews and documents have been, a joint effort between the Department of Agriculture and the Department of what is now known as Health and Human Services.

Now, as I said earlier, the fact that the guidelines are updated periodically and that we have legislation that requires that they be updated periodically for scientific accuracy and appropriateness is I think one of the reasons for their success.

Since 1980, they have been revised every five years based on this expert review by the Dietary Guidelines Advisory Committee, and that brings us to you and to today with the committee now making recommendations for what is the fifth, the year 2000, edition.

I think it is also worthwhile to be reminded that the legal requirement to review the changing body of scientific knowledge that underpins the guidelines also, to my mind, implies that there is an expectation that the guidelines are going to change over time so that they will reflect new information that has become available since the last time that they were published.

I think it also implies that there is no wedding, no bond, to the number seven as far as the number of guidelines or, you know, the fact that we have always had one about one topic or another. That has to change to reflect the evolution of scientific knowledge.

I believe the time has come to include food safety in the dietary guidelines for a number of reasons. There are four of them actually, and I have summarized them here. What I would like to do is just briefly go through the summary and to go through each one separately, as well as the evidence that I think you should take into consideration when you consider this topic.

My four arguments are first that the inclusion of food safety is consistent with the original intent of the guidelines, which is to help Americans choose diets that will meet, first of all, nutrient requirements; secondly, promote health; thirdly, support active lives; and, fourthly, reduce chronic disease risks.

My second argument is that much less was known about foodborne pathogens in 1980 when the first Dietary Guidelines Committee published its guidelines and that the new guidelines should reflect current knowledge about diet and long-term health. From that perspective, food safety is a critical factor in any discussion about diet and long-term health. Most all of the information that I am going to be presenting to you today is actually new information that has become available since 1980.

The third argument is that nutrition and food safety are inextricably intertwined and that to try to separate them out and to say no, we are only going to deal with one aspect of diet and health in these guidelines, I do not think makes sense.

The fourth argument is that foodborne diseases are preventable. For that reason, the government has an obligation to help people to protect themselves. This dietary guidelines document, because it is so widely circulated and does form the basis for so many different educational programs, is a good vehicle then to get that message out.

Let me now go through each one of these arguments in a little bit more detail. Argument number one is that food safety is consistent with the original intent of the dietary guidelines because food safety has an important role in promoting health and reducing chronic disease risks.

When the dietary guidelines were first issued, little was known about the extent of foodborne illness and just how severe foodborne illnesses are. We also know that new pathogens have emerged just in the last decade or two, and some of these pathogens are quite virulent.

I think the best example is E. coli 0157:H7, which first emerged in 1982 and was recognized as the source of an outbreak here in the United States. It is just about 17 years that this organism has emerged and is at this point practically a household word.

Now, I think it is also worthwhile to look at the original intent for the guidelines, those four points that I reviewed and that are summarized here. First of all, meeting nutrient requirements. From the food safety perspective and also from the perspective of nutritionists who work in developing countries, we know that diarrheal diseases interfere with nutrient absorption and that a very, very large proportion of those diarrheal diseases, up to 70 percent, are foodborne diseases.

The second, to promote health. Well, the flip side of that is preventing disease. The underlying intent of the dietary guidelines is to prevent disease.

The third part of that original intent for the guidelines was to support active lives, and I would say by definition preventing foodborne diseases is going to support active lives.

The fourth as far as reducing chronic disease risk -- yes, I have not left that one yet, Sandy. Reducing chronic diseases. There is a growing body of evidence that links pathogens and a number of foodborne pathogens to chronic disease. Okay. Now we can go on to the next one.

Argument number two is that I believe that the guidelines should reflect the newest knowledge about diet and long-term health, including the effects of food safety on long-term health. We also, as part of the argument about reflecting the new knowledge, do have quite a bit of information now that represents what the economic burden to society is, particularly in the United States, for foodborne diseases. I am going to present some of that information to you this afternoon.

It is also becoming increasingly associated with chronic diseases, and I am going to very briefly go into that area. Lastly, there is a growing segment of the population that is particularly susceptible to foodborne diseases.

Now let's look at each of these points in a little bit more detail. First of all, I would like to share with you some data that comes from the Council for Agricultural Science and Technology. In a report that they issued in 1994, they estimated the number of cases of foodborne disease occurring in the United States on an annual basis. Their estimate was 6,500,000 to 33,000,000 cases of foodborne illnesses and up to 9,000 deaths each year are due to foodborne microbial pathogens.

Now, these data or these estimates from CAST were actually based on data from the Centers for Disease Control and Prevention, and that original estimate from CDC was somewhat higher. It had a somewhat higher upper bound of up to 80,000,000 cases a year.

I think that the discrepancies in the numbers, in the estimates, that have been made over time and that even on some of the slides that I am going to be using today are kind of an indication of that fact that these are estimates. They are based on different assumptions. Regardless of what the upper bound is that one sets, it is a large number, and it has a huge economic impact.

I might indicate, though, that there are new data that will be coming available very soon. In fact, later this week the Centers for Disease Control will be issuing their estimates on foodborne illnesses from the FoodNet data system. I believe that publication is due out on Friday. It will focus on data from the five catchment areas that are part of the CDC active surveillance system, and those are in Minnesota, Oregon, California, Connecticut, and Georgia.

Later on this year, CDC will be coming out with a revised estimate overall, a national estimate of the burden of foodborne disease by specific types of organisms that will be a revision of these numbers that are here, the 6,500,000 to 33,000,000 cases per year.

We would be happy to provide to the committee copies of the MMWR when it comes available and also will make a note to make sure that if you are still meeting when CDC comes out with its revised estimates that we get you copies of that as well.


DR. WOTEKI: Secondly then, let's look at the estimates of the number of foodborne illnesses by organism. This is one of the tables that is in the packet that I handed out to you, and this is a good reason why we handed it out. It is not showing up.

Essentially this shows for a number of bacteria and one parasite, toxoplasmosis gondii, that there are a range of estimates on the numbers of cases and deaths that are attributable to these organisms each year. I would just like to point out for you two of these organisms.

Sandy, you might actually point to these on the slide.

The first one that I want to point out to you are the estimates for E. coli, which are 16,000 to 32,000 cases a year and deaths ranging, estimates again, from 63 to 126 per year. E. coli, although it does affect a lot of people, has a relatively low mortality rate.

In comparison, listeria, listeria monocytogenes, which is a little bit lower down, has a very much smaller number of cases, in the range of 1,000 to 2,000 each year, but it has a very high mortality rate of 20 to 25 percent. This then is an important point a little bit later when I get to what the costs are that are associated with these different organisms.

Now, even though our estimates on the numbers of people that are affected through illness -- and, tragically, through death -- leave a lot to be desired, let's say that

-- we do know, though, that we are making some significant progress on a number of these foodborne organisms.

The health promotion/disease prevention goals for the year 2000 set specific targets for four of these organisms: salmonella, campylobacter, E. coli 0157:H7, and listeria monocytogenes. And the surveillance data that were used in 1997 to update what our progress has been on these indicates that as far as the targets that were set early in the decade that we have made very significant progress on these four, and in fact the targets had already been met by the 1997 point at which this assessment was made.

I think it does give us some confidence that foodborne diseases can be reduced, and certainly it also indicates that beyond the interventions that are being done in food processing by the industry and by the regulatory agencies that education is a very important component in this strategy because consumers need to know what they can do to protect themselves.

Now, the next point that I want to make is that the costs that are associated with foodborne diseases are quite significant. This next set of estimates come from the Economic Research Service, an article by Buzby and Roberts and that was published in 1997. Their analysis shows that foodborne illnesses attributable to seven of the major pathogens have costs to society that range from $6.6 to $37 billion annually in medical costs and lost productivity.

Particularly since I am responsible for the agency that regulates meat and poultry and egg products, meat and poultry alone accounted for $5.2 to $28 billion of these costs, so on this chart the first two columns here actually show two different economic approaches to costing, so those first two columns. That gives us at the bottom then the range of $6.6 to $37 billion a year in associated health care costs and lost productivity costs.

The middle column represents the proportion of illnesses that are attributable to meat and poultry products, and then the last two columns then give you the estimates, again using these two economic approaches towards assessing or estimating what the costs are for foodborne illnesses that are attributable to meat and poultry as the vehicle for the disease.

Next I wanted to talk about microbe-induced chronic disease. This is a relatively new idea, and in some ways it probably reflects the state of knowledge about this topic as existed in the mid-1970s when the dietary goals and the dietary guidelines were under consideration.

The impact of foodborne illness on health is becoming even more significant, particularly as we recognize the ability of some infections to cause chronic complications. This is the new area I think that we are gaining a greater appreciation of. We used to think that foodborne illnesses were just an acute illness, a belly ache that would go away in a couple of days. You really did not need any treatment. Stay home. Rest. There are no chronic consequences.

We are finding that increasingly that is not the case. We are finding that bacteria such as helicobacter pylori are very significantly associated with ulcers and bacteria in a positive sense and may be partially responsible for heart disease. We are also finding that foodborne bacteria can cause serious and chronic illness.

Now, it remains to be learned what role food plays particularly as the vector for helicobacter, but we do know that helicobacter survives in chilled water, milk and vegetables for several days. Human feces is most often the source of contamination, but we also know that there are animal reservoirs for the organism, so although there is a causative link between helicobacter and ulcers, the specific foodborne route of transmission and whether it is a zoonotic disease is the area that still remains somewhat unclear at this point. I think it is quite controversial.

It is estimated, though, that chronic sequelae may occur in as great a proportion as 2 to 3 percent of foodborne disease cases and that the long-term consequences to human health and the economy may be much more detrimental than the acute disease for which those cost estimates were based. Now, the cost estimates also, to the extent that the economists could, did take into account the chronic effects as well.

Now, there are some examples of known associations such as E. coli 0157:H7 and hemolytic uremic syndrome, which is an acute renal failure that occurs particularly in children. Another is campylobacter and Guillain-Barre syndrome, a neurological disease that causes a paralysis. In many cases it is a temporary paralysis.

There is also very good information that relates rheumatoid disease to various species of urcenia, shigella, salmonella, campylobacter and E. coli, Graves disease, the autoimmune thyroid disease, to urcenia, enterocolitia, inflammatory bowel disease, to pseudomonas microbacterium,

E. fecalis and E. coli.

Jim Lindsey actually did a very good review of the relationships between foodborne diseases and chronic diseases, and I can also make that available to the committee if you would like to have that. It is relatively recent. It was published in 1997 in Emerging Infectious Diseases, and I think it is the best current review that I have seen of the topic.

Now, we also know that we have a growing segment of the population that are highly susceptible to foodborne illnesses. The impact of foodborne illnesses on these

subgroups is very disquieting. For example, more people today are able to live longer with diseases that put them at particular risk of contracting foodborne illness. An example is HIV, AIDS or also transplant patients who are taking immunosuppressing drugs.

The elderly and pregnant women are also most affected by foodborne outbreaks, particularly listeria monocytogenes, which has gotten a lot of current attention because of a large outbreak.

Lastly on this topic, I wanted to show you just a very simple chart that shows for one organism, E. coli 0157:H7, the infection rates by age. As you can see from this, the ages from less than one year to more than 65 that the infection rate is highest for children age one to four, but it is also elevated as compared to adults for all of those under the age of 15.

To kind of summarize the arguments so far on this topic, new knowledge about foodborne disease I believe warrants consideration by the committee, and particularly these relationships of foodborne diseases to chronic diseases I think is particularly important. All of this is information that has become available since the 1980s and much of it just in the decade of the 1990s.

Now, argument number three was that nutrition and food safety are inextricably intertwined. I think this is another reason for including food safety in the dietary guidelines. We know that nutrition and food safety are both critical in having a healthy diet or a health-promoting diet.

I am arguing that we take and that the committee take a holistic approach towards considering nutrition and food safety. I think educators certainly like to talk about food safety concerns when they are teaching about nutrition. We frequently get inquiries to FSIS, as well as to other organizations that I have worked with, about how to link these two topics.

We also know that the public is making their food choices with safety in mind, in addition to taste and nutrition and other cultural factors that they may use in selecting foods.

The argument for the holistic approach to food safety -- certainly within the Department of Agriculture we are taking that approach -- nutrition, food safety, food security in the environment are really being considered together when designing food and agricultural politics, and this concept I believe should extend to our dietary guidance as well.

We are also increasingly seeing providers of education, providers of health and nutrition guidance, focusing on food safety. The American Dietetic Association in 1997 issued a position statement on food and water safety emphasizing that industry and government should educate food handlers about food safety, and that is in the home as well as in industry. Healthy People 2010, which is under development now, I am told is going to have some new food safety objectives.

Several countries have included food safety in their own dietary guidelines; China, for example. Their guidelines say do not eat any food that has been left out overnight. Any guidance for educators from the food and agriculture organization also mentions some key messages about food safety.

I think we also need to take into account public concerns about food safety because they are affecting people's food choices. Pregnant women, for example, should be receiving food safety guidance along with the nutrition guidance that they need.

The recent outbreak again of listeria monocytogenes I think clearly has pointed out that women who are pregnant are not getting that food safety guidance, so I think it is extremely important that they do. In many cases, education on proper handling and preparation can help to allay concerns, but if certain foods are avoided, nutrition educators have to be ready to help patients continue to meet their nutritional needs.

Finally, the fourth argument that foodborne disease is preventable I think underlies all of the policy approaches that we are taking within the Food Safety and Inspection Service, and I think that the dietary guidelines could and should incorporate this idea as well that foodborne diseases are preventable and that we have an obligation to provide food safety guidance wherever we can.

I think this is particularly true because consumer knowledge is lacking. It needs constant updating and reinforcement, and we know that education can be successful at least in filling the knowledge gaps if it is not always leading to changes in behavior, but that is not any different from the nutrition situation either in our guidance.

We know that there is a huge interest in food safety. The International Food Information Council commissioned the Center for Media and Public Affairs to examine information that the news media provide to American consumers about diet, nutrition and food safety issues, and this just kind of summarizes their survey that was done in 1997 as compared to 1995.

Essentially what it shows is they examined 38 local and national news outlets from May through June, 1997, and they compared those findings then with the same three months from 1995. The data shows that foodborne illness was the leading topic of discussion in 1997, and the leading source of harm mentioned was bacteria in food.

Now, while the interest is there and frequently the knowledge is there, the actual food safety behaviors are not. This is an area where again there is not a lot of information, but there was an extremely interesting article that appeared in Food Technology in February of 1998. It was an audit of consumer food handling practices, and it showed that poor food safety practices are common even among the better educated segment of our population.

The data were collected from 106 households in 81 cities across the U.S. and Canada, and it was admittedly a very biased sample. Individuals were highly educated. Seventy-three percent of them had college degrees. The auditors used a critical control point approach similar to the same approach that they use when they go audit the food safety practices in restaurants. This is a commercial audit firm.

They found critical violations, including cross- contamination, sick and symptomatic food handlers, neglected hand washing and improper cooling of leftovers. Less than one percent met the minimum criteria for acceptable performance. Ninety-nine percent flunked, and at least one critical violation was observed in 96 percent of the households.

Now, I would hate to see what would happen in my household if they came in or any of yours probably, but a follow up to this study recently released showed that those participants in the 1997 survey who had received an exit interview cited significantly more improvement in their food safety habits, which really supports the belief that when provided with education and information, people will act on it, which then leads us to the Fight Bac campaign.

Many of you have probably seen this. It is an example of a major food safety campaign that is meeting the need for food safety education. The concept behind it was actually very similar to the development of the dietary pyramid.

The food safety community wanted to have an easy to follow set of guidelines that were science based, had been rigorously consumer tested and that could serve as the basis for a nationwide education program, and this is what they came up with.

It is sponsored by a public/private partnership for food safety education. The messages are purposefully very simple, to the point, action oriented. They are well researched, well founded on science. They have been tested by focus groups, and they really are the most important behaviors that need to be changed.

We believe that food safety guidance incorporated into the dietary guidelines would need to meet the same criteria. Similar to the use of the pyramid in the guidelines -- you do not have everything about the pyramid in here -- Well, we would not expect everything about this Fight Bac, Four Simple Steps, to be in there, but the concept should be, and it should be a way to reinforce that.

In closing, I support the view that there should be a food safety guideline in the dietary guidelines. I believe that the time has come, and it was certainly on the minds of the authors of the dietary goals document back in 1997 (sic).

I would like to close on a quote from them kind of harking back 20 years. The quote is this. "Guidance of consumers towards nutritionally adequate diets must include research-based knowledge on food management procedures and preparation of foods for the table to assure retention of both nutritional and eating qualities and to avoid foodborne illnesses."

I want to thank you for the invitation to speak with you today. I also want to thank Dr. Johanna Dwyer, who has been spearheading the efforts on development of such guidance.

Thank you.


Are there any questions or comments? Dr. Weinsier?

DR. WEINSIER: Cathy, you make a compelling argument for including this in the guidelines. Let me think out loud with you for a minute.

The guidelines, as I understand them, focus on the "what" issue; that is, what to eat to stay healthy. I am trying to fit that into that scheme. I am seeing this more as a functionality issue or a what issue, a what in terms of what needs to be done to select foods, to prepare foods, to handle foods, to serve foods for various purposes, one of which may be to prevent foodborne illness.

But then do we have to think about the "how" issue in terms of preventing food allergies, drug/nutrient interactions? Do we go so far as to think about the way we handle, serve and prepare foods in terms of nutrient losses, cooking, et cetera?

I am trying to separate the what issues from the how issues, so basically I have two questions. One, do you think that this really belongs in the dietary guidelines; not that it is not important. Does it belong in the dietary guidelines?

Two relates to an issue that Bert brought up at our last meeting, and that is the dietary guidelines booklet now is 40 pages long. Each revision brings it up about 20 percent. Our charge I think was to try to keep it no larger than it is right now. If you think this is a high priority, what goes?

DR. WOTEKI: Okay. With respect to the first question, do I think this is appropriate since it is a how, as opposed to a what to eat, I do think it is appropriate because unlike some of the issues that you raised, food safety affects everyone, as is how you and what you choose to eat affects your long-term health. This is guidance for everybody, not just for that select group who has a foodborne allergy, for example.

With respect to the second question of what goes, I might take the Enoch Gordis approach and say hey, committee, that is your responsibility. There are certainly a lot of areas in which there has been a huge growth of discussion within the guidelines over the past few years, and that might be an area in which you might want to look at where you could pare back.

Certainly where there are other publications that you are referencing in here, you do not necessarily have to have all of the information that is in those other publications. Contain the essence of it.

CHAIRMAN GARZA: Dr. Deckelbaum?

DR. DECKELBAUM: I think, you know, if we look at the dietary guidelines, they actually contain currently advice to avoid certain things in our diet which would be harmful -- saturated fat, perhaps excess alcohol -- so I do not think this is out of keeping with advice that we give as part of the diet to avoid certain things. Since this does come with food, I think it is definitely worth considering.

Just two other points. In terms of the dietary guidelines and preventing a wide range of diseases, I would like to just point out that helicobacter pylori also has a strong correlation with cancer risk in different populations.

Finally, there are some things -- you had parasites listed here, but without a figure. One of the reasons is because the tools are not there yet for widespread examination.

For example, in Peru and Israel where they do look for contamination of fruits and vegetables with giardia lamblia and cryptosporidium, they find them commonly. These are major causes of morbidity in children in day care populations, and they would also come along with food. Certainly cryptosporidium is a cause of mortality in HIV- positive populations.

DR. GRUNDY: How much of the problem is related to what individuals do like that last little diagram you showed versus a problem of contaminated food? It is in the food supply so that a person, even if they did those things, would still get sick? How is that divided up?

DR. WOTEKI: I do not have any good data that could really answer the question of, you know, to what extent are food handling practices in the industry attributable for these diseases, as opposed to in the home.

The one thing that we do know is that most cases of foodborne illnesses occurring in the home are because the food was contaminated when it was brought into the home and then there is some cross-contamination that occurs during the preparation in the home, but that would not have occurred if the food had not been contaminated already when it came into the kitchen.

DR. GRUNDY: My question is how much can the dietary guidelines and what you tell people to do, how much can that have a beneficial effect to the whole problem?

DR. WOTEKI: Well, it can have some very significant effects. Again, I cannot quantify, but --

DR. GRUNDY: Right.

DR. WOTEKI: -- the four simple thing that are talked about in the Fight Bac campaign, preventing cross- contamination would have -- if we could do that, I think it would have a very appreciable effect on reducing foodborne illnesses.

The other things are also very helpful as far as either minimizing the growth of bacteria or preventing that cross contamination.

DR. LICHTENSTEIN: How much information now is mandated for the consumer on things like fresh meats or poultry? Is that now mandated?

DR. WOTEKI: Yes. We do have a safe handling labeling that is on meat and poultry as it is sold.

The problem is, from our perspective, just like with aspects of nutrition labeling, the label itself is very small. It provides information, but it really does need additional education and reinforcement to go along with that labeling so that people know really what it means and what they should be doing.

DR. JOHNSON: Cathy, we were told earlier that the school nutrition programs are the one federal program that are mandated to follow the dietary guidelines.

Do you see the addition of a food safety guideline having any substantial impact over and above what is already done in the food safety area with school nutrition programs?

DR. WOTEKI: Well, I think that by virtue of the fact that the dietary guidelines are viewed as being the policy of USDA and HHS that they do carry a weight that goes far beyond the educational message.

Now, with respect to the school feeding programs, we have been working very closely with the Food and Nutrition Service on the development of further educational programs. Maybe Sandy and others could comment more specifically on the nature of those educational programs.

We get into, though, difficulties in that from a regulatory perspective what goes on in the school cafeterias, how food is stored, the temperature conditions, the cleanliness and the sanitation within those kitchens, those are really under the regulatory purview of the states and the localities.

With respect to an educational message, we are working with FNS in the development of that educational message. With respect to the regulation, that ends up to be a state and a local issue.

CHAIRMAN GARZA: Dr. Kumanyika?

DR. KUMANYIKA: I have two questions that have to do with the implications of the other dietary guidelines for food safety. One at least is probably you are going to say out of your domain, but I hope you will address it anyway.

The salt guideline will say to some people that avoiding sodium or salted foods has implications for food safety. You might want to address that, so I was wondering if you would comment on that as a food safety issue.

The other has to do with things like pesticide residues and things that are targeted for increased consumption. Where does that fit in?

DR. WOTEKI: Well, with respect to salt and its preservative effects, the importance of salt I think has declined significantly over the years.

If you go to the grocery store, you know, out of those 20,000, 30,000, 40,000 products that are available, I think proportionately those that rely on salt as the major preservative has decreased very substantially over the years. There is more food that is frozen, more food that is refrigerated, so, you know, we are not relying on salt that much as a preservative.

Also, because of the concern about salt and hypertension, a lot of foods have been reformulated to have lower salt levels, even where it was mainly taste as the criterion and not the role of salt in preservation within that product. I do not really see that as being that big a food safety issue in reducing salt and salt-containing foods.

The second question was?

DR. KUMANYIKA: EPA-type issues about pesticide residue on fruits and vegetables and things that are targeted. From a consumer point of view, they may be more concerned about those issues, perceived or real, than about these things that are very real.

DR. WOTEKI: Yes. Well, interestingly enough, some of the recent surveys have shown that pathogens now are at the top of consumers' concerns about safety where it used to be pesticides and food additives.

To my mind, that tells me that consumers have now the priorities in the order that goes along with the scientific risks that are associated with these different substances, so I think there is less concern now.

There is certainly large numbers of people that are concerned about pesticide residues in food, but it is no longer ranked all the way at the top.


DR. DWYER: Thank you, Cathy, for a wonderful presentation.

Two questions. One was the issue of whether you in your part of the Department of Agriculture have come across any good campaigns for nonbacterial foodborne illness. I think it gets back to Shiriki's question.

We could not find any as Rachel and I tried to comb the literature here, but I wondered if you --

DR. WOTEKI: Yes. Sandy, are you --

DR. DWYER: -- had any good ones that were demonstrable?

MS. FACINOLI: Nonbacterial campaigns.

FEMALE VOICE: We cannot hear you.

MS. FACINOLI: Nonbacterial campaigns.

DR. WOTEKI: Yes. Sandy, there is a mike right there.

MS. FACINOLI: I would say no.

DR. WOTEKI: No. I did not realize you were looking for that. Perhaps we can assist you in looking further for that, but nothing comes to mind immediately.

DR. DWYER: The second thing is do you think --

DR. WOTEKI: A lot of people in the audience, Johanna, are going [indicating with a gesture]. They do not know about them either.

DR. DWYER: Okay. I did not think so, but we just need to know, you know. If there is a body count of these other things, we need to know who the bodies are.

The other thing is special peer groups. Is this something that we should highlight in thinking through this and finding information about it? Are there any specific groups we should single out?

DR. WOTEKI: No. The problem -- you know, I certainly pointed out meat and poultry as being a very large contributor in the data that ERS had presented, but there are foodborne illnesses associated with virtually every category of food.

We even had a case this past summer that just surprised everybody for salmonella gondi in a breakfast cereal. It was a toasted oat cereal, and the problem seems to be the vitamin mix that was added after the cereal was toasted in a final step in the process. That seems to have been the source of the problem. Even a baked item that you would not associate something like salmonella with can be the vehicle for what at that point was a very large foodborne outbreak.

DR. LICHTENSTEIN: I guess that sort of gets back to Dr. Grundy's question. I would be really interested in how much can really be attributed to production versus the cross contamination; that is, sort of permissive once it comes into the household versus actually introduced into the household because certainly something like the example you just cited, which may be an exception, would be something that this would not really be applicable to.

DR. WOTEKI: Yes. Yes. Unfortunately, I do not have a lot of information on that.

DR. DECKELBAUM: I just want to reinforce once again that it is not only the meat and poultry, as we heard this morning, but it was especially the parasites.Another example of a parasite epidemic was the cyclospora epidemic that came in on strawberries, so that they are not often looked for. They are probably very much underdiagnosed and picked up so that all sources of food can bring contaminants.

DR. WOTEKI: That is a very good point because produce sprouts are increasingly being associated as the vehicle for foodborne outbreaks of disease.

CHAIRMAN GARZA: Meir, and then Dr. Lichtenstein?

DR. STAMPFER: To me, that example just reiterates the point that Scott and Alice made about are these going to be useful guidelines for individuals to follow.

When you gave the statistic about the households, you know, at first I was horrified, and then my second thought was why are we not all dead? Then it made me wonder whether the criteria might be sort of set too high if 99 percent of households fail to meet it, yet we still seem to be doing okay on the average.

DR. WOTEKI: Well, I think that the main point, though, is that consumers do need to have basic information about what they can do to protect themselves from foodborne disease. Certainly cooking foods that are intended to be cooked is important and cooking them to the appropriate temperatures. That is one of our four guidelines.

The second is chilling foods. As soon as you get from the grocery to the house, chill them to the appropriate temperatures and maintain them at that. That is going to prevent the growth of organisms regardless of whether it is meat or poultry or whether it is produce.

The other two recommendations both relate to prevention of cross-contamination. Washing hands and all of the cooking surfaces, preparation surfaces, is going to cut down on cross-contamination whether it is coming from meat or poultry or from some other food that you have brought into the house, and then the whole idea is to make sure that people have got the basic information that they can use to protect themselves.

The rest of us in FDA and in FSIS are certainly working with the industry and working with the states because we very much share the jurisdiction from the regulatory perspective to make sure that they are doing what they should be doing to prevent the occurrence of these organisms in the foods that they are either responsible for growing -- we are working on developing good agricultural practices. We are working with the processing industry to make sure that they are adhering to the new HACCP-based approaches that are going to reduce these organisms. With the states, we share jurisdiction for the inspection, transportation, retail and at the local level. All the restaurants are mainly locally inspected.

You know, it is very much a shared responsibility with consumers also needing to have the basic information to protect themselves.

CHAIRMAN GARZA: Dr. Deckelbaum?

DR. DECKELBAUM: I would like to suggest to Dr. Stampfer, considering his comment about, you know, this may be baseline in the population, that you have a good opportunity in the nurses' health study to see how many nurses have missed work because they have had to stay home and take care of their children with diarrhea or some other problem that could have come from food.


DR. DWYER: I am troubled by some of my colleagues who seem to think that -- I am concerned about the bad reporting system for what happens from the market to the table or toilet, whichever you want to say.


DR. DWYER: I will say table. I will settle for table. Strike that other out of the transcript.

Could you comment briefly about the existing reporting system? Is it all we would desire from a public health standpoint?

DR. WOTEKI: Heavens, no.

DR. DWYER: From market to table. Not from the poultry plants in the world, but from market to table or toilet.

DR. WOTEKI: Okay. Are you including processing in your market because --

DR. DWYER: I am going from the place where I buy the product --


DR. DWYER: -- to when I get sick. Just that system. Not the big companies, but just that.

DR. WOTEKI: Well, there is really, to my knowledge, nothing from market to table as far as reporting systems.

There is information, once people become ill and they go to see a doctor, then the doctor may culture, isolate an organism and report that to the state and to the federal authorities. But only a very small proportion of people who become ill with foodborne diseases go to see a doctor. Of those that do, a very small proportion of those actually obtain a specimen and culture that.

The state requirements for reporting vary enormously. I believe at this point there are only 40- something states that require E. coli 0157:H7 to be reported, so that is for a very high profile organism.

The reason that the Centers for Disease Control at FDA's and FSIS' request have instituted this FoodNet active surveillance system with, I described to you five of the original catchment areas -- they have now expanded to seven and will be bringing the eighth on line very soon. That system is the first time where there is actually active follow-up with the state and local health authorities to determine the numbers of cases of foodborne illness that are occurring within those catchment areas.

The surveillance system that we have has been very much a passive one up until just the last three years with the development of FoodNet, and I think it is actually also a good reason why it is so difficult for us to make very good estimates of the burden of disease that is foodborne, food associated.

CHAIRMAN GARZA: There are I think two other issues that no one else has raised that perhaps would be useful to have your comments.

One is there is some concern among consumers as to point of origin of foods and their relative safety. Should we be concerned about including any of that in guidelines?

Then also that in fact foods that are contaminated may often be the source of antibiotic resistant organisms so that they are much more dangerous than the same organism that comes through another vehicle, especially those that come from animalborne products, because of the use of antibiotics in dealing with the issue at the production end.

Can you comment on either one? Are either substantial concerns or not?

DR. WOTEKI: With respect to imported as opposed to domestically produced food, we really do not have good data that shows that imported food is any more or less risky than domestically produced food.

Particularly in the case of meat and poultry, which is the area that I have more knowledge of at this point, we require equivalent systems. Systems in countries that want to export to us have to have a regulatory system in place that produces an equivalent level of safety as to what we require here in the U.S., so for meat and poultry products, we do not see any increased risk associated with them.

CHAIRMAN GARZA: What about parasites?

DR. WOTEKI: Yes. It is equivalent level of safety.

With respect to all other foods that are under FDA's regulatory purview, FDA does not have the same statutory authority that FSIS does, so they cannot require these equivalent systems and equivalent level of protection.

Having said that, though, there have been some very high profile outbreaks that have been associated with some imported foods, but we have also had very high profile outbreaks associated with domestically produced produce and milk and ice cream and other products.

There is no indication that there is a higher level of risk associated with imported foods than domestically produced foods.

CHAIRMAN GARZA: And the antibiotic issue?

DR. WOTEKI: The antibiotic issue I think is one if you read the New York Times today, it is certainly very high profile, front page. They have a big, big story about antibiotics. I do not at this point think that --

CHAIRMAN GARZA: Some of us have not seen the Times today.

DR. WOTEKI: Well, you could share it, Alice, with the rest of the committee.

I do not think that that is the kind of thing that the dietary guidelines, the level of detail that should be gone into in the guidelines. What we are suggesting or what I am suggesting is, you know, some fairly basic messages for the public to follow that will provide them with some additional protections.

On the antibiotic issue, the article that I think you will all find quite informative is talking about a new approach that the Center for Veterinary Medicine at FDA is proposing for antibiotics.

Currently we work with CVM in the antibiotic resistance monitoring system, FSIS, the Agricultural Research Service and the Center for Veterinary Medicine. The underlying approach is to monitor for the development of antibiotic resistance and then to control it, to manage it.

CHAIRMAN GARZA: The point I was getting at was including it in our report to the Secretary as an added reason for motivating the committee's concern because of the fact that these organisms may yet be more virulent because of the antibiotic resistance.

What I am hearing from you is that in fact that may not be true?

DR. WOTEKI: Well, what I was responding to was do you put it in here.

CHAIRMAN GARZA: No, no, that --

DR. WOTEKI: Yes. I think in your technical report, as an issue that the committee feels deserves further consideration and certainly close monitoring I think is completely appropriate.

CHAIRMAN GARZA: Any other questions? Comments?

If not, again, thank you very much for --

DR. WOTEKI: Thank you.

CHAIRMAN GARZA: -- a very good presentation and also then to Dr. Gordis, who didn't come. This session has been extremely informative.

We will take a break that we should have taken several minutes ago. Let's try and be back by a little after 4:00 p.m., but not much after 4:00 p.m.

Thank you.

(Whereupon, a short recess was taken.)

CHAIRMAN GARZA: If I could ask everyone to please take your seats? We are going to very likely have to go until about 6:00 p.m. instead of 5:45 p.m., but if we are going to be done by 6:00 p.m. then we need to get started.

We are going to move to the 3:15 p.m. part of the agenda. Today and tomorrow we will be starting to look at the work of the various groups that have been looking at the guidelines, some of the special issues that we also have been examining, and we have one more invited guest who will be with us tomorrow morning.

To get started on that, our first speaker for this afternoon is the co-chair of the committee, Dr. Suzanne Murphy, who I think the last time we saw her was far from this ocean and now has gone clear to the other side of the world almost. She is now in Hawaii. She has insisted that this is because of the intellectual climate.


CHAIRMAN GARZA: I think she may have some other ideas in mind, especially after I guess the coldest winter that anybody ever spent was the summer in San Francisco.

MALE VOICE: Mark Twain.

CHAIRMAN GARZA: Mark Twain. Exactly.

Anyway, Suzanne, welcome back to the East Coast. Bring us up to date on what the group has been doing on Eat a Variety of Foods.

DR. MURPHY: Thank you, Bert, and aloha. I am learning the language.

Well, the dietary variety guideline group has been somewhat active, although I think we are the smallest group. Dr. Weinsier and I are it. I have agreed to speak for us on the variety guideline this afternoon, but he would also like an opportunity to talk to you a little bit about one part of the variety guideline, so I will take a few minutes to go over some of the general concepts, and then I will turn it over to him if that is all right.

There is in your booklet, and I want to be sure all the committee members know that Shanthy has prepared a booklet for us. I believe the outlines for all of the working groups are indeed in this booklet. I am going to refer a couple of times to the variety pages, and I am going to get the page numbers here any moment.

They are not numbered. All right. Do not worry about the page numbers, but partway in there is a variety guideline broad outline. I will come back to that in just a moment.

We have made not really any recommendations specifically for changes, but for items that need to be discussed, trying to following Dr. Garza's suggestions that we not come to any conclusions, so in my presentation I am just going to summarize some of the pros and cons for you to think about a little bit.

I do not have a walking mike, so let me get my notes. Let's see if I can be this organized. I am not positive I can.

The variety guideline is to some extent the linking guideline. As you know, it is in the center of our graphic that is on the cover of the dietary guidelines booklet, and so I think it has an importance that is perceived, anyway, by people that look at it, that gives it this central role.

When I summarize some of the pros and cons, I think probably one of the most important pros of keeping the guideline exactly the way it is is that it is very simple, and it is also positive and so there are some good reasons, I believe, to not change the variety guideline.

On the other hand, as we looked through the literature and looked through the focus group results, we found three reasons at least that one might wish to consider changing it.

One is that it is not very specific, and I refer you to the comments from the focus group which I have summarized on the next transparency, so I will come back to that one in just a minute. I think everyone got a copy of the focus group comments. I found those very interesting, and I really appreciate the work by ILSI and others who conducted those.

Although a few respondents perceived this guideline as less important than the others and some said it was unclear, they had no objection to the guideline. In other words, it was not offensive, I guess, but many respondents indicate the guideline allows people to eat foods that may not be classified as healthy choices.

I wanted to just read you a couple of the comments that people made, but now I cannot seem to find my copy. Here it is. One person said, "I think a lot of people would misinterpret it. Okay. I've got my pizza. I've got my ice cream. I've got my cake. You know, a variety of foods."


DR. MURPHY: Someone else said, "Make sure you have a lot of fun. If you enjoy it, eat it. I think those are good reasons for the variety guideline." Someone else said, "I think it means enjoy ice cream, cookies, fudge. If it's a guideline for nutrition, I think it's kind of too permissive."

All right. These are some of the concerns that consumers had when they were interviewed, and I think that reflected some of the concerns we had as we looked through the guideline.

Secondly, it was not clear how to implement it. As one of the consumers pointed out, it is one of the few guidelines that does not have any specifics. It is very vague. It does not define variety, and it does not say how to go about taking action on eat a variety of foods.

Finally, there was a concern that it might encourage overconsumption. I want to address that by showing you some of the results from an analysis that the Center for Nutrition, Policy and Promotion helped with. I have noted here at the bottom that Peter Basiotis was the person that actually did the analyses, but several people helped in designing them, and I really appreciate that help.

The question we asked was does variety improve nutrient intake after adjusting for adherence to the food guide pyramid food group servings? We were able to address this by using a tool that the people at CNPP developed, the healthy eating index.

I found that very useful in trying to separate out the effect of variety from the other parts of the diet and in particular from the food group servings, so we did a multi-variate regression analysis with the percent of RDA for 15 nutrients as the outcome variable using the CSFII 1994-1996 data, so it is almost 30,000 days of data.

Indeed, the number of foods consumed in a day is a significant positive predictor of nutrient intake for all nutrients but protein and vitamin B12. If you look in the booklet, you will see there is full table that summarizes all the results.

I included in there -- let me show you -- the table that looks like this. I included all the signs of all the regression coefficients because I thought this might be useful for some of the other guidelines' working groups.

I am in particular interested for the variety guideline in the results of the very first column that shows the effect of the number of foods consumed, the variety of foods consumed, on the different nutrients. For the 15 nutrients, it was a positive predictor of percent of RDA, which indeed says variety has an effect on the nutrient intake of Americans.

However, if you look at the very last two columns of the table, you will see that the R2 value, when you include variety in the regression analysis versus not including variety in the regression analysis, virtually is unchanged. There was one nutrient for which it went up. Let's see. For fiber it went up from .36 to .40, but for all the nutrients with an RDA the change was a maximum R2 of .01.

In other words, for example, let's just pick one. Riboflavin. Fifty-nine percent of the variants in riboflavin intake could be explained by a combination of energy intake and intake from the five pyramid food groups. After you did that regression, if you then redid it and included variety as a measure it stayed a .59. There was no change in the R2 value.

So although it was statistically significant, one could argue that the practical importance in variety after you followed the food guide pyramid was fairly negligible. I found this type of analysis fairly helpful in interpreting what the actual effect of variety might be on the American diet.

The other part of this analysis was to look at the effect of variety on the intake of some of the macro nutrients. That is actually summarized in the table that you have as well, but I have also put it on this transparency because I want to address the other issue that I brought up at the beginning, and that is what is the effect of variety on overconsumption.

For example, variety was not a predictor of added sugar intake. It was a positive predictor of grams of discretionary fat, but it was a negative predictor of percent of calories from saturated fat and fat and a positive predictor of fiber intake.

As I mentioned before, none of these R2 values -- you see they are all virtually identical, so although variety was significant for all four of these; not for sugar, but for the other four, it did not in effect increase the explanatory power of the model once you put energy and all the other food groups in there. We found this fairly interesting. Fiber, on the other hand, did increase slightly, so there is I think a more noticeable effect on fiber intake of variety.

After we had looked at these analyses and looked at the literature and gone through fairly carefully, I think, what has been published since 1995 on variety, we decided that we would like to entertain the possibility of rewording the guideline so it more specifically included the pyramid because if you look at the booklet, indeed the variety guideline is primarily a tool for introducing the pyramid.

If that is indeed what we primarily mean by variety, if we mean "follow the food guide pyramid," then I would suggest that we might consider putting the pyramid in the guideline itself specifically and furthermore that we might consider putting the pyramid graphic on the cover and in the central link if indeed the linking circle stays on the cover.

The pros for doing that would be that it would be more specific. It would still be a positive message to consumers, and it would link to a graphic that consumers are very familiar with, the food guide pyramid.

On the other hand, this particular wording is somewhat longer. You could argue it is not quite as concise as eat a variety of foods, and there is also the implication that I think we are all concerned about when we recommend or think about a change to a guideline that when you take something out of a guideline you in effect are saying that that guideline was not important.

Of course, if variety comes out of the name of the guideline or the wording of the guideline, there may be a subtle implication that somehow variety is no longer important.

Now I would like to make a couple of points here. First of all, I at least, and I think Dr. Weinsier would agree, are not saying variety is unimportant, and we would not wish to imply it was not.

Following the food guide pyramid is important, but I think variety within the food guide pyramid is still a concept that it is important to incorporate so I would still certainly, even if it was not in the text of the guideline, wish to focus on variety, for example, of fruits and vegetables in the text.

The final point I want to make is that this change was not to dictate any change in the pyramid itself. I of all people, but I think all of us have had it very clearly explained to us. We are not here trying to redesign the pyramid, and certainly nothing I have said here regarding the variety guideline says the pyramid has to change or that the pyramid does not have to change.

I think other procedures are in place for changing the pyramid, but whatever it is I think it would be nice to have it integrated better into the actual cover of our dietary guidelines, so this would be one way to consider doing that.

Now, I am going to then ask. Should we have questions on this much so far?

CHAIRMAN GARZA: Let's see if there are any points for clarification.


CHAIRMAN GARZA: We will have the discussion at the end of both, so if there are points that you wish Suzanne to clarify then --

DR. MURPHY: Right.

CHAIRMAN GARZA: -- ask those now. Then Dr. Weinsier will also present, and then we will have a general discussion.

DR. MURPHY: Right. Also, I should point out there will be a separate discussion of supplements. Although that is currently within the variety guideline, I am not going to specifically cover that because that is another presentation.

CHAIRMAN GARZA: It may be useful, since that is going to follow, to even have our general discussion once we hear all three presentations.

DR. MURPHY: All right.

CHAIRMAN GARZA: That way we can deal with all three issues in some coherent fashion.

DR. MURPHY: All right.

DR. KUMANYIKA: I just have a question. I did not hear you say what the effect of the variety is on total energy. You said overconsumption.

DR. MURPHY: Right.

DR. KUMANYIKA: Did you not say anything?

DR. MURPHY: I did not say it, but I do have it. The R2 is fairly high. Almost 50 percent of the variation in dietary variety is explained by energy consumption or vice versa. The R2 is -- actually it says .45, but when we

re-ran it with some small changes it was .49, so there is a very high correlation.

Thank you for reminding me because I meant to mention that.

CHAIRMAN GARZA: Is that as a percent of recommended or a total?

DR. MURPHY: That is percent of recommended.

CHAIRMAN GARZA: All right. Good.


FEMALE VOICE: Percent of recommended what?


DR. MURPHY: Energy. It is adjusted. Because these analyses --

CHAIRMAN GARZA: It is adjusted for body size.

DR. MURPHY: -- are for people two years and older, it is adjusted for age and gender and so forth.

DR. KUMANYIKA: But it could be interpreted depending on whether it is over 100 percent. Of course, the energy recommendations are high, but I guess the question is how does it match with the literature on overconsumption, the fact that as people's diets become more varied, they are more likely to overconsume food?

DR. MURPHY: Right.

DR. KUMANYIKA: The fiber could be carried by that total calorie effect is what you are saying?

DR. MURPHY: Right. Right.

CHAIRMAN GARZA: Okay. Dr. Weinsier?

DR. DWYER: Could I ask just one more thing? I think early on either Dr. Kennedy or you, Suzanne, mentioned there were three things that went into the pyramid. One was the DRIs, one was the dietary guidelines, and what was the third?

CHAIRMAN GARZA: Eating pattern.

DR. MURPHY: Consumption.

DR. DWYER: Eating pattern. Consumption.

DR. MURPHY: They are based on what people are actually consuming.

DR. DWYER: Thank you.

DR. WEINSIER: In the context of our discussion about perhaps changing the title and saying let the food guide pyramid be your guide -- and this is not going to work very well because I will be standing in front of you -- some of the people in our department whom I asked for comment and input on this concept, and do not think of this as a food guide pyramid. Just think of it in terms of this first guideline section, whether it's variety, or let the food guide or food circle or whatever be your guide.

This figure is in that section, and in that section there is specific reference to these various five food groups, including specifically what I am referring to as the dairy product group or dairy food group, which is milk, yogurt and cheese group.

The question came up why do we have a food group listed that is specifically targeted for one organ of the body, the health of one organ, i.e., the skeletal system?

In terms of trying to answer the question, is there evidence to support having a separate food group for a specific organ system, I went back and looked at the literature with the input of about four other individuals inside the department and outside the department of whether there is solid evidence to indicate whether that food group, the dairy group, has been demonstrated to support optimal bone health.

The two issues that we addressed were the ones shown up here under the first category or the first issue, does research support the recommendation for regular use of dairy foods by the U.S. population for optimal bone health.

There is really a subquestion. That is are there certain gender, age or ethnic groups who are more or perhaps less likely to benefit from regular use of dairy foods, and then a second issue --

CHAIRMAN GARZA: Is the department your home department or one of the two federal agencies?

DR. WEINSIER: Department of Nutrition Sciences,

University of Alabama at Birmingham.

CHAIRMAN GARZA: Okay. I just wanted to make that clear.

DR. WEINSIER: Yes. Yes. I am not the head of a department in the Federal Government.

The second issue that we are raising or have raised are the reasons why dairy foods should not be considered good vehicles for dietary calcium.

A subquestion within this second issue is are all dairy foods equivalent such that they should be listed as exchangeable within one and the same food group. These are the two issues that were addressed.

The background to this regular intake of dairy foods is recommended for the general population primarily to ensure an adequate intake of calcium. The recommendation is based on the relatively high calcium content important for maintenance of bone health, so the purpose of our review is to examine the evidence in support of the role of dairy foods for bone health.

So I am not making implications here, it is not to re-examine evidence regarding the recommended level of calcium intake for bone health. That is a separate issue that has been addressed in the NIH consensus panel, and I do not think that that has to be rehashed.

The methods for this review included a MedLine search, a literature search focusing on the key words dairy, milk, osteoporosis, bone or bone fractures. Studies were categorized then according to outcome of dairy food intake on bone health into one of three categories: favorable effect, no effect, or unfavorable effect.

Reported outcomes for our purposes had to be below the 5 percent probability of statistical significance to include it in a favorable or unfavorable category. The reason I am specifying this, it would seem fairly obvious to most of us, but there were a number of cases in which authors reported a positive or negative outcome based upon trends without statistical significance.

Continuing on the methods, to compare evidence with a variety of studied designs, outcomes were categorized into four evidence-based categories. These categories were established on priority. Everyone may not agree with these categories, but we had to have some reference point in which to be able to compare studies, so we put them into four categories.

For Category A, we considered the strongest evidence-based category, included randomized controlled trials or a large cohort study, and in each case there had to be significant associations, whether positive or negative, that were controlled for major confounding variables, but specifically including age, menopause status, physical activity and bone mass.

A Category B would include smaller cohort studies or large case control studies. Significant associations had to be controlled for most of the major confounding variables.

The weaker categories, C and D, Category C would be smaller case control study or a large cross-sectional study, significant associations controlled for at least some of the major confounding variables, and finally the weakest category, D, smaller cross-sectional or large cross-cultural studies in which significant associations were adjusted for perhaps as few as none of the major confounding variables or just some.

In terms of the outcomes of the types of studies, there were a total of 69 reported outcomes. This is actually derived from 57 separate reports, so there are 57 reports, but within those there were 12 that reported more than one outcome either because they are looking at different bone sites or they are just looking at different age groups during which dairy foods were consumed, so in some cases, i.e., 12, there were more than one outcome, so a total of 69 reported separate outcomes.

Of the study designs, 10 percent were randomized controlled trials, 13 percent longitudinal cohort studies, 26 percent case control and more than half, i.e., 51 percent, were cross-sectional studies.

The evidence levels, how these four categories of studies fell into the evidence levels, 20 percent fell in Evidence Level A, 15 percent in B, so roughly we have 35 percent, a little over a third, are going to be in the stronger evidenced-based categories, A and B. The remaining 65 percent fell out into the C and D categories.

Regarding the first issue, that is does research support recommendation for regular intake of dairy foods for optimal health, and, the subquestion, are certain gender, age, ethnic groups more or less likely to benefit, the numbers, if I can move away from the microphone for just a second, to look at -- I have broken it down again to Favorable, No Effect or Unfavorable Effect and separated coordinates for the total number of outcomes reported, 69, and then the subcategories, the stronger evidenced-based categories, A and B, there are a total of 24 reported outcomes.

If we look at Favorable Effect, 38 percent of the total reported favorable effect, 55 percent no effect, seven percent non-favorable effect. I am going to try to focus on the rest of these slides on primarily the stronger evidence- based categories, A and B.

Here we would see 17 percent, 71 and 12 percent, so if you want to look at this, if you want to appropriately call it a benefit/risk ratio, perhaps we could say, well, we have 17 percent versus 12 percent, which is about 1.4 to one benefit/risk ratio.

Now going to the subgroups, first of all, the gender groups, in women, looking again at the stronger evidence-based categories, A and B, 17 percent. These are the same numbers we just saw because essentially all of the studies included women, so it is not going to surprise us that these numbers are going to be about the same. Seventeen percent showed a favorable effect, 12 percent an unfavorable effect, the majority falling in between with no demonstrable effect.

In men it was a different story. First of all, there are relatively few studies that examined bone health and its relationship to dairy food intake in men, but of the stronger evidence-based categories, A and B, none of those fell into a favorable effect category, the majority no effect, and 14 percent fell into the unfavorable effect category. I do not know what kind of benefit/risk ratio you would put there, but I guess we would have to call it zero. Then again, it is a limited database.

In terms of age groups, we chose to break down the age groups into the following three categories: Less than 30, 30 to 50, and greater than 50. The reason for those three categories is that peak bone mass can be accrued up to about the age of 30.

That is not an exact cutoff, but this is probably a going rate or going age in terms of most reports that indicate that bone accretion occurs and maximally is reached somewhere in the neighborhood of about age 30. Then we chose the cutoff here at greater than 50 in part because it is approximately around the age of 50 that menopause, at least in the female gender, will set in.

Having divided these three categories, the numbers I just referred to would be the Evidence Levels A and B for the younger age group in which we have a little bit better benefit/risk ratio of 18 percent versus 9 percent.

As we go upward in age to the 30 to 50, we have a stronger evidence base here. The percentages are higher such that we get a one to one ratio, but larger percentages, i.e., a smaller percent fall in the equivocal category, but the relationship is about one to one in terms of favorable and unfavorable outcome.

The same thing in the greater than 50 year old age group. That is a relatively small percent show a benefit, but the same percentage show an unfavorable effect in that category.

In terms of ethnic groups, there is not a whole lot to report. The majority of the studies did not include the African-American population in the United States and worldwide. Very few included the black population. In fact, of the 69 reported outcomes, I could find only one that included -- it did not focus on the black population. It simply included blacks in that study group.

I found no study in the Evidence Categories A and B which included this population, so the conclusion I have to reach here is that we really cannot demonstrate a beneficial effect, nor can we comment or can I comment on a potential benefit or risk ratio.

I put this up as a reminder to myself that a related issue that was brought up this morning by one of our presenters that is not addressed in this review is whether regular use of dairy foods should be recommended for a population which has a high prevalence of lactose intolerance. Obviously that is a concern raised this morning, and we have to be aware of it, but this is not the focus of this review or a focus of this review.

The second issue was whether there are reasons that dairy foods should not be considered good vehicles for dietary calcium. This is, as I understand it, the primary reason dairy foods are being recommended, and a subquestion would be, are all dairy foods equivalent.

The following nutrients are found in highly variable amounts in dairy foods, and they are known each to affect calcium loss. Protein and sodium would be the strongest two in terms of the data, the evidence base, that gives information about impact on calcium loss. Protein increases calcium loss. It is well established that it is related to the renal acid load. Sodium intake increases calcium loss. It is related to approximal tubule exchange of sodium and calcium.

Lesser evidence based, but evidence clearly suggests that the three other factors, acidic phosphate intake, vitamin A and potassium, all can affect calcium excretion. Acidic phosphate also as protein increases the renal acid load, vitamin A by accelerating bone resorption.

I have to put a question mark by that because I do not think that is solid, although we do have animal data in large doses of vitamin A that is a mechanism, and potassium I clearly do not know the mechanism, but it seems to have an independent effect on decreasing calcium loss.

Having said that there is substantial reason to consider that all dairy foods may not be alike in terms of affecting calcium balance, is there any evidence to suggest that that is in fact the case? This actually is a theoretical estimate of calcium balances from ingestion of select dairy foods due to their sodium and protein content, so I am trying to back down to what is known in the literature and what seems to be fairly well established, and that is primarily for sodium and protein.

The issues on acidic phosphates on potassium and vitamin A are less clear in terms of a specific relationship between their content in the dairy food and their effect on calcium loss, so just for argument's sake I just chose sodium content and protein content, and I chose two dairy products.

The reason I chose these two is I tried to find some in which the phosphate and the vitamin A content, the potassium content, were not too extremely different. So these two were chosen as examples because of the roughly comparable potassium and phosphate contents so that this becomes less of an issue for sake of comparison, allowing me to compare the sodium/protein content.

These are the projected estimated losses of calcium due to their sodium and protein content based upon published data. This is the calcium intake of 100 grams of each of these foods. This is the calcium intent that is estimated to be required to offset that calcium loss, and then the estimated net calcium balance is shown off to the right.

Let me hesitate here for a second to say that these are not absolute values. In other words, if we did the studies, I do not know exactly what we would find. Those studies have not been done. These are theoretical estimates, but they are very, very conservative.

By saying they are very conservative, this number, this calcium content and the calcium intake required to offset the loss, is probably a marked underestimate based upon the data published by Connie Weaver.

In contrast, Robert Heaney would say they are probably increased by about fivefold the number I have shown here such that the estimated net balance may well be considerably less than this and considerably worse than shown here for cottage cheese. The only point I am trying to make is with these two examples that all dairy foods may well not be the same in terms of their potential impact on calcium balance.

In terms of effects of different dairy foods, there are only two studies that I could find in this review that actually addressed this to see if our theoretical projections have any reality; two studies, one in 1986 and one in 1992.

Milk appeared to have a more favorable effect on bone mass in each of these two studies, one in which milk was compared to cheese, the other in which milk was compared to all dairy foods combined. So it is not a strong database, but this is all I could find that would give me some reference to see if there are differences. There may be. I do not know for sure.

What are potential explanations for the inconsistent findings of dairy food intake on bone health? Two, basically. One is that in studies showing statistically significant favorable effects, the effect is often very small.

I was impressed by the number of studies that look at the amount of variance in bone mass that could be explained by dairy intake. In those cases in which it was reported a statistically significant effect, the amount of variance in bone mass as explained by dairy intake was actually quite small. In these two reports, it was less than 1 percent.

Just to give you a feeling for the impact of other factors, age, body mass, estrogen status, physical activity explained in the neighborhood of 25 to 35 percent of the variance in bone mass.

There was one study by Honkanen that reported reduction in risk ratio of bone fractures, so not bone mass, but now looking at bone fractures due to dairy intake, and they reported -- I do not know -- Meir brought this to my attention that he is surprised that this could be statistically significant, but they reported that the risk ratio -- this is not a P value; this is risk ratio -- was reduced by .0002 due to dairy food intake. So whether that is true or not I do not know, but it suggests that if dairies have an impact, it is probably, at least according to these reports, relatively small.

A second issue that may explain variations and inconsistencies are findings that all dairy foods are probably not alike. Among the few studies examining different dairy foods, milk may have a more favorable effect than some of the other dairy foods. Underline the word may.

What are potential explanations for the inconsistencies? One more to consider, and that is remember this afternoon Dr. Gordis commented about wine perhaps being a surrogate marker for a healthy lifestyle? That is almost definitely the case in terms of milk intake.

It appears that dairy food intake may be a surrogate marker for healthy lifestyle, which themselves affect bone health in that increased dairy intake is significantly associated with increased exercise, independently associated with a higher fruit intake, independently associated with a higher potassium intake. It is independently associated with less smoking, less alcohol, less phosphoric acid intake by way of sodas. Each of these six factors impact on bone mass.

In summary, trying to get back to the original question, should dairy foods be recommended for optimal bone health, among the general population groups it appears that only a minority of the outcome reports show a benefit on bone health.

If we can use this limited data set to look at a benefit/risk ratio, by looking at the stronger evidence-based data it appears that it is a marginal favorable effect in the neighborhood of about 1.4 to one. Among gender groups, if a benefit exists it is more likely to occur in female than in males. Among males, there are no stronger evidence-based data that show a benefit.

In terms of the age groups, the benefit/risk ratio appears greatest in the less than 30 year old group, age during which peak bone mass is reached. The benefit/risk ratio here appears to be something on the order of two to one in the less than 30 year old group. This is in contrast to the older age groups, i.e., 30 to 50 and greater than 50, having a ratio of one to one.

Finally, in ethnic groups, in the absence of adequate data it is unknown if dairy foods might or might not benefit bone health in the black population.

The last two overheads, one is a conclusion, and then another one is just a proposal for future reason. In conclusion, trying to draw some conclusions about the limited data set we have, if dairy foods contribute to bone health, available data suggests benefit is more likely with intake of milk and within the subpopulation of less than 30 year old, non-black women. Data appear to be inadequate to conclude that dairy foods are beneficial in the remaining majority of the population.

Because Dr. Garza reminds me to look at review areas, think in terms of perhaps we should just be talking about where the data need to be extended with future research, I would emphasize two areas to consider. One is to examine the effect of dairy foods in randomized control trials. In other words, let's try to get a stronger Evidence A level data set based upon controlled trials, controlling for the bone remodeling transient.

I cannot go into detail here because it would take a lot of time, but there are only seven RCTs in this data set. Of the seven, they were split. Three showed favorable effects. Four showed no effect on bone mass.

The problem with all the randomized control trials as pointed out by Robert Heaney is the following: that basically any remodeling suppressive intervention produces an increase in measurable bone mass. Such change does not reflect an effect of the intervention on overall remodeling balance, nor does it convey information about whether any permanent benefit may or may not have been produced.

Without considering the bone modeling transient period, which can reach up to a year to a year-and-a-half from the time of the intervention, particularly with something such as a calcium intake or supplement or as dairy foods, we really cannot say that the change in the synchrony between bone formation and bone resorption was due to the intervention, i.e., according to Heaney, you have to wait until the intervention has been in place for approximately six months to a year, perhaps as long in some groups to a year and a half, before the baseline assessment can be attained.

The second point is that future studies probably need to focus more on the etiology or calcium loss rather than ways to increase calcium intake. If in fact age- related bone loss in women is more attributable to excessive calcium loss than to inadequate calcium intake, then reducing urinary excretion of calcium may be a better means of preventing bone loss than increasing the intake of calcium.

In conclusion on this point, I really wanted to emphasize that because Robert Heaney has made a strong point about the potential effect on reducing calcium loss on requirements such that simply by reducing sodium intake/ protein intake in a population of adult women, he proposes that you could reduce calcium requirements to in the neighborhood of about 450 milligrams. On a high sodium/high protein intake, the requirement may be as high as 2,000 milligrams.

Anyway, I will stop at that point.

CHAIRMAN GARZA: Are there any questions as points of clarification? Johanna?

DR. DWYER: I wondered if there were data from -- if they have information. You said -- what was it you were suggesting?

DR. WEINSIER: Well, I was just quoting Robert Heaney from a report in 1996 where he was suggesting that if the adult female population were to reduce -- and he did not put numbers on this -- he just simply said reduce the sodium and protein content in the average diet, they could reduce calcium requirements to as low as about 450 milligrams. Conversely, it could go as high as 2,000 milligrams.

DR. DWYER: My own interest in this comes from renal disease and the whole issue of acid-based illness.

My reading of the data on that, Roland, is that it is rather difficult to interpret. Most of the studies were done by Bawdrellan [phonetic], you know, like 25 or 30 years ago at Boston City Hospital.

Do you have good, quantitative data on that? Did you come across any new papers in the reviews in terms of the protein part of the measures that you have mentioned?

DR. WEINSIER: I think the data on protein is pretty solid. I do not remember off the top of my head how many were since, you know, the last dietary guidelines in 1995, but there have been a few reports since then and a solid database before then to indicate that the effect of protein intake, particularly as animal sources of protein, that are more likely to contain sulphate and, therefore, have a higher renal acid load, are clearly -- and through the spectrum of protein intake, it does not appear to be a threshold effect -- that increasing levels of protein have a proportionate effect on increase in calcium loss. I think the data is pretty clear on that.

DR. DWYER: The reason I ask, and maybe someone else in the room was there, too. Dr. Walter from Johns Hopkins University gave a talk about a year and a half ago at the Committee on Military Nutrition Research at NIS.

I do not know if that book has come out, but it deals with this very topic of protein, I believe, and the whole issue of at what level it might become harmful or whatever. I thought the data were a little more tenuous than that, but perhaps I heard wrong.

DR. WEINSIER: I think they are quite solid.


DR. GRUNDY: There is something I did not quite understand about your argument. It seems like there is two issues. One is whether people need, if they eat other things correctly like sodium and protein, whether you need as much calcium as currently being recommended. Second is whether the dairy products are an adequate source of calcium to contribute to that total.

Were there not sort of two different things being presented there?

DR. WEINSIER: The last comment was simply to say if more research needs to be done, what areas should it go in. So that is pure speculation on my part.

The issue for the sake of this committee I think before this committee certainly for me is the question that relates to should dairy products be recommended for the general population for promotion of optimal bone health.

DR. GRUNDY: Let me just follow up. To some extent, I think one of the aims of this dietary guidelines group is to take current recommendations that are based in science like the DRI report, which recommends that we take so much calcium a day, 1,200 milligrams or something like that, and figure out how to create a diet that would provide that number of milligrams.

Maybe we could do that with all other sources of calcium, but I am trying to figure out whether you would say we should try to reach that recommended intake of calcium, but do it without dairy products. Is that the --

DR. WEINSIER: Well, I actually did not come

with -- and I did not propose a recommendation for the committee. I think we are at the stage of now open discussion.

I will raise the issue based upon what I have seen in the literature. I mean, obviously you are getting at the crux of the problem. We need to now take this to the next level. Is it worthy of further consideration, or is this not a sound review and/or are the conclusions inappropriate and we do not need to consider it?

I do not have a recommendation to throw on the table now. I think there are a number of options.

CHAIRMAN GARZA: One that Roland and I have discussed, Scott, is to send the review that he and his colleagues in Alabama have prepared to two or three calcium experts, have them comment on the review and then possibly invite one to the next meeting.

DR. WEINSIER: I would extend that just a little bit to suggest, because I agree with that totally, that this should be sent to two external reviewers expert in the area.

I would only suggest that they be individuals who on the one side are expert with a positive bias perhaps and another who have the opposite bias because this is an area that is filled, as I could tell from reading reports, with a lot of --

CHAIRMAN GARZA: The reason for suggesting three is I would like one with religion, one with the other kind of religion and then one that is an agnostic.

DR. WEINSIER: I think you are going to find it difficult to find an agnostic in this case.

DR. GRUNDY: You will have trouble finding any of those.

CHAIRMAN GARZA: I am sure in this field, as Dr. Grundy and I know only too well, we will find that and possibly two other varieties.

At any rate, Suzanne?

DR. MURPHY: One of the things I was curious about in your literature search was whether you were able to separate out the effect of a food from the effect of say a meal or a diet.

Certainly protein and sodium are known to be problems with calcium balance, but did you identify things about dairy products that you thought were specific to dairy products that would not go with a dietary pattern in general? Do you see what I am saying?

For example, you could have a vegetarian source of calcium that was very unavailable if that meal was high in protein and sodium from other foods, so is there something about the dairy products themselves that you thought was problematic, or was it because they are often accompanied by these other factors?

DR. WEINSIER: Well, I have to assume that whenever the earlier versions of the guidelines were prepared that there was some either evidence or suspicions that as the dairy product per se, not in the context of what it would be taken with, that would be beneficial for bone health. My premise going into this was, and actually I was quite convinced that the outcome would show a very positive, favorable influence.

I cannot answer the question whether, first of all, that was the original thinking, nor do I know if the effects that we are seeing here are because of dairy foods per se or in the context or out of the context of other foods taken because that comes back to RCTs. Without randomized control trials, almost all of these are confounded. Very, very few of these studies try to separate out the impact of separate nutrients.

There is an excellent study reported by New,

N-E-W, et al., who did try to separate the nutrient content of various foods. When they looked at a multivariate analysis to see what was impacting on bone mass, calcium fell off the bottom. This was within the dairy, looking at dairy and other foods in the diet. Calcium fell out very clearly in all age groups looked at.

Potassium was by far and away the strongest predictor. Magnesium was behind that. Calcium was actually quite low, and that was despite the fact that they found a positive correlation of dairy intake with bone mass.

What was it about dairy? I doubt it was the potassium. It was probably the fact it was going along with a higher potassium and higher fruit intake, as we saw in the DASH study that Johanna referred to a minute ago.

CHAIRMAN GARZA: Dr. Deckelbaum?

DR. DECKELBAUM: I think there is a natural experiment that, you know, certainly dairy products work to augment or increase bone mass, and that is all children under the age of six months where dairy products are essentially the major food, so it works. It works during a time --

DR. WEINSIER: No. I would have to --

DR. DECKELBAUM: It works during a time when growth is extremely rapid, more rapid than any other time during life. That is one experiment.

The other thing is that in terms of thinking of this in terms of the guidelines, we must consider that for children. I do not know the data so well for other groups, but for children the major predictor of calcium intake is going to be their milk intake and dairy product intake, so we have to be very careful in getting a message out or providing alternatives for milk intake in that particular group. That is over the age of two. It is still the major predictor of how much calcium the child eats is the milk intake.

DR. WEINSIER: I think it goes without saying, Richard, that human milk is ideal for the human infant. To extend beyond weaning is a slightly different story, realizing that all dairy foods really are not the same as human milk.

When you process cheese, processed cheese products are very, very different from milk, cow's milk as well as human milk. It is a whole different product. Cottage cheese was one example I gave. I am not sure that we can extend beyond the age of weaning.

CHAIRMAN GARZA: Okay. Let's move on then to the supplement discussion, and then we will come back and have a general discussion on the variety guideline.

Thank you, Dr. Weinsier.

DR. LICHTENSTEIN: Okay. What I am going to try to do, hopefully briefly, is first talk about some definitions, then what we know about supplement users, then talk a little bit about what had been done with respect to reference to supplements, what currently exists and then talk a little bit about what some of the potential options may be.

At this point, I would also like to acknowledge that Suzanne Murphy and Johanna Dwyer were also on this subcommittee and thank Kathryn McMurry for a yeoman job of collecting information and all the other staff people that were involved in that.

First with respect to the definition of a dietary supplement, a dietary supplement is defined by the Dietary Supplement Health and Education Act as a product other than tobacco intended to supplement the diet that bears or contains one or more of the following, vitamin, mineral, amino acid, herb or other botanical, or a dietary substance for use to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any ingredient described above and intended for ingestion in the form of a capsule, powder, soft gel, gel cap and not represented as a conventional food or as a sole item of a meal or the diet. That is a big mouthful, and also that is a relatively broad definition.

I also looked for some other definitions of a dietary supplement. One I found, and actually I could not find that many so if anyone has information on this if they could submit it to Shanthy.

I found one definition in a workshop on the role of dietary supplements for physically active people, and it defined dietary supplements as a plant extract, enzymes, vitamins, minerals and other hormone products that are available without prescription, and this should be may, and may be consumed in addition to the regular diet.

I then was interested in what some other positions were on the use of vitamin and mineral supplements, and I found one from the American Dietetic Association. That position states that it is the position of the American Dietetic Association that the best nutritional strategy for promoting optimal health and reducing the risk of chronic disease is to obtain adequate nutrients from a wide variety of foods. vitamin and mineral supplementation is appropriate when well-accepted, purviewed and scientific evidence shows safety and effectiveness.

Looking for additional position statements, there was one, and this is sort of a partial because this dealt with antioxidant consumption and risk of coronary heart disease that was recently published from the American Heart Association. It had two statements with reference to this.

In view of these findings, and it had summarized the findings on the relationship between antioxidant intake and cardiovascular disease, the most prudent and scientifically supportable recommendation for the general population is to consume a balanced diet with emphasis on antioxidant-rich fruits and vegetables and whole grains.

It points out one point that I would like to make that we can make different kinds of recommendations for different people, but one is going to be for the general public, the general population, and then there may be more specific groups within that.

It goes on to state that although the diet alone may not provide the levels of vitamin E intake that have been associated with the lowest risk, in a few observational studies the absence of efficacy and safety data from randomized trials precludes the establishment of a population-wide recommendation regarding vitamin E supplementation.

In the case of secondary prevention, the results from clinical trials of vitamin E have been encouraging, and if further studies confirm the findings consideration of the merits of vitamin E supplementation in individuals with cardiovascular disease would be warranted.

I did not find other statements specifically addressing vitamin and mineral supplements. Again, if somebody is aware of that, if they could provide them to Shanthy that would be appreciated.

I was then interested in the terms enrichment and fortification because those are actually mentioned in the current guidelines. What I did was looked at a number of nutrition textbooks and also checked with Kathryn McMurry on whether there was an official definition. There did not appear to be, so I am going to give you the definition from three textbooks spaced approximately a decade apart.

The first came from a basic textbook by Guthrie that was published in 1975. The definition of enrichment was, "Addition of nutrients to cereals to replace those lost during processing," and then fortification, "Addition of nutrients to foods other than cereals to replace those lost during processing." There was no mention actually in the second iteration of that.

In a basic text that was published ten years later in 1987, there was a slightly different definition for enriched food. "A food to which nutrients have been added. Specifically in the case of refined bread and cereal, four nutrients have been added, thiamine, niacin, iron in amounts approximately equivalent to those originally present in the whole grain, and riboflavin in about twice the amount originally present in the whole grain."

Fortification, "A term referring to the addition of nutrients to food often not originally present and often added in amounts greater than might have been found naturally."

Lastly, a text that was published this year. Enrichment, "A term generally meaning that the vitamins thiamine, niacin, riboflavin and folate and the mineral iron have been added to grain products to improve nutritional quality."

Fortified, "A term generally meaning that vitamins, minerals or other or both have been added to food products in excess of what was originally found in the product," so there is nothing really specific so then it becomes somewhat difficult to interpret and sort of decide what should be in the current guidelines and how the consumer can actually distinguish, although at least there is an update because now folate has to be added.

The next thing that I did was look at some of the literature in relation to the sort of incidence of supplement use and then some of the characteristics of the individuals. This is somewhat difficult because different investigators use different populations that had very different characteristics, and they also evaluated the use of dietary supplements very differently by posing different types of questions or using different methods of assessment, so these are really I would say approximations. But this had come up at the last meeting that we should have some information on this.

One way of assessing supplement use, and for the most part when supplement use was assessed it was in a much narrower definition than the ones that I gave you at the beginning. It was really now limited to vitamins and minerals and in some cases broader.

In this case it was vitamins, minerals and then one or more of 33 specific vitamins, minerals or miscellaneous dietary components that were not totally defined, but it was estimated that about 40 percent were users, of which about 52 percent consumed one supplement, and about 11 percent consumed five or more supplements, so this gives you an idea of pervasiveness.

As far as the characteristics of dietary supplement users, females had higher uses than males in all age categories. Females age 25 to 64 years had the greatest usage, whereas males of the same age category had the lowest usage.

Supplements were used more commonly in individuals that lived in the west census region, individuals with incomes greater than $25,000, individuals who finished high school and in the general population compared to the

nonwhite population.

Data from the NHANES II also looked at supplement use and reported that about 35 percent of the population was supplement users. This was broken down into those that were using them regularly, which was about 21 percent of the population, and irregularly, it should be less than once a week. Excuse me. No. It is greater than once a week, but not daily, 14 percent of the population. The users were identified as those that were older, female, white, more affluent, and more highly educated.

It was also reported that supplement use was associated with higher dietary intakes of most nutrients and that this relationship still existed after adjusting for age, income, education and caloric intake.

Looking at the picture somewhat differently, and this was now looking at factors that impact on women consuming recommended amounts of calcium, notwithstanding this presentation that we just heard, but I thought it was also interesting because it gives one some idea of those individuals that are actually consuming at least for one nutrient what is considered an adequate diet, what some of the characteristics were.

Essentially women whose diets met the RDA for calcium consumed more milk products, fruits and grains, more -- several essential nutrients, zinc, magnesium, phosphorus, riboflavin, niacin, folate, vitamin B6, A and E, protein, saturated fat and sodium and less regular sugar or regular soda.

The women whose diets did meet the RDA for calcium also -- other characteristics -- worked part-time, took vitamin and mineral supplements, reported avoidance of whole milk only, were aware of the relationship between calcium and health and reported a higher number of milk group servings being recommended, so actually they were consuming dietary sources of calcium, but they were also consuming supplements, which again tells you something about supplement users.

Those women whose RDAs were not meeting their RDAs for calcium tended to be black, be under the age of 25, to eat more food away from home, report avoidance of all types of milk and report dietary intake in either the summer or fall, which was also interesting, but it also tells you something about the difficulty in collecting these types of data.

Again, an attempt to estimate the use of supplements. Subjects in this case were asked whether they were currently taking vitamin and mineral supplement products of any type, and they were classified with respect to usage. Thirty-eight percent of the whole population reported being users, so you can see the estimates of total intake are relatively consistent.

Forty-two percent reported being light users, 16 percent moderate users, 28 percent heavy users and 14 percent very heavy users. This is on the basis of how many different supplements they were actually consuming.

Of those individuals that were heavy and very heavy users, they tended to be female, white, greater than high school education, high-income and living in the western United States, so again relatively consistent findings.

Interestingly, factors that were also associated with vitamin and mineral supplement use in this group is that they were frequent visitors to health food stores. They had a greater nutrition activity index, and that was defined as when they would use these products, let's say if they were under stress or for some other reason that they self-defined, and that there was less physician involvement.

Another way of looking at vitamin and mineral usage is to look at trends. These are data of a health interview survey, and it was have you taken any vitamin or mineral supplement in the past year. That was the question that was posed. You can see that different questions were posed in different studies.

In 1987, 51 percent reported usage. In 1992, 46 percent reported usage. Interesting was where the shifts occurred. There was a decline in the use in both white female and males, no change in blacks and Hispanics, an increase in usage in individuals with education that was classified as zero to eight years, and a decrease in calcium use among females age 55 to 64.

Factors that were reported to be associated with the use of vitamin and mineral supplements was one, media attention, and during that period of time there was media attention for vitamin C, E and betacarotene, and an emphasis on hormone replacement therapy, which was thought to explain the shift in the older women's use of calcium supplements.

More recently, a study came out that again addressed this issue of vitamin and mineral supplement use. In this case, they really attempted to assess not only the total trend, but also trends in different subgroups. The question that was posed was how often, if at all, do you take a vitamin or mineral supplement.

A user was defined as an individual that took a vitamin and mineral supplement every day or every so often, whereas a nonuser was defined as one not at all, so you can see that the definitions vary. The range was reported to be 33 to 43 percent of the sample.

The profile of supplement users in this case was again older adults, whites, females, individuals that had incomes above 170 percent of poverty level, individuals that had greater than 12 years of education and individuals that were employed.

Use of vitamin or mineral supplements was associated with increased knowledge about diet/heart relationships, asking a specific question are you aware of a

relationship between diet and cardiovascular disease, a belief that one's diet does not need to change.

That is, they thought they were doing pretty well with their diets. Therefore, the only thing left to do was to take a supplement and that nutrition was unimportant assessed by there are so many different messages they cannot really figure out what is going on. Therefore, again it really does not matter, so different issues related to the supplement use.

With respect to the diet, it was reported that the individuals that used supplements had a slightly lower mean intake of fat and saturated fat, which probably was related to the knowledge of the relationship between diet and cardiovascular disease, had higher mean densities for the other nutrients, which was interesting, had a higher diet score, which was the average intake of seven nutrients, and, even controlling for the sociodemographic variables, it actually diminished. The relationship with nutrient intake and diet score still remained significant.

Lastly, with respect to supplement users, these authors concluded that supplement use was associated with higher quality diets in some population groups, but with lower quality diets in other population groups. You could not even generalize because in some cases when the groups were subdivided it might have been higher in one

socioeconomic group and lower in another, but then if you looked at education it might be switched so that there was a lot of variability there, so broad generalizations could not be made.

That the strength and direction of the association related in part to the individual and group differences in knowledge, attitudes and beliefs concerning supplements, food and health, but not necessarily what we might have predicted would have been the determinants.

They pointed out that these findings required confirmation and larger sample size, but I thought something that was a very interesting comment at the end was that such information, that is having a larger study, could reveal the likely consequences of a permissive policy regarding supplement based approach to prevention of chronic disease.

What I took this to mean is a call for more work that really needs to be done in assessing what the impact of the message would be if there was a shift in policy towards the use of supplements away from the use of food, and so at least we could get some answers to that issue.

The next thing I did was look at the 1995 subcommittee summary. In that case, and this is sort of a refresher from what Dr. Kumanyika went over the last time, but that the phrase "and other substances needed for health" was added, and that was to emphasize the term nutrients did not cover all food components of food that may be beneficial. I think that is something we need to keep in mind.

Also, special circumstances were noted, and one example is females of child bearing age and older adults. I think that is something that we need to consider and probably should flow from the new DRIs, the ones that have been issued and the ones that will be issued, because there are specific recommendations in those for specific population groups.

In 1995, there was a stronger argument that consumers should not routinely rely on supplements to meet nutrient goals and that food should also be considered. Also with regard to the 1995 committee report, there was reference to enriched and fortified foods, which is why I went through the definitions at the beginning.

There was an elaboration of the distinction between each within the diet. It directed consumers to the food labels for information regarding enrichment and fortification because that would not necessarily come out on the nutrient label where it would just be the total, but by looking at the ingredients they could tell if a product was enriched or fortified.

Current references to supplements in the current text are as indicated under the variety guideline. One is that enriched and fortified foods have essential nutrients added to them. That is on page 10. It goes into a definition sort of of enriched and fortified.

It directs the consumer, as I indicated, to the ingredient list, and it indicates how these foods fit into the diet, depending on the amounts consumed and the other foods that are actually consumed. In that Figure 2, the actual ingredient list is highlighted, and there is an example of a food that is enriched.

Also under the variety guideline, the question is posed where do vitamin, mineral and fiber supplements fit in. The points made are that supplements may help meet special nutritional needs; that is, older individuals for calcium, for vitamin D, and they give other examples.

Supplements do not supply all nutrients and other substances present in food that are important for health so that there are other substances that may accompany those foods that are particularly in certain nutrients and that daily vitamin and mineral supplements are usually not needed by people who eat a variety of foods depicted in the food guide pyramid, so at least that wording is relatively clear on where the committee stood.

Then there is also some reference in a sense because of the fiber and the grain products, vegetables and fruit guideline, and the terminology is that plant foods provide fiber and that some of the health benefits associated with high-fiber diets may come from components present in those foods, not just from the fiber itself. For this reason, fiber is best obtained from foods rather than supplements.

I actually missed one, so I do not have an overhead for it, but it is on page 8 of the guideline book. It is under What About Vegetarian Diets? It does refer to special considerations for vegans with respect to B12 intake and then for children, also vitamin D and calcium, cautioning that there may be special considerations for that group.

I also looked at some of the international dietary guidelines just to see if any of the other countries were mentioning them. In the summary points, which was the only text that we got from those guidelines, there was no mention of them.

Therefore, I come to options to consider, and then perhaps other members of the subcommittee might want to also comment. One option is no change in the current text. Another option is to update the text consistent with changes that have occurred after 1995. An example would be folate fortification.

Another option, though, is to distinguish between nutrients added to foods as prescribed by national policy versus those that are added at the discretion of the manufacturers. That would in a sense get around the relatively changing or undefined nature of enriched and fortified.

Now, there is a lot of crossover because classically enriched did refer to nutrients that were actually in the product that had been refined out, and now with adding folate to grain products and then having other types of foods that are available to the consumer like orange juice with calcium, it may be more helpful for the consumer to know what actually is there and is added because it has to be added, and they could actually make a choice of buying a product that either did or did not have the nutrient.

I actually would argue for including text on salt because right now consumers do have the option to buy salt with or without iodine, but it is not really made explicit.

Another option is to be more specific and possibly more positive in identifying subgroups which might benefit from supplementation. That should really I think be consistent with the DRI so that there is some consistency between the two documents.

An option is to include a figure with examples for structure function statements since we know now that there are certain claims that can be made, and there are certain criteria for those, although I understand that that might be technically difficult to do, but there are in Figure 2 two examples of food labels so it would not even be adding a figure. It might just be substituting one figure for the other.

Obviously there are other options also, which are open for discussion.

Thank you.

CHAIRMAN GARZA: Are there any specific points to this presentation either for comments or questions? Scott?

DR. GRUNDY: One thing I have been thinking a lot about recently is the terminology. You know, I think that the terminology employed by the FDA for providing different categories is actually quite good, and I think we ought to think about somehow bringing into the guidelines what we mean in different categories like foods, enriched foods, food additives, supplements. That might be informative to the public to actually know the categories, and then we could divide things up accordingly.

As you went through your talk, under supplements you actually talked about several different categories, but you did not distinguish between those. It might be useful to be in sync with the FDA's recommendations.

CHAIRMAN GARZA: Dr. Kumanyika?

DR. KUMANYIKA: The issue that did not come out clearly to me in your really exhaustive review of at least the vitamin and mineral issues, but there are consumers wanting to take supplements to make sure their diet is adequate as they perceive it, and then there are consumers wanting to take supplements for extra protection.

I think those two, either the issue of whether there are optimal levels over and above DRIs or whatever reference is available, is one of the main issues with supplements. The other is whether food is a better source of nutrients for basic adequacy.

It just seems like we have a lot of work, besides the fact that those other supplements we have not even come around to dealing with what to say about other things people ingest that are remedies. I think this is a good start, but it seems like there are lots of issues.

DR. LICHTENSTEIN: I will agree with you. There are a lot of issues, and they are very, very difficult to tackle so I welcome your extensive input.

CHAIRMAN GARZA: Any other comments? Johanna?

DR. DWYER: Just three quick ones, Alice. I think this is a very nice presentation.

In terms of distinguishing between nutrients added to food prescribed by national policy -- these surveys -- as long as national policy does not mean it is required. In other words, there are some examples, perhaps iron fortified formulas and so forth, that are not required necessarily, but they are of public health significance and I think probably national really.

DR. LICHTENSTEIN: Okay, but remember that example would not fall under dietary guidelines because that would be for individuals under the age of two, but there may be others, I guess.

DR. DWYER: I am talking about formulas.

DR. LICHTENSTEIN: Right. Yes. I agree with you with the salt. I think we have to provide guidance on that.

DR. DWYER: When we are talking about high-potency vitamins, I realize that vitamin D is I do not think it is sold separately, but it is still of great concern. Maybe we should think about ways of mentioning it because it is really more like a hormone.

DR. LICHTENSTEIN: Yes. I do not know when the DRIs for that are going to come out, but we might be able to get some guidance. Well, when they are going to.

From what I understand, the committee has been appointed, but when they do come out and when they are anticipated and how that can be merged with that, but again I think your point is well taken.

CHAIRMAN GARZA: The other thing, Alice, before you get off the podium that might be very useful, and I think it was a point that Shiriki was getting at, is that we may need some help from staff to help look at the role that supplements play at least among those groups that are most at risk for meeting certain nutrient requirements.

I do not know whether the present databases permit us to be able to do that, or is it the groups that in fact now are not at risk, in fact, your analysis would tend to suggest are the principal consumers of these products.

There is a wider discussion now on the guideline itself. I do not know if any of you have any comments or questions that you want to direct to Suzanne or anyone, any of the presenters or members of the groups? Meir?

DR. STAMPFER: I had a few specific comments on both the dairy and the supplements, but I just want to limit myself to the overall guideline.

I thought Suzanne's presentation was really excellent and the analysis very informative in showing what the gain was with and without variety. It was striking to me how little there was.

I also strongly agree with the potential for confusion with the current wording, glazed donut versus chocolate covered as a variety of donuts. I think that all makes good sense.

The proposed suggestion to consider putting in the food pyramid as kind of a replacement for that, but then thinking about that, the food pyramid is actually supposed to be derived largely from the dietary guidelines so in a way it is kind of a tautology to say follow the food pyramid because the food pyramid is supposed to follow the guidelines.

My conclusion is to carry this logic just one step further and make what might sound like a somewhat radical suggestion, but I think it is not all that radical, which is just to drop this guideline as a slogan and put the content in the introduction, which we already have an introduction, and that could be expanded.

We could work out, you know, what the content would be. As a guideline, I think we have reached the logical conclusion.

CHAIRMAN GARZA: Any responses to that suggestion, other comments or other questions? Scott?

DR. GRUNDY: I had some concern, too, about linking it to the pyramid. I could see all kinds of logistic problems in going back and forth.

If the pyramid becomes part of our document, you have to get more involved in the development of that, which is going to be quite contentious in itself. I mean, I think it is a good idea, but I think we have to be careful how we would do that.


DR. MURPHY: Can I respond to that?

CHAIRMAN GARZA: Yes, and would you summarize then Scott's comments because some were unable to hear. That is at least what I heard coming from the --

DR. MURPHY: Are yours on the same line out?

DR. LICHTENSTEIN: I was concerned about tying it to the food pyramid for a different reason. That reason is that there are a lot of foods that are being introduced that could be very beneficial, but do not fall within the pyramid.

Something like calcium supplemented orange juice comes to mind, but I think we are going to see a lot more of these products of where do you put it? Do you put it in dairy? Do you put it in fruits and vegetables?

To me, it seems like our food supply is moving towards a disconnect between foods and nutrients. You can still recommend dietary patterns, but things are not fitting in where we originally thought they would or used to.

DR. MURPHY: I thought those were all helpful comments. Let's see if I can summarize what Scott said.

It is a logistics problem of who does the pyramid and who does the guidelines. Therefore, we are in a sort of circle.

Are you sort of adding on to what Dr. Stampfer said that --

DR. GRUNDY: Yes. I think that we have heard that we are not responsible for the pyramid, and I am glad because I think that that almost is a separate guideline in some ways. It certainly is linked, but it is a different concept. If we have to get involved in developing that or trying to decide how it is going to be structured, then I think that is beyond what we could do or should do.

If you just in a way, though, will you endorse it or make it an official part of our guidelines if you refer to it and say eat what is in the pyramid?

DR. MURPHY: Okay. Well, we are all agreed that we are not trying to develop the pyramid.

I would like to make a comment, and then I would like to see if Dr. Kennedy would maybe like to make a comment also or Carol or somebody on the development of the pyramid.

Let me just remind you all that really the variety guideline does focus now almost entirely on the pyramid, so unless we drop the discussion of the pyramid entirely, which I do not think any of you -- is that what you are recommending, that this document should not even discuss the pyramid?

DR. GRUNDY: Well, I think if you put it on the front like you suggested, you really codify it in a way that makes that equivalent to the guidelines so I had some problem with that. Inside maybe it is not quite so bad,

but --

CHAIRMAN GARZA: Let me make things more complicated for you, if I could have a visual, that this committee makes recommendations as to this booklet, but we are not responsible for writing this booklet either so that in fact if the Department wishes to insert a pyramid in it or discuss the pyramid, that is perfectly all right.

Since they are the authors of both this document and the authors of the pyramid, we could certainly make recommendations as to the contents of both and leave it up to them. I mean, we could say gee, if you are going to have a pyramid or another icon then use it as your first guideline or based on the sort of reasoning that Suzanne went over.

Do I understand that correctly?

DR. DWYER: Well, I did not think our job was to do the pyramid.


CHAIRMAN GARZA: No. That is what I am saying. What I am saying is we do not do this booklet either. We make recommendations as to its contents, but we are not responsible for issuing it.

DR. KENNEDY: Can I comment on that? Having said that, you are absolutely right that the mandate of the committee ends when you have the technical report, which goes in to the Secretary of HHS and Secretary of USDA.

However, given the history since we have had a Dietary Guidelines Advisory Committee 1985 onward, I think we have always taken the recommendations of the committee extraordinarily seriously. I think if you look at the concurrence between the technical report and what comes out in this, they are very close.

Where there are changes, it is because of internal reviews of the agency where there is maybe a unique policy issue, just a little tweaking of a word, but I think if you look at what comes in and what comes out, they are very close.

On the food guide pyramid, Johanna, I was taken by as Cutberto was talking. Johanna and I a couple years ago were in a meeting out in Chicago ostensibly to talk about some stakeholders from changes in the food guide pyramid. I was astounded that with the exception of one or two people there, people were commenting on the food guide pyramid and had never read the food guide pyramid booklet.

I bring this up because the development of the food guide pyramid not only is very detailed. It has excruciating levels of detail in how you publish things like this and -- I mean, this is the grunt work of it, the composite. When you think about what combination of foods meet nutrient needs, meet dietary guidelines, you have to back into what current consumption patterns are.

Suzanne and I were at lunch talking about this kumaweki kale in Kenya. Now, if we all were eating kale, the nutrient profile of the population would look very different than with the vegetables they are eating at the moment, so I think the reason Dr. Garza has been so specific that the guidelines come first is because at critical junctures we look at, we being the Center for Nutrition Policy and Promotion, revising the pyramid. It is when you have a new body of information based on DRIs, based on new dietary guidelines. I would assume that the next revisions would be based on the 1994-1996. That is the most recent consumption data we have.

Your point, Alice, about calcium-fortified orange juice, I mean, to the extent that gets reflected in the 1994-1996 then that gets built into composites, but it is a very meticulous, tedious process documenting the range of foods. I do not think with as hard as this group is working, even if you had doubled the number of feedings, you would not clearly be able to get to that point.

I think what we, and Linda may want to jump in here, but what we are looking forward to from both departments is a revision of the guidelines that then allows us to look at our communication pieces not simply to the icon everyone sees, but the bulletins that backstop it, the nutrition facts label, whatever pieces we are developing, soon to be released children's food diet pyramid, and think about what is the consistency of these what I call nutrition promotion instruments. What is the consistency of those instruments with the newly emerging guidelines?

MS. MEYERS: I would just like to add the historical note that those of you who are on the committee I think will recall, which is that the discussion of the pyramid and the food label and putting them in the variety guideline was to introduce consumers to two new educational tools that they could use, so the pyramid was highlighted and the food label was highlighted at that point.


DR. DWYER: I sort of like the new guideline. Did you come up with it together, and is it that you want a separate pyramid, Roland? I am not sure I understand.

DR. WEINSIER: Do I want a separate? No. I think the way the discussion --

DR. DWYER: First of all.

DR. WEINSIER: I mean, we met face to face in Birmingham a month or so ago. This is before I had even started on this dairy food thing. That was a result of actually our interaction and some discussion.

It seems to me our discussion revolved around variety based upon the data that Suzanne presented to us did not convince me that that is a major issue, and I agreed immediately with her that that is probably not the direction that should be the major focus of this section.

If it is then building what is the foundation of a sound diet, and we looked at the pyramid and the foundation is, you know, whole grain products, fruits, vegetables, and that made sense. The food groups are listed here, so I was not uncomfortable at all with reference to the foundation of a sound diet.

Now, whether it is called a pyramid or whatever, I think that is a secondary issue. That gets back to the technicalities of what comes first, the chicken or the egg. I am not uncomfortable at all.

I do not know how Suzanne feels, but I am not uncomfortable at all saying the section could be called develop a sound dietary plan and here is the foundation for it. We never refer to or give the icon of a pyramid.

DR. DWYER: Okay. I guess I am not as concerned about the -- not increasing the -- I guess I see other reasons for a variety that are more aesthetic than they are nutritional.

I was taken by something that Dr. Vanderbean, who is now retired, but was in FDA for many years, said that, you know, if you really looked at all of the nutrients and looked at something you ate in the same fast-food place every day, and looked at every item, it would not be that -- I mean, to some of us it would be a living hell, but in terms of the nutrients being achieved it was not that. It was the aesthetics that bothered me.

I think somehow I feel that there are broader issues than the nutrient correlations alone with respect to the variety guideline. I would hate to see it totally pitched out.

Linking to a pyramid, assuming that the pyramid we are all talking about is the USDA pyramid. As we know, there are thousands of pyramids now -- a Harvard pyramid, a Hawaii pyramid and so forth --

CHAIRMAN GARZA: Do not forget the Tufts pyramid.

DR. DWYER: Yes. It is like the Mexican pyramids on a base of water.


DR. DWYER: That is a modification of the USDA pyramid. There are no deviations.

CHAIRMAN GARZA: We should not forget the Egyptian pyramids.

DR. DWYER: I sort of like the guideline, as negative as it sounds like some other folks were.


DR. DECKELBAUM: I am not going to talk about the pyramid.

You know, listening to some of the discussions that have been going on with the variety and then Alice's presentation, it seems that this might be a good opportunity of linking the two even on a firmer basis and introducing into whatever we want to call the variety guideline the concepts that not all populations are going to be able to achieve desired intakes from their diet.

We can look at this as an opportunity, especially when I guess the new DRIs are going to be coming out, that we can sort of give different populations, as you mentioned, the option of doing this through food, but if for some reasons either food are not going to do it or some limitation to the specific population, let's say pregnant women, then you really do need supplements or certain occasions and certain population.

I think that might be a way to, one, strengthen the current guideline under variety, even if it is under a different way, and bring us up to date with what is really happening with the DRIs.

CHAIRMAN GARZA: Suzanne, would you like to comment on that?

DR. MURPHY: Sure. I mean, I think it is the place to talk about when supplements are appropriate. I, of course, basically agree that supplement are appropriate sometimes in some situations so I would not have any problem, as I think basically Alice and her group are proposing, to add more of that to the variety guideline.

I need to ask. Well, everyone else finish, and then I will ask. Sorry.

CHAIRMAN GARZA: Alice, and then Shiriki?

DR. LICHTENSTEIN: Well, I think we do need to add more advice. However, I am not exactly sure under what guideline it should appear.

I really think we should hold off and hear all the other presentations before we talk about keeping or, you know, not keeping guidelines and changing guidelines and things like that because there may be or may not be other compelling reasons for disbursing it in different ways.

CHAIRMAN GARZA: Dr. Kumanyika?

DR. KUMANYIKA: I was trying to remember how we got to have the pyramid in the booklet last time, since I am a carryover person from the 1995 committee. It really is pretty much as stated in the report on pages 21 and 22.

The committee last time essentially came to the conclusion that except for adequacy and people with marginal intakes, there was no need for the guideline and that it did not help at all with the high fat issues. I mean, that was really clear.

You could almost see this as an intermediary step between variety when we have actually thought it made a difference to the dietary pattern, which it may have, and I think it did at one point, and actually saying we think that there is a desirable dietary pattern.

This was sort of bringing in dietary pattern issues, but still calling it eat a variety of foods and hoping people would figure it out from looking at that. It seems that now we might have to move to just looking at is this supposed to be a dietary pattern guideline to say how all these things fit together. If that is so, not necessarily have it as the pyramid, but just decide do you want to recommend a dietary pattern for which there is a scientific basis.

We concluded last time that there was no scientific basis for the variety guideline except to adequacy, and that is pretty much what it says so it is a conglomeration of collecting things that each has a basis and putting them into one guideline.

CHAIRMAN GARZA: So you have to use all guidelines. You cannot choose to follow only two or three.



Okay. Roland?

DR. WEINSIER: Yes. Maybe Suzanne and I can put our heads together if we have some time during this meeting to pick up, because I think Meir initiated this conversation, and I think we ought to give some credence to his suggestion that maybe what we are talking about here is pulling together the recommendations of the other groups into one that sort of solidifies and gives an overarching image, you know, of what is the foundation of, you know, an eating plan, which includes things, moderation in sugar, salt, alcohol, even the balance the food you eat with physical activity, the weight guideline.

I mean, it is built, the way we have devised it now. It is built on the foundation of the whole grains, fruits, vegetables, unrefined starches, so it may all tie together and could satisfy what Meir is bringing out.

CHAIRMAN GARZA: Okay. Suzanne was going to wait until all of you had your opportunities. Should she go now?

DR. MURPHY: I guess my question to everybody was what are the pros and cons of dropping all mention of the pyramid from our guidelines?

DR. JOHNSON: Should I call on people?

CHAIRMAN GARZA: You did not mean that as a rhetorical question that we could answer over the next few days then?

DR. MURPHY: Well, I think that we have to give that serious consideration. If we drop this guideline, there is no place really. Possibly visually it could be put somewhere, but there is no place to talk about any parts of the pyramid other than those that are in right now grains, vegetables, and fruit.


DR. JOHNSON: I just think we have to be very careful in thinking about, you know, the question is what should Americans eat to stay healthy, so we have to be very careful about thinking about then are there any holes in the guidelines as a totality.

To me, a big issue that stands out are the problem or scarcity nutrients. I will use calcium as an example. We do not have any specific guideline related to calcium, for example, that could be fit into a variety guideline.

If we do not have that, then I think we have a big hole there where we need to think about really the totality of the diet and where those kinds of issues might fit.

CHAIRMAN GARZA: Richard, and then Alice?

DR. DECKELBAUM: In answer to should it be dropped, I do not actually know because from what I understand from Eileen, the pyramid sort of comes out of in part certainly from the deliberations of this committee, and I think from an editorial of Walter Willet, you know, does the pyramid need repair, well, maybe it needs a bit of repair, a lot of repair or whatever, but that repair process is going to come partly out of the deliberations and what this committee reports.

I think that really because of the wide acceptance of the pyramid as probably the major message that people are familiar with in the general population that it would be a mistake to drop it.

CHAIRMAN GARZA: I think you are right. At least from the data that I recall, the proportion of the population that recognizes the pyramid is much greater than those that know anything about the guidelines.

Alice, and then Scott, and then Meir?

DR. LICHTENSTEIN: I guess I am interested. I know what the intended audience for the guidelines are. I guess what I am interested in is whether there is any hard data on exactly how the guidelines are used, whether they are really used by consumers, whether they are more used by setting policy.

I think that might help me think more about which guidelines would be useful, whether they should all stay. Maybe there should be some overhaul as far as more emphasis on what people should eat, what would encourage the development of the sort of dietary patterns that have been associated with decrease disease incidents, maybe not causal, but at least associated.

I think there is a lot of data between 1990 and 1992, and then that might help with this issue of should there be this variety pyramid or some different iteration of the pyramid.


DR. GRUNDY: I think my problem with this is that the word variety and the concept is sort of open ended. It is not specific enough.

I think there are two things we need to do. One is to think through the recommendation and what do we really want to say, and the second thing is I think we need to put it in words what we actually did say. I think that is the challenge to you.

That is one of the problems I have with the pyramid is I think it, too, is kind of nebulous. Everyone that looks at it and reads those words is going to get a different message that they can interpret as they want to.

The challenge to you might be to really put it down exactly in words what you mean, and it also ought to be something that we all agree upon.

CHAIRMAN GARZA: It is clear that the difficult Scott will do himself. The impossible he contracts out to Suzanne. I have lots of faith in her.


DR. STAMPFER: I think in terms of whether we should or should not mention the pyramid, I think ideally we should if it actually works out to be what it is supposed to be, which is on page 4. The food guide pyramid serves as an educational tool to put the dietary guidelines into practice.

If our revised, and I am assuming we are going to revise the dietary guidelines. If our revised dietary guidelines were reflected in a revised pyramid, that would be the best setting, and then we could refer to that revised pyramid.

I do not see how it makes any logical sense for us to talk about revising the dietary guidelines and then refer to the existing pyramid. If we are going to change the guidelines, then that means we are recommending or hoping that there is a change in the pyramid.

If we are talking about the current pyramid, I would say no, we should not mention it. If we are talking about the ideal pyramid, yes.

CHAIRMAN GARZA: All right. Johanna?

DR. DWYER: May I make a plea for a holistic approach? Not only should we, in my view, mention the pyramid, but we should also mention the food label, the nutrient label, and we should also mention, and I will tell you more about this tomorrow, food safety because most people really do not get it -- that this is all together what is necessary for healthful eating.

Anything that can bring things together in people's minds rather than further atomizing this field, and also Dr. Lichtenstein's comments about supplements. They should all be together at least in one place.

I do not care -- my colleague from Tufts does -- whether consumers read this. My concern here is whether 5,000 county health department people in various units, whether it is education, health, agriculture, whatever it is, read it. I am very much concerned about that, and I think probably that is about all they get, at least in some counties where I grew up.

CHAIRMAN GARZA: Okay. Richard, did you have your hand up?

DR. DECKELBAUM: Yes. Actually, at our first meeting there was some discussion as to whether we would be meeting with the food pyramid people or group -- I think probably some are here -- so that we could coordinate this kind of activity with an outcome.

At the same time, I do not know how frequently, and I would have to go through, but I am not sure that the pyramid that is on page 4, except for the variety guideline, is referred to very frequently in the other sections, so that it is not absolutely necessary that we, you know, have a guarantee that we have a revised pyramid when we think of the other individual guidelines.

We would hope that the dialogue would allow some use of this and perhaps some changes so that it would be a better teaching material.

CHAIRMAN GARZA: The difficulty, Richard, in what you are suggesting is that once our guidelines are developed and our recommendations made, and I want to stress a point that Eileen made. I mean, as I understand the process, there are a number of analyses that go into the dietary and to the pyramid, which at least from a time perspective would make it very difficult for them to then come back to us and say now here is the new revised ideal pyramid based on your latest recommendation because it really, at least as I understand it, people go back.

The group goes back to look at the nutrient intakes suggested by those patterns that are gender, age and culturally specific to make sure that they are as generic as possible, so I do not know whether that sort of iteration would still permit us to meet the deadline of getting done with this process by October. I mean, is that --

DR. KENNEDY: You are right. You are absolutely right.

The other issue is, and this is a policy decision from the Department, but, given the emerging DRIs, at what point do you take the newest DRIs, take the newest dietary guidelines, take the newest consumption patterns?

It is not, and again I speak as someone who is not tasked with the day-to-day of doing the analyses, but it is not clear at this point when a new pyramid would emerge based on these new pieces of information, so there is almost a zero percent probability, knowing what has to go into this, that a new pyramid, if it were to emerge, would be available at the time the guidelines would be released. The timing just does not work.

CHAIRMAN GARZA: It may be something along the lines that Roland was alluding to. It would still permit us to bring it together, and if the group feels uncomfortable with identifying a pyramid because we will not be able to see it a priori, it is the concept that becomes important in our technical report rather than the specific prescription as to how to accomplish it.


DR. KUMANYIKA: The other thing that I got out of Roland's presentation very clearly was that the pyramid gives us some guideline that we have not made, and it does not address some that we have made so there is really not as much overlap as one would like. There are other considerations.

We have guidelines that talk about the grains, fruits, and vegetable group and about fats and sugars in moderation. We do not have a guideline that talks about meat and dairy consumption. We do have guidelines that talk about alcohol, salt and weight that are not on the pyramid.

so in one way or another, we need to come to a relationship between the pyramid and the guidelines because it really does not -- I think we kind of accept it as the main graphic, but it does not take care of the calorie and energy balance problem, and it has never had salt on it, and it adds these other issues that people are now testifying to us about -- guidelines that we have not actually made because we do not have a dairy guideline, but we heard a lot of testimony about the things that are wrong with the dairy guideline

CHAIRMAN GARZA: Let me assure you. I mean, it does attempt to provide some of that in terms of it gives you three different calorie levels, but the main, principal point that I think all of us have to recall is that this icon of the pyramid is not the only teaching tool.

I mean, there are food labels. There are a number of other mechanisms which in fact the government and other stakeholders use to translate the dietary guidelines, so it is somewhat unfair, possibly generated the unfairness by the booklet itself because the focus is on the pyramid, that we not think that is the only tool because I do not know that we could come up with a simple icon that would do what Shiriki was referring to.

I will take one more question. Obviously we did not get to the food grains. I told Richard that I did not see where we were going to be able to get there, so we are going to take that one tomorrow.

I think everyone is coming close to exhaustion, so, Alice, we will give you -- Linda had her hand up. We will go to Alice, and then we will give Linda the last word.

DR. LICHTENSTEIN: Okay. I guess after hearing all this discussion, I am more comfortable with the pyramid than when I started hearing this discussion, but I would also like to point out on page 10 and 11 that there are also examples of how to sort of cross pyramid categories because when it goes into recommendations for good sources of calcium, good sources of iron, then it is really integrating the whole pyramid so maybe that is really where we want to be.

CHAIRMAN GARZA: Okay. Suzanne, and then Linda?

DR. MURPHY: I guess do not leave me quite hanging as much.


DR. MURPHY: Roland and I have to do something.

CHAIRMAN GARZA: We want you to come up with another pyramid.

DR. MURPHY: No way. Do you all feel, I guess as I do, that we have to say something about dietary adequacy? I mean, I think that is what Roland is also saying, but say it without referring to the pyramid?

DR. GRUNDY: I think you ought to say it in words. Say it in words, and then the pyramid can be created out of those words.

DR. DWYER: I do not think we agree about this.

DR. MURPHY: I do not think we do.

DR. DWYER: -- abandon the pyramid. I have no problem with the minority report on this, if that is what it comes to.

CHAIRMAN GARZA: That is still a bit premature.

DR. DWYER: Right.

DR. MURPHY: To me, the primary measure of dietary adequacy, after all, is the DRIs, and the DRIs are what primarily generate the pyramid, right? I mean, most of the guidelines do not actually generate your pyramid servings, so it seems like you are sort of coming full circle.

You are saying do not generate the pyramid, but give us enough information on adequacy to generate a pyramid. I cannot do that. I do not think that is reasonable or possible.

CHAIRMAN GARZA: What I heard the group saying, and you can all chime in, is that in fact the pyramid attempts to accomplish a lot more because it is based on total nutrient adequacy. That was the various analyses that Eileen and Carol were describing, number one.

Number two, though, we have to recognize that in fact we do not get to choose or recommend follow only three guidelines, that somehow we have to transmit the message that in fact the guidelines are a total package.

Whether we do that with a separate guideline, which is what the variety attempts to do, or in words that accomplish this, giving enough guidance to USDA that says look, we recognize that you are going to need a teaching tool, and the teaching tool that you use should try to bring all of these guidelines together.

Now, the pyramid may have to go beyond that. One example that we have heard is its attempt to address the issue of calcium and bone health, and both Roland and I think Shiriki alluded to that.

It is not a task that I can easily see how to accomplish, but it ought to provide enough flexibility to the Department that if it wants to use a pyramid or develop other tools, you know, they have the options to do that.

What we should be doing is pointing out the centrality of the task, to getting the public to understand that you get to use all of the guidelines to achieve a healthy eating pattern, not concentrate only at the very top of the guidelines because, gee, you know, that is the part of the pyramid you like the most.

Did I reflect the group's --

DR. MURPHY: You have confused me.

CHAIRMAN GARZA: I have confused Suzanne and reflected your --

DR. MURPHY: You confused me.

CHAIRMAN GARZA: All right. Maybe somebody else thinks they can do a better job of unconfusing.

DR. KUMANYIKA: I have a suggestion. The introduction to this booklet is also kind of an interesting piece that actually could be accomplishing what this variety guideline tries to do.

I was going to suggest that we consider putting whatever we decide to say about the overall dietary pattern in the introduction and that this guideline be to get enough nutrients, because the rest of them are saying do not get too much of something, and this one is the one that says get enough.

Make this an adequacy guideline and address it that way and the other ones about the over nutrition, and then when we get back to the introduction we can figure out how to put the whole story together.

CHAIRMAN GARZA: So you are arguing for doing what I was suggesting in the introduction and then making this an outline or rather a guideline that focuses specifically on nutrient adequacy --


CHAIRMAN GARZA: -- of the total diet and picking up all of the orphan nutrients?

DR. KUMANYIKA: Right, but then putting the big picture in the introduction, which starts off with what should Americans eat to stay healthy and actually describes the pattern, but it is kind of -- we do not really talk about the introduction. It is just there.

CHAIRMAN GARZA: That is a new task on nutrient adequacy.

DR. MURPHY: You need another working group.

CHAIRMAN GARZA: That is right. No. We will just add it.

Okay. Are there other comments? Suggestions? If not, we will adjourn until tomorrow morning at 9:00 a.m.

Thank you, for those of you that have stayed on with us until the bitter end.

(Whereupon, at 6:10 p.m. the hearing was adjourned, to reconvene at 9:00 a.m. on Tuesday, March 9, 1999.)



In Re: Dietary Guidelines Advisory Committee

Name of Hearing or Event


Docket No.

Washington, DC

Place of Hearing

March 8, 1999

Date of Hearing

We, the undersigned, do hereby certify that the foregoing pages, numbers 1 through 291 , inclusive, constitute the true, accurate and complete transcript prepared from the tapes and notes prepared and reported by Sharon Bellamy , who was in attendance at the above identified hearing, in accordance with the applicable provisions of the current USDA contract, and have verified the accuracy of the transcript (1) by preparing the typewritten transcript from the reporting or recording accomplished at the hearing and (2) by comparing the final proofed typewritten transcript against the recording tapes and/or notes accomplished at the hearing.

Karen Stryker


Name and Signature of Transcriber

Heritage Reporting Corporation

George McGrath


Name and Signature of Proofreader

Heritage Reporting Corporation

Sharon Bellamy


Name and Signature of Reporter

Heritage Reporting Corporation