Mr. WEISS. Thank you very much, Dr. Swan. Let me apologize in advance if I mispronounce your names. Please correct me if I do. Dr. Shils, we will next proceed with you. We have your prepared statement, which will be entered into the record in its entirety. We would appreciate your summarizing or highlighting that statement in a way that you think most appropri ate. STATEMENT OF MAURICE E. SHILS, M.D., REPRESENTING THE NEW YORK ACADEMY OF MEDICINE Dr. SHILS. I am Maurice E. Shils, professor emeritus of medicine at Cornell University Medical College, formerly director of clinical nutrition, Memorial Sloan-Kettering Cancer Center, and now a consultant on nutrition there. Mr. WEISS. Would you pull the microphone just a little closer to you? Dr. SHILS. Yes. Can you hear what I say? Mr. WEISS. Yes, that's fine. Dr. SHILS. I'm speaking today on behalf of the New York Academy of Medicine, which is a privately endowed institution in New York City, comprising a fellowship of about 3,000 individuals, 99 percent of whom are physicians in practice and teaching and research, primarily in the 10 or so medical schools in the metropolitan New York and northern New Jersey area. And so I speak for a different constituency than does Dr. Swan because the overwhelming majority of these physicians are not physicians trained in nutrition. And yet the documents which I have submitted were unanimously adopted by the Committee on Public Health and the Council of the New York Academy of Medicine. Our first concern was the issue of consensus. I listened to the discussion this morning and consensus was a major point that was discussed. And so the first document which we issued, which is published in the bulletin of the New York Academy of Medicine (63:410-416, 1987) and of which you have a copy, dealt with the issue of where do we stand on agreement on a number of nutritionally related claims for the possibility that nutrients or foodstuffs or food supplements can prevent or modify the development of disease. That document reviewed in some detail recent information on cancer, osteoporosis, and coronary artery disease. It was the opinion of our own committees that there was no consensus among scientists. As one continues to review the literature, I would say that what appeared to be a certain amount of consensus in certain areas perhaps 8 or 9 years ago is now unraveling. As more and more research develops, we're beginning to get the feeling of increasing difficulty in reaching an agreement. And so we concluded in that document that such disease-related, nonspecific health claims on labels may lead to widespread, inaccurate, or misleading claims to the public concerning such effectiveness, and we stated further "The Committee on Public Health urges the Commissioner of the Food and Drug Administration and the Secretary for Health and Human Services not to depart from established policy under the provisions of the Food, Drug, and Cos metic Act which prohibit specific health claims on labels of foods, food products, and food and nutrient supplements." We then replied to the Dockets Management Branch of the FDA concerning the actual proposed regulations, and we limited most of our discussion to the five issues which the FDA raised. I will very briefly summarize what we said. FDA Issue No. 1 asked whether it is in the interest of the public health that health information, including information regarding specific diseases, appear on food labeling. Our statement pointed out that there is no uniform agreement supporting the FDA statement in the Federal Register to the effect that "Industry, consumer advocacy groups, professional societies and PHS components have suggested that food labels, by virtue of their proximity during the purchase, preparation and consumption of food, are suitable vehicles for conveying information to the general public, etc." This is an incorrect statement. As a matter of fact, the FDA knew as early as June 1985, that the American Society for Clinical Nutrition opposed proposed changes in health claims, long before they were formally published. To the best of our knowledge, the FDA, until maybe this week, has never formally invited scientific societies and medical societies to comment in advance on this proposal. I understand the Commissioner met this week with some representatives of scientific societies. But before that, I am not aware of any effort to find out the views of scientific societies by direct contact from the FDA. In the published proposal, the main scientific support of the FDA was the National Research Council's publication "Diet, Nutrition and Cancer." And yet the FDA fails to point out in the statement the lack of consensus which that document clearly states, particularly the contradictory statements in that NRC publication about the value of fiber, one place saying it has a value and in another place saying the value is unproven. FDA Issue 2 asked "Whether the basic principles upon which the FDA has based its criteria are reasonable." The academy commented that "the general statements on pages 288844-45 are not reasonable." It concluded "there is a major concern from recent scientific literature reports that the relationship of many aspects of major areas of preventive health interest have no consistency and the criteria may well prove to be invalid." FDA Issue 3 asked "What types of valid, reliable, recognized scientific evidence should be considered adequate to support healthy (sic) information which might appear on food labeling." The academy commented that "the evidence should be based on consistent, scientifically-valid and statistically-significant controlled experimental human data from at least several sources published in peer reviewed journals and should not be based solely on epidemiological observations. The latter have been contradictory and, at best, are only associations and not cause-effect evidence." Because of the controversial nature of such evidence, we said "it is impossible to place on a label the type of information needed by the American people in order to understand the issues involved." FDA Issue 4 asked "Whether there are sufficient data and information to allow the use of health information on dietary supplements." The academy commented that for the reasons previously stated, "the answer is no." It is our position that the only information that should be allowed on labels of dietary supplements at this time is their nutrient composition as currently permitted. FDA Issue 5 asked "What priority the FDA should assign to enforce actions against the use of therapeutic and misleading health information on food labeling." The academy's position is that "the FDA should adhere to current regulations in 21 CRF, Part 101, without change. Furthermore, the FDA should assign a sufficient priority to enforcement actions for the existing regulations to assure that there are no health-related claims on food labels such as that produced by the Kellogg Company on its box of bran. For the reasons stated above, it is our opinion that it is premature, unnecessary, and potentially counterproductive for the development of a Public Health Service Committee for devising public health measures on food labeling and the plan is opposed." We point out the FDA will either have to develop a major surveillance unit for label claims for foods and food supplements, or else ignore what will become a torrent of such claims. The academy quoted a recent statement by Mr. Richard A. Cooper, former chief counsel of the FDA, who pointed out that the Center for Food Safety and Applied Nutrition does not have the resources to review health claims and adverse effects disclosure in the way the Center for Drugs and Biologics does. Mr. Cooper commented "that the law of health claims on foods should be pretty clear to and readily applicable by thousands of manufacturers and FDA. If it is not, the result is likely to be widespread abuse by the minority of irresponsible firms, ineffective enforcement by FDA, confusion in the marketplace, cynicism and resentment on the part of the consumers, and ultimate failure of this effort in consumer education." The New York Academy of Medicine concluded its statement by stating that “if the proposed changes are made, such abuses will occur because of the lack of scientific consensus and the lack of clear-cut requirements for the FDA, compounded by difficulties in surveillance and enforcement. There will, indeed, be confusion in the marketplace, cynicism and resentment on the part of the consumers, a decreased respect for the FDA by nutrition scientists, and a failure to promote by this means any effective education of the consumer.' Thank you. [The prepared statement of Dr. Shils, with attachments, follows:] Statement of Maurice E. Shils, M.D., Sc.D. Members of the Subcommittee: I am authorized by Dr. Mary Ann Payne, President of the New York Academy of Medicine, to make this statement before your Subcommittee. The New York Academy of Medicine was founded in 1847 and incorporated in the State of New York in 1851 "for the purpose of promoting the advancement of medical science". One of its functions is to encourage those measures, public and private which would improve the public health. Its membership consists of approximately 3,000 Fellows, the overwhelming majority of whom are physicians with most being in academia and research in many prestigious medical institutions primarily in the New York metropolitan area and surrounding states. Its charter and endowment allow it to be independent of governmental agencies, industry and organized medicine; however, it maintains an objective and supportive role with each of these important areas. With respect to the issue of the proposal in the Federal · Register of August 4, 1987 to modify the regulation of the Food and Drug Administration relative to food labeling, the New York Academy of Medicine has released two documents on this subject. One is a statement prepared by its Subcommittee on Nutrition and approved by the parent Committee on Public Health and the Council of the Academy on April 20, 1987 and published in the Bulletin of the New York Academy of Medicine (Vol.63, pgs. 410-416, May, 1987), a copy of which is attached. The second is the Academy's response to the aforementioned Federal Register request for comments which was submitted to the Docket Management Branch of the Food and Drug Administration on October 8, 1987. A copy of this response is also attached. In its first statement the Academy pointed out that the proposed revision of the position by the FDA allows food labels to make explicit specific health claims with medical implications. Such claims could be widely made and could include claims for numerous nutrients and food components. Key to the issue of the validity of claims that might be made is the issue of whether or not there is a true consensus in the scientific community for the role of individual nutrients or food components in the prevention of chronic disease such as cancer, cardiovascular disease and osteoporosis. The bulk of the report deals with the fact that there are very serious differences of opinion on the findings and interpretations of much of the scientific evidence in these areas. It concludes that such disease related non-specific health claims on labels may "lead to -2 widespread inadequate, inaccurate or misleading claims to the public concerning such effectiveness", and stated that "the Committee on Public Health urges the Commissioner of the Food and Drug Administration and the Secretary for Health and Human Services not to depart from established policy under the provisions of the Food and Drug and Cosmetic Act which prohibit specific health claims on labels of foods, food products, and food and nutrient supplements". In its statement of October 8th to the Dockets Management Branch of the Food and Drug Administration which was signed by Mary Ann Payne, M.D., President of the New York Academy of Medicine, comments were restricted primarily to the five issues on which the FDA requested comments. This statement can be summarized briefly as follows: FDA Issue 1 asked "Whether it is in the interest of the public health that health information including information regarding specific diseases appear on food labeling". Our statement pointed out that there is no uniform agreement supporting the FDA statement in the Federal Register, i.e. on page 28844, to the effect that "Industry, consumer advocacy groups, professional societies and PHS components have suggested that food labels by virtue of their proximity during the purchase, preparation and consumption of food, are suitable vehicles for conveying information to the general public, etc ...... The Academy stated "This is an incorrect statement." The FDA knew that as early as June 20, 1985, the American Society for Clinical Nutrition had written to the then Secretary of the Department of Health and Human Services, Mrs. Margaret Heckler opposing any revision of current FDA regulations on this matter. The FDA knew about our statement in the Bulletin of the New York Academy of Medicine of May, 1987. To the best of our knowledge, the Food and Drug Administration never formally queried those professional societies concerned with the areas of food, diet and health about their position on this issue." It goes on to say "the statements in this section of proposed rules are also inadequate in that they do not recognize the contradictory nature of scientific evidence for many aspects of relationships of diet and nutrition in the major chronic illnesses". It refers the Docket Branch to our original statement in the Academy Bulletin. Although the FDA referred to the 1982 report of the National Research Council entitled "Diet, Nutrition and Cancer", it failed to point out evidence of lack of consensus and contradictory statements in that report about the value of fiber. Since the NRC report was published, additional evidence in humans and animals has questioned the protective role of fiber intake in colorectal cancer and of vitamin A per se in lung cancer and of the negative relationship of fat intake to colon and breast cancers. All these data were available to the Food and Drug Administration at the time its notice was published. The Academy statement pointed out that "there is essentially no data available from long term experimentation in human subjects |