FDA PROPOSALS TO PERMIT THE USE OF DISEASE-SPECIFIC HEALTH CLAIMS ON FOOD LABELS THURSDAY, DECEMBER 10, 1987 HOUSE OF REPRESENTATIVES, INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 9:35 a.m., in room 2154, Rayburn House Office Building, Hon. Ted Weiss (chairman of the subcommittee) presiding. Present: Representatives Ted Weiss, Thomas C. Sawyer, Nancy Pelosi, Jim Lightfoot, and Christopher Shays. Also present: Daniel W. Sigelman, counsel; Gwendolyn S. McFadden, secretary; and Mary Vihstadt, minority professional staff, Committee on Government Operations. OPENING STATEMENT OF CHAIRMAN WEISS Mr. WEISS. Good morning. The Human Resources and Intergovernmental Relations Subcommittee is now in session. If you will all take seats and make yourselves comfortable, we can proceed. Today the subcommittee will conduct an oversight hearing on FDA's new proposals to permit disease-specific health claims on food labels. Over the past half century, Congress has enacted important laws to protect consumers from fraudulent food labeling claims. In particular, the Food, Drug, and Cosmetic Act generally requires all articles, including foods, for which disease-specific health claims are made, to be treated as "new drugs." Under the law, before a "new drug" may be marketed, "substantial evidence" must be produced to support claims of benefit. The new FDA proposal, however, would authorize, for the first time, the marketing of foods bearing such health benefit claims without a showing of "substantial evidence" or, for that matter, prior FDA approval. [The proposal referred to is in app. 1, p. 149.] Mr. WEISS. What could well result is a marketplace inundated with unsupportable, promotionally oriented health claims, in which increasingly competitive market forces unleash ever escalating, and ever less supportable, claims. The victims in such a scenario would be many of the most vulnerable among us-those anxious for any possible respite from sickness and the ravages of the aging process. FDA would retain the authority to review the scientific evidence offered in support of those health claims, and to declare a food to be misbranded, but only after it was on the market. At that point, FDA would have the demanding burden to prove a claim false or misleading, whereas, under current preclearance procedures, the \proponent of a health claim has the burden for proving it to be true. FDA simply does not have the resources needed to conduct substantive reviews of countless new health claims, and, where necessary, to cleanse the market of those which are false or misleading. The inevitable result would be unbridled health claims with little or no evidence to support them. The implication in the health claim proposal that the food label is an appropriate place to discuss the relationship between nutrition and specific diseases raises important issues regarding the current state of knowledge in the nutritional sciences. We will hear today from experts in this field who believe the new FDA proposal is scientifically unsupportable, a view apparently shared by many major independent nutritional organizations. I expect that they will present testimony on just how difficult it is to support claims of health benefit resulting from consumption of individual foods. Previous investigations by this subcommittee have sadly revealed that FDA is often not the master of its own regulatory destiny. In April and June of this year, we held hearings on proposals foisted upon FDA by executive branch officials either unaware of, or indifferent to, matters of great concern to FDA's professional experts. Once again in this case of health claims for food, our preliminary review strongly indicates that the decisionmaking authority that Congress has vested in FDA has been usurped by political appointees in the Office of Management and Budget [OMB]. In fact, the final version of the health claims proposal, in many critical respects, bears little resemblance to the more cautious, deliberate, tentative document prepared by FDA's career professionals and endorsed in 1986 by FDA Commissioner Young and Secretary Bowen. It, instead, now strongly reflects the intervention of OMB ideologues who seek unregulated market entry of food products bearing disease-specific health claims without regard to well-settled principles of law, the complexities of nutritional science, or the views of FDA's experienced and knowledgeable policymakers, scientists, and compliance personnel. We invited OMB officials to testify today, and, as in the past, they have declined to appear. [The exchange of correspondence between the subcommittee and OMB on the matter is in app. 1, p. 156.] This is unfortunate, since that office played a pivotal role in developing these proposals. I fully expect, however, that Dr. Young is well prepared to defend the administration's views and role before the subcommittee. Before I swear in our witnesses, I note that our ranking member, Mr. Lightfoot, is at another important meeting at this point. He will be joining us shortly, and at that time I will recognize him for his opening remarks. We have been joined by another distinguished member of our subcommittee, Ms. Pelosi. Do you have any opening comments you would care to make? MS. PELOSI. No, thank you, Mr. Chairman. Mr. WEISS. Your timing, as always, is impeccable. I am pleased to recognize our distinguished ranking minority member, Mr. Lightfoot. Mr. LIGHTFOOT. Thank you, Mr. Chairman. I ask for forgiveness for my tardiness, but I was involved in a discussion about the primary difference between Congress and the Boy Scouts, being that the Boy Scouts have adult leadership. Sorry I am late. Mr. Chairman, I welcome the opportunity today to learn more about the Food and Drug Administration's proposal to allow health-related claims on food labels. Since 1984, the Food and Drug Administration has been taking a close look at its longstanding policy discouraging health claims on food labels. This review resulted in FDA's August 4, 1987, proposed rulemaking, which allowed health-related claims on food labels. Now, this proposal sets forth criteria to be used to evaluate health messages on food labeling; it establishes a Public Health Service Committee to formulate possible health messages; and it requests comments on several citizens' petitions submitted to FDA on this particular issue. The proposal has generated a great deal of public debate, including whether truthful and nonmisleading messages can be placed on labels where the American consumer would benefit from these messages, and whether the FDA has the resources to crack down on those manufacturers who go beyond the intent of the proposal. Many of these concerns will likely be expressed today by witnesses. It is my hope that we can carefully review these concerns to determine the merits of allowing health claims on food labeling and to consider other approaches to pursuing this objective. Today's discussion and comments received thus far from the FDA on this proposal should result in a final rule which is workable and which protects American consumers from deceptive labeling. As FDA officials have indicated, this is unchartered territory for them, and they plan to move very cautiously. This is demonstrated by FDA Commissioner Young's decision to extend the public comment period so that interested parties would have ample opportunity to express their specific views. In this regard I commend Dr. Young for his willingness to solicit as many comments as possible and to discuss this issue with us today. With that, Mr. Chairman, this concludes my remarks, and I extend my welcome to all the witnesses. I would also like to ask that the record be kept open for 10 days for any additional comments which might result from our hearing today. Mr. WEISS. Without objection, that will be done. Thank you for your comments. Now I am pleased to note the presence of another distinguished member of the subcommittee, Mr. Sawyer, of Ohio. I understand that you have an opening comment. I am pleased to recognize you at this time. Mr. SAWYER. Thank you, Mr. Chairman. I would like to commend you and all involved for calling this hearing today. The issue of claims on food labels is one that has implications for all Americans. Clearly, consumers deserve to have as much information as they can about what they eat. Americans have become accustomed to being able to review all of the ingredients that are contained in the products that they serve to their families. However, as we all know, it has been a longstanding policy of the FDA to restrict food labels which claim the prevention, the treatment, or the cure of disease. It seems to me that the reasons for this are as straightforward as it is difficult to establish the overall health impact of foods. I look forward to the testimony of the FDA today because, clearly, they have proposed something which potentially has great benefit but is clearly a substantial departure from past practices. I hope that the discussion will illuminate those issues. Thank you. Mr. WEISS. Thank you very much, Mr. Sawyer. Let me note that from time to time we may be joined by other members of the subcommittee. By the same token, some of our members may have to leave for some periods of time to attend to other business. However, we will try to continue our work as expeditiously as possible. Also, because there is activity on the floor today, we may from time to time be interrupted for votes on the floor. We will try, however, to keep those interruptions to a minimum. Dr. Young, as you know, it is our practice to swear in all of our witnesses. Before I do, let me indicate that we will be hearing from a number of your associates whom you were good enough to bring along. I would like to identify them all by name and ask them all to stand, since we might as well do the swearing in all at one time. We have with us, then, Dr. Frank E. Young, who is the Commissioner of the Food and Drug Administration, accompanied by John M. Taylor, Associate Commissioner for Regulatory Affairs; Richard J. Ronk, Acting Director, Center for Food Safety and Applied Nutrition [CFSAN]; Dr. Allan L. Forbes, Director, Office of Nutrition and Food Sciences, CFSAN; Thomas Scarlett, associate general counsel, Food and Drug Division, Office of the General Counsel; Mary Frances Lowe, Senior Assistant to the Commissioner for Program Policy, Office of the Commissioner; F. Edward Scarbrough, Deputy Director, Office of Nutrition and Food Sciences, CFSAN; Dr. John E. Vanderveen, Director, Division of Nutrition, CFSAN; Paul J. Sage, Office of Compliance, Center for Drug Evaluation and Research; and Fred H. Degnan, Food and Drug Division, Office of the General Counsel. If all of you will please stand and raise your right hand. Do you affirm that the testimony you are about to give will be the truth, the whole truth, and nothing but the truth? Let the record indicate that each of the witnesses has responded in the affirmative. Dr. Young, we are prepared and pleased to receive your testimony at this time. |