STATEMENT OF FRANK E. YOUNG, M.D., COMMISSIONER, 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): ALLAN L. FORBES, M.D., 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; JOHN E. VANDERVEEN, DIRECTOR, DIVISION OF NUTRITION, OFFICE OF NUTRITION AND FOOD SCIENCES, 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

Dr. YOUNG. Mr. Chairman, Mr. Lightfoot, Mr. Sawyer, Ms. Pelosi, I am pleased to be here today to get on the record the public views related to health messages for food. I fully expect and welcome the diversity of opinion that you will hear today as we all explore this topic.

Some will question the policy from the view of lawyers. In this context I would like to submit for the record an article written by Richard M. Cooper, former general counsel for FDA. I also note parenthetically that Mr. Goodrich has an opinion solicited by you for the record as well.

[The article referred to is in app. 1, p. 158.]

Dr. YOUNG. In his very scholarly article entitled "Health Claims on Foods: Reflections on Food-Drug Distinction and on the Law of Misbranding," Mr. Cooper puts the subject in focus. I would like to quote a few passages to put this into perspective from Mr. Cooper's article:

First, I want to address the notion that a food that makes a claim with respect to a specific disease renders the food a drug. That notion, it seems to me, is vastly overbroad and in discussions of our subject has been given far more prominence than it deserves. I will suggest two distinctions to help clarify when a claim is a drug claim and when it is not: The first is between avoidance and prevention; the second, between two types of prevention.

To begin with, a little law, though dangerous, is necessary. The Federal Food, Drug, and Cosmetic Act defines the term "drug" as applying to any article that fits within one of four categories: (A) articles listed in one of the official formularies; (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any of the above. Notice that the clause (C) contains an exception for foods, but clause (B) does not. Therefore, under the statute any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease is a drug even if it is also a food. Thus, any food labeled as a cure for cancer or as a useful treatment of cancer is a drug. In general, foods with such quack labeling are clearly drugs, and FDA's thinking about the health claims on foods has been riveted on such products. The agency has feared that if it opens the gates even a little it will be overwhelmed by a tidal wave of quack health claims. It is clear that the vast majority of implicit or explicit health claims by responsible firms has nothing to do with the diagnosis, cure, mitigation, or treatment. The issue, these days, is prevention, but, as I will now try to persuade you, most health claims on food don't really relate even to prevention.

In the English language we recognize the distinction between avoidance and prevention. I can avoid the rain, but I cannot prevent it: that is, I can stay indoors away from the rain, but there is no action I can take to stop it from raining. I can, however, prevent it from raining on me by taking an umbrella with me when I leave the house, spreading it above me before I walk outside, and keeping it above me until I am back inside. The word “prevent" comes from two Latin words meaning to go before. The original meaning of "prevent" in Shakespeare, for example, was to act before or in anticipation of some future time or event. Later, the word assumed its modern meaning: to keep or stop from occurring. But prevention in a modern meaning combines both senses: it requires some active intervention in advance that stops something from happening.

I don't want to read the rest of this because it is too long but, there are two other points: One on Kellogg's and one on the summary that I think are germane:

Where does this analysis leave the Kellogg All-Bran anticancer label? Plainly, Kellogg is not making an avoidance claim when it talks about fiber. I suggest that my simple prevention avoidance/distinction is too crude to address the All-Bran problem adequately. Despite the bold words of the statute, I would suggest that there may be a distinction between prevention claims that are appropriate for foods and prevention claims that are appropriate only for drugs. To develop and understand that distinction we need to understand a great deal more than I do the ways in which a normal proper diet contributes to health and disease prevention in the ordinary course of life. We know, for example, that certain diseases are nutrient deficiency diseases, and the foods that prevent such diseases do not thereby become drugs. I would argue that if I put on a can of orange juice, "This product contains vitamin C, and vitamin C prevents scurvy," I may have made a useless and confusing statement, but I have not made the product a drug. My reason is that the product prevents the disease simply by its normal use as a food supplying nutrition and without any trappings of a drug-no need for concern about dose, other directions for use, doctor's advice, diagnosis, administration under medical supervision, etc. It is a food that prevents a disease in the manner characteristic of certain foods and certain diseases. There probably are other ways in which specific foods or diets prevent disease without transcending their normal role and use as foods or diets supplying nutrition.

And finally in the conclusion, he says:

It is not surprising that we encounter very serious difficulties in creating public policy for health claims on foods. We are operating on or beyond the scientific frontier; developments are propelled by the exigencies of public demand in the marketplace rather than by the internal logic of regulatory progress; and we deal with large, complex, and very important issues. There is enormous momentum for the use of health claims in the promotion of foods and other products. The issue now, as I see it, is not whether to permit such claims, but how to do it. On that question there has been much heard from the manufacturers and lawyers. The public policymaking process needs on a continuing basis to hear from you as well.

I should point out parenthetically, this was introduced before a group of scientists, and I have equally implored the scientists to address this issue because we need their help.

Mr. WEISS. Dr. Young, before you go on to read your own statement, just so that there is no misunderstanding, you are not suggesting that Mr. Cooper supports the proposal that is before us, are you?

Dr. YOUNG. No, I am not at all.

Mr. WEISS. As a matter of fact, you should know that he has advised us that he considers the proposal to be overbroad and, therefore, he opposes it. He thinks it violates the act.

Dr. YOUNG. I am not dealing with that, per se, but he had the best development of the argument that I could find in the scientific literature, and I felt it would be an important one-

Mr. WEISS. Yes, but I think that it ought to be clear that he, in fact, thinks that the proposal itself is overbroad, and that it constitutes a violation of the act.

Dr. YOUNG. I appreciate that comment and anything that you can get on the record from Mr. Cooper, whose judgment I value, I would certainly appreciate seeing.

Mr. WEISS. We will do so.

[Mr. Cooper's January 20, 1988, letter to the subcommittee on his views of the proposal is app. 1, p. 167.]

Dr. YOUNG. The point, though, is to frame the issue so that we can see where we are going on it.

Second, you will hear controversy related to how much data is sufficient to make a valid health claim. I have met with a group of nutrition scientists-and I would like to provide these minutes for the record-and I look forward to future actions.

[The minutes referred to are in app. 1, p. 170.]

Dr. YOUNG. And Mr. Robert Krause of FASEB has assured me that his organization will participate in such future sessions, and I would welcome comments also from the American Heart Association, American Cancer Society, and others, as we evaluate this further.

I believe as we focus on the health issue, it is best framed by this statement from Dr. Forbes, and I quote:

At the outset I would like to stress that the absolute core of all nutrition guidance to the public is the total daily diet. This is clearly demonstrated by the practices of the entire dietetics profession in the Nation, by the national academic community in nutritional sciences, and by the Federal establishment as exemplified by Dietary Guidelines for Americans which was first issued by DHHS and USDA in 1980, and revised and republished in 1985.

I have brought both copies for the record and for the committee's reference these Dietary Guidelines are really quite impressive. [The copy of the Dietary Guidelines referred to is in app. 1, p. 173.] Dr. YOUNG. We have also brought for you another type of publication which we have put out, Planning for a Healthy Heart. This was long in press prior to the announcement of this hearing, but again it tries to illustrate by the symbol of a fork through the heart that there are some issues on fat and cholesterol and fatty acids that are important for Americans to know in protecting their own health.

[The publication referred to is in app. 1.

p. 198.]

Dr. YOUNG. Continuing with Dr. Forbes' statement: It is not the individual food items in the diet which are important per se, but it is how these individual foods add up to make the total diet and how much of each individual food is actually consumed.

For example, it makes little difference what specific food sources. of saturated fats are; it is how much saturated fat there is in the total diet.

The other parallel basic nutrition principle of paramount importance is the first of seven dietary guidelines: eat a variety of foods.

As further stated in the guidelines, we need "more than 40 different nutrients for good health. Adequate amounts of these nutrients are present in the foods in a well balanced diet."

Two basic elements must be paramount: the messages must be in context of the total diet and the science base for the messages must be strong.

You will also hear a controversy on whether or not we will be able to enact appropriate enforcement. Will the barriers be let down and false and misleading information let in?

The commentors, and I am particularly concerned about health fraud and, in fact, in our first action plan health fraud was selected as one of the 10 major initiatives of the agency.

Therefore, I am worried about the appropriate health messages. I want you to know that it was I who requested Mr. Taylor to examine the claims made by certain cosmetics. This action has been culminated by FDA issuing several regulatory letters dealing with drug claims in cosmetics, and thus, I am not unmindful of the need to look at this carefully.

I expect such concerns to be brought forth in an honest and vigorous fashion. Yet, I also expect people to be candid enough to realize that the Nation is looking increasingly for solid evidence that relates to diet and health. How do we then proceed?

Let me describe a capsulated approach. I have in detail analyzed it in the message for the record but I would just like to point out a few things, really three.

Mr. WEISS. Your prepared statement will be entered into the record in its entirety, without objection.

Dr. YOUNG. Thank you.

The first is a historical approach. Once we move to quantitative labeling, as I have outlined in detail in the testimony, we started down a path that would some day lead to more information on food labels. It is just not fair to list the total weight of things in percentage and not give some guidance as to what it means. For example, if I pick up a can and it says 5 percent fat, how does that relate to the universe of fat? What am I supposed to do with it-carry a calculator and add up the percent of fat each day?

The public is looking increasingly as those of us in medical schools gave more and more emphasis to prevention of disease through the proper diet for information on it.

In what better way is there to develop some form of health information than at or near or close to the point of purchase? That is the dilemma.

And thus, the agency embarked on it, as I pointed out in a section of the testimony entitled "History," even before I came to the Food and Drug Administration. There were discussions on the matter; in fact, I believe, Mr. Ronk, it was about my third or fourth briefing when I came into the agency that we had the first discussion of these issues that were already there dealing with some type of health messages.

As we had the claim come forward by Kelloggs, that introduced an urgency into a new paradigm that we began to explore, and the action by Kelloggs accelerated consideration by the agency. Eventually it led to the principles which I would like to discuss with you over here.

[Graph presentation is in app. 1, p. 207.]

Dr. YOUNG. The public health messages on food labels had these criteria as we put out in initial discussion in our document:

One, the information on the labeling must be truthful and not misleading to the consumer. Above all, fraudulent information cannot be presented to the American consumer. And how we define truthfulness and not misleading is a very important aspect of this

concern.

Second, the information should be based on, and consistent with-and I emphasize-valid, reliable, scientific evidence that is publicly available prior to any claim being made. It is not fair to have something locked in a drawer that is secluded and not present for the public and used as a health claim.

They should also have other studies performed and evaluated by persons qualified by experience and training to evaluate such studies and these should conform to the generally recognized medical nutritional principles and the weight of evidence should support these.

We had suggested that the formation of a Public Health Service Committee that would deal with these types of information and also would receive information from the outside and be publicly available and publicly involved might be a method of addressing this.

Third, the information regarding the relationship between nutrition and health shows that good nutrition is a function, not—and I emphasize—not of specific foods but of the total diet over time.

Finally, the use of health-related information constitutes a nutritional claim that triggers the requirements of FDA's regulation regarding all of nutritional labeling.

In order to get further dialog on these, I have held a number of meetings—and I will submit these for the record—with consumers and with industry and trade groups, to try to round out some answers to these questions. My testimony details some of the com

ments.

[The documents referred to are in app. 1, p. 210.]

Dr. YOUNG. But the issues that we focused on were, first, whether it is in the interest of the public health that health information, including information regarding specific diseases, appear on the labeling. And I am pleased that this discussion will occur here today as well because this information is very important, and we are seeking guidance on this.

Two, whether the basic principles on which FDA has based its criteria are reasonable.

Three, what types of valid, reliable, recognized scientific evidence should be considered adequate for the support of health information which might appear on food labeling.

Four, whether there are sufficient scientific data—and I have emphasized this over and over again-is the evidence sufficient and information available to allow us to use health information on dietary supplements, and what priority should FDA assign to enforcement actions against the use of therapeutic or misleading healthrelated information on food labeling?

I believe that this process is now one of information gathering of comments on the regulation, and we should be able to augment the public's view of these issues. There may be other issues that should be framed but these are the ones that I thought were most important.