And it is important to state for the record that as Congress considers what the standard should be for health claims on dietary supplement labels, that labeling is separate and apart from the question of whether the products should be on the shelves in the first place?

If we were to complete our June 18 rulemaking and say that the health claims standard for dietary supplements should be the same as for foods, namely significant scientific agreement, you must understand that even though we reject a particular claim, the product stays on the shelf. The product can be sold. It just can't bear the claim.

So access remains, assuming that the product is safe and should be on the shelf from a safety standpoint. If we assume safety, the product will be there. The only question is what kind of explicit claim can be made on the label.

Mr. TOWNS. Thank you.

We have been joined by Congressman Horn from California, and I yield to him at this time.

Mr. HORN. Thank you, Mr. Chairman. I am sorry to be late, but I was testifying on the reauthorization of the economic development administration that is vital to my constituency and I suspect most of my colleagues.

Some of these questions might have been asked. Let me start in with one directed to Dr. Shank. Has FDA discussed requiring vitamins to be dispensed by a licensed pharmacist on the prescription of a licensed doctor? To what degree has that been discussed within FDA?

Dr. SHANK. Congressman, we have no plans to require that vitamins be represented as drugs, either as OTC drugs or on a prescription basis, unless they are for that purpose, such as prenatal supplements.

Mr. HORN. Has it been considered at all within FDA to require prescriptions for the sale of vitamins?

Mr. ŻELLER. Mr. Horn, just a few weeks ago, I was sitting where Bill Layden is sitting, and I was on the receiving end of all of the letters, phone calls, telegrams, and mailgrams that Ted Weiss' constituents were placing because they had been told by someone that if FDA has its way you are going to need a prescription to get your vitamin C. It is completely untrue.

But I know what it must be like to be on the receiving end of that intense level of questions from your constituents. It was not true, and it is not true today. It is a very strong tactic of getting a message to Congress, but it has made a lot of citizens angry unnecessarily.

FDA has no intention of forcing consumers to go to a doctor to get a prescription for vitamins and minerals.

Mr. HORN. FDA, at this point in time, has no such intention. The question was: Has it been discussed within FDA?

Mr. ZELLER. Not to my knowledge.

Mr. HORN. I have forgotten if we take people under oath in this committee. In another committee I am on, we do.

Mr. Towns. We do in this committee.

Mr. LAKE. Let me answer that question. I am Bob Lake. I have been at the Center for Food Safety now for 19 years, and I have

not heard a serious discussion about requiring vitamins and minerals to be prescription drugs in at least the last 10 of those years. It simply has not happened.

I think-let me clarify one other thing that I think may be a concern-underlying concern here too. There seems to be a misperception that if something is classified as a drug that that automatically means that it is a prescription drug. And that is not true. You can go into any drug store, of course, and buy over-thecounter drugs; and people do so everyday.

The other point I would make, relative to your question, is—not since the Proxmire amendment, which prohibited us back in the 1970's from making vitamins and minerals drugs based on their potency. That law effectively ended the argument. Regulation of vitamins as drugs simply has not gotten serious consideration since that time except, as Dr. Shank pointed out, those specialized products such as prenatal vitamin formulations that are specifically formulated to be dispensed under a doctor's care to pregnant women and certain other similar kinds of products, but not the typical products that you buy in the drug store.

Mr. HORN. In other words, if Linus Pauling wants to take 8,000 units of vitamin C, he is free to do so?

Mr. LAKE. He or anyone else. FDA has never directed its regulations at consumers. Our regulation is directed at those who sell products, and our concern is always with either one of two things: Is the product safe? And the other one is: Is it properly labeled? Mr. HORN. Is there a division of labor within the Food and Drug Administration between the number of people devoted to, let's say, dietary supplement as a review process, versus the numbers devoted to the more obvious examples of the review by the agency of various types of prescriptions that might be applied to AIDS, HIV, this kind of thing?

What is the relative allocation of human resources in these areas?

Dr. SHANK. The resources for drugs certainly outweigh the resources that are available for premarket approval and these types of issues including labeling for food products, relative to food products.

There are more people that are available for the general food supply than there are for dietary supplements.

But I can assure you that in the recent period of time, we have allocated more resources than traditionally existed because we think that proper regulation of the dietary supplements in the future and the fair regulation of these products is very important, and we have put additional resources to that effect.

Mr. HORN. I gather your main emphasis is on false claims between the dietary supplement community? Is that your main emphasis?

Dr. SHANK. Earlier, I mentioned some concerns relative to toxicity. We are reminded of the L-tryptophan amino acid. We have had some recent reports of toxicities from herbal products. There is a safety concern from certain products as well as the labels.

Mr. HORN. Thank you.

Mr. Towns. Thank you very much, Congressman Horn.

We have also been joined by Congressman Payne, and at this time I yield to him.

Mr. PAYNE. Thank you very much.

I certainly have received many communications and calls regarding this issue also, as have other members of the committee. And I am certainly concerned about some of the claims that we have seen on labels. For example, products that boast that the immunity of people who have a compromised immune system could be upgraded by some of these medications or over-the-counter products. You know, such exaggerated claims like this certainly need to be monitored so that the people who are most vulnerable certainly will not be victimized further.

But we also have gotten some concerns about the-your proposed regulations, you know, governing nutrition labeling, nutrient content, and the health claims from these dietary products. And there is a feeling that the FDA will unnecessarily restrict these dietary supplements, as the other persons have mentioned.

We certainly need to be sure that there is balance in this approach so that we don't overregulate and strangle ourselves when we still don't have enough beef inspectors and chicken inspectors. You know what I mean, which is also kind of serious.

And so, I just wonder what degree of balance has gone into this? I understand you haven't gone out; you have done this internally inside the agency, which sometimes, I think, is the worst thing to do from what I have seen in the past.

How will input or balance be guaranteed?

Dr. SHANK. Mr. Payne, I think that I agree with you, I think that we need to be fair; we need to be evenhanded; and the comment period obviously is still open.

I want to underscore that we are talking here about an advanced notice of proposed rulemaking. That is a very preliminary stage in our development of the rules. We are truly seeking the input, the dialog with all interested parties. Following an ANPR-following this comment period, we would have to come back with another round of proposed regulations. So we are in the infancy, if you will, of establishing these.

Regarding the comment that the amount of resources and the balance that we place with enforcing the regulations for dietary supplements, I don't believe you were here when I reported earlier that we have approximately 3,000 people in the field, FDA does. And we traditionally use only 15 to 20 of those people per year to look at the enforcement of dietary supplements.

So our primary effort is dedicated toward getting this program right at the beginning through the regulatory process that we have under way.

Mr. PAYNE. You know, I guess available consumer data indicates that supplements of these kinds are primarily used by better educated people, upper income people, people who have access to preventive medicine, people who are conscientious consumers.

I wonder what you are trying to accomplish? Since you are moving in this direction, how do you plan to talk about these products in the lower income, less educated, nutritionally deprived segments, the people on public welfare, WIC, or food stamps?

I haven't seen anything in all the data that I have that there has been a notion of how to break into and educate that community to either tell them if these products are good and they should perhaps have some program to make them available or either tell them that they are not good and, you know, ensure you know, suggest that they are warned about a product's use that they don't bother with it?

I haven't seen anything currently that would say that inner cities or rural places or people who are currently health underserved are even in the mix.

Dr. SHANK. Mr. Payne, I want to make a couple of points in that regard.

No. 1, nutrition education: We, as you know, are having a new food label on the traditional food; and we will have a new label at some point for dietary supplements. It is very important to us as a Nation that we educate the consumer on the proper use of that label so that they can better identify the foods and choose the foods for more adequate diet.

The second point that I would make is relative to fortification. It is true that the supplements do not enjoy as wide an audience as could be helped by these products. And, therefore, as is the case with folic acid and the prevention of some of the neural tube defects, we are also considering changing the standards of our fortification program where more traditional foods such as enriched bread could also carry those nutrients.

So I think our answer is education, education to the general public, a better job of educating through some of our food assistance programs which USDA administers such as the WIC program. That will get right at the target group. And I know they are considering some enhanced education activities in that regard.

And then we have to look at other opportunities that are available to us such as fortification.

Mr. PAYNE. Thank you.

Mr. Towns. Thank you very much, Congressman Payne.

On that note, are there dietary supplements that should be banned outright or have their use restricted by regulation?

Dr. SHANK. Only those supplements for which we have a safety concern. And we must deal with high potency amino acids. I am not saying that they should be banned, but we must deal with these. We must deal with some of these herbal products that contain concentrations of toxic materials at such levels as they present problems. But those are the only circumstances that readily come to my mind.

Mr. Towns. How does FDA define significant scientific agreement? How does FDA determine that significant scientific agreement actually exists?

Dr. SHANK. How do we determine that?

Mr. Towns. Yes.

Dr. SHANK. Very difficultly. We recognize that our interpretation, to date, relative to the significant scientific agreement has been controversial. It has been particularly controversial among those interested in the dietary supplement industry. I think that this is one of the most important-one of the more important issues that

we had to deal with during this regulatory process that we have embarked upon.

It is true that we have held our proposal for health claims for dietary supplements to the same language, significant scientific agreement. But basically, if you would, let me say that these are FDA regulations, and we take full responsibility for them.

But I would want to also share that they were not developed in a vacuum at FDA. The PHS the Public Health Service, was provided an opportunity to participate in the detailed conclusions that were being drawn. The Deputy Assistant Secretary for Health led a major part of this initiative. The various units at NIH were involved. Two that come to mind were the National Cancer Institute and National Heart Lung and Blood Institute. The Centers for Disease Control had their input. And the final analysis was the result of notice and comment rulemaking.

Sure, FDA worked through those comments; but, again, we are trying to open that up. And we are trying to make the right decisions. And I am suggesting that you will hear more today about significant scientific agreement. It is a concern of ours.

Mr. Towns. Is that the same as scientific consensus?

Dr. SHANK. No, it isn't.

Mr. Towns. What is the difference?

Dr. SHANK. I think-I think that the consensus is a higher standard, if you would.

But your asking me those questions demonstrates the confusion that we have to work through. Consensus to me means more than a significant scientific agreement.

Mr. Towns. Thank you very much.

Any other comments or questions by members?

Mr. HORN. I have one or two questions, Mr. Chairman.

Health claims-FDA regulations refer to that language, as I understand it. Now let's say a company has an article printed on nutrition in the New England Journal of Medicine or any other scientific publication. It is a reputable figure in the field that has prepared this argument.

My understanding is that if you take literally the health claim jurisdictional reference of FDA, that would be constituted as labeling if the company distributed it around the country. Is that true?

Mr. LAKE. Mr. Horn, let me try to answer that. What FDA regulates are basically two things in this regard. One is the label itself, which is fairly clear-and we all have a good conception of that. It is the product with a piece of paper on it.

Now, in addition to that, the Food, Drug, and Cosmetic Act has, at least since 1938, also prohibited false and misleading labeling. And that is defined in the act as material that accompanies the food in close association with it. The same applies to cosmetics. It is uniform across the products that FDA regulates relative to foods, drugs, and cosmetics.

The scientific article that is published and perhaps distributed solely as an educational piece independent or separate and apart from any promotional scheme for a particular product is like all other pieces of printed material. It simply is not regulated by FDA. Also, FDA does not regulate media advertising. We don't regulate what goes on TV or what is printed in the newspaper.