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Mr. WEISS. In its prepared testimony and in the course of testimony we had today, FDA indicated that in recent years it has implicitly permitted label claims not specifically tied to particular diseases such as for sodium, calorie, fatty acids, and cholesterol content.

Do any of you support this type of labeling? And if so, how do you distinguish it from labeling for disease-specific health claims, which you oppose?

Dr. SHILS. I don't understand the question.

Do you mean the quantitative data of the FDA like the amount of sodium or the amount of cholesterol?

Mr. WEISS. Low sodium or low calorie content, or low fatty acids, yes, that kind of thing.

Dr. SHILS. It is a statement of what is in that particular food package, and I certainly have no objection to that.

Mr. WEISS. Right.

How would you distinguish that from labeling for disease-specific health claims? Dr. Swan.

Dr. SWAN. Such a statement tells you the fact of what is in the food product. It does not promise you or lead you to believe that it will do one thing or the other for your health. Obviously, such a statement is of value to a consumer who wants to behave in a certain way toward sodium if they have information from some other source, such as a dietitian or their physician, that they should behave in a certain way, eating more of it, or less of it, or what

ever.

But once they are given that information through a responsible health-related channel, then they can act on it if they can find on the label the amount of sodium, thiamin, vitamin A, et cetera, that's there.

So we are in favor of seeing the information provided but we don't want to imply at the same time that this is going to have one kind of benefit or the other kind of benefit vis-a-vis that particular

consumer.

Mr. WEISS. FDA has also testified that it has been stressing that its proposal permits generic rather than brand-specific health claim information.

In your judgment, does the proposed regulation itself preclude manufacturers from making brand-specific health claims?

Dr. Swan.

Dr. SWAN. I am really not very expert in such matters, Mr. Chairman.

In my judgment, it would be very hard for a consumer walking into a supermarket to make that distinction. If the claim is on the label of product A, it is going to be a claim that they associate with product A, in my opinion.

Mr. WEISS. And, finally, since you had the privilege of sitting through all of the prior testimony of today, would any of you have anything you want to say regarding any of the testimony that you heard earlier today, or any other matter before we terminate the hearing?

Dr. Swan.

Dr. SWAN. Thank you, Mr. Chairman.

I would like to emphasize that the societies which I represent hope that we don't appear to be completely negative about nutrition information and health information on food labels. We think that food labels are a source of information to people, and a source that should be wisely used, judiciously used.

We are ready as societies and individual members of our societies, to try to work with the Food and Drug Administration, if they desire this, to improve the kind of nutrition information and health information that is present on labels.

But I must at the same time reiterate that to date we have not been able to see any way in which we could accept disease-specific claims among that improved information.

Mr. WEISS. Thank you.

Dr. Barness.

Dr. BARNESS. I again want to echo what Dr. Swan said—the academy is especially dismayed that in none of this deliberation, has there been any consideration of age differentials. I think this is very important to the future of this country, not only to a few children.

I think we also are concerned about being too negative, whether it is labeling or to advice to give, and this we don't want to be accused of.

I think that we are saying that if there is complete labeling of content of foods that then it would be relatively easy to figure out what is a good diet and that can be offered to the child.

If somebody wants to eat candy bars all day long because they think that that is a great diet, we are not saying that you shouldn't do it. Or if somebody wants to go in the health food store and eat whatever they can get there, we are not saying not to do it if that is the way you are convinced that your life will be better. We are not trying to antagonize anybody, but we do think that for the moment the only thing that has any sound basis for is general labeling of the entire food.

Thank you.

Mr. WEISS. Thank you.

Dr. Shils.

Dr. SHILS. I have been very interested in the discussions this morning and I have come to realize that not only a casualty to the public will occur if such regulations go into effect, but I think there will also be a casualty for the FDA.

Dr. Swan mentioned this in her earlier remarks, but I think it is worth pointing out again that the FDA is a very important regulatory agency in the United States. It is the one regulatory agency that I have had a great deal of confidence in the past. I think that if it goes through with this misconceived program, its credibility is going to be seriously handicapped.

Mr. WEISS. I thank you all very, very much. Again, we may have some further questions to ask of you. If so, we will directly communicate them to you.

The record will remain open for 10 days to receive further information.

And with our appreciation, to you as well as our FDA witnesses, the hearing now is concluded.

The subcommittee stands adjourned subject to the call of the Chair. Thank you very much.

[Whereupon, at 3:30 p.m., the subcommittee adjourned, to reconvene subject to the call of the Chair.]

APPENDIXES

APPENDIX 1.—DOCUMENTS REFERRED TO IN THE HEARING RECORD

Federal Register / Vol. 52, No. 149 Tuesday, August 4, 1987 / Proposed Rules

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

28843

[blocks in formation]

[Docket No. 85N-0061)

Food Labeling; Public Health
Messages on Food Labels and
Labeling

AGENCY: Food and Drug Administration.
ACTION: Notice of propose rulemaking.

SUMMARY: In this notice, the Food and
Drug Administration (FDA) discusses a
new and innovative initiative
concerning the placing of health-related
claims or information on food labeling
and the criteria it will apply in
evaluating the propriety of such
labeling. Consistent with this new
initiative, FDA proposes to amend

certain regulations on food labeling to

codify and clarify its policy on the
appropriate use of health-related
messages. The agency also announces
its intention to form a Public Health
Service (PHS) committee that will
attempt to develop "health messages"
appropriate for use on food labeling.
FDA recognizes that this new initiative
represents a substantive change in past
agency policy, and because of the
complexity of the matter and the broad
public interest, wishes to proceed
cautiously and deliberately in its
regulatory approach.

Pending this rulemaking proceeding.
the agency will employ the criteria
discussed in the preamble to this notice
in evaluating the propriety of bringing
enforcement action against products
bearing health messages on food
labeling.

DATE: Written comments by November
2, 1987.

ADDRESS: Written comments on this

notice and on four related citizen
petitions to the Dockets Management
Branch (HFA-305), Food and Drug
Administration, Rm. 4-62, 5600 Fishers
Lane, Rockville, MD 20857. The four
citizen petitions may be reviewed in the
Dockets Management Branch.

FOR FURTHER INFORMATION CONTACT:
David Hattan, Center for Food Safety
and Applied Nutrition (HFF-204), Food
and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202-245-3117.

SUPPLEMENTARY INFORMATION:

Statement

Consumers are becoming increasingly
conscious of the relationship between
diet and health. As a result, food
manufacturers have begun to show an
interest in developing a mechanism to
inform consumers about this

relationship and how specific foods may
be used to improve one's diet, thereby

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