[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Notices]
[Pages 433-437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31818]


[[Page Unknown]]

[Federal Register: January 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Food Labeling; Health Claims for Dietary Supplements

[Docket Nos. 93N-480F, 93N-480C, 93N-480O, 93N-480A, and 93N-480Z]
AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that, in 
accordance with the Nutrition Labeling and Education Act of 1990 (the 
1990 amendments), as amended by the Dietary Supplement Act of 1992 (the 
DS act), the change in its regulations that it proposed on October 14, 
1993 (58 FR 53296 through 53305), to reflect its tentative decision not 
to authorize health claims relating an association between dietary 
fiber and cancer; dietary fiber and cardiovascular disease (CVD); 
antioxidant vitamins and cancer; omega-3 fatty acids and coronary heart 
disease (CHD); and zinc and immune deficiency in the elderly on the 
labels and in the labeling of dietary supplements of vitamins, 
minerals, herbs, and other similar nutritional substances (dietary 
supplements) is now considered a final regulation.

DATES: The final regulation will become effective on July 1, 1994.

FOR FURTHER INFORMATION CONTACT: Judith W. Riggins, Office of Policy 
(HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2831,
    or
John N. Hathcock, Center for Food Safety and Applied Nutrition (HFS-
465), Food and Drug Administration, 8301 Muirkirk Rd., Laurel, MD 
20708, 301-594-6006.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing that, in accordance with section 3(b)(1)(A)(ii), 
(b)(1)(A)(vi), (b)(1)(A)(x), and (b)(2) of the 1990 amendments (Pub. L. 
101-535), as amended by the DS act (Pub. L. 102-571), the change in its 
regulations that it proposed on October 14, 1993 (58 FR 53296 through 
53305), to reflect its tentative decision not to authorize health 
claims relating an association between dietary fiber and cancer (Docket 
No. 93N-480F); dietary fiber and CVD (Docket No. 93N-480C); antioxidant 
vitamins and cancer (Docket No. 93N-480A); omega-3 fatty acids and CHD 
(Docket No. 93N-480O); and zinc and immune deficiency in the elderly 
(Docket No. 93N-480Z) on the labels and in the labeling of dietary 
supplements is now considered a final regulation.

II. Passage of 1990 Amendments

    The 1990 amendments to the Federal Food, Drug, and Cosmetic Act 
(the act) gave the Secretary of Health and Human Services (the 
Secretary), and by delegation FDA, the authority to issue regulations 
authorizing health claims on the labels and in the labeling of foods. 
Section 403(r)(1)(B) of the act (21 U.S.C. 343(r)(1)(B)) provides that 
a product is misbranded if it bears a claim that characterizes the 
relationship of a nutrient to a disease or health-related condition, 
unless the claim is made in accordance with procedures and standards 
established under section 403(r)(3) and (r)(5)(D) of the act (21 U.S.C. 
343(r)(3) and (r)(5)(D)).
    The 1990 amendments also directed the Secretary to determine 
through rulemaking whether claims regarding 10 nutrient-disease 
relationships meet the requirements of the act. Dietary fiber and 
cancer, dietary fiber and CVD, antioxidant vitamins and cancer, zinc 
and immune function in the elderly, and omega-3 fatty acids and CHD 
were among the topics that FDA was directed to evaluate under section 
3(b)(1)(A)(vi) and (b)(1)(A)(x) of the 1990 amendments.

III. The 1991 Health Claims Proposals

    In the Federal Register of November 27, 1991, FDA proposed not to 
authorize health claims on dietary fiber and CVD (56 FR 60582); dietary 
fiber and cancer (56 FR 60566); antioxidant vitamins and cancer (56 FR 
60624); zinc and immune function in the elderly (56 FR 60652); and 
omega-3 fatty acids and CHD (56 FR 60663). The agency tentatively 
concluded that the available evidence did not establish that the 
standard that FDA had proposed for health claims for dietary 
supplements under section 403(r)(5)(D) of the act was met, that is, the 
agency tentatively concluded that there was not significant scientific 
agreement, based on the totality of publicly available scientific 
evidence that these claims are valid.

IV. The Dietary Supplement Act of 1992

    In October 1992, the DS act was enacted. This statute imposed a 
moratorium on FDA's implementation of the 1990 amendments with respect 
to dietary supplements until December 15, 1993 (although the DS act did 
provide that FDA could authorize claims for dietary supplements before 
that date). The DS act directed FDA to issue proposed rules to 
implement the 1990 amendments with respect to dietary supplements by 
June 15, 1993, and to issue final rules based on these proposals by 
December 31, 1993. The DS act also amended the so-called ``hammer'' 
provision of the 1990 amendments, section 3(b)(2) of the 1990 
amendments, to provide that if the agency did not meet the established 
December 31, 1993, timeframe for issuance of final rules, the proposed 
regulations would be considered final regulations.

V. The 1993 Final Rules For Health Claims For Foods in Conventional 
Food Form

    On January 6, 1993, FDA published final rules on the general 
requirements for health claims on the labels and in the labeling of 
foods in conventional food form (58 FR 2478), and final rules 
authorizing health claims on seven nutrient-disease relationships 
(calcium and osteoporosis; fat and cancer; saturated fat and 
cholesterol and CHD; fiber-containing grain products, fruits, and 
vegetables and cancer; fruits, vegetables, and grain products that 
contain fiber and risk of CHD; and fruits and vegetables and cancer). 
Three of the health claims that FDA authorized were for fresh fruits 
and vegetables and grains, and thus these claims were not authorized 
for dietary supplements. Because of the DS act, FDA took no final 
action with respect to the use on dietary supplements of health claims 
on dietary fiber and cancer; dietary fiber and CVD; omega-3 fatty acids 
and CHD; zinc and immune function in the elderly; and antioxidant 
vitamins and cancer. (The agency's actions with respect to health 
claims involving folic acid and neural tube defects are described in a 
notice published elsewhere in this issue of the Federal Register.)

VI. The 1993 Proposal to Not Authorize Health Claims For Dietary 
Supplements

    On October 14, 1993, FDA published a proposal to not authorize 
health claims on the labels of dietary supplements on five nutrient-
disease relationships: Dietary fiber and cancer; dietary fiber and CVD; 
antioxidant vitamins and cancer; omega-3 fatty acids and CHD; and zinc 
and immune function in the elderly (58 FR 53296). FDA provided 60 days 
for comment on this proposed action. Thus, the comment period closed on 
December 13, 1993.
    Section 3(b)(2) of the 1990 amendments, as amended by section 
202(a)(2)(B)(ii) of the DS act, provides that if the Secretary does not 
promulgate final regulations on any of the health claims applicable to 
dietary supplements in a timely manner, the proposed regulations shall 
be considered final regulations but not until after December 31, 1993. 
FDA did not issue final regulations on the use of health claims on 
dietary supplements on dietary fiber and cancer; dietary fiber and CVD; 
antioxidant vitamins and cancer; omega-3 fatty acids and CHD; and zinc 
and immune function in the elderly by December 31, 1993. Therefore, FDA 
is issuing this document announcing that by operation of law, the 
change in its regulations that FDA proposed to reflect a decision not 
to authorize health claims about the relationships of dietary fiber and 
cancer; dietary fiber and CVD; antioxidant vitamins and cancer; omega-3 
fatty acids and CHD; and zinc and immune function in the elderly, 
published in the October 14, 1993, Federal Register, is now considered 
a final regulation by operation of law. The agency proposed that 21 CFR 
part 101 be amended as follows:

PART 101--FOOD LABELING

    2. Section 101.71 is amended by revising the introductory text to 
read as follows:

Sec. 101.71  Health claims: claims not authorized.

    Health claims not authorized for foods in conventional food form or 
for dietary supplements of vitamins, minerals, herbs, or other similar 
substances:
* * * * *
    The 1990 amendments state that FDA is to promptly publish notice of 
the new status of the proposed change in its regulations in the Federal 
Register. This notice is issued in response to that requirement.
    The agency notes that this rulemaking constitutes a separate 
rulemaking from that instituted with respect to the five nutrient-
disease relationships on October 14, 1993. This separate rulemaking was 
contemplated by Congress if a final rule was not issued by December 31, 
1993. The agency notes, however, that the October 14, 1993, rulemaking 
remains ongoing.
    In particular, with regard to antioxidant vitamins and cancer, on 
November 1 through 3, 1993, FDA held a public conference on this 
nutrient-disease relationship. (The conference also covered antioxidant 
vitamins and CVD.) The transcript of that meeting has been submitted to 
the Docket as a comment, and other comments were solicited in the 
announcement of the conference (58 FR 54595, October 22, 1993). FDA 
intends to consider all comments and data received at this conference. 
FDA intends to take any actions that it concludes are warranted by this 
information either in the ongoing rulemaking on an antioxidant vitamins 
and cancer claim for dietary supplements or, if the agency concludes 
that it is appropriate, in a separate rulemaking.

    Dated: December 23, 1993.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 93-31818 Filed 12-29-93; 8:45 am]
BILLING CODE 4160-01-F