Food Labeling; Health Claims for Dietary Supplements

[Docket Nos. 93NÄ480F, 93NÄ480C, 93NÄ480O, 93NÄ480A, and 93NÄ480Z]

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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 (HFÄ23),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301Ä443Ä2831,

or

John N. Hathcock, Center for Food Safety and Applied Nutrition (HFSÄ465), Food
and Drug Administration, 8301 Muirkirk Rd., Laurel, MD 20708, 301Ä594Ä6006.

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.
101Ä535), as amended by the DS act (Pub. L. 102Ä571), 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. 93NÄ480F); dietary
fiber and CVD (Docket No. 93NÄ480C); antioxidant vitamins and cancer (Docket
No. 93NÄ480A); omega-3 fatty acids and CHD (Docket No. 93NÄ480O); and zinc and
immune deficiency in the elderly (Docket No. 93NÄ480Z) 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:

 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. 93Ä31818 Filed 12Ä29Ä93; 8:45 am]

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