[Federal Register Volume 61, Number 186 (Tuesday, September 24, 1996)]
[Rules and Regulations]
[Pages 49964-49966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 93N-0481]
RIN 0910-AA23


Food Labeling: Health Claims and Label Statements; Folate and 
Neural Tube Defects; Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the 
regulation authorizing a health claim on the relationship between folic 
acid and neural tube defects on the labels and in the labeling of 
dietary supplements that became final by operation of law. The agency 
has replaced this revoked regulation with one that it adopted in a 
final rule that published in the Federal Register of March 5, 1996 (61 
FR 8752).
EFFECTIVE DATE: October 8, 1996.
FOR FURTHER INFORMATION CONTACT: Jeanne I. Rader, Center for Food 
Safety and Applied Nutrition (HFS-175), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5375.

SUPPLEMENTARY INFORMATION:

I. Background

    The Nutrition Labeling and Education Act of 1990 (the 1990 
amendments) (Pub. L. 101-535) amended the Federal Food, Drug, and 
Cosmetic Act (the act) to give the Secretary of the Department 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.
    The 1990 amendments also directed the Secretary to determine 
through rulemaking whether claims regarding 10 nutrient-disease 
relationships met the

[[Page 49965]]

requirements of the act. The relationship of folic acid and neural tube 
defects was among those 10 topics (section 3(b)(1)(A)(x) of the 1990 
amendments).

A. The 1991 Proposed Rule

    In the Federal Register of November 27, 1991 (56 FR 60537), FDA 
proposed to not authorize a health claim on folic acid and neural tube 
defects. The agency tentatively concluded that there was not 
significant scientific agreement, based on the totality of publicly 
available scientific evidence, that such a claim would be valid. Thus, 
the standard that the act established for health claims for 
conventional foods, which FDA had proposed, under section 403(r)(5)(D), 
as the standard for health claims for dietary supplements, had not been 
met.

B. The Public Health Service Recommendation

    In September 1992, following the availability of significant new 
data, the Public Health Service (PHS) issued a recommendation that all 
women of childbearing age in the United States who are capable of 
becoming pregnant should consume 0.4 milligram (mg) of folic acid per 
day for the purpose of reducing their risk of having a pregnancy 
affected with spina bifida or other neural tube defects. The 
recommendation was based on data suggesting that folic acid, when given 
at a high dose (4 mg), can reduce the risk of recurrence of neural tube 
defects and on studies that used multivitamins containing folic acid at 
dose levels from 0 to 1,000 micrograms per day. The PHS recommendation 
identified approaches and identified outstanding issues, including the 
recommended intake of folate, the potential role of other nutrients in 
reducing the risk of neural tube defects, safety concerns, and the 
``folate-preventable'' fraction of neural tube defects.

C. The Dietary Supplement Act of 1992

    In October 1992, the Dietary Supplement Act of 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. 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.

D. The 1993 Final Rules for Health Claims for Food in Conventional Food 
Form

    In the Federal Register of January 6, 1993 (58 FR 2606), FDA 
published a final rule in which it decided not to authorize a health 
claim for folic acid and neural tube defects. However, the agency 
reaffirmed its support of the PHS recommendation that all women of 
childbearing age in the United States who are capable of becoming 
pregnant should consume 0.4 mg of folic acid daily to reduce their risk 
of having a pregnancy affected with spina bifida or other neural tube 
defects. The agency noted, however, that unresolved questions about the 
safe use of folate remained. The agency concluded that it could not 
authorize a health claim until these questions were resolved. Because 
of the DS act, FDA took no final action with respect to the use of a 
health claim on folic acid and neural tube defects on dietary 
supplements.

E. The 1993 Proposal to Authorize a Health Claim on Folic Acid and 
Neural Tube Defects

    In the Federal Register of October 14, 1993 (58 FR 53254), FDA 
published a proposed rule to authorize the use of a health claim about 
the relationship of folate and neural tube defects on the labels of 
foods in conventional food form and dietary supplements. FDA 
tentatively concluded, based on its discussions with an advisory 
committee, that it could ensure the safe use of folate. FDA provided 60 
days for comment on this proposed action. The comment period closed on 
December 13, 1993.

F. The 1994 Final Rule

    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 
issue 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 December 31, 1993. 
Because FDA was unable to publish a final rule by December 31, 1993, in 
the proceeding instituted in October of 1993, FDA published a document 
in the Federal Register of January 4, 1994 (59 FR 433), announcing that 
the regulation that it had proposed in October 1993 on folate and 
neural tube defects was considered to be a final regulation for dietary 
supplements by operation of law, effective July 1, 1994.
    This document did not conclude the rulemaking begun in October of 
1993, however. Rather, the January 4, 1994, document was part of a 
separate proceeding that is compelled under section 3(b)(2) of the 1990 
amendments (see H. Rept. 101-538, 101st Cong., 2d Sess. 18 and 136 
Congressional Record 5842 on the effect of this ``hammer'' provision).
    In the January 4, 1994, document FDA stated that the rulemaking 
that it instituted in October of 1993 was ongoing, and that it intended 
to issue a final rule that would resolve the issues in that ongoing 
proceeding. FDA issued that final rule on March 5, 1996 (61 FR 8752).
    In the Federal Register of March 5, 1996 (61 FR 8750), FDA proposed 
to withdraw the regulation that became final by operation of law on 
January 4, 1994 (the January 4, 1994, regulation). FDA tentatively 
found that this action is in the best interests of consumers, 
manufacturers, and regulatory officials for several reasons.
    The agency stated that the January 4, 1994, regulation did not have 
the benefit of public comment, and that it reflects FDA's initial views 
on the folic acid/neural tube defects health claim and what it should 
say. FDA tentatively found from the comments received in response to 
the folic acid/neural tube defects health claim proposal that the 
January 4, 1994, regulation did not adequately address several issues 
related to this health claim. Because the regulation included in the 
final rule published in the March 5, 1996, issue of the Federal 
Register addressed the comments that the agency received and included 
changes that the agency made in response to those comments, FDA 
tentatively found that the March 5, 1996, regulation is better able to 
implement the act than the January 4, 1994, regulation, and that it 
provides for a more useable and scientifically valid health claim.
    FDA tentatively found that replacing the January 4, 1994, 
regulation with the regulation included in the final rule would not 
result in any hardship to manufacturers who have relied on the January 
4, 1994, regulation. The regulation in the March 5, 1996, final rule in 
most respects was consistent with the January 4, 1994, regulation. The 
only differences were those modifications that the agency made to 
shorten the claim and to provide more flexibility to those who decide 
to use it on their labels or in their labeling.
    FDA gave interested persons 30 days to comment on its proposal to 
withdraw

[[Page 49966]]

the January 4, 1994, regulation. It also proposed to make any final 
rule that issued in this proceeding effective on the date of its 
publication. FDA received one comment that addressed this proposed 
action. This comment fully supported the agency's proposal.

II. Environmental Impact

    In the March 5, 1996 (61 FR 8750 at 8751), proposal FDA stated that 
it had determined under 21 CFR 25.24(a)(11) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. FDA received no comments on this 
conclusion. Therefore, FDA restates it in this document.

III. Analysis of Other Impacts

    In the March 5, 1996 (61 FR 8750 at 8751), proposal FDA announced 
that it had fully assessed the effects of the proposed rule under 
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354) and found that it was fully consistent with the Executive Order, 
and that it will not have a significant impact on a substantial number 
of small entities. The agency received no comments on these conclusions 
and consequently is restating them in this document.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, Sec. 101.79 
Health claims; folate and neural tube defects (as published in the 
Federal Register of January 4, 1994 (59 FR 434), which became final by 
operation of law, is removed. FDA has replaced the January 4, 1994, 
regulation with a regulation that appeared in the Federal Register of 
March 5, 1996 (61 FR 8779), and is currently codified in the 1996 
edition of Title 21 of the Code of Federal Regulations (pp. 131-134).
    This document is issued under sections 4, 5, and 6 of the Fair 
Packaging and Labeling Act (15 U.S.C. 1453, 1454, and 1455); and 
sections 201, 301, 402, 403, 409, and 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C, 321, 331, 342, 343, 348, and 371).

    Dated: September 17, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-24223 Filed 9-23-96; 8:45 am]
BILLING CODE 4160-01-F