[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