[Federal Register Volume 61, Number 44 (Tuesday, March 5, 1996)]
[Proposed Rules]
[Pages 8750-8751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5011]




[[Page 8749]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 101



Food Labeling: Health Claims and Label Statements; Folate and Neural 
Tube Defects; Proposed Rule and Final Rule

21 CFR Part 136, 137, and 139



Food Standards: Amendment of Standards of Identity for Enriched Grain 
Products To Require Addition of Folic Acid; Final Rule

21 CFR Part 172



Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Folic Acid (Folacin); Final Rule

  Federal Register / Vol. 61, No. 44 / Tuesday, March 5, 1996 / 
Proposed Rules  
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[[Page 8750]]


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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke 
a regulation authorizing a health claim on the relationship between 
folic acid and neural tube defects (NTD's) on the labels and in the 
labeling of dietary supplements that became final by operation of law. 
The agency intends to replace this revoked regulation with one that is 
published elsewhere in this issue of the Federal Register. This action 
is being taken to ensure that the regulation that authorizes claims on 
this nutrient disease relationship is fully responsive to the public 
comments that FDA has received on this matter.

DATES: Written comments by April 4, 1996. The agency is proposing that 
any final rule that may issue based on this proposal become effective 
on the date of publication of the final rule in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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 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 requirements of the act. The relationship of 
folic acid and NTD's 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 NTD's. 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, that there was not significant scientific agreement, based on the 
totality of publicly available scientific evidence, that the claim is 
valid.

B. The Public Health Service Recommendations

    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 NTD's. 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 NTD's 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 reduction of risk of 
NTD's, safety concerns, and the ``folate-preventable'' fraction of 
NTD's.

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 to not authorize a health claim for folic acid 
and NTD's. 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 NTD's. 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 NTD's on dietary 
supplements.

E. The 1993 Proposal to Authorize a Health Claim on Folic Acid and 
NTD's

    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 NTD's 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 
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 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 notice in 
the Federal Register of January 4, 1994 (59 FR 433), announcing that 
the regulation that it had proposed in the October 1993 folate/NTD 
proposal was considered to be a final regulation for dietary 

[[Page 8751]]
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. Elsewhere in this issue of the Federal Register, FDA is 
issuing a final rule to conclude that proceeding. Given that FDA has 
now issued that final rule, the regulation that resulted must to 
supersede the regulation that became final by operation of law. The 
agency is now instituting this rulemaking to bring about this 
supersession.

II.  The Proposal

    FDA is proposing to withdraw the regulation that became final by 
operation of law on January 4, 1994 (the January 4, 1994, regulation). 
FDA tentatively finds that this action is in the best interests of 
consumers, manufacturers, and regulatory officials for several reasons.
    The January 4, 1994, regulation did not have the benefit of public 
comment. It reflects FDA's initial views on the folic acid/NTD health 
claim and what it should say. From the comments received in response to 
the folic acid/NTD health claim proposal, it is clear that the January 
4, 1994, regulation does not adequately address several issues related 
to this health claim. Because the regulation included in the final rule 
published elsewhere in this issue of the Federal Register addresses the 
comments that the agency received and includes changes that the agency 
has made in response to those comments, FDA tentatively finds that that 
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 finds that replacing the January 4, 1994, 
regulation with the regulation included in the final rule will not 
result in any hardship to manufacturers who have relied on the January 
4, 1994, regulation. The regulation in the final rule in most respects 
is consistent with the January 4, 1994, regulation. The only 
differences are those modifications that have been made to shorten the 
claim and to provide more flexibility to those who decide to use it on 
their labels or in their labeling. Thus, replacing the January 4, 1994, 
regulation with the final regulation published elsewhere in this issue 
of the Federal Register will not present manufacturers with a situation 
in which they must adjust to a dramatic shift in the standard that they 
must meet.
    FDA is also proposing to limit the comment period to 30 days, and 
to make any final rule that issues in this proceeding effective on the 
date of publication. FDA is proposing both of these actions for the 
same reason. FDA believes that, if the regulation in the final rule is 
to supersede the January 4, 1994, regulation, this action should 
proceed as expeditiously as possible. Expeditious action will minimize 
the possibility for confusion and ambiguity created by this action. FDA 
tentatively finds that the proposed steps are necessary to facilitate 
expeditious action, and thus that there is good cause for both of these 
proposed actions.

III.- Environmental Impact

    The agency has 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. Therefore, neither an 
environmental assessment nor an environmental statement is required.

IV.  Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because FDA has fully assessed the economic impact 
of replacing the January 4, 1994, regulation with the regulation 
contained in the final rule and has determined this proposal will 
impose no costs, the agency certifies that the proposed rule will not 
have a significant economic impact on a substantial number of small 
entities. Therefore, under the Regulatory Flexibility Act, no further 
analysis is required.

V.  Comments

    Interested persons may, on or before April 4, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

    1.-The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

Sec. 101.79  [Removed]

    2. -Section 101.79 Health claims: folate and neural tube defects is 
removed.

    Dated: February 26, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-5011 Filed 2-20-96; 12:01pm]
BILLING CODE 4160-01-F