[Federal Register Volume 65, Number 192 (Tuesday, October 3, 2000)]
[Rules and Regulations]
[Pages 58917-58918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25352]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 91N-0101, 91N-0098, 91N-0103, and 91N-100H]
RIN 0910-AA19
Food Labeling: Health Claims and Labeling Statements; Dietary
Fiber and Cancer; Antioxidant Vitamins and Cancer; Omega-3 Fatty Acids
and Coronary Heart Disease; 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 its
regulations codifying the agency's decision not to authorize the use of
health claims for four substance-disease relationships in the labeling
of foods, including dietary supplements: Dietary fiber and cancer,
antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart
disease, and the claim that 0.8 milligram (mg) of folate in dietary
supplement form is more effective in reducing the risk of neural tube
defects than a lower amount in conventional food. This action is being
taken in response to a decision of the U.S. Court of Appeals for the
D.C. Circuit invalidating these regulations and directing FDA to
reconsider whether to authorize the four health claims. This action
will result in the removal of the regulations but does not constitute
FDA authorization of the four claims. FDA is completing its
reconsideration of the claims and expects to issue decisions on all
four claims by October 10, 2000.
DATES: This rule is effective October 3, 2000.
FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food
Safety and Applied Nutrition (HFS-832), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5429.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 6, 1993, FDA issued final rules
announcing its decision not to authorize the use of health claims for
four substance-disease relationships in the labeling of conventional
foods. (See 58 FR 2537 (dietary fiber and cancer); 58 FR 2622
(antioxidant vitamins and cancer); 58 FR 2682 (omega-3 fatty acids and
coronary heart disease); and 58 FR 2606 (folic acid \1\ and neural tube
defects\2\)). Soon after, FDA proposed in the Federal Register of
October 14, 1993 (58 FR 53296), not to authorize use of three of the
four claims in the labeling of dietary supplements. In October 1993,
after further review of evidence on the relationship between folate and
reduced risk of neural tube defects, FDA proposed to authorize a health
claim for this relationship (58 FR 53254, October 14, 1993); however,
the agency proposed not to allow such claims to include a statement
that folate from one source is more effective in reducing the risk of
neural tube defects than folate from another source. Both proposals
became final by operation of law on December 31, 1993. (See 59 FR 395,
January 4, 1994 (dietary fiber and cancer, antioxidant vitamins and
cancer, and omega-3 fatty acids and coronary heart disease); 59 FR 433,
January 4, 1994 (folate and neural tube defects).) FDA's decisions not
to authorize these four claims are codified in Sec. 101.71(a) (21 CFR
101.71(a)) (dietary fiber and cancer); Sec. 101.71(c) (antioxidant
vitamins and cancer); Sec. 101.71(e) (omega-3 fatty acids and coronary
heart disease); and Sec. 101.79(c)(2)(i)(G) (21 CFR 101.79(c)(2)(i)(G))
(claims comparing effectiveness of folate from different sources).
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\1\ In its original health claim evaluation, FDA used the term
``folic acid'' to describe this B vitamin. Later, the agency decided
that the broader term ``folate'' was more scientifically accurate
because that term encompasses both synthetic and naturally occurring
forms of the vitamin, whereas folic acid refers only to the
synthetic form (see 58 FR 53254 at 53257 through 53258 and 53280,
October 14, 1993). Accordingly, this rule uses the term ``folate.''
The two terms may be used interchangeably in food labeling.
\2\ Neural tube defects are birth defects of the brain or spinal
cord. Spina bifida and anencephaly are the most common types of
neural tube defects.
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Several dietary supplement marketers and nonprofit organizations
that had submitted comments during FDA's health claims rulemakings
filed suit in Federal district court on constitutional and statutory
grounds seeking, among other things, authorization to make the
following health claims for use in the labeling of dietary supplements:
``Consumption of fiber may reduce the risk of colorectal cancer,''
``Consumption of antioxidant vitamins may reduce the risk of certain
kinds of cancer,'' ``Consumption of omega-3 fatty acids may reduce the
risk of coronary heart disease,'' and ``0.8 mg of folic acid in a
dietary supplement is more effective in reducing the risk of neural
tube defects than a lower amount in foods in common form.'' The
district court ruled for FDA in all respects
[[Page 58918]]
(Pearson v. Shalala, 14 F. Supp. 2d 10 (D.D.C. 1998)); however, the
U.S. Court of Appeals for the D.C. Circuit reversed the district
court's decision. The court of appeals held the regulations codifying
FDA's decision not to authorize the four health claims invalid and
instructed FDA to reconsider the four health claims (Pearson v.
Shalala, 164 F.3d 650 (D.C. Cir. 1999)).
In the Nutrition Labeling and Education Act of 1990, Congress made
health claims for dietary supplements subject to a procedure and
standard to be established by FDA (see section 403(r)(5)(D) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(r)(5)(D)). FDA adopted the same procedure for health claims in
dietary supplement labeling that Congress had prescribed for health
claims in the labeling of conventional foods (see section 403(r)(3) and
(r)(4) of the act). This procedure requires the evidence supporting a
health claim to be presented to FDA for review before the claim may
appear in labeling. Unless and until FDA adopts a regulation
authorizing the claim, a dietary supplement bearing the claim is
subject to regulatory action as a misbranded food (see section
403(r)(1)(B) of the act, a misbranded drug (see section 502(f)(1) of
the act (21 U.S.C. 352(f)(1)), and as an unapproved new drug (see
section 505(a) of the act (21 U.S.C. 355(a)).
Recently, the U.S. District Court for the District of Columbia
denied the Pearson plaintiffs' motion for a preliminary injunction
granting them immediate permission to make the four health claims that
FDA is reconsidering. In their motion, the plaintiffs argued that
because the court of appeals had invalidated the regulations codifying
FDA's decision not to authorize the four claims, the claims should be
permitted in dietary supplement labeling if accompanied by disclaimers
suggested by the court of appeals. The district court rejected this
argument. The court's decision said in part that a preliminary
injunction was not in order because the plaintiffs may not bypass FDA's
pre-clearance process for health claims. ``Plaintiffs' fatal assumption
is that the Court of Appeals' invalidation of the regulations allows
them to now make their health claims with disclaimers, without any
further pre-clearance by FDA. It does not. Invalidation of the
regulations merely puts plaintiffs back at square one, which means they
must again go through the pre-clearance process * * *.'' (Pearson v.
Shalala, No. Civ. A. 95-1865, 2000 WL 767584, at *2 (D.D.C. May 24,
2000)).
Thus, while FDA is revoking the regulations codifying its original
decision not to authorize the four health claims that were challenged
in Pearson, such claims still may not be used in labeling pending
reconsideration of these claims by FDA. FDA expects to complete its
reconsideration of the four claims and issue a decision on each claim
by October 10, 2000.
II. Effective Date
The Administrative Procedure Act and FDA regulations provide that
an agency may dispense with notice-and-comment rulemaking procedures
when the agency for good cause finds that such procedures are
impracticable, unnecessary, or contrary to the public interest (5
U.S.C. 553(b)(3)(B); Sec. 10.40(e)(1) (21 CFR 10.40(e)(1))). Because
this final rule is being issued in response to a court order, FDA finds
that notice and comment are unnecessary. In addition, the Commissioner
of Food and Drugs finds good cause under 5 U.S.C. 553(d)(3) and
Sec. 10.40(c)(4)(ii) to make this final rule effective upon
publication.
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, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
Sec. 101.71 [Amended]
2. Section 101.71 Health claims: claims not authorized is amended
by removing paragraphs (a), (c), and (e); and by redesignating
paragraph (b) as paragraph (a), and paragraph (d) as paragraph (b).
Sec. 101.79 [Amended]
3. Section 101.79 Health claims: Folate and neural tube defects is
amended by removing paragraph (c)(2)(i)(G), and by redesignating
paragraph (c)(2)(i)(H) as (c)(2)(i)(G).
Dated: September 25, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-25352 Filed 10-2-00; 8:45 am]
BILLING CODE 4160-01-F