[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