[Federal Register Volume 65, Number 195 (Friday, October 6, 2000)]
[Notices]
[Pages 59855-59857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 91N-0101, 91N-0098, 91N-0103, and 91N-100H]


Food Labeling; Health Claims and Label Statements for Dietary 
Supplements; Update to Strategy for Implementation of Pearson Court 
Decision

AGENCY: Food and Drug Administration, HHS.

ACTION: :Notice.

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SUMMARY: The Food and Drug Administration (FDA) is updating its 
strategy for implementation of the court of appeals decision in Pearson 
v. Shalala (Pearson). The updated implementation strategy includes an 
interim enforcement strategy for dietary supplement health claims that 
do not meet the ``significant scientific agreement'' standard of 
evidence by which the health claims regulations require FDA to evaluate 
the scientific validity of claims. It also includes changes in the 
process that will be used for reconsidering the four Pearson health 
claims and for responding to future petitions for dietary supplement 
health claims. The agency is taking this action to inform interested 
persons of the latest developments in FDA's plans for implementation of 
Pearson.

FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food 
Safety and Applied Nutrition (HFS-832), 200 C St. SW., Washington, DC 
20204, 202-205-5372.

SUPPLEMENTARY INFORMATION:

I. Background

    After the enactment of the Nutrition Labeling and Education Act of 
1990 (the NLEA) and the Dietary Supplement Act of 1992, FDA issued 
regulations applying the general requirements for health claims for 
conventional foods to dietary supplements (59 FR 395, January 4, 1994). 
Under these regulations, a health claim is authorized for use only if 
FDA determines that there is significant scientific agreement, among 
experts qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by the totality of publicly 
available scientific evidence, including evidence from well-designed 
studies conducted in a manner that is consistent with generally 
recognized scientific procedures and principles Sec. 101.14 (21 CFR 
101.14). FDA also undertook rulemaking to consider specific health 
claims, including the four health claims at issue in the Pearson case.
    In Pearson, the plaintiffs challenged FDA's general health claims 
regulation for dietary supplements and FDA's decision not to authorize 
health claims for four specific substance/disease relationships: 
Dietary fiber and cancer, antioxidant vitamins and cancer, omega-3 
fatty acids and coronary heart disease, and the comparative claim that 
0.8 milligram of folate\1\ in dietary supplement form is more effective 
in reducing the risk of neural tube defects\2\ than a lower amount in 
conventional food form. Although the district court ruled for FDA in 
all respects (14 F. Supp. 2d 10 (D.D.C. 1998)), the U.S. Court of 
Appeals for the D.C. Circuit reversed the lower court's decision (164 
F.3d 650 (D.C. Cir. 1999)). The appeals court held that, on the 
administrative record compiled in the challenged rulemakings, the First 
Amendment does not permit FDA to reject health claims that the agency 
determines to be potentially misleading unless the agency also 
reasonably determines that no disclaimer would eliminate the potential 
deception. Accordingly, the court invalidated the regulations codifying 
FDA's decision not to authorize the four health claims listed above and 
directed the agency to reconsider the four claims. The court further 
held that the Administrative Procedure Act requires FDA to clarify the 
``significant scientific agreement'' standard for authorizing health 
claims, either by issuing a regulatory definition of significant 
scientific agreement or by defining it on a case-by-case basis.
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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 53257-58, and 53280, October 14, 
1993). Accordingly, this notice 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. Spinabifida and anencephaly are the most common types of 
neural tube defects.
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    On March 1, 1999, the Government filed a petition for rehearing en 
banc (reconsideration by the full court of appeals). The U.S. Court of 
Appeals for the D.C. Circuit denied the petition for rehearing on April 
2, 1999 (172 F.3d 72 (D.C. Cir. 1999)).

II. Strategy for Implementation of the Pearson Court Decision

A. The December 1999 Implementation Strategy Notice

    In the Federal Register of December 1, 1999 (64 FR 67289), FDA 
published a notice entitled ``Food Labeling: Health Claims and Label 
Statements for Dietary Supplements; Strategy for Implementation of 
Pearson Court Decision'' to inform the public of the steps FDA planned 
to follow to carry out the Pearson decision. The strategy included five 
components: (1) Update the scientific evidence on the four claims at 
issue in Pearson; (2) issue guidance clarifying the ``significant 
scientific agreement'' standard; (3) hold a public meeting to solicit 
input on what changes to FDA's general health claim regulations for 
dietary supplements may be warranted in light of the Pearson decision; 
(4) conduct a rulemaking to reconsider the general health claims 
regulations for dietary supplements in light of the Pearson decision; 
and (5) conduct rulemakings on the four Pearson health claims. In 
addition, the implementation strategy notice stated that, until the 
rulemaking to reconsider the general health claims regulations for 
dietary supplements was complete, FDA would deny, without prejudice, 
any petition for a dietary supplement health claim that does not meet 
the significant scientific agreement standard in Sec. 101.14(c). The 
notice further explained that, once the rulemaking was complete, the 
agency would, on its own initiative, reconsider any petitions denied 
during the interim period.
    Since the December 1999 Federal Register notice was published, FDA 
has completed the first three steps in the implementation strategy. The 
agency entered into contracts with two nongovernment firms to conduct a 
literature review for the four claims to identify relevant scientific 
information that became available after the agency's initial 1991 to 
1993 review of these claims. FDA also published a notice in the Federal 
Register of September 8, 1999 (64 FR 48841), requesting that interested 
persons submit any available scientific data concerning the substance-
disease relationships that are the subject of the four claims.
    In December 1999, FDA issued a guidance clarifying the significant 
scientific agreement standard. A notice of availability of the guidance 
was published in the Federal Register of December 22, 1999 (64 FR 
71794). The guidance is available on the Internet at http://
vm.cfsan.fda.gov/dms/ssaguide.html.

[[Page 59856]]

    In response to a request from several of the Pearson plaintiffs, 
the agency agreed to reopen the comment period for scientific data on 
the four claims after the agency issued its guidance on the significant 
scientific agreement standard. Accordingly, in the Federal Register of 
January 26, 2000 (65 FR 4252), FDA reopened the comment period for an 
additional 75 days, until April 3, 2000.
    On April 4, 2000, FDA completed the third step in the Pearson 
implementation strategy by convening a public meeting to solicit input 
on changes to the general health claims regulations for dietary 
supplements in light of the Pearson decision. Information on the public 
meeting, including the agenda and transcripts, are available on the 
Internet at http://vm.cfsan.fda.gov/dms/ds-0400.html.

B. Modifications to the December 1999 Implementation Strategy

1. Interim Enforcement Strategy for Dietary Supplement Health Claims
    In the NLEA, 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)). By regulation, FDA adopted the same 
procedure and standard for health claims in dietary supplement labeling 
that Congress had prescribed in the NLEA for health claims in the 
labeling of conventional foods (see section 403(r)(3) and (r)(4) of the 
act). The procedure requires the evidence supporting a health claim to 
be presented to FDA for review before the claim may appear in labeling 
(Secs. 101.14(d) and (e), and 101.70 (21 CFR 101.70)). The standard 
requires a finding of ``significant scientific agreement'' before FDA 
may authorize a health claim by regulation (Sec. 101.14(c)). Unless and 
until FDA adopts a regulation authorizing use of 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))). Under FDA's current general health claim regulations, the 
agency cannot authorize use of a health claim that does not meet the 
significant scientific agreement standard.
    Pending reconsideration of the general health claim regulations in 
response to Pearson, FDA is modifying its approach to processing new 
health claim petitions for dietary supplements. Absent this 
modification, FDA would have to deny all petitions that do not meet the 
significant scientific standard pending completion of the general 
rulemaking. Such an approach could lead to additional First Amendment 
challenges prior to completion of the rulemaking process.
    Rather than denying all petitions that do not meet the significant 
scientific agreement standard pending completion of the general 
rulemaking, FDA intends to exercise enforcement discretion in 
appropriate circumstances. Specifically, the agency will consider 
exercising enforcement discretion for a dietary supplement health claim 
when the following conditions are met: (1) The claim is the subject of 
a health claim petition that meets the requirements of Sec. 101.70; (2) 
the scientific evidence in support of the claim outweighs the 
scientific evidence against the claim, the claim is appropriately 
qualified, and all statements in the claim are consistent with the 
weight of the scientific evidence; (3) consumer health and safety are 
not threatened; and (4) the claim meets the general requirements for 
health claims in Sec. 101.14, except for the requirement that the 
evidence supporting the claim meet the significant scientific agreement 
standard and the requirement that the claim be made in accordance with 
an authorizing regulation.
    To the extent possible, FDA will consider these criteria while it 
is evaluating the petition and will state its conclusions in a letter 
to the petitioner; however, some criteria will have to be evaluated 
after-the-fact, because they involve information or circumstances that 
cannot be determined from the petition. For example, FDA will not be 
able to determine whether the entire claim appears in one place without 
intervening material, as required by Sec. 101.14(d)(2)(iv), until it 
actually sees the claim on products in the marketplace. Some provisions 
of Sec. 101.14 may not be relevant to a particular claim. The agency 
intends to identify any such provisions in its letter to the 
petitioner.
    As discussed below, FDA will consider exercising enforcement 
discretion only if a petition to authorize the health claim has been 
submitted; the agency has filed the petition; the agency has completed 
its scientific evaluation of the claim and communicated that evaluation 
by letter to the petitioner; and the conditions previously described, 
as well as any others stated in the letter to the petitioner, are met.
2. Interim Process for Responding to New Dietary Supplement Health 
Claim Petitions and Reconsidering the Four Pearson Health Claims
    FDA intends to respond to the four health claims at issue in the 
Pearson case and, pending rulemaking to implement Pearson, to new 
dietary supplement health claim petitions that have been filed for 
comprehensive review (see Sec. 101.70(j)(2)) in one of the following 
three ways:
    (1) If FDA determines that the significant scientific agreement 
standard is met, the agency will propose to authorize the health claim. 
FDA will consider using its interim final rule authority under section 
403(r)(7)(A)(iii) of the act to allow use of the health claim 
immediately upon publication of the proposal.
    (2) If FDA determines that the significant scientific agreement 
standard is not met, but that the scientific evidence in support of the 
claim outweighs the scientific evidence against the claim and the other 
threshold criteria listed above are met, FDA will consider exercising 
enforcement discretion with regard to dietary supplements that bear the 
health claim with appropriate qualifying language. The petitioner will 
be notified in writing of this intention. The letter to the petitioner 
will outline the agency's rationale for its determination that the 
evidence does not meet the significant scientific agreement standard 
set forth in Sec. 101.14(c) and then state the conditions under which 
the agency would ordinarily expect to exercise enforcement discretion 
for the claim.
    (3) If FDA determines that the significant scientific agreement 
standard is not met and that the evidence supporting the claim is 
outweighed by evidence against the claim (either qualitatively or 
quantitatively), or the substance poses a threat to health, or that any 
of the other criteria listed in section II.B.1 of this document are not 
met, FDA intends to deny the petition. The denial letter to the 
petitioner will: (1) Outline the agency's rationale for its 
determination that the evidence does not meet the significant 
scientific agreement standard set forth in Sec. 101.14(c); and (2) 
explain why FDA believes that the scientific evidence for the claim is 
outweighed by the evidence against the claim, that the claim would be 
otherwise misleading even if qualified, or that authorizing a health 
claim would pose a threat to consumer health or safety.
    This process is consistent with case law holding that FDA has wide 
latitude in matters of enforcement discretion.

[[Page 59857]]

(See, e.g., Heckler v. Chaney, 470 U.S. 821 (1985); Schering v. 
Heckler, 779 F.2d 683 (D.C. Cir. 1985).) It is also consistent with the 
Pearson decision, which described several circumstances in which FDA 
might be justified in banning certain health claims outright --e.g., 
where consumer health and safety are threatened, or where FDA can 
demonstrate that a health claim would be misleading even if qualified 
(see Pearson, 164 F.3d at 650, 657-60). For example, the court said 
that FDA could prohibit a health claim where the evidence in support of 
the claim is outweighed by evidence against the claim, either 
quantitatively or qualitatively (164 F.3d at 659 & n.10). The agency is 
adopting this modified process on an interim basis to minimize any 
burden on speech pending consumer research and rulemaking to complete 
the implementation of the Pearson decision.
3. Timing of FDA's Decisions on Health Claims for Dietary Supplements
    FDA will complete its reconsideration of the four Pearson claims 
and issue a final decision on each of the claims within 190 days after 
the close of the comment period seeking scientific data on the claims, 
i.e., by October 10, 2000. For new health claim petitions for dietary 
supplements, FDA will continue to follow the applicable deadlines in 
Sec. 101.70(j), as with past health claim petitions.

    Dated: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-25702 Filed 10-3-00; 4:29 pm]
BILLING CODE 4160-01-F