[Federal Register: October 6, 2000 (Volume 65, Number 195)]
[Notices]
[Page 59855-59857]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc00-96]
 
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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