[Federal Register Volume 64, Number 230 (Wednesday, December 1, 1999)]
[Notices]
[Pages 67289-67291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31122]


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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; 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 informing the public 
of its strategy to implement a recent court decision in Pearson v. 
Shalala (Pearson). The agency is taking this action to ensure that 
interested persons are aware of the steps it plans to follow to carry 
out the decision. FDA is also announcing how it plans to process 
petitions for dietary supplement health claims during the interim 
implementation period.

FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for Food 
Safety and Applied Nutrition (HFS-007), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20852, 301-827-6733.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 15, 1999, the U.S. Court of Appeals for the D.C. Circuit 
issued its decision in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 
1999). In Pearson, the plaintiffs had challenged FDA's health claim 
regulations for dietary supplements and FDA's decision not to authorize 
health claims for four specific nutrient-disease relationships: Dietary 
fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids 
and coronary heart disease, and the claim that 0.8 mg of folic acid in 
dietary supplement form is more effective in

[[Page 67290]]

reducing the risk of neural tube defects than a lower amount in 
conventional food form.
    The court held in Pearson 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 prohibiting the four 
health claims listed above and directed the agency to reconsider 
whether to authorize the 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.
    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.
    After the petition for rehearing was denied, FDA's Center for Food 
Safety and Applied Nutrition updated its 1999 Program Priorities 
document to state that developing a strategy to implement the Pearson 
decision would be a high priority for calendar year 1999.

II. Components of the Implementation Strategy

    The components of the strategy are to: (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 changes to FDA's general health 
claim regulations for dietary supplements that 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. Because of FDA's obligation to implement the 
court decision promptly, the agency intends to work on the components 
of the strategy concurrently whenever possible. As noted above, 
implementation of Pearson is one of the items on the Center for Food 
Safety and Applied Nutrition's (CFSAN's) 1999 Program Priorities list, 
which constitutes CFSAN's priority work plan for the year, and CFSAN 
will include Pearson implementation as one of its high priority items 
for fiscal year 2000.

III. Updating the Scientific Evidence on the Four Pearson Claims

    As a first step toward re-examining the evidence supporting the 
four claims at issue in Pearson, FDA 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 that 
notice, FDA requested that written comments be submitted to the agency 
by November 22, 1999. In addition, CFSAN entered into a contract with a 
nongovernment firm to conduct a literature review for the four claims 
to identify relevant scientific information that became available after 
the agency's initial 1990 to 1993 review of these claims. This data 
gathering and literature review is needed for FDA to determine the 
current nature of the scientific evidence relating to the four claims 
and is an essential step in re-considering the claims. The contracted 
literature review for the four claims is due to the agency this fall.
    In response to a request from several of the Pearson plaintiffs, 
the agency has agreed to extend or reopen the comment period on the 
September 8, 1999, notice for 75 days after the agency issues its 
guidance on the significant scientific agreement standard (described 
below). The agency will give careful consideration to any additional 
data it receives during the second 75-day comment period.

IV. Guidance on the Significant Scientific Agreement Standard

    The agency is preparing to issue guidance clarifying the meaning of 
the significant scientific agreement standard. FDA expects to issue 
such guidance before the end of calendar year 1999.

V. Rulemakings and Public Meeting

    FDA is planning to initiate several rulemakings in response to 
Pearson. First, the court's decision requires the agency to reconsider 
whether to authorize the four claims that were at issue in the case. 
The agency intends to conduct four rulemakings, one for each claim. In 
each instance, the agency will first evaluate whether the evidence 
supporting the claim meets the significant scientific agreement 
standard; if not, the agency will then proceed to consider whether 
there is any qualifying language that could render the claim 
nonmisleading. If FDA believes that the answer to either question is 
yes, the agency will propose to authorize the claim; otherwise, the 
agency will propose not to authorize it.
    Second, FDA intends to initiate rulemaking to consider changes to 
its general health claims regulations for dietary supplements that may 
be warranted in light of Pearson. A public meeting during the first 
quarter of calendar year 2000 will precede this rulemaking. FDA will 
publish a Federal Register notice announcing the date and location of 
the public meeting. In that notice, FDA will provide a list of topics 
or questions to focus public input on how the agency's approach to the 
regulation of health claims for dietary supplements could be changed in 
light of Pearson.
    Written comments received in response to the notice, and 
participation at the public meeting, will assist the agency in the 
rulemaking to reconsider its general health claims regulations for 
dietary supplements.

VI. Interim Process for Petitions

    Until the rulemaking to reconsider the general health claims 
regulations for dietary supplements is complete, FDA intends to deny, 
without prejudice, any petition for a dietary supplement health claim 
that does not meet the significant scientific agreement standard in 21 
CFR Sec. 101.14(c). Once the rulemaking is complete, the agency will, 
on its own initiative, reconsider any petitions denied during the 
interim period. Petitions will be reconsidered in the order they were 
originally received. This process does not apply to the four claims at 
issue in Pearson, which will be handled as previously described.
    FDA takes seriously its obligation to implement Pearson. The agency 
believes that the fastest and most efficient way to fully implement the 
decision is to conduct a rulemaking to reconsider the general 
procedures and standards governing health claims for dietary 
supplements before ruling on individual petitions that do not meet the 
current regulatory standard for health claim authorization. If the 
agency attempted to proceed case-by-case without establishing a 
regulatory framework applicable to all petitions, confusion among 
regulatees, inconsistent agency action, and waste of private and agency 
resources could result.
    This practice is consistent with the practice FDA adopted 
immediately following the passage of the Nutrition Labeling and 
Education Act of 1990, which provided explicit statutory authority for 
health claims on conventional foods and dietary supplements. In a 
Federal Register notice

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published March 14, 1991 (56 FR 10906), the agency announced that it 
would deny, without prejudice, any health claim petition that was 
submitted before issuance of final regulations concerning the 
submission and content of such petitions.

    Dated: November 23, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-31122 Filed 11-30-99; 8:45 am]
BILLING CODE 4160-01-F