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

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