[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Notices]
[Page 71794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33279]



[[Page 71794]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-5424]


Guidance for Industry: Significant Scientific Agreement in the 
Review of Health Claims for Conventional Foods and Dietary Supplements; 
Availability

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for Industry: 
Significant Scientific Agreement in the Review of Health Claims for 
Conventional Foods and Dietary Supplements.'' The guidance is based on 
the report of an FDA Food Advisory Committee (FAC) Working Group that 
was asked to advise the agency on interpretation of the scientific 
standard ``significant scientific agreement,'' which FDA applies in its 
review of scientific data for health claims. This action is being taken 
to provide guidance to industry and to comply with a recent court 
decision that instructed FDA to clarify the meaning of the significant 
scientific agreement standard.

DATES: Written comments should be submitted by February 22, 2000, to 
ensure adequate consideration in the preparation of a revised guidance, 
if warranted. However, written comments may be submitted at anytime.
ADDRESSES: Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Comments are to be identified with 
the docket number found in brackets in the heading of this document. 
Submit written requests for single copies of the guidance entitled 
``Guidance for Industry: Significant Scientific Agreement in the Review 
of Health Claims for Conventional Foods and Dietary Supplements'' to 
the Office of Special Nutritionals (HFS-450), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204. Send one self-addressed adhesive label to assist 
that office in processing your request, or include a fax number to 
which the guidance may be sent. Alternatively, you may request a copy 
of the guidance by calling 202-205-4168, or you may fax your request to 
202-205-5295. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Sharon A. Ross, Center for Food Safety 
and Applied Nutrition (HFS-450), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-4168.

I. Background

SUPPLEMENTARY INFORMATION: The Nutrition Labeling and Education Act of 
1990 (NLEA), which amended the Federal Food, Drug, and Cosmetic Act 
(the act), authorized FDA to allow food labels to carry statements that 
describe the relationship between a food substance and a disease or 
health-related condition (``health claims'') (section 403(r)(1)(B) of 
the act (21 U.S.C. 343(r)(1)(B))). To ensure the scientific validity of 
health claims, NLEA required that FDA authorize a health claim in the 
labeling of conventional foods only if the agency ``determines, based 
on the totality of publicly available scientific evidence (including 
evidence from well-designed studies conducted in a manner which is 
consistent with generally recognized scientific procedures and 
principles), that there is significant scientific agreement, among 
experts qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by such evidence'' (section 
403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B)(i))). By regulation, 
FDA adopted the same standard for health claims in the labeling of 
dietary supplements (Sec. 101.14(c)(21 CFR 101.14(c)).
    In 1996, FDA asked its FAC to convene a working group to develop a 
guide for preparing petitions for health claims. In response to the 
recent decision of the Court of Appeals for the District of Columbia 
Circuit in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), which 
required FDA to clarify the meaning of ``significant scientific 
agreement,'' the focus of the FAC Working Group shifted to the 
scientific review of data for health claims and the interpretation of 
the significant scientific agreement standard. The working group's 
final report entitled ``Interpretation of Significant Scientific 
Agreement in the Review of Health Claims'' was made public during the 
FAC meeting of June 24 and 25, 1999. FDA concurs with the conclusions 
of the working group and is issuing a guidance based on the working 
group's final report.
    This guidance represents the agency's current thinking on the 
meaning of the significant scientific agreement standard in section 
403(r)(3) of the act (21 U.S.C. 343(r)(3)) and Sec. 101.14(c). It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute, 
regulations, or both.
    This guidance is a Level 1 guidance under FDA's good guidance 
practices (GGP's) (62 FR 8961, February 27, 1997). Consistent with 
GGP's, the agency is soliciting public comment, but is implementing the 
guidance immediately to promptly comply with the decision in Pearson v. 
Shalala.

II. Comments

    Interested persons should submit written comments on the guidance 
to the Dockets Management Branch (address above), by February 22, 2000, 
to ensure adequate consideration in the preparation of a revised 
guidance, if warranted. However, written comments may be submitted at 
anytime. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments may be seen in the office above between 
9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    An electronic version of the guidance also is available on the 
Internet at http://www.cfsan.fda.gov/dms/guidance.html#lab.

    Dated: December 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-33279 Filed 12-20-99; 1:04 pm]
BILLING CODE 4160-01-F