[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