I
106TH CONGRESS
1ST SESSION
H. R. 3305
To require the Commissioner of Food and Drugs to issue revised regulations
relating to dietary supplement labeling, to amend the Federal Trade
Commission Act to provide that certain types of advertisements for
dietary supplements are proper, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 10, 1999
Mr. BURTON of Indiana introduced the following bill; which was referred to
the Committee on Commerce
A BILL
To require the Commissioner of Food and Drugs to issue
revised regulations relating to dietary supplement label-
ing, to amend the Federal Trade Commission Act to
provide that certain types of advertisements for dietary
supplements are proper, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Dietary Supplement
Fairness in Labeling and Advertising Act’’.
SEC. 2. LABELING OF DIETARY SUPPLEMENTS.
(a) SENSE OF CONGRESS.—It is the sense of Con-
gress that the proposed rule entitled ‘‘Regulations on
Statements Made for Dietary Supplements Concerning the
Effect of the Product on the Structure or Functions of
the Body’’, published in the Federal Register on April 29,
1998, 63 Fed. Reg. 23624 (to be codified at part 101 of
title 21, Code of Federal Regulations) would improperly
restrict use of appropriate labeling claims about the effect
of a dietary supplement or dietary ingredient on the struc-
ture or function of the human body.
(b) EFFECT OF REGULATIONS.—The proposed rule
described in subsection (a) shall not take effect.
(c) DIETARY
SUPPLEMENT
LABELING
EXEMP-
TIONS.—Section 403B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343–2) is amended by adding
at the end the following:
‘‘(d) EXEMPTION FROM REGULATION
AS LABEL-
ING.—A truthful and accurate summary of 1 or more of
the findings of a study or article that has appeared in a
peer-reviewed medical, nutritional, or other scientific pub-
lication, or in a bona fide medical, nutritional, or other
scientific textbook, shall not be subject to regulation as
labeling under this Act when used in connection with the
sale of a dietary supplement to consumers, even if the
summary is included in written, printed, or graphic matter
that accompanies the dietary supplement.’’.
SEC. 3. ADVERTISING OF DIETARY SUPPLEMENTS.
Section 5 of the Federal Trade Commission Act (15
U.S.C. 45) is amended by adding at the end the following:
‘‘(o) ADVERTISING OF DIETARY SUPPLEMENTS AND
DIETARY INGREDIENTS.—
‘‘(1) DEFINITIONS.—In this subsection:
‘‘(A) DIETARY
SUPPLEMENT.—The term
‘dietary supplement’ has the meaning given that
term by section 201(ff) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
‘‘(B) DIETARY
INGREDIENT.—The term
‘dietary ingredient’ means an ingredient listed
in section 201(ff)(1) (A) through (F) of the
Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(ff)(1) (A) through (F)) that is in-
cluded in, or that is intended to be included in,
a dietary supplement.
‘‘(2) EXEMPTIONS FROM REGULATION AS AD-
VERTISING.—
‘‘(A) LABELING.—Insofar as a publication
is exempt from regulation as labeling pursuant
to section 403B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343–2) the publication
is also exempt from regulation as advertising
under the Federal Trade Commission Act.
‘‘(B) TRUTHFUL
AND
ACCURATE
SUM-
MARY.—A truthful and accurate summary of 1
or more of the findings of a cited study or arti-
cle that has appeared in a peer-reviewed med-
ical, nutritional, or other scientific publication,
or in a bona fide medical, nutritional, or other
scientific textbook, when used in promotion for
a dietary supplement or dietary ingredient, shall
not be subject to regulation as advertising
under the Federal Trade Commission Act.
‘‘(3) ADVERTISER
ACCESS
TO
GOVERNMENT
SCIENTIFIC EXPERTS BEFORE A REGULATORY AC-
TION
IS
INITIATED.—Before the Commission files
any complaint that initiates any administrative or
judicial proceeding alleging that an advertisement or
advertiser is not in compliance with the Federal
Trade Commission Act with respect to any adver-
tising for a dietary supplement or dietary ingredient,
or for medical services or health treatments, the
Commission shall ensure that the advertiser first—
‘‘(A) has been provided a full and fair op-
portunity to consult directly with all of the indi-
viduals whom the Commission or Commission
staff have relied upon or intend to rely upon as
nutritional, medical, or other scientific experts
with respect to the particular allegations; and
‘‘(B) has been provided a reasonable time
thereafter to communicate with the Commission
staff and the Commission with respect to the
merits of the experts’ views.
‘‘(4) RELIANCE UPON SCIENTIFIC DATA OTHER
THAN CONCLUSIVE HUMAN CLINICAL STUDIES.—It
is not inherently or presumptively deceptive, unfair,
lacking in substantiation, or otherwise improper for
advertising about a dietary supplement or dietary in-
gredient, or about medical services or health treat-
ments, to describe, mention, or rely upon in vitro
laboratory studies, animal feeding studies, human
epidemiological studies, human clinical studies that
are of a preliminary nature and do not provide a
conclusive finding, meta-analyses, review articles, or
other bona fide medical, nutritional, or other sci-
entific texts if the advertising is truthful, not mis-
leading, and reveals the nature of the study or other
information.
‘‘(5) CONSENT AGREEMENTS.—In any case in
which the Commission enters into a consent agree-
ment concerning advertising about a dietary supple-