[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3305 Introduced in House (IH)]







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 labeling, 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 Representatives 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 Congress 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 structure 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 Exemptions.--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 Labeling.--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 publication, 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 included in, or that is intended to be included 
                in, a dietary supplement.
            ``(2) Exemptions from regulation as advertising.--
                    ``(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 summary.--A truthful 
                and accurate summary of 1 or more of the findings of a 
                cited study or article that has appeared in a peer-
                reviewed medical, 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 action 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 advertising 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 opportunity 
                to consult directly with all of the individuals 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 
        ingredient, or about medical services or health treatments, 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 scientific 
        texts if the advertising is truthful, not misleading, and 
        reveals the nature of the study or other information.
            ``(5) Consent agreements.--In any case in which the 
        Commission enters into a consent agreement concerning 
        advertising about a dietary supplement or dietary ingredient, 
        or about medical services or health treatments, the agreement 
        shall apply only to the particular dietary supplements/
        ingredients and particular health-related conditions, or to the 
        particular medical services or health treatments, or to other 
        particular matters, that are subjects of the complaint.''.
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