[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1951 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 1951

  To amend the Federal Food, Drug, and Cosmetic Act to allow food and 
dietary supplement manufacturers to communicate truthful, nonmisleading 
information to consumers concerning the nutritional content and disease 
   prevention benefits of their products, to repeal or clarify rules 
enacted by the Dietary Supplement Health and Education Act of 1994, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 1995

 Mr. Pallone (for himself, Mr. Hastert, Mr. Richardson, Mr. Frisa, and 
 Mr. DeFazio) introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to allow food and 
dietary supplement manufacturers to communicate truthful, nonmisleading 
information to consumers concerning the nutritional content and disease 
   prevention benefits of their products, to repeal or clarify rules 
enacted by the Dietary Supplement Health and Education Act of 1994, 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; REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Food and Dietary 
Supplement Consumer Information Act of 1995''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 2. AUTHORIZING TRUTHFUL CLAIMS THAT ARE NOT MISLEADING.

    (a) Claims Permitted.--Section 403B (21 U.S.C. 343-2) is amended to 
read as follows:

              ``food and dietary supplement labeling rule

    ``Sec. 403B. If the labeling or advertising for a food or dietary 
supplement contains a claim or other information that characterizes the 
relationship of such food or dietary supplement to a disease or health-
related condition, or characterizes the relationship of the presence or 
absence of any substance in such food or dietary supplement to a 
disease or health-related condition, such food or dietary supplement 
may not be deemed to be adulterated or misbranded by reason of such 
claim or other information, if such claim or other information is 
truthful and not misleading.''.
    (b) Conforming Repealer.--Section 403(r)(6) (21 U.S.C. 343(r)(6)) 
(pertaining to allowable statements of nutritional support) is 
repealed.

SEC. 3. REPEAL OF RULE ENACTED BY THE DIETARY SUPPLEMENT HEALTH AND 
              EDUCATION ACT OF 1994 PERTAINING TO A FOOD OR DIETARY 
              SUPPLEMENT THAT IS ALSO MARKETED AS A NEW DRUG, 
              ANTIBIOTIC, OR BIOLOGIC.

    Section 201(ff) (21 U.S.C. 321(ff)) is amended--
            (1) in paragraph (1), by inserting ``and'' after the 
        semicolon at the end;
            (2) in paragraph (2)(C), by striking ``; and'' and 
        inserting a period; and
            (3) by striking paragraph (3).

SEC. 4. REPEAL OF DIETARY INGREDIENT RULE.

    (a) Section 413 (21 U.S.C. 350b) is repealed.
    (b) Section 402(f) (21 U.S.C. 342(f)) is amended by striking 
subparagraph (B) and redesignating subparagraphs (C) and (D) as 
subparagraphs (B) and (C), respectively.

SEC. 5. FOODS AND DIETARY SUPPLEMENTS NOT TO BE TREATED AS DRUGS.

    (a) Section 201(g)(1) (21 U.S.C. 321(g)(1)) is amended--
            (1) by striking the last two sentences and inserting, 
        ``Neither a food nor a dietary supplement shall be deemed to be 
        a drug.''; and
            (2) in clause (C), by striking ``(other than food)''.
    (b) Section 201(ff)) (21 U.S.C. 321(ff)), as amended by section 3, 
is further amended by striking the last sentence (pertaining to the 
deeming of a dietary supplement to be a food).

SEC. 6. ADULTERATED DIETARY SUPPLEMENT: CLARIFICATION OF TEST.

    Section 402(f) (21 U.S.C. 342(f)), as amended by section 4, is 
further amended in paragraph (1)(A) by striking ``significant or 
unreasonable risk'' and inserting ``substantial and unreasonable 
risk''.

SEC. 7. REGULATION OF FOODS AND DIETARY SUPPLEMENTS UNDER STATE LAW.

    Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after 
section 403B the following:

           ``state regulation of food and dietary supplements

    ``Sec. 403C. (a) No State or political subdivision of a State may 
deem a food or dietary supplement to be a drug, or directly or 
indirectly establish under any authority, or continue in effect, a 
requirement applicable to such food or dietary supplement as though it 
were a drug.
    ``(b) If the labeling or advertising of a food or dietary 
supplement contains a claim or other information that complies with 
section 403B, no State or political subdivision of a State may deem 
such food or dietary supplement to be adulterated, misbranded, or 
otherwise rendered out of compliance with the law of such State or 
political subdivision, by reason of such claim.''.

SEC. 8. COMMISSION ON DIETARY SUPPLEMENT LABELS ABOLISHED.

    The Commission on Dietary Supplement Labels, established under the 
Dietary Supplement Health and Education Act of 1994, Public Law 103-
417, is abolished, and section 12 of that Act is repealed.
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