I
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 con-
tent 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 com-
municate truthful, nonmisleading information to consum-
ers concerning the nutritional content and disease pre-
vention 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 Representa-
tives 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 amend-
ment 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 provi-
sion 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 informa-
tion that characterizes the relationship of such food or die-
tary supplement to a disease or health-related condition,
or characterizes the relationship of the presence or ab-
sence of any substance in such food or dietary supplement
to a disease or health-related condition, such food or die-
tary 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 mis-
leading.’’.
(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nutritional support) is repealed.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 SUP-
PLEMENT 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 subpara-
graphs (C) and (D) as subparagraphs (B) and (C), respec-
tively.
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 in-
serting, ‘‘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 sen-
tence (pertaining to the deeming of a dietary supplement
to be a food).
SEC. 6. ADULTERATED DIETARY SUPPLEMENT: CLARIFICA-
TION 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 SUPPLE-
MENTS 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 author-
ity, or continue in effect, a requirement applicable to such
food or dietary supplement as though it were a drug.