I 
109TH CONGRESS 
1ST SESSION H. R. 2352 
To amend the Federal Food, Drug, and Cosmetic Act to ensure that health 
claims for foods and dietary supplements include accurate statements 
of the curative, mitigation, treatment, and prevention effects of nutrients 
on disease or health-related conditions, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 12, 2005 
Mr. PAUL introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
ensure that health claims for foods and dietary supple-
ments include accurate statements of the curative, miti-
gation, treatment, and prevention effects of nutrients 
on disease or health-related conditions, 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 ‘‘Consumers’ Access to 
Health Information Act’’.
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) When the Congress included health claims 
provisions in the Nutrition Labeling and Education 
Act of 1990, amending the Federal Food, Drug, and 
Cosmetic Act (‘‘FDCA’’ or ‘‘Act’’), the Congress in-
tended for those provisions to permit use of accurate 
label and labeling claims of the curative, mitigation, 
treatment, and prevention effects of foods and die-
tary supplements on disease and health-related con-
ditions. 
(2) In the 2004 decision, Whitaker v. Thomp-
son, 353 F.3d 947 (2004), rehearing den. 2004 U.S. 
App. LEXIS 4617 (D.C. Cir. March 9, 2004), the 
United States Court of Appeals for the D.C. Circuit 
erroneously construed the health claims provisions of 
the FDCA to prohibit accurate curative, mitigation, 
and treatment health claims. 
(3) The health claims provisions of the Act 
should be amended to clarify their meaning and en-
sure that accurate health claims are not suppressed; 
that consumers are given truthful and full informa-
tion about the disease curative, mitigation, treat-
ment, and prevention effects of foods and dietary 
supplements; that the intent of the Congress is hon-
ored; and that the erroneous construction of the
health claims provisions of the Act by the United 
States Court of Appeals for the D.C. Circuit in such 
2004 decision does not remain the law. 
SEC. 3. HEALTH CLAIMS; EXCEPTION FROM DRUG DEFINI-
TION. 
(a) HEALTH CLAIMS.—The Federal Food, Drug, and 
Cosmetic Act is amended— 
(1) 
in 
section 
403(r)(1)(B) 
(21 
U.S.C. 
343(r)(1)(B))— 
(A) by striking ‘‘the relationship of any 
nutrient which’’ and inserting ‘‘the curative, 
mitigation, treatment, or prevention effect of 
any nutrient (which ’’; and 
(B) by striking ‘‘the food to a disease or 
a health-related condition’’ and inserting ‘‘the 
food) on any disease or health-related condi-
tion’’; and 
(2) in section 403(r)(3)(B)(ii)(I) (21 U.S.C. 
343(r)(3)(B)(ii)(I))— 
(A) by striking ‘‘the relationship between a 
nutrient’’ and inserting ‘‘the curative, mitiga-
tion, treatment, or prevention effect of a nutri-
ent’’; and 
(B) by striking ‘‘and a disease’’ and insert-
ing ‘‘on any disease’’.
(b) EXCEPTION FROM DRUG DEFINITION.—Section 
201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(g)(1)) is amended by striking the second 
and third sentences and inserting the following: ‘‘A claim 
on the label or in the labeling of a food or dietary supple-
ment, subject to sections 403(r)(1)(B) and 403(r)(3) or 
sections 403(r)(1)(B) and 403(r)(5)(D), made in accord-
ance with the requirements of section 403(r), shall not 
cause the food or dietary supplement to be a drug. A 
truthful and not misleading statement on the label or in 
the labeling of a food or a dietary supplement made in 
accordance with section 403(r)(6) shall not cause the food 
or dietary supplement to be a drug.’’. 
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