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 supplements include accurate statements of the curative, mitigation, treatment, and prevention effects of nutrients 

on disease or health-related conditions, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Consumers’ Access to 

5 Health Information Act’’. 
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1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) When the Congress included health claims 

4 provisions in the Nutrition Labeling and Education 

5 Act of 1990, amending the Federal Food, Drug, and 

6 Cosmetic Act (‘‘FDCA’’ or ‘‘Act’’), the Congress in7 tended for those provisions to permit use of accurate 

8 label and labeling claims of the curative, mitigation, 

9 treatment, and prevention effects of foods and die10 tary supplements on disease and health-related con11 ditions. 

12 (2) In the 2004 decision, Whitaker v. Thomp13 son, 353 F.3d 947 (2004), rehearing den. 2004 U.S. 

14 App. LEXIS 4617 (D.C. Cir. March 9, 2004), the 

15 United States Court of Appeals for the D.C. Circuit 

16 erroneously construed the health claims provisions of 

17 the FDCA to prohibit accurate curative, mitigation, 

18 and treatment health claims. 

19 (3) The health claims provisions of the Act 

20 should be amended to clarify their meaning and en21 sure that accurate health claims are not suppressed; 

22 that consumers are given truthful and full informa23 tion about the disease curative, mitigation, treat24 ment, and prevention effects of foods and dietary 

25 supplements; that the intent of the Congress is hon26 ored; and that the erroneous construction of the 
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1 health claims provisions of the Act by the United 

2 States Court of Appeals for the D.C. Circuit in such 

3 2004 decision does not remain the law. 

4 SEC. 3. HEALTH CLAIMS; EXCEPTION FROM DRUG DEFINI5 TION. 

6 (a) HEALTH CLAIMS.—The Federal Food, Drug, and 

7 Cosmetic Act is amended— 

8 (1) in section 403(r)(1)(B) (21 U.S.C. 

9 343(r)(1)(B))— 

10 (A) by striking ‘‘the relationship of any 

11 nutrient which’’ and inserting ‘‘the curative, 

12 mitigation, treatment, or prevention effect of 

13 any nutrient (which ’’; and 

14 (B) by striking ‘‘the food to a disease or 

15 a health-related condition’’ and inserting ‘‘the 

16 food) on any disease or health-related condi17 tion’’; and 

18 (2) in section 403(r)(3)(B)(ii)(I) (21 U.S.C. 

19 343(r)(3)(B)(ii)(I))— 

20 (A) by striking ‘‘the relationship between a 

21 nutrient’’ and inserting ‘‘the curative, mitiga22 tion, treatment, or prevention effect of a nutri23 ent’’; and 

24 (B) by striking ‘‘and a disease’’ and insert25 ing ‘‘on any disease’’. 
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1 (b) EXCEPTION FROM DRUG DEFINITION.—Section 

2 201(g)(1) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 321(g)(1)) is amended by striking the second 

4 and third sentences and inserting the following: ‘‘A claim 

5 on the label or in the labeling of a food or dietary supple6 ment, subject to sections 403(r)(1)(B) and 403(r)(3) or 

7 sections 403(r)(1)(B) and 403(r)(5)(D), made in accord8 ance with the requirements of section 403(r), shall not 

9 cause the food or dietary supplement to be a drug. A 

10 truthful and not misleading statement on the label or in 

11 the labeling of a food or a dietary supplement made in 

12 accordance with section 403(r)(6) shall not cause the food 

13 or dietary supplement to be a drug.’’. 

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