I 

112TH CONGRESS 

1ST SESSION H. R. 2044 

To amend the Federal Food, Drug, and Cosmetic Act concerning claims 

about the effects of foods and dietary supplements on health-related 

conditions and disease, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 26, 2011 

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 concerning claims about the effects of foods and dietary 

supplements on health-related conditions and disease, 

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 ‘‘Health Freedom Act’’. 


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1 SEC. 2. LIMITATION ON SUPPRESSION BY FEDERAL GOV2 ERNMENT OF CLAIMS IN FOOD AND DIETARY 

3 SUPPLEMENTS. 

4 (a) IN GENERAL.—The Federal Government may not 

5 take any action to prevent use of a claim describing any 

6 nutrient in a food or dietary supplement (as such terms 

7 are defined in section 201 of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 321)) as mitigating, treating, or 

9 preventing any disease, disease symptom, or health-related 

10 condition, unless a Federal court in a final order following 

11 a trial on the merits finds clear and convincing evidence 

12 based on qualified expert opinion and published peer-re13 viewed scientific research that— 

14 (1) the claim is false and misleading in a mate15 rial respect; and 

16 (2) there is no less speech restrictive alternative 

17 to claim suppression, such as use of disclaimers or 

18 qualifications, that can render the claim non-mis19 leading. 

20 (b) DEFINITION.—In this section, the term ‘‘mate21 rial’’ means that the Food and Drug Administration has 

22 identified a competent consumer survey demonstrating 

23 that consumers decided to purchase the food or dietary 

24 supplement based on the portion of the claim alleged to 

25 be false or misleading. 


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1 SEC. 3. DEFINITION OF DRUG. 

2 (a) IN GENERAL.—Subparagraph (1) of section 

3 201(g) of the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 321(g)) is amended by striking the second and 

5 third sentences and inserting the following: ‘‘A food or die6 tary supplement for which a claim is made in accordance 

7 with section 403(r)(1)(B) is not a drug solely because of 

8 such claim.’’. 

9 (b) RULES.—All rules of the Food and Drug Admin10 istration in existence on the date of the enactment of this 

11 Act prohibiting nutrient-disease relationship claims are re12 voked. 

13 SEC. 4. MISBRANDED FOOD. 

14 Section 403(r) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 343(r)) is amended— 

16 (1) by striking clause (B) of subparagraph (1) 

17 and inserting the following: 

18 ‘‘(B) describes any nutrient as mitigating, 

19 treating, or preventing any disease, disease symp20 tom, or health-related condition if, and only if, the 

21 claim has been adjudicated false and misleading in 

22 a material respect by final order of a Federal court 

23 of competent jurisdiction in accordance with section 

24 2 of the Health Freedom Act.’’; 

25 (2) by striking subparagraph (3); 


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1 (3) in the first sentence of subparagraph 

2 (4)(A)(i)— 

3 (A) by striking ‘‘or (3)(B)’’; and 

4 (B) by striking ‘‘or (1)(B)’’; 

5 (4) by striking clause (C) of subparagraph (4); 

6 (5) by striking clause (D) of subparagraph (5); 

7 and 

8 (6) in subparagraph (6), in the matter following 

9 clause (C), by striking the first sentence. 

10 SEC. 5. DIETARY SUPPLEMENT LABELING EXEMPTIONS. 

11 Section 403B of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 343–2) is amended to read as fol13 lows: 

14 ‘‘FOOD AND DIETARY SUPPLEMENT LABELING

15 ‘‘SEC. 403B. The Federal Government shall take no 

16 action to prevent distribution of any publication in connec17 tion with the sale of a food or dietary supplement to con18 sumers unless it establishes that a claim contained in the 

19 publication— 

20 ‘‘(1) names the specific food or dietary supple21 ment sold by the person causing the publication to 

22 be distributed; 

23 ‘‘(2) represents that the specific food or dietary 

24 supplement mitigates, treats, or prevents a disease; 

25 and 


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1 ‘‘(3) proves the claim to be false and misleading 

2 in a material respect by final order of a Federal 

3 court of competent jurisdiction in accordance with 

4 section 2 of the Health Freedom Act.’’. 

Æ 


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