I 

111TH CONGRESS 

1ST SESSION H. R. 3395 

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 

JULY 29, 2009 

Mr. PAUL (for himself and Mr. BURTON of Indiana) 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 The Federal Government may not take any action to 

5 prevent use of a claim describing any nutrient in a food 

6 or dietary supplement (as such terms are defined in sec7 tion 201 of the Federal Food, Drug, and Cosmetic Act 

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

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

10 unless in a final order of a Federal court following a trial 

11 on the merits finds clear and convincing evidence based 

12 on qualified expert opinion and published peer-reviewed 

13 scientific research that— 

14 (1) the claim is false and misleading in any ma15 terial 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 SEC. 3. DEFINITION OF DRUG. 

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

22 201(g) of the Federal Food, Drug, and Cosmetic Act (21 

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

24 third sentences and inserting the following: ‘‘A food or die25 tary supplement for which a claim is made in accordance 

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

2 such claim.’’. 

3 (b) RULES.—All rules of the Food and Drug Admin4 istration in existence on the date of the enactment of this 

5 Act prohibiting nutrient-disease relationship claims are re6 voked. 

7 SEC. 4. MISBRANDED FOOD. 

8 Section 403(r) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 343(r)) is amended— 

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

11 and inserting the following: 

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

13 treating, or preventing any disease, disease symp14 tom, or health-related condition if, and only if, the 

15 claim has been adjudicated false and misleading in 

16 any material respect by final order of a Federal 

17 court of competent jurisdiction in accordance with 

18 section 2 of the Health Freedom Protection Act.’’; 

19 (2) by striking subparagraph (3); 

20 (3) in the first sentence of subparagraph 

21 (4)(A)(i)— 

22 (A) by striking ‘‘or (3)(B)’’; and 

23 (B) by striking ‘‘or (1)(B)’’; 

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

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

2 and 

3 (6) in subparagraph (6), by striking the second 

4 sentence. 

5 SEC. 5. DIETARY SUPPLEMENT LABELING EXEMPTIONS. 

6 Section 403B of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 343–2) is amended to read as fol8 lows: 

9 ‘‘FOOD AND DIETARY SUPPLEMENT LABELING

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

11 action to prevent distribution of any publication in connec12 tion with the sale of a food or dietary supplement to con13 sumers unless it establishes that a claim contained in the 

14 publication— 

15 ‘‘(1) names the specific food or dietary supple16 ment sold by the person causing the publication to 

17 be distributed; 

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

19 supplement mitigates, treats, or prevents a disease; 

20 and 

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

22 in any material respect by final order of a Federal 

23 court of competent jurisdiction in accordance with 

24 section 2 of the Health Freedom Protection Act.’’. 

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