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 con-
cerning claims about the effects of foods and dietary 
supplements on health-related conditions and disease, 
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 ‘‘Health Freedom Act’’. 
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SEC. 2. LIMITATION ON SUPPRESSION BY FEDERAL GOV-
ERNMENT OF CLAIMS IN FOOD AND DIETARY 
SUPPLEMENTS. 
The Federal Government may not take any action to 
prevent use of a claim describing any nutrient in a food 
or dietary supplement (as such terms are defined in sec-
tion 201 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321)) as mitigating, treating, or preventing 
any disease, disease symptom, or health-related condition, 
unless in a final order of a Federal court following a trial 
on the merits finds clear and convincing evidence based 
on qualified expert opinion and published peer-reviewed 
scientific research that— 
(1) the claim is false and misleading in any ma-
terial respect; and 
(2) there is no less speech restrictive alternative 
to claim suppression, such as use of disclaimers or 
qualifications, that can render the claim non-mis-
leading. 
SEC. 3. DEFINITION OF DRUG. 
(a) IN GENERAL.—Subparagraph (1) of section 
201(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g)) is amended by striking the second and 
third sentences and inserting the following: ‘‘A food or die-
tary supplement for which a claim is made in accordance 
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with section 403(r)(1)(B) is not a drug solely because of 
such claim.’’. 
(b) RULES.—All rules of the Food and Drug Admin-
istration in existence on the date of the enactment of this 
Act prohibiting nutrient-disease relationship claims are re-
voked. 
SEC. 4. MISBRANDED FOOD. 
Section 403(r) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(r)) is amended— 
(1) by striking clause (B) of subparagraph (1) 
and inserting the following: 
‘‘(B) describes any nutrient as mitigating, 
treating, or preventing any disease, disease symp-
tom, or health-related condition if, and only if, the 
claim has been adjudicated false and misleading in 
any material respect by final order of a Federal 
court of competent jurisdiction in accordance with 
section 2 of the Health Freedom Protection Act.’’; 
(2) by striking subparagraph (3); 
(3) in the first sentence of subparagraph 
(4)(A)(i)— 
(A) by striking ‘‘or (3)(B)’’; and 
(B) by striking ‘‘or (1)(B)’’; 
(4) by striking clause (C) of subparagraph (4); 
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(5) by striking clause (D) of subparagraph (5); 
and 
(6) in subparagraph (6), by striking the second 
sentence. 
SEC. 5. DIETARY SUPPLEMENT LABELING EXEMPTIONS. 
Section 403B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343–2) is amended to read as fol-
lows: 
‘‘FOOD AND DIETARY SUPPLEMENT LABELING 
‘‘SEC. 403B. The Federal Government shall take no 
action to prevent distribution of any publication in connec-
tion with the sale of a food or dietary supplement to con-
sumers unless it establishes that a claim contained in the 
publication— 
‘‘(1) names the specific food or dietary supple-
ment sold by the person causing the publication to 
be distributed; 
‘‘(2) represents that the specific food or dietary 
supplement mitigates, treats, or prevents a disease; 
and 
‘‘(3) proves the claim to be false and misleading 
in any material respect by final order of a Federal 
court of competent jurisdiction in accordance with 
section 2 of the Health Freedom Protection Act.’’. 
Æ 
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