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 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. 
(a) IN GENERAL.—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 section 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 a Federal court in a final order following 
a trial on the merits finds clear and convincing evidence 
based on qualified expert opinion and published peer-re-
viewed scientific research that— 
(1) the claim is false and misleading in a mate-
rial 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. 
(b) DEFINITION.—In this section, the term ‘‘mate-
rial’’ means that the Food and Drug Administration has 
identified a competent consumer survey demonstrating 
that consumers decided to purchase the food or dietary 
supplement based on the portion of the claim alleged to 
be false or misleading. 
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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 
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 
a material respect by final order of a Federal court 
of competent jurisdiction in accordance with section 
2 of the Health Freedom Act.’’; 
(2) by striking subparagraph (3); 
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(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); 
(5) by striking clause (D) of subparagraph (5); 
and 
(6) in subparagraph (6), in the matter following 
clause (C), by striking the first 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 
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‘‘(3) proves the claim to be false and misleading 
in a material respect by final order of a Federal 
court of competent jurisdiction in accordance with 
section 2 of the Health Freedom Act.’’. 
Æ 
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