I 
112TH CONGRESS 
1ST SESSION H. R. 1364 
To amend the Federal Food, Drug, and Cosmetic Act concerning the distribu-
tion of information on legitimate scientific research in connection with 
foods and dietary supplements, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 5, 2011 
Mr. CHAFFETZ (for himself and Mr. POLIS) 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 the distribution of information on legitimate sci-
entific research in connection with foods and dietary 
supplements, 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 ‘‘Free Speech About 
Science Act of 2011’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) Federal regulators have forbidden— 
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(A) cherry growers and food producers to 
cite independent and respected scientific re-
search on their produce that references health 
benefits; and 
(B) a variety of dietary supplement makers 
to cite independent scientific research on health 
benefits from supplements from respected, peer- 
reviewed scientific journals. 
(2) Americans want access and have a right to 
access legitimate scientific information about foods 
and dietary supplements to ensure informed deci-
sions about diet and health care. While the Amer-
ican public is inundated daily with advertisements 
about prescription drugs for health conditions, many 
of which could be prevented through lifestyle 
changes, proper nutrition, and informed use of die-
tary supplements, Americans are denied access to 
the very information that assists in making informed 
lifestyle and health care decisions. 
(3) Providing access to scientific information 
promotes self-responsibility, thereby empowering 
Americans to exercise independent judgment in car-
ing for themselves and ultimately reducing health 
care costs and improving quality of life. 
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(4) The United States has a long commitment 
to the free dissemination of scientific research with 
the exception of limited extreme situations for na-
tional security. This commitment goes back to the 
First Amendment to the Constitution and has con-
tributed vitally to the Nation’s economic progress. 
SEC. 3. MISBRANDED FOOD AND DIETARY SUPPLEMENTS. 
Section 403(r) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(r)) is amended— 
(1) in subparagraph (3)— 
(A) by redesignating clause (D) as clause 
(E); 
(B) by inserting after clause (C) the fol-
lowing: 
‘‘(D) Notwithstanding the provisions of clauses (A)(i) 
and (B), a claim of the type described in subparagraph 
(1)(B) which is not authorized by the Secretary in a regu-
lation promulgated in accordance with clause (B) shall be 
authorized and may be made with respect to a food if— 
‘‘(i) the claim is based on legitimate scientific 
research; 
‘‘(ii) the claim and the food for which the claim 
is made are in compliance with clause (A)(ii) and 
are otherwise in compliance with paragraph (a) and 
section 201(n); 
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‘‘(iii) the claim is stated in a manner so that 
the claim— 
‘‘(I) is an accurate balanced summary of 
such research; and 
‘‘(II) enables the public to comprehend the 
information provided in the claim and the rel-
ative significance of such information in the 
context of a total daily diet; 
‘‘(iv) the claim includes a citation to such re-
search; and 
‘‘(v) the claim identifies each party that funded 
such research.’’; 
(C) in clause (E), as so redesignated, by 
striking ‘‘clause (C)’’ each place it appears and 
inserting ‘‘clause (C) or (D)’’; and 
(D) by adding at the end the following: 
‘‘(F) In this subparagraph, the term ‘legitimate sci-
entific research’ means scientific research, whether per-
formed in vitro, in vivo, in animals, or in humans, that— 
‘‘(i) is conducted in accordance with sound sci-
entific principles; 
‘‘(ii) has been evaluated and accepted by a sci-
entific or medical panel; and 
‘‘(iii) has been published in its entirety, or as 
an accurate, balanced summary or scientific review 
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including a citation to the research in its entirety, 
in— 
‘‘(I) a peer-reviewed article or book; 
‘‘(II) a recognized textbook; 
‘‘(III) a peer-reviewed scientific publica-
tion; or 
‘‘(IV) any publication of the United States 
Government (including ones published by or at 
the request of a Federal department, agency, 
institute, center, or academy).’’; 
(2) by amending subparagraph (6) to read as 
follows: 
‘‘(6)(A) For purposes of subparagraph (1)(B), a 
statement for a dietary supplement may be made if— 
‘‘(i) the statement claims a benefit related to a 
classical nutrient deficiency condition and discloses 
the prevalence of such condition in the United 
States, describes the role of a nutrient or dietary in-
gredient intended to affect the structure or function 
in humans, characterizes the documented mechanism 
by which a nutrient or dietary ingredient acts to 
maintain such structure or function, or describes 
general well-being from consumption of a nutrient or 
dietary ingredient; 
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‘‘(ii) the manufacturer of the dietary supple-
ment has substantiation that such statement is 
truthful and not misleading; 
‘‘(iii) the statement contains, prominently dis-
played and in boldface type, the following: ‘This 
statement has not been evaluated by the Food and 
Drug Administration. This product is not intended 
to diagnose, treat, cure, or prevent any disease.’; and 
‘‘(iv) the statement does not claim to diagnose, 
mitigate, treat, cure, or prevent a specific disease or 
class of diseases. 
‘‘(B) Notwithstanding subparagraph (1)(B), a state-
ment for a dietary supplement may be made if— 
‘‘(i) the statement claims to diagnose, mitigate, 
treat, cure, or prevent a specific disease or class of 
diseases, based on legitimate scientific research (as 
defined in subparagraph (3)(F)); 
‘‘(ii) the manufacturer of the dietary supple-
ment has substantiation that such statement is 
truthful and not misleading; 
‘‘(iii) the statement contains, prominently dis-
played and in boldface type, the following: ‘This 
statement has not been evaluated by the Food and 
Drug Administration.’; 
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‘‘(iv) the claim includes a citation to the re-
search referred to in subclause (i); and 
‘‘(v) the claim identifies each party that funded 
such research. 
If the manufacturer of a dietary supplement proposes to 
make a statement described in clause (A) or (B) in the 
labeling of the dietary supplement, the manufacturer shall 
notify the Secretary no later than 30 days after the first 
marketing of the dietary supplement with such statement 
that such a statement is being made.’’; and 
(3) by adding at the end the following: 
‘‘(8) Subject to subparagraph (1) (relating to claims 
in the label or labeling of food), the Secretary shall take 
no action to restrict in any way the distribution of infor-
mation that is not false or misleading on legitimate sci-
entific research (as defined in subparagraph (3)(F)) in 
connection with the sale of food.’’. 
SEC. 4. FALSE ADVERTISING. 
(a) DISSEMINATION OF LEGITIMATE SCIENTIFIC RE-
SEARCH IN CONNECTION WITH SALE OR DISTRIBUTION 
OF FOOD OR DIETARY SUPPLEMENT.—Section 12 of the 
Federal Trade Commission Act (15 U.S.C. 52) is amended 
by adding at the end the following: 
‘‘(c)(1) The dissemination of legitimate scientific re-
search in connection with the sale or distribution of a food 
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