I 

112TH CONGRESS 

1ST SESSION H. R. 1364 

To amend the Federal Food, Drug, and Cosmetic Act concerning the distribution 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 concerning the distribution of information on legitimate scientific research in connection with foods and dietary 

supplements, 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 ‘‘Free Speech About 

5 Science Act of 2011’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 

8 (1) Federal regulators have forbidden— 


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1 (A) cherry growers and food producers to 

2 cite independent and respected scientific re3 search on their produce that references health 

4 benefits; and 

5 (B) a variety of dietary supplement makers 

6 to cite independent scientific research on health 

7 benefits from supplements from respected, peer8 reviewed scientific journals. 

9 (2) Americans want access and have a right to 

10 access legitimate scientific information about foods 

11 and dietary supplements to ensure informed deci12 sions about diet and health care. While the Amer13 ican public is inundated daily with advertisements 

14 about prescription drugs for health conditions, many 

15 of which could be prevented through lifestyle 

16 changes, proper nutrition, and informed use of die17 tary supplements, Americans are denied access to 

18 the very information that assists in making informed 

19 lifestyle and health care decisions. 

20 (3) Providing access to scientific information 

21 promotes self-responsibility, thereby empowering 

22 Americans to exercise independent judgment in car23 ing for themselves and ultimately reducing health 

24 care costs and improving quality of life. 


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1 (4) The United States has a long commitment 

2 to the free dissemination of scientific research with 

3 the exception of limited extreme situations for na4 tional security. This commitment goes back to the 

5 First Amendment to the Constitution and has con6 tributed vitally to the Nation’s economic progress. 

7 SEC. 3. MISBRANDED FOOD AND DIETARY SUPPLEMENTS. 

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

10 (1) in subparagraph (3)— 

11 (A) by redesignating clause (D) as clause 

12 (E); 

13 (B) by inserting after clause (C) the fol14 lowing: 

15 ‘‘(D) Notwithstanding the provisions of clauses (A)(i) 

16 and (B), a claim of the type described in subparagraph 

17 (1)(B) which is not authorized by the Secretary in a regu18 lation promulgated in accordance with clause (B) shall be 

19 authorized and may be made with respect to a food if— 

20 ‘‘(i) the claim is based on legitimate scientific 

21 research; 

22 ‘‘(ii) the claim and the food for which the claim 

23 is made are in compliance with clause (A)(ii) and 

24 are otherwise in compliance with paragraph (a) and 

25 section 201(n); 


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1 ‘‘(iii) the claim is stated in a manner so that 

2 the claim— 

3 ‘‘(I) is an accurate balanced summary of 

4 such research; and 

5 ‘‘(II) enables the public to comprehend the 

6 information provided in the claim and the rel7 ative significance of such information in the 

8 context of a total daily diet; 

9 ‘‘(iv) the claim includes a citation to such re10 search; and 

11 ‘‘(v) the claim identifies each party that funded 

12 such research.’’; 

13 (C) in clause (E), as so redesignated, by 

14 striking ‘‘clause (C)’’ each place it appears and 

15 inserting ‘‘clause (C) or (D)’’; and 

16 (D) by adding at the end the following: 

17 ‘‘(F) In this subparagraph, the term ‘legitimate sci18 entific research’ means scientific research, whether per19 formed in vitro, in vivo, in animals, or in humans, that— 

20 ‘‘(i) is conducted in accordance with sound sci21 entific principles; 

22 ‘‘(ii) has been evaluated and accepted by a sci23 entific or medical panel; and 

24 ‘‘(iii) has been published in its entirety, or as 

25 an accurate, balanced summary or scientific review 


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1 including a citation to the research in its entirety, 

2 in— 

3 ‘‘(I) a peer-reviewed article or book; 

4 ‘‘(II) a recognized textbook; 

5 ‘‘(III) a peer-reviewed scientific publica6 tion; or 

7 ‘‘(IV) any publication of the United States 

8 Government (including ones published by or at 

9 the request of a Federal department, agency, 

10 institute, center, or academy).’’; 

11 (2) by amending subparagraph (6) to read as 

12 follows: 

13 ‘‘(6)(A) For purposes of subparagraph (1)(B), a 

14 statement for a dietary supplement may be made if— 

15 ‘‘(i) the statement claims a benefit related to a 

16 classical nutrient deficiency condition and discloses 

17 the prevalence of such condition in the United 

18 States, describes the role of a nutrient or dietary in19 gredient intended to affect the structure or function 

20 in humans, characterizes the documented mechanism 

21 by which a nutrient or dietary ingredient acts to 

22 maintain such structure or function, or describes 

23 general well-being from consumption of a nutrient or 

24 dietary ingredient; 


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1 ‘‘(ii) the manufacturer of the dietary supple2 ment has substantiation that such statement is 

3 truthful and not misleading; 

4 ‘‘(iii) the statement contains, prominently dis5 played and in boldface type, the following: ‘This 

6 statement has not been evaluated by the Food and 

7 Drug Administration. This product is not intended 

8 to diagnose, treat, cure, or prevent any disease.’; and 

9 ‘‘(iv) the statement does not claim to diagnose, 

10 mitigate, treat, cure, or prevent a specific disease or 

11 class of diseases. 

12 ‘‘(B) Notwithstanding subparagraph (1)(B), a state13 ment for a dietary supplement may be made if— 

14 ‘‘(i) the statement claims to diagnose, mitigate, 

15 treat, cure, or prevent a specific disease or class of 

16 diseases, based on legitimate scientific research (as 

17 defined in subparagraph (3)(F)); 

18 ‘‘(ii) the manufacturer of the dietary supple19 ment has substantiation that such statement is 

20 truthful and not misleading; 

21 ‘‘(iii) the statement contains, prominently dis22 played and in boldface type, the following: ‘This 

23 statement has not been evaluated by the Food and 

24 Drug Administration.’; 


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1 ‘‘(iv) the claim includes a citation to the re2 search referred to in subclause (i); and 

3 ‘‘(v) the claim identifies each party that funded 

4 such research. 

5 If the manufacturer of a dietary supplement proposes to 

6 make a statement described in clause (A) or (B) in the 

7 labeling of the dietary supplement, the manufacturer shall 

8 notify the Secretary no later than 30 days after the first 

9 marketing of the dietary supplement with such statement 

10 that such a statement is being made.’’; and 

11 (3) by adding at the end the following: 

12 ‘‘(8) Subject to subparagraph (1) (relating to claims 

13 in the label or labeling of food), the Secretary shall take 

14 no action to restrict in any way the distribution of infor15 mation that is not false or misleading on legitimate sci16 entific research (as defined in subparagraph (3)(F)) in 

17 connection with the sale of food.’’. 

18 SEC. 4. FALSE ADVERTISING. 

19 (a) DISSEMINATION OF LEGITIMATE SCIENTIFIC RE20 SEARCH IN CONNECTION WITH SALE OR DISTRIBUTION

21 OF FOOD OR DIETARY SUPPLEMENT.—Section 12 of the 

22 Federal Trade Commission Act (15 U.S.C. 52) is amended 

23 by adding at the end the following: 

24 ‘‘(c)(1) The dissemination of legitimate scientific re25 search in connection with the sale or distribution of a food 


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1 or dietary supplement to consumers shall not be deter2 mined to be false advertising by virtue of the fact that 

3 the research does not directly correlate to the type of food 

4 or dietary supplement (including any component thereof) 

5 being sold or distributed if the dissemination includes a 

6 clear disclosure that the research does not directly cor7 relate to such type of food or dietary supplement. 

8 ‘‘(2) In any proceeding under section 13, the burden 

9 of proof shall be on the Commission to establish that the 

10 literature being disseminated is not legitimate scientific 

11 research.’’. 

12 (b) DEFINITIONS.—Section 15 of the Federal Trade 

13 Commission Act (15 U.S.C. 55) is amended by adding at 

14 the end the following: 

15 ‘‘(g) The term ‘dietary supplement’ has the meaning 

16 given to such term in section 201 of the Federal Food, 

17 Drug, and Cosmetic Act. 

18 ‘‘(h) The term ‘legitimate scientific research’ has the 

19 meaning given to such term in section 403(r) of the Fed20 eral Food, Drug, and Cosmetic Act.’’. 

Æ 


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