I 

112TH CONGRESS 

1ST SESSION H. R. 2045 

To amend the Federal Trade Commission Act concerning the burden of 

proof in false advertising cases involving dietary supplements and dietary 

ingredients. 

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 Trade Commission Act concerning 

the burden of proof in false advertising cases involving 

dietary supplements and dietary ingredients. 

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 ‘‘Freedom of Health 

5 Speech Act’’. 

6 SEC. 2. HEALTH INFORMATION. 

7 Section 5 of the Federal Trade Commission Act (15 

8 U.S.C. 45) is amended by adding at the end the following: 


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1 ‘‘(o) ADVERTISING OF DIETARY SUPPLEMENTS AND

2 DIETARY INGREDIENTS.—— 

3 ‘‘(1) DEFINITIONS.—In this subsection— 

4 ‘‘(A) the term ‘dietary supplement’ has the 

5 meaning given to that term in section 201(ff) 

6 (21 U.S.C. 321(ff)) of the Federal Food, Drug, 

7 and Cosmetic Act; and 

8 ‘‘(B) the term ‘dietary ingredient’ means 

9 an ingredient listed in subparagraphs (A) 

10 through (F) of section 201(ff)(1) (21 U.S.C. 

11 321(ff)(1)) of the Federal Food, Drug, and 

12 Cosmetic Act that is included in, or that is in13 tended to be included in, a dietary supplement. 

14 ‘‘(2) EXEMPTIONS FROM REGULATION AS AD15 VERTISING.—No content of any publication shall be 

16 considered advertising regulated under this Act un17 less the content is intended by the seller of a prod18 uct to promote the sale of that product and the con19 tent includes— 

20 ‘‘(A) the name of the product offered for 

21 sale; 

22 ‘‘(B) an express offer to sell the named 

23 product; and 

24 ‘‘(C) a purchase price for the product. 


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1 No content excerpted in whole or part from a peer2 reviewed scientific publication shall be considered 

3 advertising regulated under this Act. 

4 ‘‘(3) NO IMPLIED CLAIMS.—In any investiga5 tion commenced by the Commission and in any adju6 dicative proceeding in which the Commission is a 

7 party, the Commission shall not attribute to an ad8 vertiser accused of false advertisement any adver9 tising statement not actually made by that adver10 tiser. 

11 ‘‘(4) NOTICE, OPPORTUNITY TO CURE, AND

12 BURDEN OF PROOF FOR INVESTIGATION.—Before 

13 the Commission authorizes an investigation of false 

14 advertisement by an advertiser of a dietary supple15 ment or a dietary ingredient, the Commission shall 

16 send the advertiser a written ‘Notice of Suspected 

17 Violation and Opportunity to Cure’ informing the 

18 advertiser of— 

19 ‘‘(A) the precise advertising statement that 

20 the Commission suspects may be false or mis21 leading; 

22 ‘‘(B) the scientific basis for the Commis23 sion’s view that any statement of health benefit 

24 may be false or misleading; and 


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1 ‘‘(C) a date certain, not less than 30 days 

2 after the date of the advertiser’s receipt of the 

3 notice, by which the advertiser may voluntarily 

4 discontinue further use of the statement the 

5 Commission suspects may be false or mis6 leading and, upon so doing, the advertiser shall 

7 not be subject to an investigation of false adver8 tisement by the Commission for the statement. 

9 The Commission shall not commence any investiga10 tion of an advertiser of a dietary supplement or a di11 etary ingredient to determine whether the advertiser 

12 has disseminated a false advertisement unless it pos13 sesses before the commencement of such investiga14 tion clear and convincing evidence that the advertise15 ment is false and misleading. 

16 ‘‘(5) BURDEN OF PROOF FOR FALSE ADVER17 TISEMENT CASES.—In every proceeding before a 

18 court or the Commission in which an advertiser of 

19 a dietary supplement or a dietary ingredient is 

20 charged with false advertising, the burden of proof 

21 shall be on the Commission to establish by clear and 

22 convincing evidence that the advertisement is false, 

23 that the advertisement actually caused consumers to 

24 be misled into believing to be true that which is 

25 false, and that but for the false advertising content 


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1 the consumer would not have made the purchase at 

2 the price paid. If a claimed health benefit of a die3 tary supplement or dietary ingredient is alleged to 

4 be false advertising, the Commission must addition5 ally establish based on expert scientific opinion and 

6 published peer-reviewed scientific evidence that the 

7 claim is false. No order adverse to the advertiser 

8 shall be entered except upon the Commission satis9 fying this burden of proof.’’. 

Æ 


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