I 

111TH CONGRESS 

1ST SESSION H. R. 3394 

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 

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 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: 

mstockstill on DSKH9S0YB1PROD with BILLS

2 

•HR 3394 IH

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 subparagraph (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 regulable 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 (A) the name of the product offered for 

20 sale; (B) an express offer to sell the named product; 

21 and (C) a purchase price for the product. No con22 tent excerpted in whole or part from a peer-reviewed 

23 scientific publication shall be considered advertising 

24 regulable under this Act. 

mstockstill on DSKH9S0YB1PROD with BILLS

3 

•HR 3394 IH

1 ‘‘(3) NO IMPLIED CLAIMS.—In any investiga2 tion commenced by the Commission and in any adju3 dicative proceeding in which the Commission is a 

4 party, the Commission shall not attribute to an ad5 vertiser accused of false advertisement any adver6 tising statement not actually made by that adver7 tiser. 

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

9 BURDEN OF PROOF FOR INVESTIGATION.—Before 

10 the Commission authorizes an investigation of false 

11 advertisement by an advertiser of a dietary supple12 ment or a dietary ingredient, the Commission shall 

13 send the advertiser a written ‘Notice of Suspected 

14 Violation and Opportunity to Cure’ informing the 

15 advertiser of— 

16 ‘‘(A) the precise advertising statement that 

17 the Commission suspects may be false or mis18 leading; 

19 ‘‘(B) the scientific basis for the Commis20 sion’s view that any statement of health benefit 

21 may be false or misleading; and 

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

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

24 notice, by which the advertiser may voluntarily 

25 discontinue further use of the statement the 

mstockstill on DSKH9S0YB1PROD with BILLS

4 

•HR 3394 IH

1 Commission suspects may be false or mis2 leading and, upon so doing, the advertiser shall 

3 not be subject to an investigation of false adver4 tisement by the Commission for the statement. 

5 The Commission shall not commence any investiga6 tion of an advertiser of a dietary supplement or a di7 etary ingredient to determine whether the advertiser 

8 has disseminated a false advertisement unless it pos9 sesses before the commencement of such investiga10 tion clear and convincing evidence that the advertise11 ment is false and misleading. 

12 ‘‘(5) BURDEN OF PROOF FOR FALSE ADVER13 TISEMENT CASES.—In every proceeding before a 

14 court or the Commission in which an advertiser of 

15 a dietary supplement or a dietary ingredient is 

16 charged with false advertising, the burden of proof 

17 shall be on the Commission to establish by clear and 

18 convincing evidence that the advertisement is false, 

19 that the advertisement actually caused consumers to 

20 be misled into believing to be true that which is 

21 false, and that but for the false advertising content 

22 the consumer would not have made the purchase at 

23 the price paid. If a claimed health benefit of a die24 tary supplement or dietary ingredient is alleged to 

25 be false advertising, the Commission must additionmstockstill on DSKH9S0YB1PROD with BILLS

5 

•HR 3394 IH

1 ally establish based on expert scientific opinion and 

2 published peer-reviewed scientific evidence that the 

3 claim is false. No order adverse to the advertiser 

4 shall be entered except upon the Commission satis5 fying this burden of proof.’’. 

Æ 

mstockstill on DSKH9S0YB1PROD with BILLS