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. 
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 ‘‘Freedom of Health 
Speech Act’’. 
SEC. 2. HEALTH INFORMATION. 
Section 5 of the Federal Trade Commission Act (15 
U.S.C. 45) is amended by adding at the end the following: 
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‘‘(o) ADVERTISING OF DIETARY SUPPLEMENTS AND 
DIETARY INGREDIENTS.— 
‘‘(1) DEFINITIONS.—In this subsection— 
‘‘(A) the term ‘dietary supplement’ has the 
meaning given to that term in section 201(ff) 
(21 U.S.C. 321(ff)) of the Federal Food, Drug, 
and Cosmetic Act; and 
‘‘(B) the term ‘dietary ingredient’ means 
an ingredient listed in subparagraph (A) 
through (F) of section 201(ff)(1) (21 U.S.C. 
321(ff)(1)) of the Federal Food, Drug, and 
Cosmetic Act that is included in, or that is in-
tended to be included in, a dietary supplement. 
‘‘(2) EXEMPTIONS FROM REGULATION AS AD-
VERTISING.—No content of any publication shall be 
considered advertising regulable under this Act un-
less the content is intended by the seller of a prod-
uct to promote the sale of that product and the con-
tent includes (A) the name of the product offered for 
sale; (B) an express offer to sell the named product; 
and (C) a purchase price for the product. No con-
tent excerpted in whole or part from a peer-reviewed 
scientific publication shall be considered advertising 
regulable under this Act. 
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‘‘(3) NO IMPLIED CLAIMS.—In any investiga-
tion commenced by the Commission and in any adju-
dicative proceeding in which the Commission is a 
party, the Commission shall not attribute to an ad-
vertiser accused of false advertisement any adver-
tising statement not actually made by that adver-
tiser. 
‘‘(4) NOTICE, OPPORTUNITY
TO
CURE, AND 
BURDEN
OF
PROOF
FOR
INVESTIGATION.—Before 
the Commission authorizes an investigation of false 
advertisement by an advertiser of a dietary supple-
ment or a dietary ingredient, the Commission shall 
send the advertiser a written ‘Notice of Suspected 
Violation and Opportunity to Cure’ informing the 
advertiser of— 
‘‘(A) the precise advertising statement that 
the Commission suspects may be false or mis-
leading; 
‘‘(B) the scientific basis for the Commis-
sion’s view that any statement of health benefit 
may be false or misleading; and 
‘‘(C) a date certain, not less than 30 days 
after the date of the advertiser’s receipt of the 
notice, by which the advertiser may voluntarily 
discontinue further use of the statement the 
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Commission suspects may be false or mis-
leading and, upon so doing, the advertiser shall 
not be subject to an investigation of false adver-
tisement by the Commission for the statement. 
The Commission shall not commence any investiga-
tion of an advertiser of a dietary supplement or a di-
etary ingredient to determine whether the advertiser 
has disseminated a false advertisement unless it pos-
sesses before the commencement of such investiga-
tion clear and convincing evidence that the advertise-
ment is false and misleading. 
‘‘(5) BURDEN OF PROOF FOR FALSE ADVER-
TISEMENT
CASES.—In every proceeding before a 
court or the Commission in which an advertiser of 
a dietary supplement or a dietary ingredient is 
charged with false advertising, the burden of proof 
shall be on the Commission to establish by clear and 
convincing evidence that the advertisement is false, 
that the advertisement actually caused consumers to 
be misled into believing to be true that which is 
false, and that but for the false advertising content 
the consumer would not have made the purchase at 
the price paid. If a claimed health benefit of a die-
tary supplement or dietary ingredient is alleged to 
be false advertising, the Commission must addition-
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ally establish based on expert scientific opinion and 
published peer-reviewed scientific evidence that the 
claim is false. No order adverse to the advertiser 
shall be entered except upon the Commission satis-
fying this burden of proof.’’. 
Æ 
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