< Back to H.R. 3394 (111th Congress, 2009–2010)

Text of the Freedom of Health Speech Act

This bill was introduced on July 29, 2009, in a previous session of Congress, but was not enacted. The text of the bill below is as of Jul 29, 2009 (Introduced).

Source: GPO

I

111th CONGRESS

1st Session

H. R. 3394

IN THE HOUSE OF REPRESENTATIVES

July 29, 2009

(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.

Short title

This Act may be cited as the Freedom of Health Speech Act.

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:

(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 intended to be included in, a dietary supplement.

(2)

Exemptions from regulation as advertising

No content of any publication shall be considered advertising regulable under this Act unless the content is intended by the seller of a product to promote the sale of that product and the content 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 content excerpted in whole or part from a peer-reviewed scientific publication shall be considered advertising regulable under this Act.

(3)

No implied claims

In any investigation commenced by the Commission and in any adjudicative proceeding in which the Commission is a party, the Commission shall not attribute to an advertiser accused of false advertisement any advertising statement not actually made by that advertiser.

(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 supplement 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 misleading;

(B)

the scientific basis for the Commission’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 Commission suspects may be false or misleading and, upon so doing, the advertiser shall not be subject to an investigation of false advertisement by the Commission for the statement.

The Commission shall not commence any investigation of an advertiser of a dietary supplement or a dietary ingredient to determine whether the advertiser has disseminated a false advertisement unless it possesses before the commencement of such investigation clear and convincing evidence that the advertisement is false and misleading.
(5)

Burden of proof for false advertisement 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 dietary supplement or dietary ingredient is alleged to be false advertising, the Commission must additionally 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 satisfying this burden of proof.

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