<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="H7F85552014154E8AB4B74F1C1DFDF9F2" public-private="public">
	<form>
		<distribution-code display="yes">I</distribution-code>
		<congress>111th CONGRESS</congress>
		<session>1st Session</session>
		<legis-num>H. R. 3394</legis-num>
		<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
		<action>
			<action-date date="20090729">July 29, 2009</action-date>
			<action-desc><sponsor name-id="P000583">Mr. Paul</sponsor> (for himself
			 and <cosponsor name-id="B001149">Mr. Burton of Indiana</cosponsor>) introduced
			 the following bill; which was referred to the
			 <committee-name committee-id="HIF00">Committee on Energy and
			 Commerce</committee-name></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>To amend the Federal Trade Commission Act concerning the
		  burden of proof in false advertising cases involving dietary supplements and
		  dietary ingredients.</official-title>
	</form>
	<legis-body id="H43CE7F2EBBCB4D7391E834C17612DE6E" style="OLC">
		<section id="H82F99ECC073E446D8812034E07CEFC11" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the
			 <quote><short-title>Freedom of Health Speech Act</short-title></quote>.</text>
		</section><section id="HF3C14416C3A149BA90527E67168F9E10"><enum>2.</enum><header>Health
			 information</header><text display-inline="no-display-inline">Section 5 of the
			 Federal Trade Commission Act (15 U.S.C. 45) is amended by adding at the end the
			 following:</text>
			<quoted-block display-inline="no-display-inline" id="H0F255659205C4B27B35A7C0446462E15" style="OLC">
				<subsection id="H9CCAC1252A504975B727EF43DE0FD50D"><enum>(o)</enum><header>Advertising of
				Dietary Supplements and Dietary Ingredients</header>
					<paragraph id="HB17B472FEC3B4BECBAEC7ADA1A3DC686"><enum>(1)</enum><header>Definitions</header><text>In
				this subsection—</text>
						<subparagraph id="HC5CCC53707E043C3AF0AB190FDC0608F"><enum>(A)</enum><text>the term
				<term>dietary supplement</term> 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</text>
						</subparagraph><subparagraph id="HCEE42A1F842841B1B862BF69B21110F7"><enum>(B)</enum><text>the term
				<term>dietary ingredient</term> 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.</text>
						</subparagraph></paragraph><paragraph id="H8A3F22FD25E74DDA92850DEBCE8F1E5F"><enum>(2)</enum><header>Exemptions from
				regulation as advertising</header><text display-inline="yes-display-inline">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.</text>
					</paragraph><paragraph id="HAF13169EA54C4DCAB9C15B3A20BBBDC2"><enum>(3)</enum><header>No implied
				claims</header><text>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.</text>
					</paragraph><paragraph id="H721A5749F7FC40A996A0114E26C8F686"><enum>(4)</enum><header>Notice,
				opportunity to cure, and burden of proof for investigation</header><text display-inline="yes-display-inline">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
				<quote>Notice of Suspected Violation and Opportunity to Cure</quote> informing
				the advertiser of—</text>
						<subparagraph id="HB361EE4D98D5403594826BD1A54EB14C"><enum>(A)</enum><text>the precise
				advertising statement that the Commission suspects may be false or
				misleading;</text>
						</subparagraph><subparagraph id="HE803EABE883B416794D94D2B39517588"><enum>(B)</enum><text>the scientific
				basis for the Commission’s view that any statement of health benefit may be
				false or misleading; and</text>
						</subparagraph><subparagraph id="H517E3FC99FBB4E79AAD3FB218DB8763D"><enum>(C)</enum><text>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.</text>
						</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph id="H2D327CEB8D214C43B483E7B9A55E497A"><enum>(5)</enum><header>Burden of proof
				for false advertisement cases</header><text>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.</text>
					</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
		</section></legis-body>
</bill>
