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<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="HCC048A7C5CA64D530058DF26E660E000" public-private="public">
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<dublinCore>
<dc:title>110 HR 7187 IH: LEAN Act of 2008</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2008-09-27</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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</metadata>
	<form>
		<distribution-code display="yes">I</distribution-code>
		<congress>110th CONGRESS</congress>
		<session>2d Session</session>
		<legis-num>H. R. 7187</legis-num>
		<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
		<action>
			<action-date date="20080927">September 27, 2008</action-date>
			<action-desc><sponsor name-id="M001142">Mr. Matheson</sponsor>
			 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 Food, Drug, and Cosmetic Act with
		  respect to nutrition labeling of food offered for sale in food service
		  establishments.</official-title>
	</form>
	<legis-body id="H05D17E58A16C4FB2BC99FE659145FF73" style="OLC">
		<section id="H33DE81BDD7E640AD8E85E952C73D3101" section-type="section-one"><enum>1.</enum><header>Short title; table of
			 contents</header>
			<subsection id="H3FB0AEC49F934D37B1D39E8C72968C55"><enum>(a)</enum><header>Short
			 title</header><text display-inline="yes-display-inline">This Act may be cited
			 as the <quote><short-title>Labeling Education and
			 Nutrition Act of 2008</short-title></quote> or the <quote><short-title>LEAN Act of 2008</short-title></quote>.</text>
			</subsection><subsection id="H2F3AAA07BE304A7EA71E3434D72DE0F1"><enum>(b)</enum><header>Table of
			 contents</header><text>The table of contents of this Act is as follows:</text>
				<toc>
					<toc-entry idref="H33DE81BDD7E640AD8E85E952C73D3101" level="section">Sec. 1. Short title; table of contents.</toc-entry>
					<toc-entry idref="HF02E9EE31D8942E8BD1117008BADD058" level="section">Sec. 2. Findings.</toc-entry>
					<toc-entry idref="HBE702466544B43D1B23BC0910248284" level="section">Sec. 3. Definitions.</toc-entry>
					<toc-entry idref="H658E685FB6AD4C95A45F4602A2CAA38" level="section">Sec. 4. Nutrition labeling exemption.</toc-entry>
					<toc-entry idref="H1E8666D9603241D498C4295165EAF66F" level="section">Sec. 5. Voluntary nutrition labeling.</toc-entry>
					<toc-entry idref="HD86772227D214C3EBFD8E56D8805D9F9" level="section">Sec. 6. Mandatory nutrition labeling.</toc-entry>
					<toc-entry idref="HB8EB7141A12C483F90B3CB8B93495E9B" level="section">Sec. 7. National uniformity.</toc-entry>
					<toc-entry idref="HC66FCA378A514AA199A7000156FC4D08" level="section">Sec. 8. Implementing regulations.</toc-entry>
					<toc-entry idref="H573DC941F3004BC890B400B61296EB9B" level="section">Sec. 9. Effective dates.</toc-entry>
					<toc-entry idref="H749FF585279F48DC9855C23040DC8FCC" level="section">Sec. 10. Technical and conforming amendments.</toc-entry>
				</toc>
			</subsection></section><section id="HF02E9EE31D8942E8BD1117008BADD058"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds that—</text>
			<paragraph id="H18111BBE3B0F4FC4A4BCB0CC00C64430"><enum>(1)</enum><text>a
			 healthy lifestyle includes a balanced diet as well as physical activity;</text>
			</paragraph><paragraph id="HB2B494B213624779A08F80276D00B260"><enum>(2)</enum><text>approximately more
			 than 60 percent of American adults and 30 percent of American children suffer
			 from being overweight and obese, which can lead to many chronic health risks,
			 including diabetes, heart disease, and hypertension;</text>
			</paragraph><paragraph id="HA71636A3853442F295FB59DD26CF3148"><enum>(3)</enum><text>the United States
			 ranks last in reducing the number of preventable deaths resulting from
			 obesity-related chronic illnesses;</text>
			</paragraph><paragraph id="H05533D3667E0475686D1BCEC27F907A0"><enum>(4)</enum><text>during the
			 2-decade period preceding the date of enactment of this Act, there has been a
			 significant increase in the number of meals prepared or eaten outside the
			 home;</text>
			</paragraph><paragraph id="H08EBED25B0FC4415ABFB7919CF00346C"><enum>(5)</enum><text>nutrition labeling
			 pursuant to the Nutrition Labeling and Education Act of 1990 has increased
			 significantly American consumers' access to nutrition information regarding the
			 foods they consume;</text>
			</paragraph><paragraph id="H395E78409C424B84808C7386008C7F77"><enum>(6)</enum><text>the Department of
			 Agriculture and leading health groups recognize that many individuals require
			 different information based on individual and specific health needs and
			 risks;</text>
			</paragraph><paragraph id="HE1B230BF8CA54238BE9C1114CFCA6792"><enum>(7)</enum><text>the nutrients
			 provided pursuant to the Nutrition Labeling and Education Act of 1990 provides
			 consumers with all the tools needed to make healthy choices;</text>
			</paragraph><paragraph id="HB224ED97651243A3857CAD2CB3913E4C"><enum>(8)</enum><text>as of 2008,
			 nutrition information for standard food items is voluntarily provided by
			 various delivery methods at many major chains of food service
			 establishments;</text>
			</paragraph><paragraph id="H8FE1C907C9F842EF81B3006087FBE424"><enum>(9)</enum><text>the nutrient
			 content of a food offered for sale in a food service establishment can be
			 determined with appropriate accuracy by consulting nutrient databases,
			 cookbooks, laboratory analyses, or other sources that provide a reasonable
			 basis for information regarding the nutrient content of a food, notwithstanding
			 variability in the portion size, formulation, and other characteristics of such
			 food or its preparation method; and</text>
			</paragraph><paragraph id="HF88A95D5A8764FFB9E9BA68865092284"><enum>(10)</enum><text>public health and
			 welfare are advanced if food service establishment nutrition information is not
			 subject to frivolous litigation.</text>
			</paragraph></section><section id="HBE702466544B43D1B23BC0910248284"><enum>3.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 403(q) of the Federal Food, Drug,
			 and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)</external-xref>) is amended by adding at the end the
			 following:</text>
			<quoted-block display-inline="no-display-inline" id="HE1FE5994FA8843399753B01225C3F4B5" style="OLC">
				<paragraph id="H65200734CA224364A2B1B4FA45100D9"><enum>(6)</enum><header>Definitions</header><text>For
				purposes of subparagraphs (7) and (8):</text>
					<subparagraph id="H9B40F5F1CC324F08AF098D8E000130E4"><enum>(A)</enum><text>The term
				<term>standard food item</term> means a food offered for sale at least 90 days
				per calendar year, but does not include food not separately offered for sale or
				food exempt under subparagraph (5)(C).</text>
					</subparagraph><subparagraph id="H1A5A2F5AD450497FB0CC9EC9BD7E5442"><enum>(B)</enum><text>The term
				<term>menu</term> or <term>menu board</term> means the primary writing on the
				premises of the food service establishment from which consumers make their
				order selection.</text>
					</subparagraph><subparagraph id="HDA878619EBDE4C2B896000D24EF870A8"><enum>(C)</enum><text>The term
				<term>reasonable basis</term> means any means of determining nutrition
				information for a standard food item made without an intent to deceive,
				including nutrient databases, cookbooks, laboratory analyses, and other
				reasonable means.</text>
					</subparagraph><subparagraph id="HE4E3D3DA9CB7495991683BAA412EE617"><enum>(D)</enum><text>The term
				<term>food service establishment</term> means an establishment that offers for
				sale food described in subclause (i) or (ii) of subparagraph
				(5)(A).</text>
					</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
		</section><section id="H658E685FB6AD4C95A45F4602A2CAA38"><enum>4.</enum><header>Nutrition labeling
			 exemption</header><text display-inline="no-display-inline">Section 403(q)(5)(A)
			 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(5)(A)</external-xref>) is
			 amended—</text>
			<paragraph id="H44831CB555DA400CAC4BB1B538006285"><enum>(1)</enum><text>by adding at the
			 end of subclause (i) the following: <quote>except that such food shall not be
			 considered exempt under this subclause for purposes of providing nutrition
			 information under subparagraph (7) or (8).</quote>; and</text>
			</paragraph><paragraph id="H4291C799522042389B381DFFAFE1C1EF"><enum>(2)</enum><text>by adding at the
			 end of subclause (ii) the following: <quote>except that such food shall not be
			 considered exempt under this subclause for purposes of providing nutrition
			 information under subparagraph (7) or (8).</quote>.</text>
			</paragraph></section><section id="H1E8666D9603241D498C4295165EAF66F"><enum>5.</enum><header>Voluntary
			 nutrition labeling</header><text display-inline="no-display-inline">Section
			 403(q) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)</external-xref>), as
			 amended by section 3, is further amended by adding at the end the
			 following:</text>
			<quoted-block display-inline="no-display-inline" id="H953FA36ED6C24A638B62932564865196" style="OLC">
				<paragraph id="H50C874DB21614E77A9DF1217E7298723"><enum>(7)</enum><header>Voluntary
				nutrition labeling of food service establishment food</header><text>A food
				service establishment may provide nutrition information for a food item under
				this subparagraph by meeting the following requirements:</text>
					<subparagraph id="HE8794270F2B142A6900054696E8600AC"><enum>(A)</enum><text>Providing
				nutrition information for all of the nutrients required by subparagraphs (1)(C)
				and (1)(D), determined with a reasonable basis.</text>
					</subparagraph><subparagraph id="HD9BF474338834247B7D3A467BDB85C47"><enum>(B)</enum><text>Disclosing such
				information in written form on the premises of the food service
				establishment.</text>
					</subparagraph><subparagraph id="HD8FFC61BAC93440700425D3E562C2F2B"><enum>(C)</enum><text>Making such
				disclosure available upon request prior to
				purchase.</text>
					</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
		</section><section id="HD86772227D214C3EBFD8E56D8805D9F9"><enum>6.</enum><header>Mandatory
			 nutrition labeling</header><text display-inline="no-display-inline">Section
			 403(q) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)</external-xref>), as
			 amended by section 5, is further amended by adding at the end the
			 following:</text>
			<quoted-block display-inline="no-display-inline" id="H72D193D5175645B8A2405E003F9200C8" style="OLC">
				<paragraph id="H5923461BA13545C59E29268F46590071"><enum>(8)</enum><header>In
				general</header><text>The labeling of a standard food item served or offered
				for sale in a food service establishment that is part of a chain that operates
				20 or more establishments under the same trade name (regardless of the type of
				ownership of the establishments) shall, except as provided in clause (E),
				disclose, in a clear and conspicuous manner in accordance with paragraph (f),
				the following information, determined with a reasonable basis, as
				follows:</text>
					<subparagraph id="H42717B5F1FE74796ACDA18E84D492124"><enum>(A)</enum><header>Disclosure of
				calories</header>
						<clause id="H344D2ACC2A9A4B29888D6CC43251CDEE"><enum>(i)</enum><header>Calories on the
				menu board</header><text>The number of calories shall be disclosed prior to the
				point of purchase by one of the following means:</text>
							<subclause id="H6693D52E278D448F8D19D4BFE9641B79"><enum>(I)</enum><text>On the menu
				board.</text>
							</subclause><subclause id="H1BD184E34FC745BA9619004FDFF283EF"><enum>(II)</enum><text>On a sign
				presenting standard food items in a manner similar to the menu board and
				located on the same wall as the menu board.</text>
							</subclause><subclause id="H4ACEA3EFA60940DA8DFB9EEB576BC5CE"><enum>(III)</enum><text>On a sign at eye
				level in the consumer queue prior to the point of purchase.</text>
							</subclause></clause><clause id="HB65A207D2A93401A9864D8F03D63273"><enum>(ii)</enum><header>Calories on the
				menu</header><text>The number of calories shall be disclosed prior to the point
				of purchase by one of the following means:</text>
							<subclause id="HC1FECB2369D8400389A8B0433FFA7261"><enum>(I)</enum><text>In the
				menu.</text>
							</subclause><subclause id="H0C817FAC906C478B876BAB5F315304F5"><enum>(II)</enum><text>In an insert that
				accompanies the menu.</text>
							</subclause><subclause id="H2BF4AFDD139E4F15A165DA310030F557"><enum>(III)</enum><text>In an appendix
				that is attached to the back of the menu.</text>
							</subclause><subclause id="H0C6B2E8955C044049B75C526BD92FB07"><enum>(IV)</enum><text>In a supplemental
				menu that accompanies the menu.</text>
							</subclause></clause></subparagraph><subparagraph id="H1381B797091A46928F00F4895DB47B72"><enum>(B)</enum><header>Additional
				nutrition information</header><text>The nutrition information for all nutrients
				required by subparagraphs (1)(C) and (1)(D) shall be located on the premises of
				the food service establishment, in writing, and available to the consumer upon
				request prior to the point of purchase.</text>
					</subparagraph><subparagraph id="HA34AD3306DAA4A74B2A4C96CFC7C5E58"><enum>(C)</enum><header>Referral
				statement</header><text>A menu, menu board, or other writing prior to the point
				of purchase shall bear a statement directing the consumer to the availability
				of additional nutrition information required under clause (B).</text>
					</subparagraph><subparagraph id="HF5E1B724AE4C4C8B98CE0749C1D66D2"><enum>(D)</enum><header>Calorie
				information statement</header><text>If calories are not listed directly on a
				menu or menu board pursuant to subclause (i)(I), (i)(II), or (ii)(I) of clause
				(A), then the menu or menu board shall state the suggested daily caloric intake
				as 2000 calories or an alternative statement prescribed by the Secretary
				through guidance.</text>
					</subparagraph><subparagraph id="H7F9A058BD19345CFB7DBD22EE47C04D5"><enum>(E)</enum><header>Applicability</header><text>This
				subparagraph shall not apply to—</text>
						<clause id="HBC535A58108E48C98CCF989840AA26D0"><enum>(i)</enum><text>food offered for
				sale in a nonprofit food service establishment;</text>
						</clause><clause id="HED38DE5C66A14544B3C1C372C83DB21B"><enum>(ii)</enum><text>food that is not
				food described in subclause (i) or (ii) of subparagraph (5)(A); and</text>
						</clause><clause id="HCE38F9C8D57A456A8B255BA432232FEE"><enum>(iii)</enum><text>such other food
				as the Secretary may exempt by regulation.</text>
						</clause></subparagraph><subparagraph id="H20F5ED688ABC44D600F677C205F1B654"><enum>(F)</enum><header>Violations</header><text>A
				person shall have knowingly or willfully violated the requirements of this
				paragraph if the person—</text>
						<clause id="H8ABDECE33DD04C42ABF7D0136CB950B0"><enum>(i)</enum><text>purposefully
				failed to make a disclosure required by this paragraph; or</text>
						</clause><clause id="H921DDA9D83AF439E8DF1EE0955FB64"><enum>(ii)</enum><text>made a disclosure
				under this paragraph with an intent to deceive.</text>
						</clause></subparagraph><subparagraph id="HAAB7B396BA924FBFACEF50F3B832C8D"><enum>(G)</enum><header>One determination
				per item</header><text>A reasonable basis determination of nutrition
				information shall be required only once per standard food item if the portion
				size is reasonably consistent and the food service establishment follows a
				standardized recipe and trains to a consistent method of
				preparation.</text>
					</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
		</section><section id="HB8EB7141A12C483F90B3CB8B93495E9B"><enum>7.</enum><header>National
			 uniformity</header><text display-inline="no-display-inline">Section 403A(a)(4)
			 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343-1">21 U.S.C. 343–1(a)(4)</external-xref>) is amended
			 to read as follows:</text>
			<quoted-block display-inline="no-display-inline" id="H4527B28E510A4873819B24CA732CFDDB" style="OLC">
				<paragraph id="HBBB4671B838D478F9903CBF3A1B6C455"><enum>(4)</enum><text>any requirement
				for nutrition labeling of food that is not identical to the requirement of
				section 403(q), except a requirement for nutrition labeling of food which is
				exempt under subclause (i) or (ii) of section 403(q)(5)(A), other than food
				served in an establishment that is not part of a chain that operates twenty or
				more establishments under the same trade name,
				or</text>
				</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
		</section><section id="HC66FCA378A514AA199A7000156FC4D08"><enum>8.</enum><header>Implementing
			 regulations</header><text display-inline="no-display-inline">The Secretary of
			 Health and Human Services (referred to in this section as the
			 <quote>Secretary</quote>) shall carry out the following:</text>
			<paragraph id="HBEC40F59B73D44BA95FEF2A3C6839679"><enum>(1)</enum><text display-inline="yes-display-inline">Not later than 1 year after the date of
			 enactment of this Act, the Secretary shall promulgate proposed regulations to
			 mandate nutrition labeling of food service establishment food in accordance
			 with section 403(q)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
			 343(q)(8)) (as added by section 6).</text>
			</paragraph><paragraph id="H7EE2AEA3E02A4F8F9C3744DE9D7FB376"><enum>(2)</enum><text>Not later than 2
			 years after the date of enactment of this Act, the Secretary shall promulgate
			 final regulations to mandate nutrition labeling of food service establishment
			 food in accordance with section 403(q)(8) of the Federal Food, Drug, and
			 Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(8)</external-xref>) (as added by section 6).</text>
			</paragraph><paragraph id="H88FA08BD0B8A4ACBB8E684F1974D7CE3"><enum>(3)</enum><text>If the Secretary
			 determines that a nutrient other than a nutrient required by section 403(q)(8)
			 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(8)</external-xref>) should be
			 included in the labeling of food menu items subject to such section 403(q)(8)
			 for purposes of providing information regarding the nutritional value of such
			 food that will assist consumers in maintaining healthy dietary practices, the
			 Secretary may by regulation require that information relating to such an
			 additional nutrient be included in the labeling of such food items.</text>
			</paragraph><paragraph id="H9424B552A32C4109844D28CF49BD3000"><enum>(4)</enum><text>If the Secretary
			 determines that the information relating to a nutrient required by section
			 403(q)(8) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(8)</external-xref>) or
			 paragraph (3) of this section to be included in the labeling of food menu items
			 is not necessary to assist consumers in maintaining healthy dietary practices,
			 the Secretary may by regulation strike the requirement to include such
			 information relating to such nutrient.</text>
			</paragraph><paragraph id="H3524D340FDDC4C1AB4F120A08021A4C0"><enum>(5)</enum><text>The Secretary may
			 prescribe by regulation alternative clear and conspicuous means of meeting the
			 requirements of section 403(q)(8)(A) of the Federal Food, Drug, and Cosmetic
			 Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(8)(A)</external-xref>) (as added by section 6).</text>
			</paragraph></section><section id="H573DC941F3004BC890B400B61296EB9B"><enum>9.</enum><header>Effective
			 dates</header><text display-inline="no-display-inline">The amendments made by
			 this Act shall take effect on the date of enactment of this Act, except that
			 the amendment made by section 6 shall take effect 180 days after the Secretary
			 of Health and Human Services promulgates final regulations under section
			 8(2).</text>
		</section><section id="H749FF585279F48DC9855C23040DC8FCC"><enum>10.</enum><header>Technical and
			 conforming amendments</header>
			<subsection id="H1D31E91692D84138BD72BD4BE1D93BA5"><enum>(a)</enum><text display-inline="yes-display-inline">Section 403(q)(1) of the Federal Food,
			 Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(1)</external-xref>) is amended by striking
			 <quote>subparagraphs (3), (4), and (5)</quote> and inserting
			 <quote>subparagraphs (3), (4), (5), (7), and (8).</quote></text>
			</subsection><subsection id="H040B965E019F494396EAEA5C9FBBEF95"><enum>(b)</enum><text display-inline="yes-display-inline">Section 403(q)(5)(G) of the Federal Food,
			 Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(5)(G)</external-xref>) is amended by striking
			 <quote>Subparagraphs (1), (2), (3) and (4)</quote> and inserting
			 <quote>Subparagraphs (1), (2), (3), (4), (7) and (8).</quote></text>
			</subsection></section></legis-body>
</bill>


