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<dc:title>108 HR 2339 RH: Reversing the Youth Tobacco Epidemic Act of 2019</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2020-02-21</dc:date>
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<dc:language>EN</dc:language>
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<distribution-code display="yes">IB</distribution-code><calendar display="yes">Union Calendar No. 324</calendar><congress display="yes">116th CONGRESS</congress><session display="yes">2d Session</session><legis-num display="yes">H. R. 2339</legis-num><associated-doc role="report" display="yes">[Report No. 116–402]</associated-doc><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20190418">April 18, 2019</action-date><action-desc><sponsor name-id="P000034">Mr. Pallone</sponsor> (for himself and <cosponsor name-id="S001206">Ms. Shalala</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><action display="yes"><action-date date="20200221">February 21, 2020</action-date><action-desc>Additional sponsors: <cosponsor name-id="R000515">Mr. Rush</cosponsor>, <cosponsor name-id="L000551">Ms. Lee of California</cosponsor>, <cosponsor name-id="S001168">Mr. Sarbanes</cosponsor>, <cosponsor name-id="U000040">Ms. Underwood</cosponsor>, <cosponsor name-id="B001303">Ms. Blunt Rochester</cosponsor>, <cosponsor name-id="M001207">Ms. Mucarsel-Powell</cosponsor>, <cosponsor name-id="S001145">Ms. Schakowsky</cosponsor>, <cosponsor name-id="N000191">Mr. Neguse</cosponsor>, <cosponsor name-id="Q000023">Mr. Quigley</cosponsor>, <cosponsor name-id="S001201">Mr. Suozzi</cosponsor>, <cosponsor name-id="R000577">Mr. Ryan</cosponsor>, <cosponsor name-id="R000606">Mr. Raskin</cosponsor>, <cosponsor name-id="T000469">Mr. Tonko</cosponsor>, <cosponsor name-id="C001068">Mr. Cohen</cosponsor>, <cosponsor name-id="E000179">Mr. Engel</cosponsor>, <cosponsor name-id="S001185">Ms. Sewell of Alabama</cosponsor>, <cosponsor name-id="K000379">Mr. Kennedy</cosponsor>, <cosponsor name-id="P000597">Ms. Pingree</cosponsor>, <cosponsor name-id="W000797">Ms. Wasserman Schultz</cosponsor>, <cosponsor name-id="L000560">Mr. Larsen of Washington</cosponsor>, <cosponsor name-id="C000984">Mr. Cummings</cosponsor>, <cosponsor name-id="N000147">Ms. Norton</cosponsor>, <cosponsor name-id="L000582">Mr. Ted Lieu of California</cosponsor>, <cosponsor name-id="C001119">Ms. Craig</cosponsor>, <cosponsor name-id="K000210">Mr. King of New York</cosponsor>, <cosponsor name-id="L000480">Mrs. Lowey</cosponsor>, <cosponsor name-id="L000287">Mr. Lewis</cosponsor>, <cosponsor name-id="M001143">Ms. McCollum</cosponsor>, <cosponsor name-id="W000822">Mrs. Watson Coleman</cosponsor>, <cosponsor name-id="H001087">Ms. Hill of California</cosponsor>, <cosponsor name-id="C001124">Mr. Cox of California</cosponsor>, <cosponsor name-id="T000481">Ms. Tlaib</cosponsor>, <cosponsor name-id="S001216">Ms. Schrier</cosponsor>, <cosponsor name-id="H000324">Mr. Hastings</cosponsor>, <cosponsor name-id="K000368">Mrs. Kirkpatrick</cosponsor>, <cosponsor name-id="R000486">Ms. Roybal-Allard</cosponsor>, <cosponsor name-id="K000381">Mr. Kilmer</cosponsor>, <cosponsor name-id="S001215">Ms. Stevens</cosponsor>, <cosponsor name-id="D000624">Mrs. Dingell</cosponsor>, <cosponsor name-id="K000382">Ms. Kuster of New Hampshire</cosponsor>, <cosponsor name-id="T000193">Mr. Thompson of Mississippi</cosponsor>, <cosponsor name-id="P000614">Mr. Pappas</cosponsor>, <cosponsor name-id="D000610">Mr. Deutch</cosponsor>, <cosponsor name-id="B001285">Ms. Brownley of California</cosponsor>, <cosponsor name-id="F000454">Mr. Foster</cosponsor>, <cosponsor name-id="H001064">Mr. Heck</cosponsor>, <cosponsor name-id="R000616">Mr. Rouda</cosponsor>, <cosponsor name-id="N000179">Mrs. Napolitano</cosponsor>, <cosponsor name-id="K000391">Mr. Krishnamoorthi</cosponsor>, <cosponsor name-id="P000607">Mr. Pocan</cosponsor>, <cosponsor name-id="D000096">Mr. Danny K. Davis of Illinois</cosponsor>, <cosponsor name-id="L000593">Mr. Levin of California</cosponsor>, <cosponsor name-id="C001123">Mr. Cisneros</cosponsor>, <cosponsor name-id="D000598">Mrs. Davis of California</cosponsor>, <cosponsor name-id="M001188">Ms. Meng</cosponsor>, <cosponsor name-id="G000583">Mr. Gottheimer</cosponsor>, <cosponsor name-id="L000586">Mr. Lawson of Florida</cosponsor>, <cosponsor name-id="J000126">Ms. Johnson of Texas</cosponsor>, <cosponsor name-id="P000617">Ms. Pressley</cosponsor>, <cosponsor name-id="B001300">Ms. Barragán</cosponsor>, <cosponsor name-id="P000610">Ms. Plaskett</cosponsor>, <cosponsor name-id="C001090">Mr. Cartwright</cosponsor>, <cosponsor name-id="K000385">Ms. Kelly of Illinois</cosponsor>, <cosponsor name-id="R000613">Mr. Rose of New York</cosponsor>, <cosponsor name-id="K000394">Mr. Kim</cosponsor>, <cosponsor name-id="P000604">Mr. Payne</cosponsor>, <cosponsor name-id="C001055">Mr. Case</cosponsor>, <cosponsor name-id="H001081">Mrs. Hayes</cosponsor>, <cosponsor name-id="N000188">Mr. Norcross</cosponsor>, <cosponsor name-id="L000559">Mr. Langevin</cosponsor>, <cosponsor name-id="M001163">Ms. Matsui</cosponsor>, <cosponsor name-id="R000599">Mr. Ruiz</cosponsor>, <cosponsor name-id="H001068">Mr. Huffman</cosponsor>, <cosponsor name-id="D000627">Mrs. Demings</cosponsor>, <cosponsor name-id="K000380">Mr. Kildee</cosponsor>, <cosponsor name-id="H001085">Ms. Houlahan</cosponsor>, <cosponsor name-id="D000623">Mr. DeSaulnier</cosponsor>, <cosponsor name-id="B001287">Mr. Bera</cosponsor>, <cosponsor name-id="L000581">Mrs. Lawrence</cosponsor>, <cosponsor name-id="T000472">Mr. Takano</cosponsor>, <cosponsor name-id="K000389">Mr. Khanna</cosponsor>, <cosponsor name-id="M001166">Mr. McNerney</cosponsor>, <cosponsor name-id="L000570">Mr. Luján</cosponsor>, <cosponsor name-id="G000586">Mr. García of Illinois</cosponsor>, <cosponsor name-id="S001200">Mr. Soto</cosponsor>, <cosponsor name-id="B000574">Mr. Blumenauer</cosponsor>, <cosponsor name-id="C001080">Ms. Judy Chu of California</cosponsor>, <cosponsor name-id="D000631">Ms. Dean</cosponsor>, <cosponsor name-id="M001160">Ms. Moore</cosponsor>, <cosponsor name-id="L000397">Ms. Lofgren</cosponsor>, <cosponsor name-id="S001205">Ms. Scanlon</cosponsor>, <cosponsor name-id="G000551">Mr. Grijalva</cosponsor>, <cosponsor name-id="T000483">Mr. Trone</cosponsor>, <cosponsor name-id="P000618">Ms. Porter</cosponsor>, <cosponsor name-id="M001203">Mr. Malinowski</cosponsor>, <cosponsor name-id="C001117">Mr. Casten of Illinois</cosponsor>, <cosponsor name-id="S001156">Ms. Sánchez</cosponsor>, <cosponsor name-id="E000296">Mr. Evans</cosponsor>, <cosponsor name-id="C001091">Mr. Castro of Texas</cosponsor>, <cosponsor name-id="S001193">Mr. Swalwell of California</cosponsor>, <cosponsor name-id="B001281">Mrs. Beatty</cosponsor>, <cosponsor name-id="S001175">Ms. Speier</cosponsor>, <cosponsor name-id="B001278">Ms. Bonamici</cosponsor>, <cosponsor name-id="E000297">Mr. Espaillat</cosponsor>, <cosponsor name-id="S000248">Mr. Serrano</cosponsor>, <cosponsor name-id="S001208">Ms. Slotkin</cosponsor>, <cosponsor name-id="M001185">Mr. Sean Patrick Maloney of New York</cosponsor>, <cosponsor name-id="J000294">Mr. Jeffries</cosponsor>, <cosponsor name-id="M001208">Mrs. McBath</cosponsor>, <cosponsor name-id="R000602">Miss Rice of New York</cosponsor>, <cosponsor name-id="N000002">Mr. Nadler</cosponsor>, <cosponsor name-id="G000587">Ms. Garcia of Texas</cosponsor>, <cosponsor name-id="C001072">Mr. Carson of Indiana</cosponsor>, <cosponsor name-id="W000187">Ms. Waters</cosponsor>, <cosponsor name-id="G000585">Mr. Gomez</cosponsor>, <cosponsor name-id="H001080">Ms. Haaland</cosponsor>, <cosponsor name-id="T000460">Mr. Thompson of California</cosponsor>, <cosponsor name-id="L000557">Mr. Larson of Connecticut</cosponsor>, <cosponsor name-id="V000130">Mr. Vargas</cosponsor>, <cosponsor name-id="C001084">Mr. Cicilline</cosponsor>, <cosponsor name-id="F000466">Mr. Fitzpatrick</cosponsor>, <cosponsor name-id="C001049">Mr. Clay</cosponsor>, <cosponsor name-id="L000592">Mr. Levin of Michigan</cosponsor>, <cosponsor name-id="J000032">Ms. Jackson Lee</cosponsor>, and <cosponsor name-id="P000616">Mr. Phillips</cosponsor></action-desc></action><action display="yes"><action-date date="20200221">February 21, 2020</action-date><action-desc>Reported with an amendment; committed to the Committee of the Whole House on the State of the Union and ordered to be printed</action-desc><action-instruction>Strike out all after the enacting clause and insert the part printed in italic</action-instruction><action-instruction>For text of introduced bill, see copy of bill as introduced on April 18, 2019</action-instruction></action><legis-type>A BILL</legis-type><official-title display="yes">To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale and marketing of tobacco products, and for other purposes.<pagebreak></pagebreak></official-title></form><legis-body display-enacting-clause="yes-display-enacting-clause" changed="added" style="OLC" committee-id="HIF00" reported-display-style="italic" id="H8BCFC5A5B7094A51A3506F7183BAB770"><section id="HA6237C63C9724292AED7E13AD1C03249" 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>Reversing the Youth Tobacco Epidemic Act of 2019</short-title></quote>.</text></section><section id="HE0F766644D544982A2DCD11C239778E8"><enum>2.</enum><header>Table of contents</header><text display-inline="no-display-inline">The table of contents of this Act is as follows:</text><toc container-level="legis-body-container" lowest-bolded-level="division-lowest-bolded" lowest-level="section" quoted-block="no-quoted-block" regeneration="yes-regeneration" changed="added" reported-display-style="italic" committee-id="HIF00"><toc-entry idref="HA6237C63C9724292AED7E13AD1C03249" level="section">Sec. 1. Short title.</toc-entry><toc-entry idref="HE0F766644D544982A2DCD11C239778E8" level="section">Sec. 2. Table of contents.</toc-entry><toc-entry idref="H5521161E1B89435A9FC4849CF5B3D84E" level="title">Title I—Food and Drug Administration</toc-entry><toc-entry idref="H12F0DCE2EC76449585F7DC8CE6648797" level="section">Sec. 101. Cigarette graphic health warnings.</toc-entry><toc-entry idref="H31EEE455F2EA4E96ABE2234827B200EF" level="section">Sec. 102. Advertising and sales parity for all deemed tobacco products.</toc-entry><toc-entry idref="HCB9E4DE2897843AAABC3956D79E0D492" level="section">Sec. 103. Reducing child and adolescent nicotine addiction.</toc-entry><toc-entry idref="H7676C07DD87B412EA541A9C7799B1455" level="section">Sec. 104. Prohibition against remote retail sales.</toc-entry><toc-entry idref="HBEEF9EEDA9F844569EBF4849E42F3AF4" level="section">Sec. 105. Fees applicable to all tobacco products.</toc-entry><toc-entry idref="H8DF7F3F2D1E049AFAEC55EBDAC393726" level="section">Sec. 106. Regulation of products containing synthetic nicotine.</toc-entry><toc-entry idref="H552129C2743348B9A5A5D1F98B06A581" level="section">Sec. 107. Update to youth tobacco prevention public awareness campaigns.</toc-entry><toc-entry idref="H2B30C8206C0D48598B2D6300AE04CE50" level="section">Sec. 108. Exemption from premarket approval of certain tobacco products.</toc-entry><toc-entry idref="H79E7845DC3B74DAF90CC155A07F0D92F" level="section">Sec. 109. Public education.</toc-entry><toc-entry idref="H606CAB3FE7C64D478E2AE5B495DDC044" level="section">Sec. 110. Regulations for recordkeeping concerning tracking and tracing.</toc-entry><toc-entry idref="H391E70CDC586436E9FE13E16FC1EF674" level="title">Title II—Federal Trade Commission</toc-entry><toc-entry idref="H8C50B7DA1CA8433A9B74A183DD52BADE" level="section">Sec. 201. Advertising of tobacco products.</toc-entry><toc-entry idref="HD6F0520EC64648A48DE6B8CFEC9BAC9E" level="title">Title III—Public Health Programs</toc-entry><toc-entry idref="HA0745F158A804ABBB3C2B5FB7F348634" level="section">Sec. 301. Outreach to medically underserved communities.</toc-entry><toc-entry idref="H69E0A587C93D4D45992A68B70FE8CAEF" level="section">Sec. 302. Demonstration grant program to develop strategies for smoking cessation in medically underserved communities.</toc-entry><toc-entry idref="H8562ABB786EB40798B296408579CC752" level="title">Title IV—Nicotine or Vaping Access Protection and Enforcement</toc-entry><toc-entry idref="HA27881A5EF4745B9833691FF1B0784EC" level="section">Sec. 401. Short title.</toc-entry><toc-entry idref="H76A4469702944F1CA8676C2675D7CCC0" level="section">Sec. 402. Increasing civil penalties applicable to certain violations of restrictions on sale and distribution of tobacco products.</toc-entry><toc-entry idref="HBF741EAAD6FA4771B16278D4653350F0" level="section">Sec. 403. Study and report on e-cigarettes.</toc-entry></toc></section><title id="H5521161E1B89435A9FC4849CF5B3D84E"><enum>I</enum><header>Food and Drug Administration</header><section id="H12F0DCE2EC76449585F7DC8CE6648797"><enum>101.</enum><header>Cigarette graphic health warnings</header><subsection id="H2FFDC13E8D1849BA907EA8865D6F5987"><enum>(a)</enum><header>Issuance deadlines</header><text display-inline="yes-display-inline">Not later than March 15, 2020, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a final rule pursuant to section 4(d) of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333(d)</external-xref>). If the Secretary fails to promulgate such final rule by March 15, 2020, then the proposed rule titled <quote>Tobacco Products; Required Warnings for Cigarette Packages and Advertisements</quote> published by the Food and Drug Administration on August 16, 2019 (84 Fed. Reg. 42754) shall be treated as a final rule beginning on March 16, 2020.</text></subsection><subsection id="HB40359C7A4974B2C9EBAFE06ABF3CCF6"><enum>(b)</enum><header>Conforming change</header><text>The first section 4(d) of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333(d)</external-xref>) (relating to graphic labeling statements) is amended by striking <quote>Not later than 24 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary</quote> and inserting <quote>The Secretary</quote>.</text></subsection></section><section id="H31EEE455F2EA4E96ABE2234827B200EF"><enum>102.</enum><header>Advertising and sales parity for all deemed tobacco products</header><subsection id="HB41DEEA2308B463DA193E428957422D1"><enum>(a)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate a final rule amending part 1140 of subchapter K of title 21, Code of Federal Regulations—</text><paragraph id="H054392FA4FA24D10B9FC6F1EE685940B"><enum>(1)</enum><text>to apply the provisions of such part 1140 to all tobacco products, as applicable, to which chapter IX of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387a">21 U.S.C. 387a</external-xref> et seq.) applies pursuant to section 901(b) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387a">21 U.S.C. 387a(b)</external-xref>), as amended by section 103(a) of this Act; and</text></paragraph><paragraph id="HEC322B0886B843449520009E1EE45116"><enum>(2)</enum><text display-inline="yes-display-inline">to make such changes as may be necessary for consistency with the amendments made by section 103 of this Act, including by updating all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations.</text></paragraph></subsection><subsection id="H6DB9C4A6C986493482CFB8764BB353E6"><enum>(b)</enum><header>Effective date</header><text>The final rule required by subsection (a) shall take effect on the date that is 2 years after the date of enactment of this Act.</text></subsection></section><section id="HCB9E4DE2897843AAABC3956D79E0D492"><enum>103.</enum><header>Reducing child and adolescent nicotine addiction</header><subsection id="HFC7BD3C76DDF414395513C90773856E2"><enum>(a)</enum><header>Applicability to all tobacco products</header><paragraph id="H7D408CABAC6A45DCA3801AB0601BDAAA"><enum>(1)</enum><header>In general</header><text>Subsection (b) of section 901 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387a">21 U.S.C. 387a</external-xref>) is amended to read as follows:</text><quoted-block display-inline="no-display-inline" id="HDC9220395FF34F538A9F3CCF98730C31" style="OLC" changed="added" reported-display-style="italic" committee-id="HIF00"><subsection id="H2EB6D7A3D67F4E9E81CE49FFCF38A576"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">This chapter shall apply to all tobacco products.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H5E5A971283304DACBCD601D166C38BC9"><enum>(2)</enum><header>Rule of construction</header><text>Paragraph (1) and the amendment made thereby shall not be construed to limit the applicability of chapter IX of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387a">21 U.S.C. 387a</external-xref> et seq.) to—</text><subparagraph id="HA1E43753F2DD4273AE945B87D252BCB8"><enum>(A)</enum><text>products that were listed in section 901(b) of such Act as in effect on the day before the date of enactment of this Act; and</text></subparagraph><subparagraph id="H6462E3738D8741579E4E23F37DACB300"><enum>(B)</enum><text>products that were deemed by regulation to be subject to such chapter pursuant to section 901(b) of such Act as in effect on the day before the date of enactment of this Act.</text></subparagraph></paragraph></subsection><subsection id="H64880732CEDA4EDA82A3325B5D894C20"><enum>(b)</enum><header>Minimum age restrictions</header><paragraph id="H2A23B3BB8CDD41F8A65F1DF0E1D18029"><enum>(1)</enum><header>In general</header><text>Section 906(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387f">21 U.S.C. 387f(d)</external-xref>) is amended by striking paragraph (3) and inserting the following:</text><quoted-block id="HED6ECB4228F04CF2842DB807C3FCED45" style="OLC" changed="added" reported-display-style="italic" committee-id="HIF00"><paragraph id="H841925EA15D34CF0921DE700A9FD1F21"><enum>(3)</enum><header>Minimum age restrictions</header><subparagraph id="H834D07846F314E2F95BF467EC12BE502"><enum>(A)</enum><header>Restriction</header><text display-inline="yes-display-inline">It shall be unlawful for any retailer, manufacturer, distributor, third-party marketplace, or any other commercial entity to sell a tobacco product to any person younger than 21 years of age.</text></subparagraph><subparagraph id="H2E33C8148F794B74992EA34642CFEFAD"><enum>(B)</enum><header>Age verification</header><text display-inline="yes-display-inline">To ensure compliance with subparagraph (A), a retailer shall, at a minimum, verify by means of a government-issued photographic identification the age of the individual purchasing the product as prescribed in—</text><clause id="H07C9293B67974F94A5C6CE110E43BBDB"><enum>(i)</enum><text>subpart B of part 1140 of subchapter K of title 21, Code of Federal Regulations; and</text></clause><clause id="H7B01976440074341811E91E267491453"><enum>(ii)</enum><text>successor regulations, including the regulation required by section 102 of the <short-title>Reversing the Youth Tobacco Epidemic Act of 2019</short-title> and any applicable regulation imposing restrictions pursuant to paragraph (1).</text></clause></subparagraph><subparagraph id="H99666674615D48498DB7A0DEBE845444"><enum>(C)</enum><header>Regulations</header><text>Not later than 180 days after the date of enactment of the <short-title>Reversing the Youth Tobacco Epidemic Act of 2019</short-title>, the Secretary shall promulgate a final regulation to implement and enforce subparagraphs (A) and (B).</text></subparagraph><subparagraph id="H79A02F7A54F744888DE12320A5F02370"><enum>(D)</enum><header>Timing</header><text display-inline="yes-display-inline">Subparagraphs (A) and (B) shall take effect on the date that is 180 days after the date of enactment of the <short-title>Reversing the Youth Tobacco Epidemic Act of 2019</short-title>, regardless of whether the Secretary has promulgated the final regulations required by subparagraph (C).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HB256A7D1E2B949848ED86059DCF4979C"><enum>(2)</enum><header>Preservation of State and local authority</header><text>Nothing in the amendment made by paragraph (1) shall be construed to affect the preservation of State and local authority pursuant to section 916 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387p">21 U.S.C. 387p</external-xref>).</text></paragraph></subsection><subsection id="HC9917F7F177C4707A46159B591ECAD4A"><enum>(c)</enum><header>Prohibiting flavoring of tobacco products</header><paragraph id="HA285E2FE137148FDB443420024E0A3C2"><enum>(1)</enum><header>Prohibition</header><subparagraph id="H1D4CB8E203794528BE48DDF286FBF95E"><enum>(A)</enum><header>In general</header><text>Subparagraph (A) of section 907(a)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387g">21 U.S.C. 387g(a)(1)</external-xref>) is amended to read as follows:</text><quoted-block display-inline="no-display-inline" id="H4DED4D77B6384E05BB63E7C10E9ED97F" style="OLC" changed="added" reported-display-style="italic" committee-id="HIF00"><subparagraph id="HAFC3D06252324864AC9E22451F7C406B"><enum>(A)</enum><header>Special rules</header><clause id="HD09B0ECBD18E4FF89EBFA164FB3A35E7"><enum>(i)</enum><header>In general</header><text>Beginning on the date that is 1 year after the date of enactment of the <short-title>Reversing the Youth Tobacco Epidemic Act of 2019</short-title>, a tobacco product (including its components, parts, and accessories, including the tobacco, filter, or paper) that is not an electronic nicotine delivery system shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco) that is a characterizing flavor of the tobacco product or tobacco smoke or an herb or spice, including menthol, mint, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee.</text></clause><clause id="H0215B87192184859B7ED069CE81D435E"><enum>(ii)</enum><header>Rule of construction</header><text>Nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this Act applicable to any artificial or natural flavor, herb, or spice.</text></clause><clause id="H23D726E58A024CC99E57095260044508"><enum>(iii)</enum><header>Applicability to certain individuals</header><text display-inline="yes-display-inline">Notwithstanding any provision of this Act, no individual who purchases or possess for consumption a tobacco product that is in violation of the prohibition under this subparagraph shall be subject to any criminal penalty under this Act for such purchase or possession, nor shall it be used as a justification to stop, search, or conduct any other investigative measure against any individual.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph><subparagraph id="H2A8B3470F1804034BBDEEC34457D2C60"><enum>(B)</enum><header>Savings provision</header><text display-inline="yes-display-inline">Section 907(a)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387g">21 U.S.C. 387g(a)(1)</external-xref>), as in effect on the date of enactment of this Act, shall remain in effect until the amendments made to such section 907(a)(1) by this paragraph take effect.</text></subparagraph></paragraph><paragraph id="H41E4539CF3654C8582B25FFFD9380765"><enum>(2)</enum><header>Flavored electronic nicotine delivery system</header><text display-inline="yes-display-inline">Section 910 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387j">21 U.S.C. 387j</external-xref>) is amended by inserting at the end the following:</text><quoted-block style="OLC" id="H65AAEE485E50467FA7CFFAE66CA92203" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subsection id="H76294302998944AA96A8C05E51DEC7B8"><enum>(h)</enum><header>Flavored electronic nicotine delivery systems</header><paragraph id="H7C1D78A478D24733B93C097D9905E79D"><enum>(1)</enum><header>Restriction</header><text display-inline="yes-display-inline">Beginning on the date that is 30 days after the date of enactment of the <short-title>Reversing the Youth Tobacco Epidemic Act of 2019</short-title>, any flavored electronic nicotine delivery system that is a new tobacco product, including any liquid, solution, or other component or part or its aerosol, shall not contain an artificial or natural flavor (other than tobacco) that is a characterizing flavor, including menthol, mint, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, unless the Secretary has issued a marketing order as described in paragraph (2). Nothing in this paragraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this Act applicable to any artificial or natural flavor, herb, or spice.</text></paragraph><paragraph id="HF01B0BEF502547DCB654A29B0B3B1FE3"><enum>(2)</enum><header>Review</header><text display-inline="yes-display-inline">The Secretary shall not issue a marketing order under subsection (c)(1)(A)(i) or a substantial equivalence order under subsection (a)(2)(A)(i) for any electronic nicotine delivery system, including any liquid, solution, or other component or part or its aerosol, that contains an artificial or natural flavor (other than tobacco) that is a characterizing flavor, unless the Secretary issues an order finding that the manufacturer has demonstrated that—</text><subparagraph id="H5154F948FE1744E388FAF2E2F6A0FB37"><enum>(A)</enum><text>use of the characterizing flavor—</text><clause id="H1488E43B9BAC4FB28547A24C1CA5C45D"><enum>(i)</enum><text>will significantly increase the likelihood of smoking cessation among current users of tobacco products; and</text></clause><clause id="H80FC98CA6CEA4FB18EC9AE1D0D13D79F"><enum>(ii)</enum><text>will not increase the likelihood that individuals who do not use tobacco products, including youth, will start using any tobacco product, including an electronic nicotine delivery system; and</text></clause></subparagraph><subparagraph id="H1F3E0B597C274B52BACA83239A07C9B3"><enum>(B)</enum><text>such electronic nicotine delivery system is not more harmful to users than an electronic nicotine delivery system that does not contain any characterizing flavors.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HE45C76A466584692BD7C45B0ECB4783F"><enum>(3)</enum><header>Definition of electronic nicotine delivery system</header><text>Section 900 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387">21 U.S.C. 387</external-xref>) is amended—</text><subparagraph id="H3FF1DED894CC4E78AF1DF1AD4EC3DF48"><enum>(A)</enum><text>by redesignating paragraphs (8) through (22) as paragraphs (9) through (23), respectively; and</text></subparagraph><subparagraph id="H2BFB1F9DBA1F4B7EAD2E9E2DED289F84"><enum>(B)</enum><text>by inserting after paragraph (7) the following new paragraph:</text><quoted-block style="OLC" id="H3FEFF1918D4D44618E1D64908FE410FC" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><paragraph id="H36191FF30E934A2FB791D76DE8FEA831"><enum>(8)</enum><header>Electronic nicotine delivery system</header><text display-inline="yes-display-inline">The term <quote>electronic nicotine delivery system</quote>—</text><subparagraph id="H813A55FEB1E646B1848D48E340A90B7D"><enum>(A)</enum><text>means any electronic device that delivers nicotine, flavor, or another substance via an aerosolized solution to the user inhaling from the device (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and any component, liquid, part, or accessory of such a device, whether or not sold separately; and</text></subparagraph><subparagraph id="H748383128A0E4CD499C3CA0F296F383B"><enum>(B)</enum><text>does not include a product that—</text><clause id="H3D087C7350B84B9BB2AFED2CA499E405"><enum>(i)</enum><text>is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose; and</text></clause><clause id="HC09E7519BF2C4357831559CA1EA8C32B"><enum>(ii)</enum><text>is marketed and sold solely for a purpose described in clause (i).</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection></section><section id="H7676C07DD87B412EA541A9C7799B1455"><enum>104.</enum><header>Prohibition against remote retail sales</header><subsection id="HE27B5BB3EE644C83AD708BBF41C24515"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraph (4) of section 906(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387f">21 U.S.C. 387f(d)</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" id="H56D82962D50040B8AAE171ECA3FE8624" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><paragraph id="H933F20CA36BE4A44B4A68130DF517B1C"><enum>(4)</enum><header>Prohibition against remote retail sales</header><subparagraph id="HA8750A3DF8434D88985AF7064A7CD0B4"><enum>(A)</enum><header>Prohibition</header><text>Not later than 18 months after the date of enactment of the <short-title>the Reversing the Youth Tobacco Epidemic Act of 2019</short-title>, the Secretary shall promulgate a final regulation prohibiting the retail sale of all tobacco products other than retail sales through a direct, face-to-face exchange between a retailer and a consumer.</text></subparagraph><subparagraph id="HEA70908B099241F686E1ACC5C8C9F3DC"><enum>(B)</enum><header>Exception for certain cigar tobacco products</header><clause id="HF3148FFDA2DC428580435B2C035EA53F"><enum>(i)</enum><header>Exception</header><text display-inline="yes-display-inline">The regulation required by subparagraph (A) shall not apply to tobacco products described in section 910(a)(2)(A)(iii).</text></clause><clause id="HA38F983395DF41BE8ECF6DC458CE17D2"><enum>(ii)</enum><header>Applicable requirements</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>the Reversing the Youth Tobacco Epidemic Act of 2019</short-title>, the Secretary shall promulgate regulations regarding the sale and distribution of tobacco products described in section 910(a)(2)(A)(iii) that occur through means other than a direct, face-to-face exchange between a retailer and a consumer in order to prevent the sale and distribution of tobacco products described in section 910(a)(2)(A)(iii) to individuals who have not attained the minimum age established by applicable law for the purchase of such products, including requirements for age verification.</text></clause></subparagraph><subparagraph id="HBF807F5811AF40C5AF08E116A47040CD"><enum>(C)</enum><header>Relation to other authority</header><text display-inline="yes-display-inline">Nothing in this paragraph—</text><clause id="HF9A538058AA749ADB2C9912E5087C0F9"><enum>(i)</enum><text display-inline="yes-display-inline">limits the authority of the Secretary to take additional actions under the other paragraphs of this subsection; or</text></clause><clause id="H40418C7043EC440886C6DCADE6877262"><enum>(ii)</enum><text>preempts the authority of a State or local government to establish restrictions on the retail sale of tobacco products that are at least as restrictive as the prohibition under subparagraph (A).</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H285078F56220444B8B56C3157D1C467A"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">Section 906(d)(4) of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of enactment of this Act, shall continue to apply until the effective date of the regulations required by section 906(d)(4) of such Act, as amended by subsection (a).</text></subsection></section><section id="HBEEF9EEDA9F844569EBF4849E42F3AF4"><enum>105.</enum><header>Fees applicable to all tobacco products</header><subsection id="HAC6508EC9BF54A9BAFE897BF117A60DB"><enum>(a)</enum><header>Increase in total amount</header><text display-inline="yes-display-inline">Section 919(b)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s(b)(1)</external-xref>) is amended by striking subparagraph (K) and inserting the following subparagraphs:</text><quoted-block style="OLC" id="H2BA450D536EB4ACA897FCDDDC8995657" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subparagraph id="H2C405080F7D44701A5E163BE8C7D2481"><enum>(K)</enum><text display-inline="yes-display-inline">For fiscal year 2019, $712,000,000.</text></subparagraph><subparagraph id="HA348D808357744B280305D0E5DF31D4F"><enum>(L)</enum><text display-inline="yes-display-inline">For fiscal year 2020, $812,000,000.</text></subparagraph><subparagraph id="HFA081D8B9A5A404ABF27625108FADACE"><enum>(M)</enum><text>For each subsequent fiscal year, the amount that was applicable for the previous fiscal year, increased by the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H2802095AAA004FE08F405E8F55FEB0CD"><enum>(b)</enum><header>Application of user fees to all classes of tobacco product</header><paragraph id="H8E90C436B38E4FFDBEEDD1DF0FA4812C"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subparagraph (A) of section 919(b)(2) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s(b)(2)</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" id="H89361C7E50184086850E7ACB86732076" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subparagraph id="H77E3A2DB2B344258A592C0BFA15F2180"><enum>(A)</enum><header>In general</header><clause id="H04D318918F5241A3B7F714E3C4964E0E"><enum>(i)</enum><header>Fiscal years 2020 and 2021</header><text>For fiscal years 2020 and 2021, user fees shall be assessed and collected under subsection (a) only with respect to the classes of tobacco products listed in subparagraph (B)(i), and the total such user fees with respect to each such class shall be an amount that is equal to the applicable percentage of each such class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.</text></clause><clause id="H70B8DC8BF56143FBADC15608E13913DF"><enum>(ii)</enum><header>Subsequent fiscal years</header><text display-inline="yes-display-inline">For fiscal year 2022 and each subsequent fiscal year, user fees shall be assessed and collected under subsection (a) with respect to each class of tobacco products to which this chapter applies (including tobacco products that the Secretary by regulation deems to be subject to this chapter), and the total user fees with respect to each such class shall be—</text><subclause id="HC12F9DADBFB345D693FEB6CA9CCA4959"><enum>(I)</enum><text display-inline="yes-display-inline">with respect to each class of tobacco products listed in subparagraph (B)(i), an amount that is calculated in the same way as the amounts calculated for fiscal years 2020 and 2021 under clause (i), except that for purposes of fiscal years 2022 and subsequent fiscal years, instead of multiplying the applicable percentage of each such class by <quote>the amount specified in paragraph (1) for the fiscal year</quote>, the applicable percentage shall be multiplied by—</text><item id="HC8B32848D8F2428F9AA5E32C3AA3E630"><enum>(aa)</enum><text>the amount specified in paragraph (1) for the fiscal year, reduced by</text></item><item id="H4A2CE3CA4FB04E7C8232D9F14EE0279F"><enum>(bb)</enum><text>the total user fees assessed and collected pursuant to subclause (II) for the fiscal year; and</text></item></subclause><subclause id="H375F105D0B324D1BBEC26E3ECE42B78A"><enum>(II)</enum><text display-inline="yes-display-inline">with respect to each class of tobacco products to which this chapter applies but which is not listed in subparagraph (B)(i), an amount determined pursuant to a formula under subparagraph (C).</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H78786FD54BD24869BA21BABCBB0C73EA"><enum>(2)</enum><header>Other tobacco products</header><text display-inline="yes-display-inline">Section 919(b)(2) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s(b)(2)</external-xref>), as amended by paragraph (1), is further amended by adding at the end the following new subparagraphs:</text><quoted-block style="OLC" id="HEAFEA1CE50B446158D03F8407433770B" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subparagraph id="HB029720E66994172975B7C3557344E21"><enum>(C)</enum><header>Allocation for other tobacco products</header><clause id="H2E3DFBF732F24263865F1CF6F890E56F"><enum>(i)</enum><header>In general</header><text>Beginning with fiscal year 2022, the total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products not listed in subparagraph (B)(i) shall be an amount that is determined pursuant to a formula developed by the Secretary by regulation using information required to be submitted under subparagraph (D).</text></clause><clause id="HF3D7026FA0294F72BA17878B9152CFDE"><enum>(ii)</enum><header>Allocation for other tobacco products</header><text>For each class of tobacco products not listed in subparagraph (B)(i), the percentage of fees under the formula under clause (i) for the respective fiscal year shall be equal to the percentage of the gross domestic sales in the previous calendar year that is attributable to such class of tobacco products in such calendar year, as determined by the Secretary.</text></clause><clause id="H08DE8CFDD22244C0A4D09FAD4AB87AF1"><enum>(iii)</enum><header>Allocation of assessment within each class of other tobacco products</header><text>The percentage of the total user fee to be paid by each manufacturer or importer of tobacco products in a class not listed in subparagraph (B)(i) shall be determined by the Secretary, based on the percentage of the gross domestics sales of all such classes of tobacco products by all manufacturers and importers in the previous calendar year that is attributable to such manufacturer or importer.</text></clause><clause id="H6443760E7B9042EFA7B4CBB62E5DFD43"><enum>(iv)</enum><header>Effect of failure To finalize formula on time</header><text display-inline="yes-display-inline">If the Secretary for any reason fails to finalize by fiscal year 2022 the formula required by this subparagraph for the assessment and collection of user fees for classes of tobacco products not listed in subparagraph (B)(i)—</text><subclause id="H1F35890037DB48FF84FE6605FE31AEE0"><enum>(I)</enum><text>the Secretary shall continue to assess and collect fees under subsection (a) with respect to each class of tobacco products listed in subparagraph (B)(i); and</text></subclause><subclause id="H112FB079AB3647AE8A83494E55069D8C"><enum>(II)</enum><text>until the first fiscal year commencing after the finalization of such formula, the exception described in subparagraph (A)(ii)(I) shall not apply.</text></subclause></clause><clause id="H4C5878F5A3DC4F83A35970E6F913215B"><enum>(v)</enum><header>Revisions by regulation</header><text display-inline="yes-display-inline">Any revisions to the formula promulgated pursuant to this subparagraph shall be by regulation.</text></clause><clause id="H98B0D75ED2334947B9E89E62CED6F8ED"><enum>(vi)</enum><header>Definition</header><text display-inline="yes-display-inline">In this subparagraph, the term <quote>gross domestic sales</quote> means the total value in dollars of the sale or distribution by manufacturers and importers of tobacco products in the United States in classes not listed in subparagraph (B)(i), as determined based on the aggregation of sales data from every manufacturer and importer of tobacco products that submits sales data to the Secretary.</text></clause></subparagraph><subparagraph id="H7DBFC04707D14BCDAA4B26EDBCEEDDC4"><enum>(D)</enum><header>Information required to be submitted</header><text>Each manufacturer or importer of any tobacco product shall submit to the Secretary the information required under this subparagraph by March 1, 2021, for calendar year 2020, by April 1, 2021, for the period of January 1, 2021, through March 30, 2021, and monthly thereafter. Such information shall include—</text><clause id="H5F3F5D5F0EEE46EB8D179D61386C3D58"><enum>(i)</enum><text>the identification of the manufacturer or importer;</text></clause><clause id="H343A44DA217E4DFE83B19E92A107B782"><enum>(ii)</enum><text>the class or classes of tobacco products sold by the manufacturer or importer;</text></clause><clause id="H9E7EF6A5C14E4F8EA36E012F230B7555"><enum>(iii)</enum><text>the full listing of the finished tobacco products in a class not listed in subparagraph (B)(i) sold or distributed by the manufacturer or importer in the United States; and</text></clause><clause id="H25169DFDF7DF41DDB15B62B76A755839"><enum>(iv)</enum><text>the gross domestic sales data for each class of finished tobacco products sold or distributed by the manufacturer or importer in the United States.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H3C72C6566A4E499AB1B8075A1BE7EA37"><enum>(3)</enum><header>Prohibited act</header><text display-inline="yes-display-inline">Section 301(q)(1)(B) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331(q)(1)(B)</external-xref>) is amended by inserting <quote>919(b)(2)(D),</quote> before <quote>or 920</quote>.</text></paragraph></subsection><subsection id="HDB1CD9B5336946F1BFF7C9812B4B358A"><enum>(c)</enum><header>Allocation of assessment within each class of tobacco product</header><text>Section 919(b)(4) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s(b)(4)</external-xref>) is amended by striking <quote>shall be the percentage determined for purposes of allocations under subsections (e) through (h) of section 625 of <external-xref legal-doc="public-law" parsable-cite="pl/108/357">Public Law 108–357</external-xref></quote> and inserting <quote>shall be the percentage determined by the Secretary</quote>.</text></subsection><subsection id="H0EED419149F34FC4BCA4919962807A2F"><enum>(d)</enum><header>Conforming amendments</header><text display-inline="yes-display-inline">Section 919(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s(b)</external-xref>) is amended—</text><paragraph id="H146D7261E5F84F83AF03E9FA44EA5D97"><enum>(1)</enum><text>by striking paragraph (5);</text></paragraph><paragraph id="H288C6CC5490F4916A3D13A78847BA245"><enum>(2)</enum><text>by redesignating paragraphs (6) and (7) as paragraphs (5) and (6), respectively; and</text></paragraph><paragraph id="H20F7BEC50EDA489786D11104022067DD"><enum>(3)</enum><text>by amending paragraph (6), as redesignated, to read as follows:</text><quoted-block style="OLC" id="H5CAFDC8837F74FC5A81B5C7B933E798F" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><paragraph id="HA78B0C93CE0E45A48375D3F8077B9CD5"><enum>(6)</enum><header>Memorandum of understanding</header><text display-inline="yes-display-inline">The Secretary shall request the appropriate Federal agency to enter into a memorandum of understanding that provides for the regular and timely transfer from the head of such agency to the Secretary of all necessary information regarding all tobacco product manufacturers and importers required to pay user fees. The Secretary shall maintain all disclosure restrictions established by the head of such agency regarding the information provided under the memorandum of understanding.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HFCA608C8926540489E6DD3FAD5C2844C"><enum>(e)</enum><header>Applicability</header><text>The amendments made by subsections (b), (c), and (d) apply beginning with fiscal year 2022. Subject to the amendment made by subsection (a), section 919 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s</external-xref>), as in effect on the day before the date of enactment of this Act, shall apply with respect to fiscal years preceding fiscal year 2022.</text></subsection><subsection id="H13E26097C6444933A2A203E097D2A24F"><enum>(f)</enum><header>Report</header><text display-inline="yes-display-inline">For fiscal year 2020 and each subsequent fiscal year for which fees are collected under section 919 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387s">21 U.S.C. 387s</external-xref>), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall, by the end of the respective fiscal year, submit to the Congress financial and performance reports with respect to such fees.</text></subsection></section><section id="H8DF7F3F2D1E049AFAEC55EBDAC393726"><enum>106.</enum><header>Regulation of products containing synthetic nicotine</header><subsection id="H49333C903676439C918512E625FE6409"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—</text><paragraph id="H4A0EC0FF217A407C87711C8DF96CE72D"><enum>(1)</enum><text>not later than 1 year after the date of enactment of this Act, issue an interim final rule providing for the regulation of products containing synthetic nicotine under the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301</external-xref> et seq.); and</text></paragraph><paragraph id="HA0BC91231CEE4D4B9C92F58D10386349"><enum>(2)</enum><text>not later than 2 years after such date of enactment, issue a final rule providing for such regulation.</text></paragraph></subsection><subsection id="H7D5E99C94D554220AF2514877E0E2674"><enum>(b)</enum><header>Synthetic nicotine defined</header><text display-inline="yes-display-inline">In this section, the term <quote>synthetic nicotine</quote> means nicotine that is not made or derived from tobacco.</text></subsection></section><section id="H552129C2743348B9A5A5D1F98B06A581"><enum>107.</enum><header>Update to youth tobacco prevention public awareness campaigns</header><subsection id="HCE5074FD08624C9E832AE803C9F85854"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—</text><paragraph id="H304276AA50404DE6AF869FC650DE1C55"><enum>(1)</enum><text>review all public health awareness campaigns of the Department of Health and Human Services designed to educate at-risk individuals about the harmful effects of tobacco use, including the use of e-cigarettes and other electronic nicotine delivery systems; and</text></paragraph><paragraph id="HFC69525E49374B838B9CFFED48F1D6F0"><enum>(2)</enum><text>as applicable, modify such campaigns to include awareness and education materials designated for individuals who are 18 to 21 years of age.</text></paragraph></subsection><subsection id="HC2DB4E3184CE4D06BA8E34F68251B7D4"><enum>(b)</enum><header>Consultation</header><text>In carrying out subsection (a), the Secretary of Health and Human Services may consult with medical and public health associations and nonprofit organizations. </text></subsection></section><section id="H2B30C8206C0D48598B2D6300AE04CE50" section-type="subsequent-section"><enum>108.</enum><header>Exemption from premarket approval of certain tobacco products</header><subsection id="H1F550AD596DC420C8C1888B9B69EDC4D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 910(a)(2) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387j">21 U.S.C. 387j(a)(2)</external-xref>) is amended—</text><paragraph id="HEBE7069245DC4AF19B73F50546BBB71B"><enum>(1)</enum><text>in subparagraph (A)—</text><subparagraph id="HB4D64B0D1F07472F837EAD1EA26BFFCB"><enum>(A)</enum><text>in clause (i)(II), by striking <quote>or</quote>;</text></subparagraph><subparagraph id="H75359A340C014C558A6D6C7E0A76A626"><enum>(B)</enum><text>in clause (ii), by striking the period at the end and inserting <quote>; or</quote>; and</text></subparagraph><subparagraph id="H201603084F374DA89C427C3C54C8C3D7"><enum>(C)</enum><text>by adding at the end the following: </text><quoted-block style="OLC" id="H48F4AEDC821B4C43A60B3554654EE5AF" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><clause id="H85F436BB6CEC40099B42834BB28FA02F"><enum>(iii)</enum><text display-inline="yes-display-inline">subject to subparagraph (C), for the period beginning on the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 and ending on September 30, 2028, the tobacco product is a cigar and—</text><subclause id="HB3CB6430BBA148919135B66AA87C735D"><enum>(I)</enum><text>is wrapped in whole tobacco leaf;</text></subclause><subclause id="HF9CAB163BA4A42CA943D517B6A1EE4CC"><enum>(II)</enum><text>contains a 100-percent leaf tobacco binder;</text></subclause><subclause id="HD19FAF5E02B44AE4BAD4D7445F2861C0"><enum>(III)</enum><text>contains primarily long filler tobacco;</text></subclause><subclause id="H72D823125F7B483485C33D9C05C2AA81"><enum>(IV)</enum><text>does not have a characterizing flavor other than tobacco; </text></subclause><subclause id="HC1FFDF80006E41E6A07DBB989AF40584"><enum>(V)</enum><text>weighs more than 6 pounds per 1000 units;</text></subclause><subclause id="H3595CEC7E81D433599EC004C5B3D6912"><enum>(VI)</enum><text>has no filter, tip, or non-tobacco mouthpiece; </text></subclause><subclause id="HF48351F8180D44C298475F7EA83D4466"><enum>(VII)</enum><item commented="no" display-inline="yes-display-inline" id="HC4EB7A793BB947E48B39026CEC3AD00A"><enum>(aa)</enum><text>is made by combining manually the wrapper, filler, and binder and is capped by hand; or</text></item><item id="HF29A05EDA8B441F287301FF4A4162AC5" indent="up1"><enum>(bb)</enum><text display-inline="yes-display-inline">has a homogenized tobacco leaf binder and is made in the United States using human hands to lay the 100-percent leaf tobacco binder onto only one machine that bunches, wraps, and caps each individual cigar; and</text></item></subclause><subclause id="H9ED3A0ACE030418F8F182F8C4E061D9A"><enum>(VIII)</enum><text>has a retail price (after discounts or coupons) per cigar of no less than—</text><item id="HE80341D5022F49F584D28F0AD2F6DB2E"><enum>(aa)</enum><text>for calendar years 2019 and 2020, $12; and</text></item><item id="H08A16D4DEE9149148A34728FC67716F3"><enum>(bb)</enum><text display-inline="yes-display-inline">for each subsequent calendar year, $12 multiplied by any percent increase in the Consumer Price Index for all urban consumers (all items; U.S. city average) since calendar year 2020.</text></item></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HA088A308B2FF4D22BC665EAAD54F3A4F"><enum>(2)</enum><text>by adding at the end the following: </text><quoted-block style="OLC" id="H8822FEF0E6D74DE1896301A22EABF874" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subparagraph id="HF73BA3EA14124041ABB8B91EA97A67D3"><enum>(C)</enum><header>Determination of applicability</header><clause id="H68C28FC687C14DB3A3CB82DD65B5F618"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall, notwithstanding subparagraph (A)(iii) or any determination of substantial equivalence, if any of the conditions specified in clause (ii) are met—</text><subclause id="H7213F4D417C04240BC7A2BBB7AE24E04"><enum>(I)</enum><text>withdraw any exemption applicable to a tobacco product or products described in such subparagraph;</text></subclause><subclause id="H183E2EF398244C94B2B3E28307BC8A2B"><enum>(II)</enum><text display-inline="yes-display-inline">require that applications for review under this section be submitted with respect to such product or products; and</text></subclause><subclause id="HEF84965BC3B84768B51819E0B01AE7CB"><enum>(III)</enum><text display-inline="yes-display-inline">require that manufacturers may only market such tobacco product after the issuance of an order under subsection (c)(1)(A)(i) with respect to such product or products.</text></subclause></clause><clause id="HDAFA236A83F14525BA255684ABCC11D1"><enum>(ii)</enum><header>Conditions</header><text>The conditions specified in this clause are that—</text><subclause id="HE75C71670A4A47DF8A9D0A8129B38CD5"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the use of a tobacco product or products described in subparagraph (A)(iii) has resulted in an emerging public health threat; </text></subclause><subclause id="HBA90495CA25F4B65A646159C73033A26"><enum>(II)</enum><text display-inline="yes-display-inline">data from a National Youth Tobacco Survey (or successor survey) conducted after the date of the enactment of <short-title>the Reversing the Youth Tobacco Epidemic Act of 2019</short-title> identifies a rise in youth usage of tobacco products described in section 910(a)(2)(A)(iii); or</text></subclause><subclause id="HD1973B4521A643CEAD381291A0A171A0"><enum>(III)</enum><text>the Secretary determines that a tobacco product or products no longer meets the criteria specified in such subparagraph.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H31A506C3A3BF4C2FBF8306F49E6BB9DB"><enum>(b)</enum><header>National Academies study and report</header><paragraph id="HF6EAE9674C8544278987B996B5E966D2"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine under which the National Academies shall conduct a study on—</text><subparagraph id="HF09B72F181834A47B83BD67D85E93045"><enum>(A)</enum><text display-inline="yes-display-inline">the public health impact of having tobacco products described in subsection (a)(2)(A)(iii) of section 910 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387j">21 U.S.C. 387j(a)(2)</external-xref>), as amended by subsection (a), exempt from premarket review under such section;</text></subparagraph><subparagraph id="H190BDC9754094182BE5693C08A7E2704"><enum>(B)</enum><text>the youth usage of such tobacco products; and</text></subparagraph><subparagraph id="HE17DD0F1E9B84886A3FD0D73BE8320D6"><enum>(C)</enum><text display-inline="yes-display-inline">the market share of such products.</text></subparagraph></paragraph><paragraph id="H4E94A7BBDB5F4D9898134D8CAFE28582"><enum>(2)</enum><header>Report</header><text display-inline="yes-display-inline">The agreement under paragraph (1) shall include a requirement that the National Academies of Sciences, Engineering, and Medicine submit to Congress, not later than December 31, 2026, a report on the findings of the study conducted under such paragraph. </text></paragraph></subsection></section><section id="H79E7845DC3B74DAF90CC155A07F0D92F"><enum>109.</enum><header>Public education</header><text display-inline="no-display-inline">Section 906 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387f">21 U.S.C. 387f</external-xref>) is amended by adding at the end the following: </text><quoted-block style="OLC" id="HF2CAC8D14EDF433AB772F6746758ABFE" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subsection id="H4AAC0EB3963241DDA2309AB1E11C6391"><enum>(g)</enum><header>Education on tobacco products</header><paragraph id="H2761F9F53F534AC5A765C9C195ACE83C"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 6 months after the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall provide educational materials for health care providers, members of the public, and law enforcement officials, regarding—</text><subparagraph id="H49E9DF6EFB7849CC901F291810B4E42D"><enum>(A)</enum><text>the authority of the Food and Drug Administration with respect to the regulation of tobacco products (including enforcement of such regulation);</text></subparagraph><subparagraph id="H6953DD884C754DD4BC887509EADA3C58"><enum>(B)</enum><text>the processes of the Food and Drug Administration for enforcing restrictions on the manufacture and sale of tobacco products;</text></subparagraph><subparagraph id="HD5BC6CA22DB941859DA0C3D424C8A149"><enum>(C)</enum><text>the prohibition on characterizing flavors in tobacco products and the under section 907(a)(1) and the exception from such prohibition under subparagraph (C) of such section; </text></subparagraph><subparagraph id="HD41E1821E8FF452EB3024711C3DC5095"><enum>(D)</enum><text>the public health impact of tobacco products with characterizing flavors; and</text></subparagraph><subparagraph id="H8CC7B56F9AAD4CE6828B131D1F085017"><enum>(E)</enum><text>other information as the Secretary determines appropriate.</text></subparagraph></paragraph><paragraph id="H25E19DB6F8AB463C81AC35FFD653528D"><enum>(2)</enum><header>Content</header><text display-inline="yes-display-inline">Educational materials provided under paragraph (1) may include—</text><subparagraph id="HBE8B4C71615E406985E027E6B8C0D241"><enum>(A)</enum><text>explanations of key statutory and regulatory terms, including the terms <quote>tobacco product,</quote><quote>component parts</quote>, <quote>accessories</quote>, <quote>constituent</quote>, <quote>additive</quote>, <quote>tobacco product manufacturer</quote>, and <quote>characterizing flavor</quote>;</text></subparagraph><subparagraph id="H4FAE7822EE8A42778F4978F821FCC24B"><enum>(B)</enum><text>an explanation of the Food and Drug Administration’s jurisdiction to regulate tobacco products, including tobacco products with characterizing flavors under section 907(a)(1); </text></subparagraph><subparagraph id="H556001D6AA324791992EF848C37A0EE2"><enum>(C)</enum><text>information related to enforcement tools and processes used by the Food and Drug Administration for violations of the prohibition specified in section 907(a)(1); </text></subparagraph><subparagraph id="HD55E2F8082E1426A8BADCDF6D338B3EF"><enum>(D)</enum><text display-inline="yes-display-inline">an explanation of the health effects of using tobacco products, including those with characterizing flavors; and</text></subparagraph><subparagraph id="H5474AE161C5C42419033607AE6CCE766"><enum>(E)</enum><text>information on resources available related to smoking cessation.</text></subparagraph></paragraph><paragraph id="H99D5AF6A49FA4388B7EF68D5BA946249"><enum>(3)</enum><header>Format</header><text display-inline="yes-display-inline">Educational materials provided under paragraph (1) may be—</text><subparagraph id="H48B6ADB4573641FDA96C35D96CD72C91"><enum>(A)</enum><text>published in any format, including an Internet website, video, fact sheet, infographic, webinar, or other format, as the Secretary determines is appropriate and applicable; and</text></subparagraph><subparagraph id="HA2656157F9A04C8FB9960776CDFCDD5E"><enum>(B)</enum><text>tailored for the unique needs of health care providers, members of the public, law enforcement officers, and other audiences, as the Secretary determines appropriate.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H606CAB3FE7C64D478E2AE5B495DDC044"><enum>110.</enum><header>Regulations for recordkeeping concerning tracking and tracing</header><text display-inline="no-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate the regulations required by section 920(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387t">21 U.S.C. 387t</external-xref>) in accordance with the following schedule:</text><paragraph id="HDABBAB901C8443E4B11A4E41DF89C4CD"><enum>(1)</enum><text>Not later than 1 year after the date of enactment of this Act, the Secretary shall issue proposed regulations.</text></paragraph><paragraph id="HCD389A88C7AF430EB4107CB677D2929F"><enum>(2)</enum><text>Not later than 2 years after the date of enactment of this Act, the Secretary shall promulgate final regulations.</text></paragraph></section></title><title id="H391E70CDC586436E9FE13E16FC1EF674"><enum>II</enum><header>Federal Trade Commission</header><section commented="no" id="H8C50B7DA1CA8433A9B74A183DD52BADE"><enum>201.</enum><header>Advertising of tobacco products</header><subsection commented="no" id="HA5BD9DC6D0594D6C8D6DDC03CD0C85FF"><enum>(a)</enum><header>Advertising of electronic nicotine delivery systems</header><paragraph id="H18AC6FEA3342467E89AAE8AF28FB765A"><enum>(1)</enum><header>In general</header><text>It shall be unlawful—</text><subparagraph id="H95A473661C194988ABC6A35DAE9DCCEF"><enum>(A)</enum><text>to market, advertise, or promote any electronic nicotine delivery system in a manner that appeals to an individual under 21 years of age; or</text></subparagraph><subparagraph id="HF11A8229A7A34B23B8A2B9ACE6A5959C"><enum>(B)</enum><text display-inline="yes-display-inline">to market, advertise, promote, or endorse, or to compensate any person for the marketing, advertising, promotion, or endorsement of, any electronic nicotine delivery system without clearly disclosing that the communication is an advertisement, unless the communication is unambiguously identifiable as an advertisement.</text></subparagraph></paragraph><paragraph id="H7AD3302368E84B9F9D5C01AF423DFB4A"><enum>(2)</enum><header>Enforcement by Commission</header><subparagraph id="HB8E1A76ABBDD42DAAEBE5BA62A7EDD63"><enum>(A)</enum><header>Unfair or deceptive acts or practices</header><text>A violation of paragraph (1) shall be treated as a violation of a regulation under section 18(a)(1)(B) of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a(a)(1)(B)</external-xref>) regarding unfair or deceptive acts or practices.</text></subparagraph><subparagraph id="H8CE396F9EEE64916ABCC819C0FDDD8E9"><enum>(B)</enum><header>Powers of Commission</header><text display-inline="yes-display-inline">The Commission shall enforce paragraph (1) in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41</external-xref> et seq.) were incorporated into and made a part of this Act. Any person who violates such paragraph shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act.</text></subparagraph></paragraph><paragraph id="HE8EF8884B53548D6B7B5E36A2FC078F2"><enum>(3)</enum><header>Enforcement by State attorneys general</header><subparagraph id="HF591544AC0EC4D818878EE65D2817F18"><enum>(A)</enum><header>In general</header><text>If the attorney general of a State has reason to believe a violation of paragraph (1) has occurred or is occurring, the attorney general, in addition to any authority the attorney general may have to bring an action in State court under the law of the State, may bring a civil action in any court of competent jurisdiction to—</text><clause id="H38E02DE67CBA42498BA5DBF8A5DD7FBF"><enum>(i)</enum><text>enjoin further such violation by the defendant;</text></clause><clause id="HBDCB561420954C61BCDEB01668EBEC8D"><enum>(ii)</enum><text>enforce compliance with such paragraph;</text></clause><clause id="H69F99D96E03E483DAFBBDB6BF3D08C69"><enum>(iii)</enum><text>obtain civil penalties in the same amount as may be obtained by the Commission in a civil action under section 5(m) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(m)</external-xref>); or</text></clause><clause id="H213F68CAE24944C3A7E0B38D0E5B849F"><enum>(iv)</enum><text>obtain damages, restitution, or other compensation on behalf of residents of the State.</text></clause></subparagraph><subparagraph commented="no" id="H6F7296183AD041C88D94996D158F5FA1"><enum>(B)</enum><header>Notice</header><text>Before filing an action under subparagraph (A), the attorney general of a State shall provide to the Commission a written notice of such action and a copy of the complaint for such action. If the attorney general determines that it is not feasible to provide the notice described in this subparagraph before the filing of the action, the attorney general shall provide written notice of the action and a copy of the complaint to the Commission immediately upon the filing of the action.</text></subparagraph><subparagraph commented="no" id="H8B48706912F64B71AD3DC6A9918C76BA"><enum>(C)</enum><header>Authority of Federal Trade Commission</header><clause id="H52A196406BB64553A4BB2C4A0C9C702B"><enum>(i)</enum><header>In general</header><text>On receiving notice under subparagraph (B) of an action under subparagraph (A), the Commission shall have the right—</text><subclause commented="no" id="H00668B65A83042C0B3DF032033E1258B"><enum>(I)</enum><text>to intervene in the action;</text></subclause><subclause id="HDDBC3AA21AC845CE95FE55D4CDEF8A59"><enum>(II)</enum><text>upon so intervening, to be heard on all matters arising therein; and</text></subclause><subclause commented="no" id="H8A94B63A70C64AB493A7BC07C962383C"><enum>(III)</enum><text>to file petitions for appeal.</text></subclause></clause><clause commented="no" id="HB3B6572FA2324100A9AA9F35A3E7B8FF"><enum>(ii)</enum><header>Limitation on State action while Federal action is pending</header><text display-inline="yes-display-inline">If the Commission has instituted a civil action for violation of paragraph (1) (referred to in this clause as the <quote>Federal action</quote>), no attorney general of a State may bring an action under subparagraph (A) during the pendency of the Federal action against any defendant named in the complaint in the Federal action for any violation of such paragraph alleged in such complaint.</text></clause></subparagraph><subparagraph id="H0AA6C61E56FA417BB5B5DE9DD5CB97DA"><enum>(D)</enum><header>Relationship with State-law claims</header><clause id="H1964481EC7044B53844CF449B4734A0A"><enum>(i)</enum><header>Preservation of State-law claims</header><text display-inline="yes-display-inline">Nothing in this section shall prevent the attorney general of a State from bringing an action under State law for acts or practices that also violate paragraph (1).</text></clause><clause id="H3B0932AA63E94E3EAB19EC271FF44D3A"><enum>(ii)</enum><header>Assertion in same civil action</header><text>If the attorney general of a State has authority to bring an action under State law for acts or practices that also violate paragraph (1), the attorney general may assert the State-law claim and the claim for violation of such paragraph in the same civil action.</text></clause></subparagraph><subparagraph id="HF5733A05A2844E40BB87616FDDFD49CB"><enum>(E)</enum><header>Actions by other State officials</header><text display-inline="yes-display-inline">In addition to civil actions brought by attorneys general under subparagraph (A), any other consumer protection officer of a State who is authorized by the State to do so may bring a civil action under such subparagraph, subject to the same requirements and limitations that apply under this paragraph to civil actions brought by attorneys general.</text></subparagraph></paragraph><paragraph commented="no" id="HE9C3559A3C4A4BD180277BDE8831D454"><enum>(4)</enum><header>Rulemaking authority</header><text>The Commission may promulgate regulations under section 553 of title 5, United States Code, to implement paragraph (1).</text></paragraph></subsection><subsection commented="no" id="HC493727099904F89B037A48F4DB38E00"><enum>(b)</enum><header>Report to Congress on tobacco product advertising</header><paragraph id="HA7D3BA43F1384AC4B550D153D999A165"><enum>(1)</enum><header>In general</header><text>Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Commission shall submit to Congress a report relating to each category of products described in paragraph (2) (or a single report a portion of which relates to each such category) that contains the following:</text><subparagraph id="H6D66A13CF4264FE7B313221B04E85AAB"><enum>(A)</enum><text>Information on domestic sales and advertising and promotional activity by the manufacturers that have the largest market shares of the product category.</text></subparagraph><subparagraph id="HC382DD6B2CAB474F9FDBB7E081E94CAB"><enum>(B)</enum><text>Such recommendations for legislation as the Commission may consider appropriate.</text></subparagraph></paragraph><paragraph id="H23124F80DB1044C981C2895C56BF77A1"><enum>(2)</enum><header>Product categories described</header><text>The categories of products described in this paragraph are the following:</text><subparagraph id="H91A58A1B0CAD42E888788065F693C4BB"><enum>(A)</enum><text>Cigarettes.</text></subparagraph><subparagraph id="H8B4CD56C6F5D4C96979D9BF50B97077A"><enum>(B)</enum><text>Cigars.</text></subparagraph><subparagraph id="HD890BCA67BDD46E2887B7583636A86BE"><enum>(C)</enum><text>Smokeless tobacco.</text></subparagraph><subparagraph id="H53DC61DE70014E9B948715848B538002"><enum>(D)</enum><text>Electronic nicotine delivery systems.</text></subparagraph></paragraph></subsection><subsection id="H3EBBCEC91CD242FFA9C38114F9333982"><enum>(c)</enum><header>Preservation of authority</header><text display-inline="yes-display-inline">Nothing in this section may be construed in any way to limit the Commission’s authority under any other provision of law.</text></subsection><subsection id="H3AB1A465D50F42FF954B4860CB4674C7"><enum>(d)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H12298F63A4584A4E8F2751C375A3C441"><enum>(1)</enum><header>Cigar</header><text display-inline="yes-display-inline">The term <quote>cigar</quote> means a tobacco product that—</text><subparagraph id="H583F5CC1546C464482311A5C0DC254D7"><enum>(A)</enum><text>is not a cigarette; and</text></subparagraph><subparagraph id="H3D021A3A32374E469B8DDBAC5018B78B"><enum>(B)</enum><text>is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco.</text></subparagraph></paragraph><paragraph id="H6C25348991344E1ABA78EB777408066B"><enum>(2)</enum><header>Cigarette</header><text>The term <term>cigarette</term> has the meaning given such term in section 900 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387">21 U.S.C. 387</external-xref>).</text></paragraph><paragraph id="HFA27B76C29E3467E8476E30FB92056F3"><enum>(3)</enum><header>Commission</header><text>The term <term>Commission</term> means the Federal Trade Commission.</text></paragraph><paragraph id="H6A2B33E4E5BF45268CE272B1788E58D8"><enum>(4)</enum><header>Electronic nicotine delivery system</header><text display-inline="yes-display-inline">The term <quote>electronic nicotine delivery system</quote>—</text><subparagraph id="HDF80580074B049C6B1F2DB090F8042AE"><enum>(A)</enum><text>means any electronic device that delivers nicotine, flavor, or another substance via an aerosolized solution to the user inhaling from the device (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and any component, liquid, part, or accessory of such a device, whether or not sold separately; and</text></subparagraph><subparagraph id="H2F02DC62BF2E4E6EAD0222CEE5C45EAE"><enum>(B)</enum><text>does not include a product that—</text><clause id="HDB6CEB97265A4C4BA7AABBA678243C77"><enum>(i)</enum><text>is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose; and</text></clause><clause id="HFCDF8FF0C2EB40F293F3F384130F69A3"><enum>(ii)</enum><text>is marketed and sold solely for a purpose described in clause (i).</text></clause></subparagraph></paragraph><paragraph id="H64FF67433A5842C1B1BB4E2E999274C4"><enum>(5)</enum><header>Endorse</header><text display-inline="yes-display-inline">The term <term>endorse</term> means to communicate an advertising message (including a verbal statement, demonstration, or depiction of the name, signature, likeness, or other identifying personal characteristics of an individual or the name or seal of an organization) that consumers are likely to believe reflects the opinions, beliefs, findings, or experiences of a party other than the sponsoring advertiser, even if the views expressed by such party are identical to those of the sponsoring advertiser.</text></paragraph><paragraph id="H795354C796F747C18CDF612C2BE93594"><enum>(6)</enum><header>Nicotine</header><text display-inline="yes-display-inline">The term <term>nicotine</term> has the meaning given such term in section 900 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387">21 U.S.C. 387</external-xref>).</text></paragraph><paragraph id="H955B2689DA624BD8B4C6A04ACD271ADB"><enum>(7)</enum><header>Smokeless tobacco</header><text display-inline="yes-display-inline">The term <term>smokeless tobacco</term> has the meaning given such term in section 900 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387">21 U.S.C. 387</external-xref>).</text></paragraph><paragraph id="H62D7961C6FB84F2598BBE6794D12A3BD"><enum>(8)</enum><header>Tobacco product</header><text display-inline="yes-display-inline">The term <term>tobacco product</term> has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text></paragraph></subsection></section></title><title id="HD6F0520EC64648A48DE6B8CFEC9BAC9E"><enum>III</enum><header>Public Health Programs</header><section id="HA0745F158A804ABBB3C2B5FB7F348634"><enum>301.</enum><header>Outreach to medically underserved communities</header><text display-inline="no-display-inline">The Secretary shall ensure that programs at the Centers for Disease Control and Prevention related to outreach to medically underserved communities, including racial and ethnic minority populations, include efforts to educate and provide guidance regarding effective evidence-based strategies— </text><paragraph id="H037CCBBFB881497FA834B841C44FC9FE"><enum>(1)</enum><text>to prevent tobacco, e-cigarette, and nicotine addiction; and </text></paragraph><paragraph id="H6AFDA4EE581D45A09CBD552206089109"><enum>(2)</enum><text>for smoking cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems. </text></paragraph></section><section id="H69E0A587C93D4D45992A68B70FE8CAEF"><enum>302.</enum><header>Demonstration grant program to develop strategies for smoking cessation in medically underserved communities</header><subsection id="H14A2EB2526AF4E0DA5CBF7289CE63BD4"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a demonstration program to award grants to or contract with State, local, Tribal, or territorial public health departments to support— </text><paragraph id="H3B94A750B6EE4250B4FA527C9A1C5121"><enum>(1)</enum><text>the development of improved evidence-based strategies for smoking cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems for populations in medically underserved communities, particularly racial and ethnic minority populations; </text></paragraph><paragraph id="H16F933E3618141BFA3425F5C00796C5A"><enum>(2)</enum><text>the development of improved communication and outreach tools to reach populations in medically underserved communities, particularly racial and ethnic minority populations, addicted to tobacco and e-cigarette products; and </text></paragraph><paragraph id="HBF324B6358CB4A84A967FE359F0B56C5"><enum>(3)</enum><text>improved coordination, access, and referrals to services for smoking cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems, including smoking cessation products and mental health and counseling services. </text></paragraph></subsection><subsection id="H58BC71C44C334A10831364E0E36D8E5C"><enum>(b)</enum><header>Application</header><text>To be eligible to receive a grant under subsection (a), a State, local, Tribal, or territorial public health department shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. </text></subsection><subsection id="HE2F5B94742D34DF1998AA0DBC677AD94"><enum>(c)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section, $3,000,000 for each of fiscal years 2020 through 2024. </text></subsection></section></title><title id="H8562ABB786EB40798B296408579CC752"><enum>IV</enum><header>Nicotine or Vaping Access Protection and Enforcement</header><section id="HA27881A5EF4745B9833691FF1B0784EC" section-type="section-one"><enum>401.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Nicotine or Vaping Access Protection and Enforcement Act of 2019</short-title></quote> or the <quote><short-title>NO VAPE Act of 2019</short-title></quote>.</text></section><section id="H76A4469702944F1CA8676C2675D7CCC0"><enum>402.</enum><header>Increasing civil penalties applicable to certain violations of restrictions on sale and distribution of tobacco products</header><subsection id="HAC7C40B4EE4A4C44B4E7D9742A8663F1"><enum>(a)</enum><header>Penalties</header><text display-inline="yes-display-inline">Subparagraph (A) of section 103(q)(2) of the Family Smoking Prevention and Tobacco Control Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref> note) is amended to read as follows:</text><quoted-block style="OLC" id="H5B0FA3CAF11146FF970A7DCB7A342811" display-inline="no-display-inline" changed="added" reported-display-style="italic" committee-id="HIF00"><subparagraph id="HDD3EB459D8634DC9A38F782FE62916FF"><enum>(A)</enum><header>In general</header><text>The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows:</text><clause id="HBB990C084EA749239598BE31426B9C2D"><enum>(i)</enum><text>With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed—</text><subclause id="H6D2485463E434352BAB634671F78BF0E"><enum>(I)</enum><text display-inline="yes-display-inline">in the case of the first violation, $0, together with the issuance of a warning letter to the retailer;</text></subclause><subclause id="H67BB376633A24272B0986C4B36657E9D"><enum>(II)</enum><text>in the case of a second violation within a 12-month period, $500;</text></subclause><subclause id="H56CA609245D5457CBBE1BE40C0881A76"><enum>(III)</enum><text>in the case of a third violation within a 24-month period, $1,000;</text></subclause><subclause id="H79B576DD76EC485689A2C3B3636D199A"><enum>(IV)</enum><text>in the case of a fourth violation within a 24-month period, $4,000;</text></subclause><subclause id="H7F50CBA10E1A495FB8BD538A168A4C87"><enum>(V)</enum><text>in the case of a fifth violation within a 36-month period, $10,000; and</text></subclause><subclause id="H5C61C9DFF0A24C2FB1A03301C9889852"><enum>(VI)</enum><text>in the case of a sixth or subsequent violation within a 48-month period, $20,000 as determined by the Secretary on a case-by-case basis.</text></subclause></clause><clause id="HBCEE22D2E5A5444790D6A2DA96DAE7BC"><enum>(ii)</enum><text>With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed—</text><subclause id="HAEBC1628075E4D66BC4B2C99F39AA534"><enum>(I)</enum><text>in the case of the first violation, $500;</text></subclause><subclause id="H38CF99B715424BC28E476646BCAE7104"><enum>(II)</enum><text>in the case of a second violation within a 12-month period, $1,000;</text></subclause><subclause id="H6705967C6B524DD787FFF020F68A868E"><enum>(III)</enum><text>in the case of a third violation within a 24-month period, $2,000;</text></subclause><subclause id="HF74A18551A894E71843BE5360099BDE1"><enum>(IV)</enum><text>in the case of a fourth violation within a 24-month period, $4,000;</text></subclause><subclause id="HB2976767BD67400A9B54767BDA4EF230"><enum>(V)</enum><text>in the case of a fifth violation within a 36-month period, $10,000; and</text></subclause><subclause id="HFBD70A34210941A9AD02FD59E9769300"><enum>(VI)</enum><text>in the case of a sixth or subsequent violation within a 48-month period, $20,000 as determined by the Secretary on a case-by-case basis.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H303D468AC764463EA525BF756289ED15"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">The amendment made by subsection (a) applies with respect to a violation of a restriction promulgated under section 906(d)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387f">21 U.S.C. 387f(d)(1)</external-xref>), as described in section 103(q)(1) of the Family Smoking Prevention and Tobacco Control Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref> note), occurring on or after the date that is 6 months after the enactment of this Act. The penalties specified in such section 103(q)(1), as in effect on the day before such date, shall continue to apply to violations occurring before such date.</text></subsection></section><section id="HBF741EAAD6FA4771B16278D4653350F0"><enum>403.</enum><header>Study and report on e-cigarettes</header><text display-inline="no-display-inline">Not later than 5 years after the date of enactment of this Act, the Comptroller General of the United States shall—</text><paragraph id="H0734BBB7E6A14A81A328740C912642C8"><enum>(1)</enum><text>complete a study on—</text><subparagraph id="H1B4636C3E6FC4EC280393166BB9D8FD0"><enum>(A)</enum><text>the relationship of e-cigarettes to tobacco cessation;</text></subparagraph><subparagraph id="H793F46ED6DE94F35BDF77C29B0C43FE8"><enum>(B)</enum><text>the perception of the harmful effects of e-cigarettes; and</text></subparagraph><subparagraph id="H85B1043AE7CB46FB81B7B393B5D86E1A"><enum>(C)</enum><text>the effects of secondhand exposure to smoke from e-cigarettes; and</text></subparagraph></paragraph><paragraph id="HA1BCDF0E7D524A428799BCDB7A57C87E"><enum>(2)</enum><text>submit to the Congress a report on the results of such study, including recommendations based on such results.</text></paragraph></section></title></legis-body><endorsement display="yes"><action-date>February 21, 2020</action-date><action-desc>Reported with an amendment; committed to the Committee of the Whole House on the State of the Union and ordered to be printed</action-desc></endorsement></bill> 

