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<dc:title>117 HR 3051 IH: Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act of 2021</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-05-07</dc:date>
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<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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<distribution-code display="yes">I</distribution-code><congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 3051</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20210507">May 7, 2021</action-date><action-desc><sponsor name-id="K000391">Mr. Krishnamoorthi</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 display="yes">To amend the Federal Food, Drug, and Cosmetic Act to establish a tobacco product standard prohibiting any e-liquid with a concentration of nicotine higher than 20 milligrams per milliliter, and for other purposes.</official-title></form><legis-body id="H6A6809FEA3CF4EEA83D5AB693A18EAB5" style="OLC"><section id="HBC0516E1150242E8838308D333F47A02" 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>Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act of 2021</short-title></quote> or the <quote><short-title>END ENDS Act of 2021</short-title></quote>.</text></section><section id="HC31A3CF55C474A36916E33E21CB36284"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds as follows:</text><paragraph id="HDED784DA10814D91BAE48C35C27DB400"><enum>(1)</enum><text>According to the Centers for Disease Control and Prevention (in this section referred to as the <quote>CDC</quote>), the brain keeps developing until approximately age 25, and nicotine exposure can harm the parts of the brain that control attention, learning, mood, and impulse control.</text></paragraph><paragraph id="HEB80CF5BE04F4E7498F48B808E1917A6"><enum>(2)</enum><text>Adolescent nicotine use may also increase the risk of future addiction to other drugs.</text></paragraph><paragraph id="H9F17A1F112094786B0E03A23F6D2DE38"><enum>(3)</enum><text>A recent CDC study found that 99 percent of e-cigarettes sold in the United States contain nicotine.</text></paragraph><paragraph id="H9BD54EFFE6D246CABA6455B49356791F"><enum>(4)</enum><text>In congressional testimony before the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives on September 24, 2019, CDC Principal Deputy Director Anne Schuchat stated that <quote>fourth generation e-cigarette devices</quote> were first sold in 2015 and <quote>use nicotine salts, which can lead to much more available nicotine</quote>.</text></paragraph><paragraph id="H4D95B01F651142B88EE9C5A307997F69"><enum>(5)</enum><text>According to Dr. Schuchat’s testimony, fourth generation devices <quote>can cross the blood-brain barrier and lead to potentially more effects on the developing brain in adolescents</quote>. Further, <quote>the very high levels of accessible nicotine and the discreet use of the product</quote> directly link the growing popularity of fourth generation e-cigarette devices to the rise in youth e-cigarette use.</text></paragraph><paragraph id="H308B4EF5F113455CA2DAFC12A96F4322"><enum>(6)</enum><text>Prior to the use of nicotine salts, which are now used in the e-liquids of the most popular e-cigarettes, most e-cigarettes contained <quote>freebase nicotine</quote>. Because freebase nicotine has a much harsher effect on the inhaler, these e-cigarette devices contained much less nicotine than devices which contain nicotine salts.</text></paragraph><paragraph id="HBF527D5556D14EE3A5F4B365847B3C4B"><enum>(7)</enum><text>The most popular e-cigarette manufactured and sold in the United States, which is considered a <quote>fourth generation device</quote>, most frequently contains an <quote>e-liquid</quote> with 59 milligrams per milliliter of nicotine.</text></paragraph><paragraph id="H519C8D6233D14BCB8FB49913FC688B0E"><enum>(8)</enum><text>In response, the European Union, the United Kingdom, and Israel implemented regulations to cap the concentration of nicotine in e-cigarette e-liquids to 20 milligrams per milliliter.</text></paragraph><paragraph id="H51A095AC589E45A3A92B29628D207BFD"><enum>(9)</enum><text display-inline="yes-display-inline">The United Kingdom’s nicotine cap went into effect on May 20, 2017. As youth use skyrocketed in the United States between 2017 and 2018, the percentage of youth e-cigarette users who use more than once a week only rose from 1.2 percent to 1.7 percent, and the percentage of youth who use less than weekly decreased from 2.2 percent to 1.8 percent.</text></paragraph><paragraph id="H3EFCEB1ADB154F36B632FC6313543EE6"><enum>(10)</enum><text>E-cigarettes manufactured and sold in the United States are currently not subject to any nicotine cap, and e-cigarette manufacturers are permitted to design their products to be as addictive as possible.</text></paragraph><paragraph id="H73E9B5860507497C86D2372A83D5F1C2"><enum>(11)</enum><text display-inline="yes-display-inline">According to the 2020 National Youth Tobacco Survey, approximately 3,600,000 youths use e-cigarettes, including 19.6 percent of high school students and 4.7 percent of middle school students.</text></paragraph><paragraph id="H934CAEFA64764D2387F91277D1E3461E"><enum>(12)</enum><text display-inline="yes-display-inline">Among high school students who smoke e-cigarettes, nearly 40 percent report using them 20 or more days per month, and nearly one-quarter report using them daily.</text></paragraph><paragraph id="HB491729709C449D9BDDAE3ED29262843"><enum>(13)</enum><text>The CDC, the Food and Drug Administration, the Department of Health and Human Services, the Surgeon General of the Public Health Service, and various State and local health authorities have determined the skyrocketing e-cigarette use amongst American youth to be an “epidemic”.</text></paragraph></section><section id="HCAA4164A947A44DFA4C5B6446A2339A5"><enum>3.</enum><header>Sense of Congress</header><text display-inline="no-display-inline">It is the sense of the Congress that—</text><paragraph id="HB03278A6D89B42E48DA97802BA21D1B2"><enum>(1)</enum><text>effectively combating the youth e-cigarette epidemic will require the implementation of bold and enduring policy solutions;</text></paragraph><paragraph id="H8A43DE3DF0374FE5B3EC16A721A7D3C8"><enum>(2)</enum><text>under the current regulatory framework, American youth have easy access to highly addictive <quote>fourth generation</quote> e-cigarette devices that hook them into a lifelong addiction to nicotine;</text></paragraph><paragraph id="H883420C2A95C4BA794D8B12D502EE346"><enum>(3)</enum><text>in order to significantly decrease youth e-cigarette use and to reduce the dangers associated with excessive nicotine inhalation, the Federal Government should regulate nicotine levels in e-cigarettes in order to make them less addictive and less harmful to youth; and</text></paragraph><paragraph id="HF3566A9B7A9A45ED9BF3E9C51CA0251A"><enum>(4)</enum><text>in addition to regulating nicotine levels, the Federal Government should also review other factors related to the composition and function of fourth generation e-cigarettes in order to make them less addictive and appealing to youth, including battery power and design.</text></paragraph></section><section id="H79155BD508CC4790AA37C7B30DCB365B"><enum>4.</enum><header>Maximum nicotine content in e-liquids</header><subsection id="HA1A094AF9E1D4BF2BB9C0CA35022D805"><enum>(a)</enum><header>Tobacco product standard</header><text display-inline="yes-display-inline">Paragraph (1) of section 907(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/387g">21 U.S.C. 387g(a)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block display-inline="no-display-inline" id="HCB6721B65ADA4BF598982FAACAA593D1" style="OLC"><subparagraph id="H144FAE3DD0DF421D9BBB9A9D7DF9F974"><enum>(C)</enum><header>Nicotine content in e-liquids</header><text display-inline="yes-display-inline">Beginning on the date of enactment of the <short-title>Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act of 2021</short-title>, an e-liquid shall not have a concentration of nicotine higher than—</text><clause id="H2639D4F1A1B14FDDB3C84E73F848E169"><enum>(i)</enum><text>20 milligrams per milliliter; or</text></clause><clause id="H236B4847CB8B4E64B8F075FEC3D0D4FE"><enum>(ii)</enum><text>such lower nicotine concentration as is determined by the Secretary to be minimally addictive or non-addictive.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HE59A8B9CA4E04EDC92DFD4063FB752F7"><enum>(b)</enum><header>Definitions</header><paragraph id="HECB191237F984F01AAFA327C8155F317"><enum>(1)</enum><header>In general</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="H51059CC83E174B9F913CBDA00EF0BD6F"><enum>(A)</enum><text>by redesignating paragraphs (8) through (22) as paragraphs (10) through (24), respectively; and</text></subparagraph><subparagraph id="HD3D3FEA93DBE42A587639D07A6ADF8A9"><enum>(B)</enum><text>by inserting after paragraph (7) the following:</text><quoted-block display-inline="no-display-inline" id="H2DEE851F0ECD43E8AF8EC081723BE12E" style="OLC"><paragraph id="HD553EF0617664DF3BF99439A3FCBEA66"><enum>(8)</enum><header>Electronic nicotine delivery system</header><text display-inline="yes-display-inline">The term <term>electronic nicotine delivery system</term> means a tobacco product that is an 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.</text></paragraph><paragraph id="H3E3B3D3F19C24D20ABBEC2E55DFCF992"><enum>(9)</enum><header>E-liquid</header><text>The term <term>e-liquid</term> means any liquid intended for use with an electronic nicotine delivery system.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H23AF7191215D47C59BDE1EC10F4F934C"><enum>(2)</enum><header>Conforming amendment</header><text>Section 9(1) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/15/4408">15 U.S.C. 4408(1)</external-xref>) is amended by striking <quote>900(18)</quote> and inserting <quote>900(20)</quote>.</text></paragraph></subsection></section></legis-body></bill> 

