[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3051 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 3051

   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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 7, 2021

Mr. Krishnamoorthi introduced the following bill; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Ending Nicotine Dependence from 
Electronic Nicotine Delivery Systems Act of 2021'' or the ``END ENDS 
Act of 2021''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) According to the Centers for Disease Control and 
        Prevention (in this section referred to as the ``CDC''), 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.
            (2) Adolescent nicotine use may also increase the risk of 
        future addiction to other drugs.
            (3) A recent CDC study found that 99 percent of e-
        cigarettes sold in the United States contain nicotine.
            (4) 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 
        ``fourth generation e-cigarette devices'' were first sold in 
        2015 and ``use nicotine salts, which can lead to much more 
        available nicotine''.
            (5) According to Dr. Schuchat's testimony, fourth 
        generation devices ``can cross the blood-brain barrier and lead 
        to potentially more effects on the developing brain in 
        adolescents''. Further, ``the very high levels of accessible 
        nicotine and the discreet use of the product'' directly link 
        the growing popularity of fourth generation e-cigarette devices 
        to the rise in youth e-cigarette use.
            (6) 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 ``freebase nicotine''. 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.
            (7) The most popular e-cigarette manufactured and sold in 
        the United States, which is considered a ``fourth generation 
        device'', most frequently contains an ``e-liquid'' with 59 
        milligrams per milliliter of nicotine.
            (8) 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.
            (9) 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.
            (10) 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.
            (11) 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.
            (12) 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.
            (13) 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''.

SEC. 3. SENSE OF CONGRESS.

    It is the sense of the Congress that--
            (1) effectively combating the youth e-cigarette epidemic 
        will require the implementation of bold and enduring policy 
        solutions;
            (2) under the current regulatory framework, American youth 
        have easy access to highly addictive ``fourth generation'' e-
        cigarette devices that hook them into a lifelong addiction to 
        nicotine;
            (3) 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
            (4) 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.

SEC. 4. MAXIMUM NICOTINE CONTENT IN E-LIQUIDS.

    (a) Tobacco Product Standard.--Paragraph (1) of section 907(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)) is amended 
by adding at the end the following new subparagraph:
                    ``(C) Nicotine content in e-liquids.--Beginning on 
                the date of enactment of the Ending Nicotine Dependence 
                from Electronic Nicotine Delivery Systems Act of 2021, 
                an e-liquid shall not have a concentration of nicotine 
                higher than--
                            ``(i) 20 milligrams per milliliter; or
                            ``(ii) such lower nicotine concentration as 
                        is determined by the Secretary to be minimally 
                        addictive or non-addictive.''.
    (b) Definitions.--
            (1) In general.--Section 900 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 387) is amended--
                    (A) by redesignating paragraphs (8) through (22) as 
                paragraphs (10) through (24), respectively; and
                    (B) by inserting after paragraph (7) the following:
            ``(8) Electronic nicotine delivery system.--The term 
        `electronic nicotine delivery system' 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.
            ``(9) E-liquid.--The term `e-liquid' means any liquid 
        intended for use with an electronic nicotine delivery 
        system.''.
            (2) Conforming amendment.--Section 9(1) of the 
        Comprehensive Smokeless Tobacco Health Education Act of 1986 
        (15 U.S.C. 4408(1)) is amended by striking ``900(18)'' and 
        inserting ``900(20)''.
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