[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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