[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2194 Introduced in House (IH)]
<DOC>
115th CONGRESS
1st Session
H. R. 2194
To protect the public health by providing the Food and Drug
Administration with certain authority to regulate e-liquids and
personal electronic vaporizers, to reduce the morbidity and mortality
resulting from cigarette smoking through the responsible regulation of
e-liquids and personal electronic vaporizers as a tobacco harm
reduction strategy, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 27, 2017
Mr. Hunter introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To protect the public health by providing the Food and Drug
Administration with certain authority to regulate e-liquids and
personal electronic vaporizers, to reduce the morbidity and mortality
resulting from cigarette smoking through the responsible regulation of
e-liquids and personal electronic vaporizers as a tobacco harm
reduction strategy, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Cigarette Smoking
Reduction and Electronic Vapor Alternatives Act of 2017''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purposes of the Family Smoking Prevention and Tobacco Control
Act.
Sec. 4. Regulation of electronic vapor products.
Sec. 5. Joint comparative health risk assessment.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Cigarette smoking is the practice of burning tobacco
rolled in a paper and inhaling the smoke. According to the
Department of Health and Human Services--
(A) the burning of tobacco produces a chemical
mixture of more than 7,000 compounds;
(B) cigarette smoking causes cancer, heart disease,
stroke, lung diseases, diabetes, and chronic
obstructive pulmonary disease, and harms nearly every
organ of the body;
(C) cigarette smoking causes more than 480,000
deaths each year, including nearly 42,000 deaths due to
secondhand tobacco smoke;
(D) the economic cost of cigarette smoking is more
than $300 billion a year, including nearly $170 billion
in direct medical care, and more than $156 billion in
lost productivity; and
(E) nearly 7 in 10 adult cigarette smokers want to
quit smoking.
(2) Electronic vapor products, also known as ``electronic
cigarettes'' or ``e-cigarettes'', are battery-operated devices
that use low heat to turn e-liquid, which generally contains
nicotine, into a vaporized aerosol which is inhaled--there is
no burning of tobacco or generation of smoke for inhalation.
(3) Evidence from numerous studies strongly suggests that
electronic vapor products are magnitudes safer than
traditional, combustible cigarettes. Studies have found that
several million regular vapers in the United States no longer
regularly smoke cigarettes.
(4) Studies of cigarette smokers who switched to vapor
found significant improvements in lung function, including a
study finding asthmatic smokers who switched to vapor had
significant improvements in spirometry data, asthma control,
airway hyperresponsiveness, and lower blood pressure.
(5) The Royal College of Physicians 2016 report on e-
cigarettes titled, ``Nicotine without smoke: Tobacco harm
reduction'' issued the following findings:
(A) The available evidence to date indicates that
e-cigarettes are being used almost exclusively as safer
alternatives to smoked tobacco, by confirmed smokers
who are trying to reduce harm to themselves or others
from smoking, or to quit smoking completely.
(B) The hazard to health arising from long-term
vapor inhalation from the e-cigarettes available today
is unlikely to exceed 5 percent of the harm from
smoking tobacco.
(C) E-cigarettes are marketed as consumer products
and are proving much more popular than Food and Drug
Administration-approved nicotine replacement therapies
(NRT) as a substitute and competitor for tobacco
cigarettes.
(6) ``E-liquid'' is the liquid that is heated into vapor.
It contains, principally, propylene glycol, vegetable glycerin,
in some cases food flavoring, in some cases nicotine, and in
some cases water; propylene glycol and vegetable glycerin are
designated as ``generally recognized as safe'' by the Food and
Drug Administration (FDA) as food additives.
(7) Surveys have found that a significant majority of
regular users of electronic vapor products had previously tried
FDA-approved smoking cessation drugs to quit smoking without
success.
(8) An expert independent evidence review published by
Public Health England (PHE) concluded that--
(A) the use of vapor products is about 95 percent
less harmful than cigarette smoking;
(B) nearly half the population doesn't realize
vapor is much less harmful than smoking; and
(C) there is no evidence suggesting electronic
vapor products act as a route into smoking for children
or nonsmokers.
(9) Electronic vapor product sales in the United States
have increased from an estimated $100 million in 2010 to $4
billion in 2016 while cigarette consumption in the United
States declined from $307 billion in 2010 to an estimated $265
billion in 2016.
(10) On May 10, 2016, the Food and Drug Administration
issued its ``Deeming Regulation'' to deem e-cigarettes or
electronic vapor products to be subject to its authority. The
regulation will, as a practical matter, because of its
significant compliance costs and poorly articulated standard
for protecting public health, ban the sale of all electronic
vapor products by August 2018.
(11) The Food and Drug Administration's Deeming Regulation,
by effectively banning electronic vapor products, will push
vapers who have quit or reduced cigarette smoking by switching
to electronic vapor products back to smoking deadly cigarettes.
(12) The 2015 Monitoring the Future survey of the National
Institute on Drug Abuse found past-30-day use of an electronic
vapor product by 8th, 10th, and 12th graders combined declined
from 13.9 percent in 2014 to 9.9 percent in 2016; however, that
survey found that fewer than 20 percent of teens who used an
electronic vapor product in the past 30 days reported using a
product containing nicotine.
(13) Electronic vapor products show tremendous promise in
reducing cigarette smoking, and cigarette smoking attributable
morbidity, mortality, and health care costs.
(14) According to an April 13, 2017, Centers for Disease
Control and Prevention study, more Americans who are trying to
quit smoking use vapor products (35.3 percent) than any other
smoking cessation tool. This includes using a nicotine patch or
gum (25.4 percent), getting help from a doctor or other health
professional (15.2 percent), using smoking cessation
medications approved by the Food and Drug Administration (12.2
percent), and getting help from a website (7.1 percent) or a
telephone quitline (5.4 percent).
(15) Since the Food and Drug Administration was granted
authority to regulate tobacco products in 2009, the agency has
failed to grant market approval to any modified risk tobacco
product.
SEC. 3. PURPOSES OF THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL
ACT.
Section 3 of the Family Smoking Prevention and Tobacco Control Act
(21 U.S.C. 387 note) is amended by amending paragraph (9) to read as
follows:
``(9) to promote--
``(A) cessation to reduce disease risk and the
social costs associated with tobacco-related diseases;
and
``(B) harm reduction strategies; and''.
SEC. 4. REGULATION OF ELECTRONIC VAPOR PRODUCTS.
(a) Center for Tobacco Products and Tobacco Harm Reduction.--
Section 901(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
387a(e)) is amended--
(1) in the subsection heading, by striking ``Center for
Tobacco Products'' and inserting ``Center for Tobacco Products
and Tobacco Harm Reduction'';
(2) by striking ``Center for Tobacco Products'' and
inserting ``Center for Tobacco Products and Tobacco Harm
Reduction''; and
(3) by striking ``this chapter'' and inserting ``this
chapter and chapter X''.
(b) FDA Authority Over Electronic Vapor Products.--
(1) Exclusion from definition of tobacco product.--Section
201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(rr)) is amended--
(A) in paragraph (2), by inserting ``an e-liquid
(as defined in section 1001), a personal electronic
vaporizer (as defined in section 1001),'' before ``or a
combination product''; and
(B) in paragraph (3), by inserting after ``The
products described in paragraph (2)'' the following:
``(other than an e-liquid or personal electronic
vaporizer)''.
(2) Combination products.--Section 503(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is amended--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking ``or
biological product'' and inserting ``,
biological product, e-liquid, or personal
electronic vaporizer''; and
(ii) in subparagraph (D)--
(I) in clause (ii), by striking
``or'' at the end;
(II) in clause (iii), by striking
the period at the end and inserting ``;
or''; and
(III) by adding at the end the
following:
``(iv) an e-liquid or personal electronic vaporizer, the
agency center charged with regulating e-liquids and personal
electronic vaporizers shall have primary jurisdiction.''; and
(B) in paragraph (9)--
(i) by redesignating subparagraphs (C) and
(D) as subparagraphs (D) and (E), respectively;
and
(ii) by inserting after subparagraph (B)
the following:
``(C) The terms `e-liquid' and `personal electronic
vaporizer' have the meanings given to such terms in section
1001.''.
(3) Regulatory authority.--The Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(A) by redesignating chapter X as chapter XI;
(B) by redesignating sections 1001 through 1014 as
sections 1101 through 1114, respectively;
(C) in section 505(n)(2), by striking ``1004'' and
inserting ``1104'';
(D) in sections 523(b)(2)(D) and 704(g)(13), by
striking ``1003(g)'' and inserting ``1103(g)'';
(E) in section 1109(a)(5)(A), as redesignated by
paragraph (4), by striking ``1008'' and inserting
``1108''; and
(F) by inserting after chapter IX the following:
``CHAPTER X--ELECTRONIC VAPOR PRODUCTS
``SEC. 1001. DEFINITIONS.
``In this chapter:
``(1) The term `e-liquid' means any liquid solution that--
``(A) may or may not contain nicotine; and
``(B) is intended to be converted into an aerosol,
vapor, or vapor-like mist for users to inhale through
the mouthpiece of a personal electronic vaporizer.
``(2) The term `personal electronic vaporizer' means an
electronic device that employs a heating element or atomizer
that converts an e-liquid into an aerosol, vapor, or vapor-like
mist through a noncombustive process.
``(3) The terms `e-liquid' and `personal electronic
vaporizer' exclude--
``(A) a drug as defined in section 201(g)(1);
``(B) a device as defined in section 201(h); and
``(C) a biological product as defined in section
351 of the Public Health Service Act.
``SEC. 1002. EXCLUSIVE AUTHORITY FOR REGULATING E-LIQUIDS AND PERSONAL
ELECTRONIC VAPORIZERS.
``The authorities vested by this chapter constitute the exclusive
authorities of the Secretary to regulate e-liquids and personal
electronic vaporizers, except to the extent e-liquids and personal
electronic vaporizers are within combination products regulated
pursuant to section 503(g).
``SEC. 1003. PROHIBITED ACTS; PENALTIES.
``(a) Prohibitions.--
``(1) In general.--The following acts and the causing
thereof are hereby prohibited:
``(A) The sale of an electronic vapor product or e-
liquid to any person younger than 18 years of age.
``(B) The manufacture of an e-liquid or personal
electronic vaporizer in noncompliance with the
standards under section 1004(b) in violation of an
order issued under section 1004(e).
``(C) The offering of e-liquids or personal
electronic vaporizers for sale in interstate commerce
by an e-liquid or personal electronic vaporizer
manufacturer that does not have a certification in
effect as required by section 1004(c).
``(D) The failure by an e-liquid or personal
electronic vaporizer manufacturer to provide access for
inspection as required by section 1004(d).
``(E) The introduction or delivery for introduction
in interstate commerce of an e-liquid or personal
electronic vaporizer by any person that is adulterated
or misbranded, as described in subsection (b) or (c)
respectively.
``(2) Retailers.--Notwithstanding subparagraphs (A) and (E)
of paragraph (1), a retailer may be found to be in violation of
either such subparagraph (with respect to sale or introduction
or delivery for introduction in interstate commerce at retail)
only if the violation occurs knowingly.
``(b) Adulteration.--An e-liquid or personal electronic vaporizer
shall be treated as adulterated if--
``(1) it was manufactured in noncompliance with the
standards under section 1004(b) in violation of an order issued
under section 1004(e); or
``(2) it was manufactured by an e-liquid or personal
electronic vaporizer manufacturer that does not have a
certification in effect as required by section 1004(c).
``(c) Misbranding.--An e-liquid or personal electronic vaporizer
shall be treated as misbranded if its labeling (as such term is defined
in section 201 with respect to drugs) is in noncompliance with the
standards under section 1004(b) in violation of an order issued under
section 1004(e).
``(d) Penalties.--Any person who violates a provision of subsection
(a) shall be imprisoned not more than 3 years, fined not more than
$10,000 (notwithstanding section 3571(e) of title 18, United States
Code) for each day on which the violation continues, or both.
``SEC. 1004. STANDARDS FOR THE MANUFACTURING OF E-LIQUIDS AND PERSONAL
ELECTRONIC VAPORIZERS; COMPLIANCE.
``(a) Requirement.--Beginning on the date that is 1 year after the
date of enactment of the Cigarette Smoking Reduction and Electronic
Vapor Alternatives Act of 2017, any e-liquid or personal electronic
vaporizer introduced or delivered for introduction into interstate
commerce shall conform to the e-liquid or personal electronic vaporizer
(as applicable) manufacturing standards under subsection (b), including
the labeling standards therein.
``(b) Manufacturing Standards.--
``(1) E-liquids.--The manufacturing standards for e-liquids
under this subsection shall consist of the following:
``(A) Interim standards.--The e-liquid
manufacturing standards issued by the American E-Liquid
Manufacturing Standards Association (version 2.3.2) on
March 8, 2017 (including any revision to such standards
made in accordance with paragraph (3)), apply to the
introduction or delivery for introduction into
interstate commerce of e-liquids during the period
beginning on the date described in subsection (a) and
ending on the date described in subparagraph (B).
``(B) Subsequent standards.--The e-liquid
manufacturing standards of the American National
Standards Institute (including any revision to such
standards made in accordance with paragraph (3)) apply
to the introduction or delivery for introduction into
interstate commerce of e-liquids beginning on the date
of the adoption of such standards by the American
National Standards Institute.
``(2) Personal electronic vaporizers.--The manufacturing
standards for personal electronic vaporizers under this
subsection shall consist of the following:
``(A) Battery safety.--Any battery used in a
personal electronic vaporizer shall conform to the IEC
62133 standards of the International Electrotechnical
Commission, as in effect on the date of enactment of
the Cigarette Smoking Reduction and Electronic Vapor
Alternatives Act of 2017 and including any revision to
such standards made in accordance with paragraph (3).
``(B) Short circuit protection.--A personal
electronic vaporizer shall have a mechanism to ensure
user and battery safety in the event of a short circuit
of the heating element.
``(C) Discharge monitoring.--A rechargeable
personal electronic vaporizer shall have a mechanism to
prevent the battery from being discharged below a safe
voltage during use or discharged faster than the
battery can sustain safely.
``(D) Charge monitoring.--A personal electronic
vaporizer that contains an onboard charger shall
include circuitry to monitor the battery voltage and
charge current and limit these to safe levels. A
personal electronic vaporizer that contains multiple
battery cells in series shall monitor the cells
individually.
``(E) Serial and lot numbers.--A personal
electronic vaporizer shall include a serial or lot
number on the label that allows the vaporizer to be
traced to its time and place of manufacture.
Notwithstanding the preceding sentence, a single-use
personal electronic vaporizer may have such serial or
lot number on the packaging of the vaporizer other than
the label.
``(F) Verification and validation.--A personal
electronic vaporizer shall be constructed with
sufficiently validated processes, or subject to
sufficient verification and testing, to ensure that
each individual vaporizer conforms to its
specifications.
``(G) Tracking and recalls.--The manufacturer of a
personal electronic vaporizer shall record all
shipments of one or more personal electronic vaporizers
by the manufacturer to a distributor, retailer, or end
user, and correlate each such shipment to serial or lot
numbers, to enable batch tracking and recalls.
``(H) Materials.--The manufacturer of a personal
electronic vaporizer shall ensure that--
``(i) materials that come in contact with
e-liquids or vapor during manufacture or
reasonably foreseeable use of the personal
electronic vaporizer are limited to approved
medical or food contact grade products with
established safety and biocompatibility
characteristics; and
``(ii) components of a personal electronic
vaporizer which are expected to be subject to
heat are appropriate for the expected
temperatures.
``(3) Revisions.--Before issuing a revision to the
standards applicable under paragraph (1)(A), (1)(B), or (2)(A),
the American E-Liquid Manufacturing Standards Association, the
American National Standards Institute, or the International
Electrotechnical Commission, as applicable, shall notify the
Secretary in writing of the proposed revision. Not later than
90 days after the date of receipt of such notice, the Secretary
shall determine whether the proposed revision enhances the
safety and quality of e-liquid products or personal electronic
vaporizers, as applicable. If the Secretary determines that the
proposed revision does enhance the safety and quality of e-
liquid products or personal electronic vaporizers, as
applicable, the Secretary shall give notice of such
determination to the public for a period of 90 days and,
effective at the end of such period, incorporate the revision
into the standards applicable under paragraph (1)(A), (1)(B),
or (2)(A), as applicable.
``(c) Certification of Compliance With Manufacturing Standards.--
Beginning not later than 1 year after the date of enactment of the
Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of
2017, each e-liquid and personal electronic vaporizer manufacturer
offering e-liquids for sale in interstate commerce shall have in effect
a certification filed with the Secretary in writing that all such e-
liquids or personal electronic vaporizers, as applicable, are
manufactured, labeled, and otherwise in compliance with the standards
under subsection (b).
``(d) Inspections for Compliance With Manufacturing Standards.--E-
liquid and personal electronic vaporizer manufacturers shall provide
the Secretary with access to their facilities used in manufacturing e-
liquids or personal electronic vaporizers, as applicable, for
inspection.
``(e) Failure To Comply With Manufacturing Standards.--
``(1) In general.--If the Secretary finds that an e-liquid
or personal electronic vaporizer manufacturer is in
noncompliance with the standards under subsection (b)--
``(A) the Secretary shall not take any enforcement
action based on such noncompliance unless--
``(i) the Secretary gives the manufacturer
notice of, and a period of 90 days to correct,
such noncompliance; and
``(ii) the manufacturer fails, by the end
of such 90-day period, to correct such
noncompliance; and
``(B) if the manufacturer fails to correct such
noncompliance, as described in paragraph (1)(A)(ii),
the Secretary may issue an order requiring the
manufacturer--
``(i) to suspend any commercial activity
that the Secretary finds to be in
noncompliance; and
``(ii) to not resume such activity until
the manufacturer demonstrates to the
Secretary's satisfaction that such
noncompliance has been corrected.
``(2) Immediate danger to public health.--Notwithstanding
paragraph (1), if the Secretary determines that an e-liquid or
personal electronic vaporizer manufacturer is in noncompliance
with the standards under subsection (b), and that such
noncompliance presents an immediate danger to public health,
the Secretary may issue an order requiring the manufacturer to
suspend production of such e-liquid or personal electronic
vaporizer until the Secretary determines that such
noncompliance is corrected.
``SEC. 1005. PROHIBITION AGAINST ADVERTISING OR PROMOTING TO MINORS.
``(a) Prohibition.--The Secretary may by regulation prohibit any
manufacturer of an e-liquid or personal electronic vaporizer from
advertising or promoting the e-liquid or personal electronic vaporizer
to individuals who have not attained 18 years of age.
``(b) Penalty.--If a manufacturer violates a prohibition
established under subsection (a), the Secretary may refuse to accept
for filing or renewal, and may revoke, the manufacturer's certification
under section 1004(c).
``SEC. 1006. PREEMPTION OF CERTAIN STATE AND LOCAL REQUIREMENTS.
``(a) In General.--No State or political subdivision of a State may
establish or continue in effect any requirement with respect to the
manufacture, warning requirements, marketing, distribution, or sale of
an e-liquid or personal electronic vaporizer which is different from,
or in addition to, any requirement under the provisions of this chapter
or pursuant to section 503(g), including the exclusion of e-liquids and
personal electronic vaporizers from the definition of a tobacco product
under section 201.
``(b) Exception.--Information disclosed to a State consistent with
subsection (a) that is exempt from disclosure under section 552(b)(4)
of title 5, United States Code, shall be treated as a trade secret and
confidential information by the State.
``SEC. 1007. OFFICE FOR E-LIQUID AND PERSONAL ELECTRONIC VAPORIZER
STANDARDS COMPLIANCE.
``Not later than 90 days after the date of enactment of the
Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of
2017, the Secretary shall establish within the Food and Drug
Administration's Center for Tobacco Products and Tobacco Harm Reduction
an Office of E-Liquid and Personal Electronic Vaporizer Standards
Compliance. The Office shall--
``(1) be responsible for the implementation of this chapter
and related matters assigned by the Director of such Center;
and
``(2) provide technical and other nonfinancial assistance
to e-liquid and personal electronic vaporizer manufacturers to
assist them in complying with the requirements of this Act.''.
SEC. 5. JOINT COMPARATIVE HEALTH RISK ASSESSMENT.
Chapter X of the Federal Food, Drug, and Cosmetic Act, as added by
section 4, is further amended by adding at the end the following:
``SEC. 1008. TOBACCO PRODUCTS AND NICOTINE DELIVERY ALTERNATIVES:
COMPARATIVE HEALTH RISK ASSESSMENT.
``(a) Assessment.--The Secretary shall undertake a tobacco products
and other nicotine delivery alternatives comparative health risk
assessment and rank each category of products on a scale according to
the reasonable expectation for morbidity and mortality risk when
compared to smoking cigarettes based on laboratory studies and existing
scientific data. For purposes of such assessment, tobacco and nicotine
delivery alternative product categories shall include at a minimum--
``(1) cigarettes;
``(2) loose tobacco for roll-your-own tobacco products;
``(3) little cigars;
``(4) cigars;
``(5) pipe tobacco;
``(6) moist snuff;
``(7) dry snuff;
``(8) chewing tobacco;
``(9) snus;
``(10) vaporized tobacco, meaning `heat not burn'
technology intended for inhalation;
``(11) vapor produced by a personalized electronic
vaporizer containing e-liquid with nicotine;
``(12) shisha and other tobacco products that are heated
and inhaled via a hookah, water pipe, or other type of pipe
(treated collectively as a single category);
``(13) dissolvable, chewable, drinkable, and other tobacco
and nicotine products intended for oral ingestion (treated
collectively as a single category);
``(14) tobacco and nicotine skin creams, patches, and other
tobacco and nicotine products intended for transdermal
consumption (treated collectively as a single category);
``(15) tobacco and nicotine sprays, droplets, and mists
intended for nasal consumption (treated as a single category);
and
``(16) other nicotine-containing products (treated
collectively as a single category).
``(b) Report.--Not later than 18 months after the date of enactment
of the Cigarette Smoking Reduction and Electronic Vapor Alternatives
Act of 2017, the Secretary shall report to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate on the results of the
comparative health risk assessment under subsection (a). Based on such
results, such report shall include recommendations on--
``(1) new or improved tobacco harm reduction strategies;
and
``(2) the possible need for additional legislative
authorities to implement such strategies.''.
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