Stop Selling and Marketing to Our Kids E-Cigarettes Act or the SMOKE Act - Amends the Food, Drug, and Cosmetic Act to define "electronic nicotine delivery system" (e-cigarette) and "e-liquid" (solution used in an e-cigarette). Gives the Food and Drug Administration (FDA) authority to regulate e-cigarettes and e-liquids as tobacco products.
Amends the Federal Cigarette Labeling and Advertising Act to include e-cigarettes and e-liquids in the definition of cigarettes, thereby: (1) requiring warning labels to appear on packaging and advertising, and (2) prohibiting advertising in electronic media regulated by the Federal Communications Commission (FCC).
Requires the FDA to study the effects of flavorings added to e-cigarettes and e-liquids, including whether flavorings appeal to children or help adults quit smoking. Requires, upon completion of the study, the FDA to consider restricting the use of flavorings.
Directs the FDA to require child-proof packaging for e-cigarettes and e-liquids.
Directs the FDA to set nicotine dosage and concentration limits for e-cigarettes and e-liquids, respectively, and allows for exceptions.
Prohibits advertisement, promotion, or marketing of e-cigarettes and e-liquids in a manner that increases their use by minors. Sets forth authority for: (1) the Federal Trade Commission (FTC) to enforce violations as an unfair or deceptive act or practice, and (2) states to bring civil actions on behalf of residents threatened or adversely affected by such a violation. Allows the FTC to intervene and appeal in state actions.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5010 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 5010
To provide greater clarity in the regulation of electronic nicotine
delivery systems, including electronic cigarettes, cigars, cigarillos,
pipes, and hookahs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 26, 2014
Ms. Speier (for herself, Mr. Cardenas, Mr. Rangel, and Ms. Schakowsky)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To provide greater clarity in the regulation of electronic nicotine
delivery systems, including electronic cigarettes, cigars, cigarillos,
pipes, and hookahs, 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 ``Stop Selling and Marketing to Our
Kids E-Cigarettes Act'' or the ``SMOKE Act''.
SEC. 2. FINDINGS; SENSE OF CONGRESS.
(a) Findings.--Congress finds the following:
(1) According to the Food and Drug Administration, because
electronic cigarettes have not been fully studied, consumers
currently do not know--
(A) the potential risks of electronic cigarettes
when used as intended;
(B) how much nicotine or other potentially harmful
chemicals are being inhaled during use; or
(C) if there are any benefits associated with using
these products.
(2) Use of electronic cigarettes has risen in youth
according to a study by the Centers for Disease Control and
Prevention that was released in September 2013, which found
that in one year, from 2011 to 2012, the percentage of middle
and high school students who had ever used electronic
cigarettes more than doubled.
(3) Electronic cigarette use may lead children to become
addicted to nicotine and could be a gateway to various tobacco
products.
(4) Additionally, according to the Centers for Disease
Control and Prevention, 1 in 5 middle school students who
reported ever using electronic cigarettes had never tried
conventional cigarettes.
(5) Marketing of electronic cigarettes to youth is
occurring in the form of advertising using cartoons and
sponsorships of events popular with youth such as concerts and
sporting events.
(6) According to the Centers for Disease Control and
Prevention, Poison Control Centers reported rapid increase in
electronic cigarette-related exposures, of which 51.1 percent
were among young children. Electronic cigarette exposure calls
per month increased from one in September 2010 to 215 in
February 2014.
(7) Due to the lack of long-term studies, we do not know
the viability of claims that electronic cigarettes help to
lessen dependence on regular cigarettes.
(8) According to a paper entitled ``E-Cigarettes: A
Scientific Review'' published in the American Heart
Association's peer-reviewed journal Circulation, electronic
cigarettes contain particles small enough to get into the lungs
and then cross into the systemic circulation just like
cigarettes. Therefore, electronic cigarettes do not only
produce ``water vapor'' as is claimed in the marketing of these
products. Furthermore, the particle size distribution and
number of particles delivered by electronic cigarettes are
similar to those contained in conventional cigarettes. There is
already strong evidence that frequent low or short-term levels
of exposure to these types of particles from tobacco smoke or
air pollution can contribute to health problems such as the
increased risk of cardiovascular and respiratory disease and
death.
(9) The e-liquids used in electronic cigarettes may be
toxic if ingested or absorbed through the skin at relatively
low quantities. The lack of childproof containers makes this
even more of a safety risk for children.
(b) Sense of Congress.--It is the sense of Congress that--
(1) the Food and Drug Administration--
(A) has been authorized to regulate the sale,
labeling, packaging, marketing, and advertising of
electronic nicotine delivery systems and e-liquids
since the enactment of the Family Smoking Prevention
and Tobacco Control Act on June 22, 2009; and
(B) should exercise this authority; and
(2) the Federal Trade Commission should prohibit the
advertising, promoting, and marketing in commerce of electronic
nicotine delivery systems and e-liquids to children as an
unfair or deceptive act or practice, in order to protect the
health of the youth of the United States.
SEC. 3. FDA REGULATION OF ELECTRONIC NICOTINE DELIVERY SYSTEMS AND E-
LIQUIDS.
(a) Definitions.--Section 900 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 387) is amended--
(1) by redesignating paragraphs (8) through (22) as
paragraphs (10) through (24), respectively; and
(2) by inserting after paragraph (7) the following:
``(8) Electronic nicotine delivery system.--The term
`electronic nicotine delivery system'--
``(A) means any product, the use of which may
resemble smoking, that provides an inhalable dose of
nicotine by delivery of a vaporized solution, including
any such product that is marketed as an electronic
cigarette, cigar, cigarillo, pipe, or hookah; and
``(B) includes any component, part, or
paraphernalia of such a product, including cartridges,
cartomizers, e-liquid, smoke juice, tips, atomizers,
batteries, and chargers, whether or not the component,
part, or paraphernalia is sold separately.
``(9) E-liquid.--The term `e-liquid' means a solution that
contains nicotine, flavorings, or other chemicals that is
intended to be used to produce an inhaled vapor from an
electronic nicotine delivery system.''.
(b) Regulation as Tobacco Products Under Federal Food, Drug, and
Cosmetic Act.--Section 901(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 387a(b)) is amended by striking ``This chapter shall
apply to all cigarettes,'' and inserting ``This chapter shall apply to
all cigarettes, electronic nicotine delivery systems, e-liquids,''.
(c) Regulation as Cigarettes Under Federal Cigarette Labeling and
Advertising Act.--Section 3(1) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1332(1)) is amended--
(1) in subparagraph (A), by striking ``and'' at the end;
(2) in subparagraph (B), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(C) any electronic nicotine delivery system (as
such term is defined in section 900 of the Federal
Food, Drug, and Cosmetic Act).''.
(d) Characterizing Flavors.--
(1) Study.--By not later than one 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 complete a study on--
(A) any purported health benefits associated with
flavorings for electronic nicotine delivery systems and
e-liquids, including whether any such flavorings help
adults to quit smoking; and
(B) whether any such flavorings would appeal to
children and increase their likelihood to use
electronic nicotine delivery systems or e-liquids.
(2) Consideration of tobacco product standard.--Upon
completion of the study under paragraph (1), the Secretary of
Health and Human Services, acting through the Commissioner of
Food and Drugs, shall consider whether to adopt a tobacco
product standard under section 907(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 387g(a)(3)) prohibiting or
restricting the use of flavorings in electronic nicotine
delivery systems and e-liquids.
(e) Child-Proof Packaging.--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 tobacco product standard under section 907 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 387g) requiring child-proof packaging
for electronic nicotine delivery systems and e-liquids.
(f) Dosage Limits.--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--
(1) shall promulgate a final tobacco product standard under
section 907 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387g) establishing dosage limits for electronic nicotine
delivery systems and e-liquids that are adequate for the
majority of smokers using an electronic nicotine delivery
system as a substitute to smoking; and
(2) may include in such tobacco product standard an
exception allowing consumers to access electronic nicotine
delivery systems and e-liquids containing nicotine in excess of
the dosage limit established under paragraph (1) pursuant to a
prescription.
(g) Concentrations.--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--
(1) shall promulgate a final tobacco product standard under
section 907 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387g) establishing for e-liquids maximum levels for the
concentration of nicotine, and establishing labeling
requirements with respect to the concentration of nicotine,
that are adequate for the majority of smokers using an
electronic nicotine delivery system as a substitute to smoking;
and
(2) may include in such tobacco product standard an
exception allowing consumers to access e-liquids containing
nicotine in excess of the dosage limit established under
paragraph (1) pursuant to a prescription.
(h) Regulations.--The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall make such
changes to the final rule promulgated under section 102 of the Family
Smoking Prevention and Tobacco Control Act (21 U.S.C. 387a-1) (or any
successor regulation) as may be necessary to implement the provisions
of this section and the amendments made by this section.
SEC. 4. PROHIBITION ON MARKETING OF ELECTRONIC NICOTINE DELIVERY
SYSTEMS TO CHILDREN.
(a) Prohibition.--No person may advertise, promote, or market in
commerce an electronic nicotine delivery system or an e-liquid in a
manner that the person knows or should know will have the effect of
increasing the use of an electronic nicotine delivery system or e-
liquid by a child.
(b) Enforcement by Federal Trade Commission.--
(1) Unfair or deceptive act or practice.--A violation of
subsection (a) shall be treated as a violation of a rule
defining an unfair or deceptive act or practice described under
section 18(a)(1)(B) of the Federal Trade Commission Act (15
U.S.C. 57a(a)(1)(B)).
(2) Powers of commission.--
(A) In general.--The Federal Trade Commission shall
enforce this section 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 Federal Trade Commission Act (15 U.S.C. 41 et seq.)
were incorporated into and made a part of this section.
(B) Privileges and immunities.--Any person who
violates this section shall be subject to the penalties
and entitled to the privileges and immunities provided
in the Federal Trade Commission Act (15 U.S.C. 41 et
seq.).
(C) Rulemaking.--The Federal Trade Commission may
promulgate standards and rules to carry out this
section in accordance with section 553 of title 5,
United States Code.
(c) Enforcement by States.--
(1) In general.--In any case in which the attorney general
of a State has reason to believe that an interest of the
residents of the State has been or is threatened or adversely
affected by the engagement of any person subject to subsection
(a) in a practice that violates such subsection, the attorney
general of the State may, as parens patriae, bring a civil
action on behalf of the residents of the State in an
appropriate district court of the United States--
(A) to enjoin further violation of such subsection
by such person;
(B) to compel compliance with such subsection;
(C) to obtain damages, restitution, or other
compensation on behalf of such residents;
(D) to obtain such other relief as the court
considers appropriate; or
(E) to obtain civil penalties in the amount
determined under paragraph (2).
(2) Civil penalties.--
(A) Calculation.--For purposes of imposing a civil
penalty under paragraph (1)(E) with respect to a person
who violates subsection (a), the amount determined
under this paragraph is the amount calculated by
multiplying the number of days that the person is not
in compliance with subsection (a) by an amount not
greater than $16,000.
(B) Adjustment for inflation.--Beginning on the
date on which the Bureau of Labor Statistics first
publishes the Consumer Price Index after the date that
is 1 year after the date of the enactment of this Act,
and annually thereafter, the amounts specified in
subparagraph (A) shall be increased by the percentage
increase in the Consumer Price Index published on that
date from the Consumer Price Index published the
previous year.
(3) Rights of federal trade commission.--
(A) Notice to federal trade commission.--
(i) In general.--Except as provided in
clause (iii), the attorney general of a State
shall notify the Federal Trade Commission in
writing that the attorney general intends to
bring a civil action under paragraph (1) not
later than 10 days before initiating the civil
action.
(ii) Contents.--The notification required
by clause (i) with respect to a civil action
shall include a copy of the complaint to be
filed to initiate the civil action.
(iii) Exception.--If it is not feasible for
the attorney general of a State to provide the
notification required by clause (i) before
initiating a civil action under paragraph (1),
the attorney general shall notify the Federal
Trade Commission immediately upon instituting
the civil action.
(B) Intervention by federal trade commission.--The
Federal Trade Commission may--
(i) intervene in any civil action brought
by the attorney general of a State under
paragraph (1); and
(ii) upon intervening--
(I) be heard on all matters arising
in the civil action; and
(II) file petitions for appeal of a
decision in the civil action.
(4) Investigatory powers.--Nothing in this subsection may
be construed to prevent the attorney general of a State from
exercising the powers conferred on the attorney general by the
laws of the State to conduct investigations, to administer
oaths or affirmations, or to compel the attendance of witnesses
or the production of documentary or other evidence.
(5) Preemptive action by federal trade commission.--If the
Federal Trade Commission institutes a civil action or an
administrative action with respect to a violation of subsection
(a), the attorney general of a State may not, during the
pendency of such action, bring a civil action under paragraph
(1) against any defendant named in the complaint of the
Commission for the violation with respect to which the
Commission instituted such action.
(6) Venue; service of process.--
(A) Venue.--Any action brought under paragraph (1)
may be brought in--
(i) the district court of the United States
that meets applicable requirements relating to
venue under section 1391 of title 28, United
States Code; or
(ii) another court of competent
jurisdiction.
(B) Service of process.--In an action brought under
paragraph (1), process may be served in any district in
which the defendant--
(i) is an inhabitant; or
(ii) may be found.
(7) Actions by other state officials.--
(A) In general.--In addition to civil actions
brought by attorneys general under paragraph (1), any
other officer of a State who is authorized by the State
to do so may bring a civil action under paragraph (1),
subject to the same requirements and limitations that
apply under this subsection to civil actions brought by
attorneys general.
(B) Savings provision.--Nothing in this subsection
may be construed to prohibit an authorized official of
a State from initiating or continuing any proceeding in
a court of the State for a violation of any civil or
criminal law of the State.
(d) Construction.--Nothing in this section shall be construed to
limit or diminish the authority of the Food and Drug Administration to
regulate the marketing of electronic nicotine delivery systems,
including the marketing of electronic nicotine delivery systems to
children.
(e) Relation to State Law.--This section shall not be construed as
superseding, altering, or affecting any provision of law of a State,
except to the extent that such provision of law is inconsistent with
the provisions of this section, and then only to the extent of the
inconsistency.
SEC. 5. DEFINITIONS.
In this Act:
(1) Electronic nicotine delivery system.--The term
``electronic nicotine delivery system''--
(A) means any product, the use of which may
resemble smoking, that provides an inhalable dose of
nicotine by delivery of a vaporized solution, including
any such product that is marketed as an electronic
cigarette, cigar, cigarillo, pipe, or hookah; and
(B) includes any component, part, or paraphernalia
of such a product, including cartridges, cartomizers,
e-liquid, smoke juice, tips, atomizers, batteries, and
chargers, whether or not the component, part, or
paraphernalia is sold separately.
(2) E-liquid.--The term ``e-liquid'' means a solution that
contains nicotine, flavorings, or other chemicals that is
intended to be used to produce an inhaled vapor from an
electronic nicotine delivery system.
(3) Child.--The term ``child'' means an individual who is
under the age of 18 years.
(4) Commerce.--The term ``commerce'' has the meaning given
such term in section 4 of the Federal Trade Commission Act (15
U.S.C. 44).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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