I 
114TH CONGRESS 
1ST SESSION H. R. 1517 
To provide greater clarity in the regulation of electronic nicotine delivery 
systems, including electronic cigarettes, cigars, cigarillos, pipes, and hook-
ahs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 19, 2015 
Ms. SPEIER (for herself, Mr. CA´RDENAS, Mr. DEFAZIO, Mr. HONDA, 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 pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Stop Selling and Mar-
keting to Our Kids E–Cigarettes Act’’ or the ‘‘SMOKE 
Act’’. 
SEC. 2. FINDINGS; SENSE OF CONGRESS. 
(a) FINDINGS.—Congress finds the following: 
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(1) According to the Food and Drug Adminis-
tration, because electronic cigarettes have not been 
fully studied, consumers currently do not know— 
(A) the potential risks of electronic ciga-
rettes 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 Dis-
ease Control and Prevention that was released in 
August 2014, which found that in two years, from 
2011 to 2013, the percentage of middle and high 
school students who had ever used electronic ciga-
rettes more than tripled. 
(3) According to a policy statement from the 
American Association for Cancer Research and the 
American Society of Clinical Oncology published in 
Clinical Cancer Research in January 2015, ‘‘Elec-
tronic nicotine delivery systems may also be harmful, 
particularly to youth, if they increase the likelihood 
that nonsmokers or former smokers will use combus-
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tible tobacco products or if they discourage smokers 
from quitting.’’. 
(4) The New England Journal of Medicine pub-
lished a study in January 2015 conducted by Port-
land State University researchers which revealed 
that e-cigarette vapor can contain hidden formalde-
hyde at levels five to 15 times higher than regular 
cigarettes. The International Agency for Research 
on Cancer has classified formaldehyde in the riskiest 
category, saying it causes cancer in humans. 
(5) The 2014 Surgeon General’s report on 
smoking, commemorating the 50th anniversary of 
the first Surgeon General report on smoking and 
health, concludes that nicotine adversely affect ma-
ternal and fetal health during pregnancy contrib-
uting to multiple adverse outcomes such as preterm 
delivery and stillbirth. Overall, that exposure to nico-
tine during fetal development has lasting adverse 
consequences for brain development. Moreover, evi-
dence suggests that nicotine exposure during adoles-
cence may also have lasting consequences on the de-
veloping brain. 
(6) Marketing of electronic cigarettes to youth 
is occurring in the form of advertising using car-
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toons and sponsorships of events popular with youth 
such as concerts and sporting events. 
(7) According to the Centers for Disease Con-
trol and Prevention, Poison Control Centers reported 
a rapid increase in electronic cigarette-related expo-
sures, of which 51.1 percent were among young chil-
dren. Electronic cigarette exposure calls per month 
increased from one in September 2010 to 215 in 
February 2014. 
(8) Due to the lack of long-term studies, we do 
not know the viability of claims that electronic ciga-
rettes help to lessen dependence on regular ciga-
rettes. 
(9) According to a paper entitled ‘‘E–Ciga-
rettes: A Scientific Review’’ published in the Amer-
ican Heart Association’s peer-reviewed journal Cir-
culation, 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 prod-
ucts. Furthermore, the particle size distribution and 
number of particles delivered by electronic cigarettes 
are similar to those contained in conventional ciga-
rettes. There is already strong evidence that fre-
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quent low or short-term levels of exposure to these 
types of particles from tobacco smoke or air pollu-
tion can contribute to health problems such as the 
increased risk of cardiovascular and respiratory dis-
ease and death. 
(10) 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 Con-
gress that— 
(1) the Food and Drug Administration— 
(A) has been authorized to regulate the 
sale, labeling, packaging, marketing, and adver-
tising 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 pro-
hibit the advertising, promoting, and marketing in 
commerce of electronic nicotine delivery systems and 
e-liquids to children as an unfair or deceptive act or 
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practice, in order to protect the health of the youth 
of the United States. 
SEC. 3. FDA REGULATION OF ELECTRONIC NICOTINE DE-
LIVERY 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 fol-
lowing: 
‘‘(8) ELECTRONIC
NICOTINE
DELIVERY
SYS-
TEM.—The term ‘electronic nicotine delivery sys-
tem’— 
‘‘(A) means any product, the use of which 
may resemble smoking, that provides an 
inhalable dose of nicotine by delivery of a va-
porized solution, including any such product 
that is marketed as an electronic cigarette, 
cigar, cigarillo, pipe, or hookah; and 
‘‘(B) includes any component, part, or par-
aphernalia of such a product, including car-
tridges, cartomizers, e-liquid, smoke juice, tips, 
atomizers, batteries, and chargers, whether or 
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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: 
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‘‘(C) any electronic nicotine delivery sys-
tem (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 associ-
ated with flavorings for electronic nicotine deliv-
ery systems and e-liquids, including whether 
any such flavorings help adults to quit smoking; 
and 
(B) whether any such flavorings would ap-
peal to children and increase their likelihood to 
use electronic nicotine delivery systems or e-liq-
uids. 
(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 to-
bacco product standard under section 907(a)(3) of 
the Federal Food, Drug, and Cosmetic Act (21 
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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 Com-
missioner of Food and Drugs, shall promulgate a final to-
bacco 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 sys-
tems 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) estab-
lishing dosage limits for electronic nicotine delivery 
systems and e-liquids that are adequate for the ma-
jority of smokers using an electronic nicotine deliv-
ery system as a substitute to smoking; and 
(2) may include in such tobacco product stand-
ard an exception allowing consumers to access elec-
tronic nicotine delivery systems and e-liquids con-
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taining nicotine in excess of the dosage limit estab-
lished under paragraph (1) pursuant to a prescrip-
tion. 
(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) estab-
lishing for e-liquids maximum levels for the con-
centration of nicotine, and establishing labeling re-
quirements with respect to the concentration of nico-
tine, that are adequate for the majority of smokers 
using an electronic nicotine delivery system as a sub-
stitute to smoking; and 
(2) may include in such tobacco product stand-
ard an exception allowing consumers to access e-liq-
uids containing nicotine in excess of the dosage limit 
established under paragraph (1) pursuant to a pre-
scription. 
(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 
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Prevention and Tobacco Control Act (21 U.S.C. 387a–1) 
(or any successor regulation) as may be necessary to im-
plement the provisions of this section and the amendments 
made by this section. 
SEC. 4. PROHIBITION ON MARKETING OF ELECTRONIC NIC-
OTINE DELIVERY SYSTEMS TO CHILDREN. 
(a) PROHIBITION.—No person may advertise, pro-
mote, or market in commerce an electronic nicotine deliv-
ery 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 COMMIS-
SION.— 
(1) UNFAIR
OR
DECEPTIVE
ACT
OR
PRAC-
TICE.—A violation of subsection (a) shall be treated 
as a violation of a rule defining an unfair or decep-
tive 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 
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all applicable terms and provisions of the Fed-
eral 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 at-
torney 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 engage-
ment 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— 
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(A) to enjoin further violation of such sub-
section by such person; 
(B) to compel compliance with such sub-
section; 
(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 im-
posing a civil penalty under paragraph (1)(E) 
with respect to a person who violates subsection 
(a), the amount determined under this para-
graph 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.—Be-
ginning 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 an-
nually thereafter, the amounts specified in sub-
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paragraph (A) shall be increased by the per-
centage increase in the Consumer Price Index 
published on that date from the Consumer 
Price Index published the previous year. 
(3) RIGHTS
OF
FEDERAL
TRADE
COMMIS-
SION.— 
(A) NOTICE TO FEDERAL TRADE COMMIS-
SION.— 
(i) IN GENERAL.—Except as provided 
in clause (iii), the attorney general of a 
State shall notify the Federal Trade Com-
mission in writing that the attorney gen-
eral intends to bring a civil action under 
paragraph (1) not later than 10 days be-
fore initiating the civil action. 
(ii) CONTENTS.—The notification re-
quired 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 pro-
vide the notification required by clause (i) 
before initiating a civil action under para-
graph (1), the attorney general shall notify 
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the Federal Trade Commission imme-
diately 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 aris-
ing 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 con-
ferred on the attorney general by the laws of the 
State to conduct investigations, to administer oaths 
or affirmations, or to compel the attendance of wit-
nesses or the production of documentary or other 
evidence. 
(5) PREEMPTIVE ACTION BY FEDERAL TRADE 
COMMISSION.—If the Federal Trade Commission in-
stitutes a civil action or an administrative action 
with respect to a violation of subsection (a), the at-
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torney general of a State may not, during the pend-
ency of such action, bring a civil action under para-
graph (1) against any defendant named in the com-
plaint of the Commission for the violation with re-
spect to which the Commission instituted such ac-
tion. 
(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 juris-
diction. 
(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 ac-
tions brought by attorneys general under para-
graph (1), any other officer of a State who is 
authorized by the State to do so may bring a 
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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 au-
thorized 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 mar-
keting 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
SYS-
TEM.—The term ‘‘electronic nicotine delivery sys-
tem’’— 
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(A) means any product, the use of which 
may resemble smoking, that provides an 
inhalable dose of nicotine by delivery of a va-
porized solution, including any such product 
that is marketed as an electronic cigarette, 
cigar, cigarillo, pipe, or hookah; and 
(B) includes any component, part, or para-
phernalia of such a product, including car-
tridges, 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 indi-
vidual 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). 
Æ 
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