I 

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. CA ́RDENAS, 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Stop Selling and Mar5 keting to Our Kids E–Cigarettes Act’’ or the ‘‘SMOKE 

6 Act’’. 

7 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

8 (a) FINDINGS.—Congress finds the following: 


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1 (1) According to the Food and Drug Adminis2 tration, because electronic cigarettes have not been 

3 fully studied, consumers currently do not know— 

4 (A) the potential risks of electronic ciga5 rettes when used as intended; 

6 (B) how much nicotine or other potentially 

7 harmful chemicals are being inhaled during use; 

8 or 

9 (C) if there are any benefits associated 

10 with using these products. 

11 (2) Use of electronic cigarettes has risen in 

12 youth according to a study by the Centers for Dis13 ease Control and Prevention that was released in 

14 September 2013, which found that in one year, from 

15 2011 to 2012, the percentage of middle and high 

16 school students who had ever used electronic ciga17 rettes more than doubled. 

18 (3) Electronic cigarette use may lead children 

19 to become addicted to nicotine and could be a gate20 way to various tobacco products. 

21 (4) Additionally, according to the Centers for 

22 Disease Control and Prevention, 1 in 5 middle 

23 school students who reported ever using electronic 

24 cigarettes had never tried conventional cigarettes. 


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1 (5) Marketing of electronic cigarettes to youth 

2 is occurring in the form of advertising using car3 toons and sponsorships of events popular with youth 

4 such as concerts and sporting events. 

5 (6) According to the Centers for Disease Con6 trol and Prevention, Poison Control Centers reported 

7 rapid increase in electronic cigarette-related expo8 sures, of which 51.1 percent were among young chil9 dren. Electronic cigarette exposure calls per month 

10 increased from one in September 2010 to 215 in 

11 February 2014. 

12 (7) Due to the lack of long-term studies, we do 

13 not know the viability of claims that electronic ciga14 rettes help to lessen dependence on regular ciga15 rettes. 

16 (8) According to a paper entitled ‘‘E–Ciga17 rettes: A Scientific Review’’ published in the Amer18 ican Heart Association’s peer-reviewed journal Cir19 culation, electronic cigarettes contain particles small 

20 enough to get into the lungs and then cross into the 

21 systemic circulation just like cigarettes. Therefore, 

22 electronic cigarettes do not only produce ‘‘water 

23 vapor’’ as is claimed in the marketing of these prod24 ucts. Furthermore, the particle size distribution and 

25 number of particles delivered by electronic cigarettes 


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1 are similar to those contained in conventional ciga2 rettes. There is already strong evidence that fre3 quent low or short-term levels of exposure to these 

4 types of particles from tobacco smoke or air pollu5 tion can contribute to health problems such as the 

6 increased risk of cardiovascular and respiratory dis7 ease and death. 

8 (9) The e-liquids used in electronic cigarettes 

9 may be toxic if ingested or absorbed through the 

10 skin at relatively low quantities. The lack of 

11 childproof containers makes this even more of a 

12 safety risk for children. 

13 (b) SENSE OF CONGRESS.—It is the sense of Con14 gress that— 

15 (1) the Food and Drug Administration— 

16 (A) has been authorized to regulate the 

17 sale, labeling, packaging, marketing, and adver18 tising of electronic nicotine delivery systems and 

19 e-liquids since the enactment of the Family 

20 Smoking Prevention and Tobacco Control Act 

21 on June 22, 2009; and 

22 (B) should exercise this authority; and 

23 (2) the Federal Trade Commission should pro24 hibit the advertising, promoting, and marketing in 

25 commerce of electronic nicotine delivery systems and 


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1 e-liquids to children as an unfair or deceptive act or 

2 practice, in order to protect the health of the youth 

3 of the United States. 

4 SEC. 3. FDA REGULATION OF ELECTRONIC NICOTINE DE5 LIVERY SYSTEMS AND E-LIQUIDS. 

6 (a) DEFINITIONS.—Section 900 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 387) is amended— 

8 (1) by redesignating paragraphs (8) through 

9 (22) as paragraphs (10) through (24), respectively; 

10 and 

11 (2) by inserting after paragraph (7) the fol12 lowing: 

13 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS14 TEM.—The term ‘electronic nicotine delivery sys15 tem’— 

16 ‘‘(A) means any product, the use of which 

17 may resemble smoking, that provides an 

18 inhalable dose of nicotine by delivery of a va19 porized solution, including any such product 

20 that is marketed as an electronic cigarette, 

21 cigar, cigarillo, pipe, or hookah; and 

22 ‘‘(B) includes any component, part, or par23 aphernalia of such a product, including car24 tridges, cartomizers, e-liquid, smoke juice, tips, 

25 atomizers, batteries, and chargers, whether or 


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1 not the component, part, or paraphernalia is 

2 sold separately. 

3 ‘‘(9) E-LIQUID.—The term ‘e-liquid’ means a 

4 solution that contains nicotine, flavorings, or other 

5 chemicals that is intended to be used to produce an 

6 inhaled vapor from an electronic nicotine delivery 

7 system.’’. 

8 (b) REGULATION AS TOBACCO PRODUCTS UNDER

9 FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Section 

10 901(b) of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 387a(b)) is amended by striking ‘‘This chapter 

12 shall apply to all cigarettes,’’ and inserting ‘‘This chapter 

13 shall apply to all cigarettes, electronic nicotine delivery 

14 systems, e-liquids,’’. 

15 (c) REGULATION AS CIGARETTES UNDER FEDERAL

16 CIGARETTE LABELING AND ADVERTISING ACT.—Section 

17 3(1) of the Federal Cigarette Labeling and Advertising 

18 Act (15 U.S.C. 1332(1)) is amended— 

19 (1) in subparagraph (A), by striking ‘‘and’’ at 

20 the end; 

21 (2) in subparagraph (B), by striking the period 

22 at the end and inserting ‘‘; and’’; and 

23 (3) by adding at the end the following: 


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1 ‘‘(C) any electronic nicotine delivery sys2 tem (as such term is defined in section 900 of 

3 the Federal Food, Drug, and Cosmetic Act).’’. 

4 (d) CHARACTERIZING FLAVORS.— 

5 (1) STUDY.—By not later than one year after 

6 the date of enactment of this Act, the Secretary of 

7 Health and Human Services, acting through the 

8 Commissioner of Food and Drugs, shall complete a 

9 study on— 

10 (A) any purported health benefits associ11 ated with flavorings for electronic nicotine deliv12 ery systems and e-liquids, including whether 

13 any such flavorings help adults to quit smoking; 

14 and 

15 (B) whether any such flavorings would ap16 peal to children and increase their likelihood to 

17 use electronic nicotine delivery systems or e-liq18 uids. 

19 (2) CONSIDERATION OF TOBACCO PRODUCT

20 STANDARD.—Upon completion of the study under 

21 paragraph (1), the Secretary of Health and Human 

22 Services, acting through the Commissioner of Food 

23 and Drugs, shall consider whether to adopt a to24 bacco product standard under section 907(a)(3) of 

25 the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 387g(a)(3)) prohibiting or restricting the use 

2 of flavorings in electronic nicotine delivery systems 

3 and e-liquids. 

4 (e) CHILD-PROOF PACKAGING.—Not later than 1 

5 year after the date of enactment of this Act, the Secretary 

6 of Health and Human Services, acting through the Com7 missioner of Food and Drugs, shall promulgate a final to8 bacco product standard under section 907 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 387g) requiring 

10 child-proof packaging for electronic nicotine delivery sys11 tems and e-liquids. 

12 (f) DOSAGE LIMITS.—Not later than 1 year after the 

13 date of enactment of this Act, the Secretary of Health and 

14 Human Services, acting through the Commissioner of 

15 Food and Drugs— 

16 (1) shall promulgate a final tobacco product 

17 standard under section 907 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 387g) estab19 lishing dosage limits for electronic nicotine delivery 

20 systems and e-liquids that are adequate for the ma21 jority of smokers using an electronic nicotine deliv22 ery system as a substitute to smoking; and 

23 (2) may include in such tobacco product stand24 ard an exception allowing consumers to access elec25 tronic nicotine delivery systems and e-liquids conVerDate Mar 15 2010 16:50 Jul 07, 2014 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5010.IH H5010

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1 taining nicotine in excess of the dosage limit estab2 lished under paragraph (1) pursuant to a prescrip3 tion. 

4 (g) CONCENTRATIONS.—Not later than 1 year after 

5 the date of enactment of this Act, the Secretary of Health 

6 and Human Services, acting through the Commissioner of 

7 Food and Drugs— 

8 (1) shall promulgate a final tobacco product 

9 standard under section 907 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 387g) estab11 lishing for e-liquids maximum levels for the con12 centration of nicotine, and establishing labeling re13 quirements with respect to the concentration of nico14 tine, that are adequate for the majority of smokers 

15 using an electronic nicotine delivery system as a sub16 stitute to smoking; and 

17 (2) may include in such tobacco product stand18 ard an exception allowing consumers to access e-liq19 uids containing nicotine in excess of the dosage limit 

20 established under paragraph (1) pursuant to a pre21 scription. 

22 (h) REGULATIONS.—The Secretary of Health and 

23 Human Services, acting through the Commissioner of 

24 Food and Drugs, shall make such changes to the final rule 

25 promulgated under section 102 of the Family Smoking 


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1 Prevention and Tobacco Control Act (21 U.S.C. 387a–1) 

2 (or any successor regulation) as may be necessary to im3 plement the provisions of this section and the amendments 

4 made by this section. 

5 SEC. 4. PROHIBITION ON MARKETING OF ELECTRONIC NIC6 OTINE DELIVERY SYSTEMS TO CHILDREN. 

7 (a) PROHIBITION.—No person may advertise, pro8 mote, or market in commerce an electronic nicotine deliv9 ery system or an e-liquid in a manner that the person 

10 knows or should know will have the effect of increasing 

11 the use of an electronic nicotine delivery system or e-liquid 

12 by a child. 

13 (b) ENFORCEMENT BY FEDERAL TRADE COMMIS14 SION.— 

15 (1) UNFAIR OR DECEPTIVE ACT OR PRAC16 TICE.—A violation of subsection (a) shall be treated 

17 as a violation of a rule defining an unfair or decep18 tive act or practice described under section 

19 18(a)(1)(B) of the Federal Trade Commission Act 

20 (15 U.S.C. 57a(a)(1)(B)). 

21 (2) POWERS OF COMMISSION.— 

22 (A) IN GENERAL.—The Federal Trade 

23 Commission shall enforce this section in the 

24 same manner, by the same means, and with the 

25 same jurisdiction, powers, and duties as though 


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1 all applicable terms and provisions of the Fed2 eral Trade Commission Act (15 U.S.C. 41 et 

3 seq.) were incorporated into and made a part of 

4 this section. 

5 (B) PRIVILEGES AND IMMUNITIES.—Any 

6 person who violates this section shall be subject 

7 to the penalties and entitled to the privileges 

8 and immunities provided in the Federal Trade 

9 Commission Act (15 U.S.C. 41 et seq.). 

10 (C) RULEMAKING.—The Federal Trade 

11 Commission may promulgate standards and 

12 rules to carry out this section in accordance 

13 with section 553 of title 5, United States Code. 

14 (c) ENFORCEMENT BY STATES.— 

15 (1) IN GENERAL.—In any case in which the at16 torney general of a State has reason to believe that 

17 an interest of the residents of the State has been or 

18 is threatened or adversely affected by the engage19 ment of any person subject to subsection (a) in a 

20 practice that violates such subsection, the attorney 

21 general of the State may, as parens patriae, bring 

22 a civil action on behalf of the residents of the State 

23 in an appropriate district court of the United 

24 States— 


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1 (A) to enjoin further violation of such sub2 section by such person; 

3 (B) to compel compliance with such sub4 section; 

5 (C) to obtain damages, restitution, or other 

6 compensation on behalf of such residents; 

7 (D) to obtain such other relief as the court 

8 considers appropriate; or 

9 (E) to obtain civil penalties in the amount 

10 determined under paragraph (2). 

11 (2) CIVIL PENALTIES.— 

12 (A) CALCULATION.—For purposes of im13 posing a civil penalty under paragraph (1)(E) 

14 with respect to a person who violates subsection 

15 (a), the amount determined under this para16 graph is the amount calculated by multiplying 

17 the number of days that the person is not in 

18 compliance with subsection (a) by an amount 

19 not greater than $16,000. 

20 (B) ADJUSTMENT FOR INFLATION.—Be21 ginning on the date on which the Bureau of 

22 Labor Statistics first publishes the Consumer 

23 Price Index after the date that is 1 year after 

24 the date of the enactment of this Act, and an25 nually thereafter, the amounts specified in subVerDate Mar 15 2010 16:50 Jul 07, 2014 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5010.IH H5010

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1 paragraph (A) shall be increased by the per2 centage increase in the Consumer Price Index 

3 published on that date from the Consumer 

4 Price Index published the previous year. 

5 (3) RIGHTS OF FEDERAL TRADE COMMIS6 SION.— 

7 (A) NOTICE TO FEDERAL TRADE COMMIS8 SION.— 

9 (i) IN GENERAL.—Except as provided 

10 in clause (iii), the attorney general of a 

11 State shall notify the Federal Trade Com12 mission in writing that the attorney gen13 eral intends to bring a civil action under 

14 paragraph (1) not later than 10 days be15 fore initiating the civil action. 

16 (ii) CONTENTS.—The notification re17 quired by clause (i) with respect to a civil 

18 action shall include a copy of the complaint 

19 to be filed to initiate the civil action. 

20 (iii) EXCEPTION.—If it is not feasible 

21 for the attorney general of a State to pro22 vide the notification required by clause (i) 

23 before initiating a civil action under para24 graph (1), the attorney general shall notify 


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1 the Federal Trade Commission imme2 diately upon instituting the civil action. 

3 (B) INTERVENTION BY FEDERAL TRADE

4 COMMISSION.—The Federal Trade Commission 

5 may— 

6 (i) intervene in any civil action 

7 brought by the attorney general of a State 

8 under paragraph (1); and 

9 (ii) upon intervening— 

10 (I) be heard on all matters aris11 ing in the civil action; and 

12 (II) file petitions for appeal of a 

13 decision in the civil action. 

14 (4) INVESTIGATORY POWERS.—Nothing in this 

15 subsection may be construed to prevent the attorney 

16 general of a State from exercising the powers con17 ferred on the attorney general by the laws of the 

18 State to conduct investigations, to administer oaths 

19 or affirmations, or to compel the attendance of wit20 nesses or the production of documentary or other 

21 evidence. 

22 (5) PREEMPTIVE ACTION BY FEDERAL TRADE

23 COMMISSION.—If the Federal Trade Commission in24 stitutes a civil action or an administrative action 

25 with respect to a violation of subsection (a), the atVerDate Mar 15 2010 16:50 Jul 07, 2014 Jkt 039200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5010.IH H5010

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1 torney general of a State may not, during the pend2 ency of such action, bring a civil action under para3 graph (1) against any defendant named in the com4 plaint of the Commission for the violation with re5 spect to which the Commission instituted such ac6 tion. 

7 (6) VENUE; SERVICE OF PROCESS.— 

8 (A) VENUE.—Any action brought under 

9 paragraph (1) may be brought in— 

10 (i) the district court of the United 

11 States that meets applicable requirements 

12 relating to venue under section 1391 of 

13 title 28, United States Code; or 

14 (ii) another court of competent juris15 diction. 

16 (B) SERVICE OF PROCESS.—In an action 

17 brought under paragraph (1), process may be 

18 served in any district in which the defendant— 

19 (i) is an inhabitant; or 

20 (ii) may be found. 

21 (7) ACTIONS BY OTHER STATE OFFICIALS.— 

22 (A) IN GENERAL.—In addition to civil ac23 tions brought by attorneys general under para24 graph (1), any other officer of a State who is 

25 authorized by the State to do so may bring a 


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1 civil action under paragraph (1), subject to the 

2 same requirements and limitations that apply 

3 under this subsection to civil actions brought by 

4 attorneys general. 

5 (B) SAVINGS PROVISION.—Nothing in this 

6 subsection may be construed to prohibit an au7 thorized official of a State from initiating or 

8 continuing any proceeding in a court of the 

9 State for a violation of any civil or criminal law 

10 of the State. 

11 (d) CONSTRUCTION.—Nothing in this section shall be 

12 construed to limit or diminish the authority of the Food 

13 and Drug Administration to regulate the marketing of 

14 electronic nicotine delivery systems, including the mar15 keting of electronic nicotine delivery systems to children. 

16 (e) RELATION TO STATE LAW.—This section shall 

17 not be construed as superseding, altering, or affecting any 

18 provision of law of a State, except to the extent that such 

19 provision of law is inconsistent with the provisions of this 

20 section, and then only to the extent of the inconsistency. 

21 SEC. 5. DEFINITIONS. 

22 In this Act: 

23 (1) ELECTRONIC NICOTINE DELIVERY SYS24 TEM.—The term ‘‘electronic nicotine delivery sys25 tem’’— 


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1 (A) means any product, the use of which 

2 may resemble smoking, that provides an 

3 inhalable dose of nicotine by delivery of a va4 porized solution, including any such product 

5 that is marketed as an electronic cigarette, 

6 cigar, cigarillo, pipe, or hookah; and 

7 (B) includes any component, part, or para8 phernalia of such a product, including car9 tridges, cartomizers, e-liquid, smoke juice, tips, 

10 atomizers, batteries, and chargers, whether or 

11 not the component, part, or paraphernalia is 

12 sold separately. 

13 (2) E-LIQUID.—The term ‘‘e-liquid’’ means a 

14 solution that contains nicotine, flavorings, or other 

15 chemicals that is intended to be used to produce an 

16 inhaled vapor from an electronic nicotine delivery 

17 system. 

18 (3) CHILD.—The term ‘‘child’’ means an indi19 vidual who is under the age of 18 years. 

20 (4) COMMERCE.—The term ‘‘commerce’’ has 

21 the meaning given such term in section 4 of the 

22 Federal Trade Commission Act (15 U.S.C. 44). 

Æ 


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