```

[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>
```