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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2339 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 2339

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
    sale and marketing of tobacco products, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 18, 2019

  Mr. Pallone (for himself and Ms. Shalala) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
    sale and marketing of tobacco products, 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 ``Reversing the Youth Tobacco Epidemic 
Act of 2019''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
                 TITLE I--FOOD AND DRUG ADMINISTRATION

Sec. 101. Cigarette graphic health warnings.
Sec. 102. Advertising and sales parity for all deemed tobacco products.
Sec. 103. Reducing child and adolescent nicotine addiction.
Sec. 104. Fees applicable to all tobacco products.
Sec. 105. Regulation of products containing synthetic nicotine.
                   TITLE II--FEDERAL TRADE COMMISSION

Sec. 201. Advertising of tobacco products.

                 TITLE I--FOOD AND DRUG ADMINISTRATION

SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS.

    (a) Issuance Deadlines.--Not later than 12 months after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall publish a 
final rule pursuant to section 4(d) of the Federal Cigarette Labeling 
and Advertising Act (15 U.S.C. 1333(d)).
    (b) Conforming Change.--Section 4(d) of the Federal Cigarette 
Labeling and Advertising Act (15 U.S.C. 1333(d)) is amended by striking 
``Not later than 24 months after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the Secretary'' and 
inserting ``The Secretary''.

SEC. 102. ADVERTISING AND SALES PARITY FOR ALL DEEMED TOBACCO PRODUCTS.

    (a) In General.--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 rule 
amending part 1140 of subchapter K of title 21, Code of Federal 
Regulations--
            (1) to apply the provisions of such part 1140 to all 
        tobacco products to which chapter IX of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 387a et seq.) applies pursuant to 
        section 901(b) of such Act (21 U.S.C. 387a(b)), as amended by 
        section 103(a) of this Act; and
            (2) to make such changes as may be necessary for 
        consistency with the amendments made by section 103 of this 
        Act.
    (b) Effective Date.--The final rule required by subsection (a) 
shall take effect on the date that is 2 years after the date of 
enactment of this Act.

SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE ADDICTION.

    (a) Applicability to All Tobacco Products.--
            (1) In general.--Subsection (b) of section 901 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a) is 
        amended to read as follows:
    ``(b) Applicability.--This chapter shall apply to all tobacco 
products.''.
            (2) Rule of construction.--Paragraph (1) and the amendment 
        made thereby shall not be construed to limit the applicability 
        of chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 387a et seq.) to--
                    (A) products that were listed in section 901(b) of 
                such Act as in effect on the day before the date of 
                enactment of this Act; and
                    (B) products that were deemed by regulation to be 
                subject to such chapter pursuant to section 901(b) of 
                such Act as in effect on the day before the date of 
                enactment of this Act.
    (b) Minimum Age Restrictions.--Section 906(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is amended by striking 
paragraph (3) and inserting the following:
            ``(3) Minimum age restrictions.--
                    ``(A) Restriction.--It shall be unlawful for any 
                retailer, manufacturer, distributor, third-party 
                marketplace, or any other commercial entity to sell a 
                tobacco product to any person younger than 21 years of 
                age.
                    ``(B) Age verification.--To ensure compliance with 
                subparagraph (A), a retailer shall, at a minimum, 
                verify by means of a government-issued photographic 
                identification the age of the individual purchasing the 
                product as prescribed in--
                            ``(i) subpart B of part 1140 of subchapter 
                        K of title 21, Code of Federal Regulations; and
                            ``(ii) successor regulations, including the 
                        regulation required by section 102 of the 
                        Reversing the Youth Tobacco Epidemic Act of 
                        2019 and any applicable regulation imposing 
                        restrictions pursuant to paragraph (1).
                    ``(C) Non-preemption.--Subparagraphs (A) and (B) 
                shall not be construed to limit the authority of a 
                State or political subdivision of a State, or the 
                government of an Indian tribe, as such authority is 
                described in section 916.
                    ``(D) Regulations.--Not later than 180 days after 
                the date of enactment of the Reversing the Youth 
                Tobacco Epidemic Act of 2019, the Secretary shall 
                promulgate a final regulation to implement and enforce 
                subparagraphs (A) and (B).
                    ``(E) Timing.--Subparagraphs (A) and (B) shall take 
                effect on the date that is 180 days after the date of 
                enactment of the Reversing the Youth Tobacco Epidemic 
                Act of 2019, regardless of whether the Secretary has 
                promulgated the final regulations required by 
                subparagraph (D).''.
    (c) Prohibition Against Remote Retail Sales.--Paragraph (4) of 
section 906(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387f(d)) is amended to read as follows:
            ``(4) Prohibition against remote retail sales.--Not later 
        than 2 years after the date of enactment of the Reversing the 
        Youth Tobacco Epidemic Act of 2019, the Secretary shall 
        promulgate a final regulation under paragraph (1) prohibiting 
        the retail sale of all tobacco products, including electronic 
        nicotine delivery systems and electronic nicotine delivery 
        system accessories, other than retail sales through a direct, 
        face-to-face exchange between a retailer and a consumer.''.
    (d) Prohibiting Flavoring of Tobacco Products.--
            (1) Prohibition.--Subparagraph (A) of section 907(a)(1) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)(1)) 
        is amended to read as follows:
                    ``(A) Special rule.--Beginning on the date that is 
                1 year after the date of enactment of the Reversing the 
                Youth Tobacco Epidemic Act of 2019, except as provided 
                in subparagraph (C), a tobacco product or any of its 
                component parts or accessories (including the tobacco, 
                filter, or paper) shall not contain, as a constituent 
                (including a smoke constituent) or additive, an 
                artificial or natural flavor (other than tobacco) that 
                is a characterizing flavor of the tobacco product or 
                tobacco smoke or an herb or spice, including menthol, 
                mint, strawberry, grape, orange, clove, cinnamon, 
                pineapple, vanilla, coconut, licorice, cocoa, 
                chocolate, cherry, or coffee. Nothing in this 
                subparagraph shall be construed to limit the 
                Secretary's authority to take action under this section 
                or other sections of this Act applicable to any 
                artificial or natural flavor, herb, or spice.''.
            (2) Exception.--Paragraph (1) of section 907(a) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)) is 
        amended by adding at the end the following new subparagraph:
                    ``(C) Exception for characterizing flavors to 
                decrease smoking.--Notwithstanding subparagraph (A), an 
                electronic nicotine delivery system product or any 
                component or part of such a product may contain, as a 
                constituent (including a smoke constituent) or 
                additive, an artificial or natural flavor or an herb or 
                spice, that is a characterizing flavor of the tobacco 
                product or tobacco smoke so long as the Secretary, in 
                coordination with the Commissioner of Food and Drugs, 
                determines that such characterizing flavor will be 
                appropriate for the protection of public health because 
                it--
                            ``(i) will significantly increase the 
                        likelihood of smoking cessation among current 
                        users of tobacco products;
                            ``(ii) will not increase the likelihood 
                        that individuals who do not use tobacco 
                        products, including youth, will start using 
                        such products; and
                            ``(iii) will not increase the likelihood of 
                        harm to the person using the product.''.
            (3) Savings provision.--Section 907(a)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)(1)), as in 
        effect on the date of enactment of this Act, shall remain in 
        effect until the amendments made to such section 907(a)(1) by 
        this subsection take effect.

SEC. 104. FEES APPLICABLE TO ALL TOBACCO PRODUCTS.

    (a) Increase in Total Amount.--Section 919(b)(1)(K) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(1)(K)) is amended by 
striking ``$712,000,000'' and inserting ``$812,000,000''.
    (b) Application of User Fees to All Classes of Tobacco Products.--
Paragraph (2) of section 919(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387s(b)(2)) is amended to read as follows:
            ``(2) Allocations of assessment by class of tobacco 
        products.--The total user fees assessed and collected under 
        subsection (a) each fiscal year with respect to each class of 
        tobacco products shall be an amount that is determined pursuant 
        to a formula developed by the Secretary. Such formula shall 
        ensure that the amount of fees collected is increased by the 
        total percentage change that occurred in the Consumer Price 
        Index for all urban consumers (all items; United States city 
        average) for the 12-month period ending June 30 preceding the 
        fiscal year.''.
    (c) Allocation of Assessment Within Each Class of Tobacco 
Product.--Section 919(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387s(b)(4)) is amended by striking ``shall be the percentage 
determined for purposes of allocations under subsections (e) through 
(h) of section 625 of Public Law 108-357'' and inserting ``shall be the 
percentage determined by the Secretary''.
    (d) Conforming Amendments.--Section 919(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is amended--
            (1) by striking paragraphs (5) and (7); and
            (2) by redesignating paragraph (6) as paragraph (5).
    (e) Applicability.--The amendments made by this section apply 
beginning with fiscal year 2022. Section 919 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 387s), as in effect on the day before the 
date of enactment of this Act, shall apply with respect to fiscal years 
preceding fiscal year 2022.

SEC. 105. REGULATION OF PRODUCTS CONTAINING SYNTHETIC NICOTINE.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall--
            (1) not later than 1 year after the date of enactment of 
        this Act, issue an interim final rule providing for the 
        regulation of products containing synthetic nicotine under the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); 
        and
            (2) not later than 2 years after such date of enactment, 
        issue a final rule providing for such regulation.
    (b) Synthetic Nicotine Defined.--In this section, the term 
``synthetic nicotine'' means nicotine that is not made or derived from 
tobacco.

                   TITLE II--FEDERAL TRADE COMMISSION

SEC. 201. ADVERTISING OF TOBACCO PRODUCTS.

    (a) Advertising of Electronic Nicotine Delivery Systems.--
            (1) In general.--It shall be unlawful--
                    (A) to market, advertise, or promote any electronic 
                nicotine delivery system in a manner that appeals to an 
                individual under 21 years of age; or
                    (B) to market, advertise, promote, or endorse, or 
                to compensate any person for the marketing, 
                advertising, promotion, or endorsement of, any 
                electronic nicotine delivery system without clearly 
                disclosing that the communication is an advertisement, 
                unless the communication is unambiguously identifiable 
                as an advertisement.
            (2) Enforcement by commission.--
                    (A) Unfair or deceptive acts or practices.--A 
                violation of paragraph (1) shall be treated as a 
                violation of a regulation under section 18(a)(1)(B) of 
                the Federal Trade Commission Act (15 U.S.C. 
                57a(a)(1)(B)) regarding unfair or deceptive acts or 
                practices.
                    (B) Powers of commission.--The Commission shall 
                enforce paragraph (1) 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 Act. Any 
                person who violates such paragraph shall be subject to 
                the penalties and entitled to the privileges and 
                immunities provided in the Federal Trade Commission 
                Act.
            (3) Enforcement by state attorneys general.--
                    (A) In general.--If the attorney general of a State 
                has reason to believe a violation of paragraph (1) has 
                occurred or is occurring, the attorney general, in 
                addition to any authority the attorney general may have 
                to bring an action in State court under the law of the 
                State, may bring a civil action in any court of 
                competent jurisdiction to--
                            (i) enjoin further such violation by the 
                        defendant;
                            (ii) enforce compliance with such 
                        paragraph;
                            (iii) obtain civil penalties in the same 
                        amount as may be obtained by the Commission in 
                        a civil action under section 5(m) of the 
                        Federal Trade Commission Act (15 U.S.C. 45(m)); 
                        or
                            (iv) obtain damages, restitution, or other 
                        compensation on behalf of residents of the 
                        State.
                    (B) Notice.--Before filing an action under 
                subparagraph (A), the attorney general of a State shall 
                provide to the Commission a written notice of such 
                action and a copy of the complaint for such action. If 
                the attorney general determines that it is not feasible 
                to provide the notice described in this subparagraph 
                before the filing of the action, the attorney general 
                shall provide written notice of the action and a copy 
                of the complaint to the Commission immediately upon the 
                filing of the action.
                    (C) Authority of federal trade commission.--
                            (i) In general.--On receiving notice under 
                        subparagraph (B) of an action under 
                        subparagraph (A), the Commission shall have the 
                        right--
                                    (I) to intervene in the action;
                                    (II) upon so intervening, to be 
                                heard on all matters arising therein; 
                                and
                                    (III) to file petitions for appeal.
                            (ii) Limitation on state action while 
                        federal action is pending.--If the Commission 
                        has instituted a civil action for violation of 
                        paragraph (1) (referred to in this clause as 
                        the ``Federal action''), no attorney general of 
                        a State may bring an action under subparagraph 
                        (A) during the pendency of the Federal action 
                        against any defendant named in the complaint in 
                        the Federal action for any violation of such 
                        paragraph alleged in such complaint.
                    (D) Relationship with state-law claims.--
                            (i) Preservation of state-law claims.--
                        Nothing in this section shall prevent the 
                        attorney general of a State from bringing an 
                        action under State law for acts or practices 
                        that also violate paragraph (1).
                            (ii) Assertion in same civil action.--If 
                        the attorney general of a State has authority 
                        to bring an action under State law for acts or 
                        practices that also violate paragraph (1), the 
                        attorney general may assert the State-law claim 
                        and the claim for violation of such paragraph 
                        in the same civil action.
                    (E) Actions by other state officials.--In addition 
                to civil actions brought by attorneys general under 
                subparagraph (A), any other consumer protection officer 
                of a State who is authorized by the State to do so may 
                bring a civil action under such subparagraph, subject 
                to the same requirements and limitations that apply 
                under this paragraph to civil actions brought by 
                attorneys general.
            (4) Rulemaking authority.--The Commission may promulgate 
        regulations under section 553 of title 5, United States Code, 
        to implement paragraph (1).
    (b) Report to Congress on Tobacco Product Advertising.--
            (1) In general.--Not later than 2 years after the date of 
        the enactment of this Act, and annually thereafter, the 
        Commission shall submit to Congress a report relating to each 
        category of products described in paragraph (2) (or a single 
        report a portion of which relates to each such category) that 
        contains the following:
                    (A) Information on domestic sales and advertising 
                and promotional activity by the manufacturers that have 
                the largest market shares of the product category.
                    (B) Such recommendations for legislation as the 
                Commission may consider appropriate.
            (2) Product categories described.--The categories of 
        products described in this paragraph are the following:
                    (A) Cigarettes.
                    (B) Cigars.
                    (C) Smokeless tobacco.
                    (D) Electronic nicotine delivery systems.
    (c) Preservation of Authority.--Nothing in this section may be 
construed in any way to limit the Commission's authority under any 
other provision of law.
    (d) Definitions.--In this section:
            (1) Cigar.--The term ``cigar'' means any roll of tobacco 
        wrapped in leaf tobacco or in any substance containing tobacco 
        (other than any roll of tobacco which is a cigarette within the 
        meaning of paragraph (2)).
            (2) Cigarette.--The term ``cigarette'' has the meaning 
        given such term in section 900 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 387).
            (3) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.
            (4) Electronic nicotine delivery system.--
                    (A) In general.--The term ``electronic nicotine 
                delivery system'' means--
                            (i) an electronic device that--
                                    (I) converts a mixture containing 
                                nicotine or other substances into an 
                                aerosol to be inhaled by the user; and
                                    (II) is a tobacco product; or
                            (ii) a mixture that--
                                    (I) contains nicotine or other 
                                substances that can be aerosolized and 
                                inhaled by the user; and
                                    (II) is a tobacco product.
                    (B) Exclusion.--The term ``electronic nicotine 
                delivery system'' does not include any product that--
                            (i) has been approved or otherwise 
                        authorized by the Food and Drug Administration 
                        for the purpose of sale as a tobacco cessation 
                        product or for other therapeutic purposes; and
                            (ii) is marketed and sold solely for such 
                        purpose or purposes.
            (5) Endorse.--The term ``endorse'' means to communicate an 
        advertising message (including a verbal statement, 
        demonstration, or depiction of the name, signature, likeness, 
        or other identifying personal characteristics of an individual 
        or the name or seal of an organization) that consumers are 
        likely to believe reflects the opinions, beliefs, findings, or 
        experiences of a party other than the sponsoring advertiser, 
        even if the views expressed by such party are identical to 
        those of the sponsoring advertiser.
            (6) Nicotine.--The term ``nicotine'' has the meaning given 
        such term in section 900 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 387).
            (7) Smokeless tobacco.--The term ``smokeless tobacco'' has 
        the meaning given such term in section 900 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 387).
            (8) Tobacco product.--The term ``tobacco product'' has the 
        meaning given such term in section 201 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 321).
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