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

<DOC>





                                                 Union Calendar No. 324
116th CONGRESS
  2d Session
                                H. R. 2339

                          [Report No. 116-402]

 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

                           February 21, 2020

Additional sponsors: Mr. Rush, Ms. Lee of California, Mr. Sarbanes, Ms. 
 Underwood, Ms. Blunt Rochester, Ms. Mucarsel-Powell, Ms. Schakowsky, 
 Mr. Neguse, Mr. Quigley, Mr. Suozzi, Mr. Ryan, Mr. Raskin, Mr. Tonko, 
Mr. Cohen, Mr. Engel, Ms. Sewell of Alabama, Mr. Kennedy, Ms. Pingree, 
  Ms. Wasserman Schultz, Mr. Larsen of Washington, Mr. Cummings, Ms. 
 Norton, Mr. Ted Lieu of California, Ms. Craig, Mr. King of New York, 
 Mrs. Lowey, Mr. Lewis, Ms. McCollum, Mrs. Watson Coleman, Ms. Hill of 
    California, Mr. Cox of California, Ms. Tlaib, Ms. Schrier, Mr. 
Hastings, Mrs. Kirkpatrick, Ms. Roybal-Allard, Mr. Kilmer, Ms. Stevens, 
Mrs. Dingell, Ms. Kuster of New Hampshire, Mr. Thompson of Mississippi, 
  Mr. Pappas, Mr. Deutch, Ms. Brownley of California, Mr. Foster, Mr. 
 Heck, Mr. Rouda, Mrs. Napolitano, Mr. Krishnamoorthi, Mr. Pocan, Mr. 
Danny K. Davis of Illinois, Mr. Levin of California, Mr. Cisneros, Mrs. 
 Davis of California, Ms. Meng, Mr. Gottheimer, Mr. Lawson of Florida, 
  Ms. Johnson of Texas, Ms. Pressley, Ms. Barragan, Ms. Plaskett, Mr. 
 Cartwright, Ms. Kelly of Illinois, Mr. Rose of New York, Mr. Kim, Mr. 
 Payne, Mr. Case, Mrs. Hayes, Mr. Norcross, Mr. Langevin, Ms. Matsui, 
  Mr. Ruiz, Mr. Huffman, Mrs. Demings, Mr. Kildee, Ms. Houlahan, Mr. 
   DeSaulnier, Mr. Bera, Mrs. Lawrence, Mr. Takano, Mr. Khanna, Mr. 
McNerney, Mr. Lujan, Mr. Garcia of Illinois, Mr. Soto, Mr. Blumenauer, 
   Ms. Judy Chu of California, Ms. Dean, Ms. Moore, Ms. Lofgren, Ms. 
   Scanlon, Mr. Grijalva, Mr. Trone, Ms. Porter, Mr. Malinowski, Mr. 
 Casten of Illinois, Ms. Sanchez, Mr. Evans, Mr. Castro of Texas, Mr. 
  Swalwell of California, Mrs. Beatty, Ms. Speier, Ms. Bonamici, Mr. 
 Espaillat, Mr. Serrano, Ms. Slotkin, Mr. Sean Patrick Maloney of New 
York, Mr. Jeffries, Mrs. McBath, Miss Rice of New York, Mr. Nadler, Ms. 
  Garcia of Texas, Mr. Carson of Indiana, Ms. Waters, Mr. Gomez, Ms. 
  Haaland, Mr. Thompson of California, Mr. Larson of Connecticut, Mr. 
    Vargas, Mr. Cicilline, Mr. Fitzpatrick, Mr. Clay, Mr. Levin of 
              Michigan, Ms. Jackson Lee, and Mr. Phillips

                           February 21, 2020

  Reported with an amendment; committed to the Committee of the Whole 
       House on the State of the Union and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on April 
                               18, 2019]

_______________________________________________________________________

                                 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. Prohibition against remote retail sales.
Sec. 105. Fees applicable to all tobacco products.
Sec. 106. Regulation of products containing synthetic nicotine.
Sec. 107. Update to youth tobacco prevention public awareness 
                            campaigns.
Sec. 108. Exemption from premarket approval of certain tobacco 
                            products.
Sec. 109. Public education.
Sec. 110. Regulations for recordkeeping concerning tracking and 
                            tracing.

                   TITLE II--FEDERAL TRADE COMMISSION

Sec. 201. Advertising of tobacco products.

                   TITLE III--PUBLIC HEALTH PROGRAMS

Sec. 301. Outreach to medically underserved communities.
Sec. 302. Demonstration grant program to develop strategies for smoking 
                            cessation in medically underserved 
                            communities.

     TITLE IV--NICOTINE OR VAPING ACCESS PROTECTION AND ENFORCEMENT

Sec. 401. Short title.
Sec. 402. Increasing civil penalties applicable to certain violations 
                            of restrictions on sale and distribution of 
                            tobacco products.
Sec. 403. Study and report on e-cigarettes.

                 TITLE I--FOOD AND DRUG ADMINISTRATION

SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS.

    (a) Issuance Deadlines.--Not later than March 15, 2020, 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)). If the Secretary fails to promulgate such final rule by March 
15, 2020, then the proposed rule titled ``Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisements'' published by the 
Food and Drug Administration on August 16, 2019 (84 Fed. Reg. 42754) 
shall be treated as a final rule beginning on March 16, 2020.
    (b) Conforming Change.--The first section 4(d) of the Federal 
Cigarette Labeling and Advertising Act (15 U.S.C. 1333(d)) (relating to 
graphic labeling statements) 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, as applicable, 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, including by updating all references to persons younger 
        than 18 years of age in subpart B of part 1140 of title 21, 
        Code of Federal Regulations.
    (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.--
            (1) In general.--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) 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).
                    ``(D) 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 (C).''.
            (2) Preservation of state and local authority.--Nothing in 
        the amendment made by paragraph (1) shall be construed to 
        affect the preservation of State and local authority pursuant 
        to section 916 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 387p).
    (c) Prohibiting Flavoring of Tobacco Products.--
            (1) Prohibition.--
                    (A) In general.--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 rules.--
                            ``(i) In general.--Beginning on the date 
                        that is 1 year after the date of enactment of 
                        the Reversing the Youth Tobacco Epidemic Act of 
                        2019, a tobacco product (including its 
                        components, parts, and accessories, including 
                        the tobacco, filter, or paper) that is not an 
                        electronic nicotine delivery system 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.
                            ``(ii) Rule of construction.--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.
                            ``(iii) Applicability to certain 
                        individuals.--Notwithstanding any provision of 
                        this Act, no individual who purchases or 
                        possess for consumption a tobacco product that 
                        is in violation of the prohibition under this 
                        subparagraph shall be subject to any criminal 
                        penalty under this Act for such purchase or 
                        possession, nor shall it be used as a 
                        justification to stop, search, or conduct any 
                        other investigative measure against any 
                        individual.''.
                    (B) 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 paragraph take 
                effect.
            (2) Flavored electronic nicotine delivery system.--Section 
        910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        387j) is amended by inserting at the end the following:
    ``(h) Flavored Electronic Nicotine Delivery Systems.--
            ``(1) Restriction.--Beginning on the date that is 30 days 
        after the date of enactment of the Reversing the Youth Tobacco 
        Epidemic Act of 2019, any flavored electronic nicotine delivery 
        system that is a new tobacco product, including any liquid, 
        solution, or other component or part or its aerosol, shall not 
        contain an artificial or natural flavor (other than tobacco) 
        that is a characterizing flavor, including menthol, mint, 
        strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, 
        coconut, licorice, cocoa, chocolate, cherry, or coffee, unless 
        the Secretary has issued a marketing order as described in 
        paragraph (2). Nothing in this paragraph 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) Review.--The Secretary shall not issue a marketing 
        order under subsection (c)(1)(A)(i) or a substantial 
        equivalence order under subsection (a)(2)(A)(i) for any 
        electronic nicotine delivery system, including any liquid, 
        solution, or other component or part or its aerosol, that 
        contains an artificial or natural flavor (other than tobacco) 
        that is a characterizing flavor, unless the Secretary issues an 
        order finding that the manufacturer has demonstrated that--
                    ``(A) use of the characterizing flavor--
                            ``(i) will significantly increase the 
                        likelihood of smoking cessation among current 
                        users of tobacco products; and
                            ``(ii) will not increase the likelihood 
                        that individuals who do not use tobacco 
                        products, including youth, will start using any 
                        tobacco product, including an electronic 
                        nicotine delivery system; and
                    ``(B) such electronic nicotine delivery system is 
                not more harmful to users than an electronic nicotine 
                delivery system that does not contain any 
                characterizing flavors.''.
            (3) Definition of electronic nicotine delivery system.--
        Section 900 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 387) is amended--
                    (A) by redesignating paragraphs (8) through (22) as 
                paragraphs (9) through (23), respectively; and
                    (B) by inserting after paragraph (7) the following 
                new paragraph:
            ``(8) Electronic nicotine delivery system.--The term 
        `electronic nicotine delivery system'--
                    ``(A) means any electronic device that delivers 
                nicotine, flavor, or another substance via an 
                aerosolized solution to the user inhaling from the 
                device (including e-cigarettes, e-hookah, e-cigars, 
                vape pens, advanced refillable personal vaporizers, and 
                electronic pipes) and any component, liquid, part, or 
                accessory of such a device, whether or not sold 
                separately; and
                    ``(B) does not include a product that--
                            ``(i) is approved by the Food and Drug 
                        Administration for sale as a tobacco cessation 
                        product or for another therapeutic purpose; and
                            ``(ii) is marketed and sold solely for a 
                        purpose described in clause (i).''.

SEC. 104. PROHIBITION AGAINST REMOTE RETAIL SALES.

    (a) In General.--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.--
                    ``(A) Prohibition.--Not later than 18 months after 
                the date of enactment of the the Reversing the Youth 
                Tobacco Epidemic Act of 2019, the Secretary shall 
                promulgate a final regulation prohibiting the retail 
                sale of all tobacco products other than retail sales 
                through a direct, face-to-face exchange between a 
                retailer and a consumer.
                    ``(B) Exception for certain cigar tobacco 
                products.--
                            ``(i) Exception.--The regulation required 
                        by subparagraph (A) shall not apply to tobacco 
                        products described in section 
                        910(a)(2)(A)(iii).
                            ``(ii) Applicable requirements.--Not later 
                        than 18 months after the date of enactment of 
                        the the Reversing the Youth Tobacco Epidemic 
                        Act of 2019, the Secretary shall promulgate 
                        regulations regarding the sale and distribution 
                        of tobacco products described in section 
                        910(a)(2)(A)(iii) that occur through means 
                        other than a direct, face-to-face exchange 
                        between a retailer and a consumer in order to 
                        prevent the sale and distribution of tobacco 
                        products described in section 910(a)(2)(A)(iii) 
                        to individuals who have not attained the 
                        minimum age established by applicable law for 
                        the purchase of such products, including 
                        requirements for age verification.
                    ``(C) Relation to other authority.--Nothing in this 
                paragraph--
                            ``(i) limits the authority of the Secretary 
                        to take additional actions under the other 
                        paragraphs of this subsection; or
                            ``(ii) preempts the authority of a State or 
                        local government to establish restrictions on 
                        the retail sale of tobacco products that are at 
                        least as restrictive as the prohibition under 
                        subparagraph (A).''.
    (b) Applicability.--Section 906(d)(4) of the Federal Food, Drug, 
and Cosmetic Act, as in effect on the day before the date of enactment 
of this Act, shall continue to apply until the effective date of the 
regulations required by section 906(d)(4) of such Act, as amended by 
subsection (a).

SEC. 105. FEES APPLICABLE TO ALL TOBACCO PRODUCTS.

    (a) Increase in Total Amount.--Section 919(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(1)) is amended by 
striking subparagraph (K) and inserting the following subparagraphs:
                    ``(K) For fiscal year 2019, $712,000,000.
                    ``(L) For fiscal year 2020, $812,000,000.
                    ``(M) For each subsequent fiscal year, the amount 
                that was applicable for the previous fiscal year, 
                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.''.
    (b) Application of User Fees to All Classes of Tobacco Product.--
            (1) In general.--Subparagraph (A) of section 919(b)(2) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)) 
        is amended to read as follows:
                    ``(A) In general.--
                            ``(i) Fiscal years 2020 and 2021.--For 
                        fiscal years 2020 and 2021, user fees shall be 
                        assessed and collected under subsection (a) 
                        only with respect to the classes of tobacco 
                        products listed in subparagraph (B)(i), and the 
                        total such user fees with respect to each such 
                        class shall be an amount that is equal to the 
                        applicable percentage of each such class for 
                        the fiscal year multiplied by the amount 
                        specified in paragraph (1) for the fiscal year.
                            ``(ii) Subsequent fiscal years.--For fiscal 
                        year 2022 and each subsequent fiscal year, user 
                        fees shall be assessed and collected under 
                        subsection (a) with respect to each class of 
                        tobacco products to which this chapter applies 
                        (including tobacco products that the Secretary 
                        by regulation deems to be subject to this 
                        chapter), and the total user fees with respect 
                        to each such class shall be--
                                    ``(I) with respect to each class of 
                                tobacco products listed in subparagraph 
                                (B)(i), an amount that is calculated in 
                                the same way as the amounts calculated 
                                for fiscal years 2020 and 2021 under 
                                clause (i), except that for purposes of 
                                fiscal years 2022 and subsequent fiscal 
                                years, instead of multiplying the 
                                applicable percentage of each such 
                                class by `the amount specified in 
                                paragraph (1) for the fiscal year', the 
                                applicable percentage shall be 
                                multiplied by--
                                            ``(aa) the amount specified 
                                        in paragraph (1) for the fiscal 
                                        year, reduced by
                                            ``(bb) the total user fees 
                                        assessed and collected pursuant 
                                        to subclause (II) for the 
                                        fiscal year; and
                                    ``(II) with respect to each class 
                                of tobacco products to which this 
                                chapter applies but which is not listed 
                                in subparagraph (B)(i), an amount 
                                determined pursuant to a formula under 
                                subparagraph (C).''.
            (2) Other tobacco products.--Section 919(b)(2) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)), as 
        amended by paragraph (1), is further amended by adding at the 
        end the following new subparagraphs:
                    ``(C) Allocation for other tobacco products.--
                            ``(i) In general.--Beginning with fiscal 
                        year 2022, the total user fees assessed and 
                        collected under subsection (a) each fiscal year 
                        with respect to each class of tobacco products 
                        not listed in subparagraph (B)(i) shall be an 
                        amount that is determined pursuant to a formula 
                        developed by the Secretary by regulation using 
                        information required to be submitted under 
                        subparagraph (D).
                            ``(ii) Allocation for other tobacco 
                        products.--For each class of tobacco products 
                        not listed in subparagraph (B)(i), the 
                        percentage of fees under the formula under 
                        clause (i) for the respective fiscal year shall 
                        be equal to the percentage of the gross 
                        domestic sales in the previous calendar year 
                        that is attributable to such class of tobacco 
                        products in such calendar year, as determined 
                        by the Secretary.
                            ``(iii) Allocation of assessment within 
                        each class of other tobacco products.--The 
                        percentage of the total user fee to be paid by 
                        each manufacturer or importer of tobacco 
                        products in a class not listed in subparagraph 
                        (B)(i) shall be determined by the Secretary, 
                        based on the percentage of the gross domestics 
                        sales of all such classes of tobacco products 
                        by all manufacturers and importers in the 
                        previous calendar year that is attributable to 
                        such manufacturer or importer.
                            ``(iv) Effect of failure to finalize 
                        formula on time.--If the Secretary for any 
                        reason fails to finalize by fiscal year 2022 
                        the formula required by this subparagraph for 
                        the assessment and collection of user fees for 
                        classes of tobacco products not listed in 
                        subparagraph (B)(i)--
                                    ``(I) the Secretary shall continue 
                                to assess and collect fees under 
                                subsection (a) with respect to each 
                                class of tobacco products listed in 
                                subparagraph (B)(i); and
                                    ``(II) until the first fiscal year 
                                commencing after the finalization of 
                                such formula, the exception described 
                                in subparagraph (A)(ii)(I) shall not 
                                apply.
                            ``(v) Revisions by regulation.--Any 
                        revisions to the formula promulgated pursuant 
                        to this subparagraph shall be by regulation.
                            ``(vi) Definition.--In this subparagraph, 
                        the term `gross domestic sales' means the total 
                        value in dollars of the sale or distribution by 
                        manufacturers and importers of tobacco products 
                        in the United States in classes not listed in 
                        subparagraph (B)(i), as determined based on the 
                        aggregation of sales data from every 
                        manufacturer and importer of tobacco products 
                        that submits sales data to the Secretary.
                    ``(D) Information required to be submitted.--Each 
                manufacturer or importer of any tobacco product shall 
                submit to the Secretary the information required under 
                this subparagraph by March 1, 2021, for calendar year 
                2020, by April 1, 2021, for the period of January 1, 
                2021, through March 30, 2021, and monthly thereafter. 
                Such information shall include--
                            ``(i) the identification of the 
                        manufacturer or importer;
                            ``(ii) the class or classes of tobacco 
                        products sold by the manufacturer or importer;
                            ``(iii) the full listing of the finished 
                        tobacco products in a class not listed in 
                        subparagraph (B)(i) sold or distributed by the 
                        manufacturer or importer in the United States; 
                        and
                            ``(iv) the gross domestic sales data for 
                        each class of finished tobacco products sold or 
                        distributed by the manufacturer or importer in 
                        the United States.''.
            (3) Prohibited act.--Section 301(q)(1)(B) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(1)(B)) is 
        amended by inserting ``919(b)(2)(D),'' before ``or 920''.
    (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 paragraph (5);
            (2) by redesignating paragraphs (6) and (7) as paragraphs 
        (5) and (6), respectively; and
            (3) by amending paragraph (6), as redesignated, to read as 
        follows:
            ``(6) Memorandum of understanding.--The Secretary shall 
        request the appropriate Federal agency to enter into a 
        memorandum of understanding that provides for the regular and 
        timely transfer from the head of such agency to the Secretary 
        of all necessary information regarding all tobacco product 
        manufacturers and importers required to pay user fees. The 
        Secretary shall maintain all disclosure restrictions 
        established by the head of such agency regarding the 
        information provided under the memorandum of understanding.''.
    (e) Applicability.--The amendments made by subsections (b), (c), 
and (d) apply beginning with fiscal year 2022. Subject to the amendment 
made by subsection (a), 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.
    (f) Report.--For fiscal year 2020 and each subsequent fiscal year 
for which fees are collected under section 919 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387s), the Secretary of Health and 
Human Services, acting through the Commissioner of Food and Drugs, 
shall, by the end of the respective fiscal year, submit to the Congress 
financial and performance reports with respect to such fees.

SEC. 106. 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.

SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUBLIC AWARENESS 
              CAMPAIGNS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall--
            (1) review all public health awareness campaigns of the 
        Department of Health and Human Services designed to educate at-
        risk individuals about the harmful effects of tobacco use, 
        including the use of e-cigarettes and other electronic nicotine 
        delivery systems; and
            (2) as applicable, modify such campaigns to include 
        awareness and education materials designated for individuals 
        who are 18 to 21 years of age.
    (b) Consultation.--In carrying out subsection (a), the Secretary of 
Health and Human Services may consult with medical and public health 
associations and nonprofit organizations.

SEC. 108. EXEMPTION FROM PREMARKET APPROVAL OF CERTAIN TOBACCO 
              PRODUCTS.

    (a) In General.--Section 910(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387j(a)(2)) is amended--
            (1) in subparagraph (A)--
                    (A) in clause (i)(II), by striking ``or'';
                    (B) in clause (ii), by striking the period at the 
                end and inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) subject to subparagraph (C), for 
                        the period beginning on the date of the 
                        enactment of the Reversing the Youth Tobacco 
                        Epidemic Act of 2019 and ending on September 
                        30, 2028, the tobacco product is a cigar and--
                                    ``(I) is wrapped in whole tobacco 
                                leaf;
                                    ``(II) contains a 100-percent leaf 
                                tobacco binder;
                                    ``(III) contains primarily long 
                                filler tobacco;
                                    ``(IV) does not have a 
                                characterizing flavor other than 
                                tobacco;
                                    ``(V) weighs more than 6 pounds per 
                                1000 units;
                                    ``(VI) has no filter, tip, or non-
                                tobacco mouthpiece;
                                    ``(VII)(aa) is made by combining 
                                manually the wrapper, filler, and 
                                binder and is capped by hand; or
                                    ``(bb) has a homogenized tobacco 
                                leaf binder and is made in the United 
                                States using human hands to lay the 
                                100-percent leaf tobacco binder onto 
                                only one machine that bunches, wraps, 
                                and caps each individual cigar; and
                                    ``(VIII) has a retail price (after 
                                discounts or coupons) per cigar of no 
                                less than--
                                            ``(aa) for calendar years 
                                        2019 and 2020, $12; and
                                            ``(bb) for each subsequent 
                                        calendar year, $12 multiplied 
                                        by any percent increase in the 
                                        Consumer Price Index for all 
                                        urban consumers (all items; 
                                        U.S. city average) since 
                                        calendar year 2020.''; and
            (2) by adding at the end the following:
                    ``(C) Determination of applicability.--
                            ``(i) In general.--The Secretary shall, 
                        notwithstanding subparagraph (A)(iii) or any 
                        determination of substantial equivalence, if 
                        any of the conditions specified in clause (ii) 
                        are met--
                                    ``(I) withdraw any exemption 
                                applicable to a tobacco product or 
                                products described in such 
                                subparagraph;
                                    ``(II) require that applications 
                                for review under this section be 
                                submitted with respect to such product 
                                or products; and
                                    ``(III) require that manufacturers 
                                may only market such tobacco product 
                                after the issuance of an order under 
                                subsection (c)(1)(A)(i) with respect to 
                                such product or products.
                            ``(ii) Conditions.--The conditions 
                        specified in this clause are that--
                                    ``(I) the Secretary determines that 
                                the use of a tobacco product or 
                                products described in subparagraph 
                                (A)(iii) has resulted in an emerging 
                                public health threat;
                                    ``(II) data from a National Youth 
                                Tobacco Survey (or successor survey) 
                                conducted after the date of the 
                                enactment of the Reversing the Youth 
                                Tobacco Epidemic Act of 2019 identifies 
                                a rise in youth usage of tobacco 
                                products described in section 
                                910(a)(2)(A)(iii); or
                                    ``(III) the Secretary determines 
                                that a tobacco product or products no 
                                longer meets the criteria specified in 
                                such subparagraph.''.
    (b) National Academies Study and Report.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs, 
        shall enter into an agreement with the National Academies of 
        Sciences, Engineering, and Medicine under which the National 
        Academies shall conduct a study on--
                    (A) the public health impact of having tobacco 
                products described in subsection (a)(2)(A)(iii) of 
                section 910 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 387j(a)(2)), as amended by subsection (a), 
                exempt from premarket review under such section;
                    (B) the youth usage of such tobacco products; and
                    (C) the market share of such products.
            (2) Report.--The agreement under paragraph (1) shall 
        include a requirement that the National Academies of Sciences, 
        Engineering, and Medicine submit to Congress, not later than 
        December 31, 2026, a report on the findings of the study 
        conducted under such paragraph.

SEC. 109. PUBLIC EDUCATION.

    Section 906 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387f) is amended by adding at the end the following:
    ``(g) Education on Tobacco Products.--
            ``(1) In general.--Not later than 6 months after the date 
        of the enactment of the Reversing the Youth Tobacco Epidemic 
        Act of 2019, the Secretary of Health and Human Services, acting 
        through the Commissioner of Food and Drugs, shall provide 
        educational materials for health care providers, members of the 
        public, and law enforcement officials, regarding--
                    ``(A) the authority of the Food and Drug 
                Administration with respect to the regulation of 
                tobacco products (including enforcement of such 
                regulation);
                    ``(B) the processes of the Food and Drug 
                Administration for enforcing restrictions on the 
                manufacture and sale of tobacco products;
                    ``(C) the prohibition on characterizing flavors in 
                tobacco products and the under section 907(a)(1) and 
                the exception from such prohibition under subparagraph 
                (C) of such section;
                    ``(D) the public health impact of tobacco products 
                with characterizing flavors; and
                    ``(E) other information as the Secretary determines 
                appropriate.
            ``(2) Content.--Educational materials provided under 
        paragraph (1) may include--
                    ``(A) explanations of key statutory and regulatory 
                terms, including the terms `tobacco product,' 
                `component parts', `accessories', `constituent', 
                `additive', `tobacco product manufacturer', and 
                `characterizing flavor';
                    ``(B) an explanation of the Food and Drug 
                Administration's jurisdiction to regulate tobacco 
                products, including tobacco products with 
                characterizing flavors under section 907(a)(1);
                    ``(C) information related to enforcement tools and 
                processes used by the Food and Drug Administration for 
                violations of the prohibition specified in section 
                907(a)(1);
                    ``(D) an explanation of the health effects of using 
                tobacco products, including those with characterizing 
                flavors; and
                    ``(E) information on resources available related to 
                smoking cessation.
            ``(3) Format.--Educational materials provided under 
        paragraph (1) may be--
                    ``(A) published in any format, including an 
                Internet website, video, fact sheet, infographic, 
                webinar, or other format, as the Secretary determines 
                is appropriate and applicable; and
                    ``(B) tailored for the unique needs of health care 
                providers, members of the public, law enforcement 
                officers, and other audiences, as the Secretary 
                determines appropriate.''.

SEC. 110. REGULATIONS FOR RECORDKEEPING CONCERNING TRACKING AND 
              TRACING.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall promulgate the regulations 
required by section 920(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387t) in accordance with the following schedule:
            (1) Not later than 1 year after the date of enactment of 
        this Act, the Secretary shall issue proposed regulations.
            (2) Not later than 2 years after the date of enactment of 
        this Act, the Secretary shall promulgate final regulations.

                   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 a tobacco product 
        that--
                    (A) is not a cigarette; and
                    (B) is a roll of tobacco wrapped in leaf tobacco or 
                any substance containing tobacco.
            (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.--The term 
        ``electronic nicotine delivery system''--
                    (A) means any electronic device that delivers 
                nicotine, flavor, or another substance via an 
                aerosolized solution to the user inhaling from the 
                device (including e-cigarettes, e-hookah, e-cigars, 
                vape pens, advanced refillable personal vaporizers, and 
                electronic pipes) and any component, liquid, part, or 
                accessory of such a device, whether or not sold 
                separately; and
                    (B) does not include a product that--
                            (i) is approved by the Food and Drug 
                        Administration for sale as a tobacco cessation 
                        product or for another therapeutic purpose; and
                            (ii) is marketed and sold solely for a 
                        purpose described in clause (i).
            (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).

                   TITLE III--PUBLIC HEALTH PROGRAMS

SEC. 301. OUTREACH TO MEDICALLY UNDERSERVED COMMUNITIES.

    The Secretary shall ensure that programs at the Centers for Disease 
Control and Prevention related to outreach to medically underserved 
communities, including racial and ethnic minority populations, include 
efforts to educate and provide guidance regarding effective evidence-
based strategies--
            (1) to prevent tobacco, e-cigarette, and nicotine 
        addiction; and
            (2) for smoking cessation and the cessation of the use of 
        e-cigarettes and electronic nicotine delivery systems.

SEC. 302. DEMONSTRATION GRANT PROGRAM TO DEVELOP STRATEGIES FOR SMOKING 
              CESSATION IN MEDICALLY UNDERSERVED COMMUNITIES.

    (a) In General.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall establish a 
demonstration program to award grants to or contract with State, local, 
Tribal, or territorial public health departments to support--
            (1) the development of improved evidence-based strategies 
        for smoking cessation and the cessation of the use of e-
        cigarettes and electronic nicotine delivery systems for 
        populations in medically underserved communities, particularly 
        racial and ethnic minority populations;
            (2) the development of improved communication and outreach 
        tools to reach populations in medically underserved 
        communities, particularly racial and ethnic minority 
        populations, addicted to tobacco and e-cigarette products; and
            (3) improved coordination, access, and referrals to 
        services for smoking cessation and the cessation of the use of 
        e-cigarettes and electronic nicotine delivery systems, 
        including smoking cessation products and mental health and 
        counseling services.
    (b) Application.--To be eligible to receive a grant under 
subsection (a), a State, local, Tribal, or territorial public health 
department shall submit to the Secretary an application at such time, 
in such manner, and containing such information as the Secretary may 
require.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $3,000,000 for each of fiscal 
years 2020 through 2024.

     TITLE IV--NICOTINE OR VAPING ACCESS PROTECTION AND ENFORCEMENT

SECTION 401. SHORT TITLE.

    This title may be cited as the ``Nicotine or Vaping Access 
Protection and Enforcement Act of 2019'' or the ``NO VAPE Act of 
2019''.

SEC. 402. INCREASING CIVIL PENALTIES APPLICABLE TO CERTAIN VIOLATIONS 
              OF RESTRICTIONS ON SALE AND DISTRIBUTION OF TOBACCO 
              PRODUCTS.

    (a) Penalties.--Subparagraph (A) of section 103(q)(2) of the Family 
Smoking Prevention and Tobacco Control Act (21 U.S.C. 333 note) is 
amended to read as follows:
                    ``(A) In general.--The amount of the civil penalty 
                to be applied for violations of restrictions 
                promulgated under section 906(d), as described in 
                paragraph (1), shall be as follows:
                            ``(i) With respect to a retailer with an 
                        approved training program, the amount of the 
                        civil penalty shall not exceed--
                                    ``(I) in the case of the first 
                                violation, $0, together with the 
                                issuance of a warning letter to the 
                                retailer;
                                    ``(II) in the case of a second 
                                violation within a 12-month period, 
                                $500;
                                    ``(III) in the case of a third 
                                violation within a 24-month period, 
                                $1,000;
                                    ``(IV) in the case of a fourth 
                                violation within a 24-month period, 
                                $4,000;
                                    ``(V) in the case of a fifth 
                                violation within a 36-month period, 
                                $10,000; and
                                    ``(VI) in the case of a sixth or 
                                subsequent violation within a 48-month 
                                period, $20,000 as determined by the 
                                Secretary on a case-by-case basis.
                            ``(ii) With respect to a retailer that does 
                        not have an approved training program, the 
                        amount of the civil penalty shall not exceed--
                                    ``(I) in the case of the first 
                                violation, $500;
                                    ``(II) in the case of a second 
                                violation within a 12-month period, 
                                $1,000;
                                    ``(III) in the case of a third 
                                violation within a 24-month period, 
                                $2,000;
                                    ``(IV) in the case of a fourth 
                                violation within a 24-month period, 
                                $4,000;
                                    ``(V) in the case of a fifth 
                                violation within a 36-month period, 
                                $10,000; and
                                    ``(VI) in the case of a sixth or 
                                subsequent violation within a 48-month 
                                period, $20,000 as determined by the 
                                Secretary on a case-by-case basis.''.
    (b) Applicability.--The amendment made by subsection (a) applies 
with respect to a violation of a restriction promulgated under section 
906(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387f(d)(1)), as described in section 103(q)(1) of the Family Smoking 
Prevention and Tobacco Control Act (21 U.S.C. 333 note), occurring on 
or after the date that is 6 months after the enactment of this Act. The 
penalties specified in such section 103(q)(1), as in effect on the day 
before such date, shall continue to apply to violations occurring 
before such date.

SEC. 403. STUDY AND REPORT ON E-CIGARETTES.

    Not later than 5 years after the date of enactment of this Act, the 
Comptroller General of the United States shall--
            (1) complete a study on--
                    (A) the relationship of e-cigarettes to tobacco 
                cessation;
                    (B) the perception of the harmful effects of e-
                cigarettes; and
                    (C) the effects of secondhand exposure to smoke 
                from e-cigarettes; and
            (2) submit to the Congress a report on the results of such 
        study, including recommendations based on such results.
                                                 Union Calendar No. 324

116th CONGRESS

  2d Session

                               H. R. 2339

                          [Report No. 116-402]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                           February 21, 2020

  Reported with an amendment; committed to the Committee of the Whole 
       House on the State of the Union and ordered to be printed