[House Report 116-402]
[From the U.S. Government Publishing Office]


116th Congress}                                          { Report

  2d Session  }        HOUSE OF REPRESENTATIVES	         { 116-402   

======================================================================
 
           REVERSING THE YOUTH TOBACCO EPIDEMIC ACT OF 2019

                                _______
                                

 February 21, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 2339]

    The Committee on Energy and Commerce, to whom was referred 
the bill (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, having considered the same, 
reports favorably thereon with an amendment and recommends that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
   I. Purpose and Summary............................................12
  II. Background and Need for the Legislation........................13
 III. Committee Hearings.............................................17
  IV. Committee Consideration........................................17
   V. Committee Votes................................................18
  VI. Oversight Findings.............................................27
 VII. New Budget Authority, Entitlement Authority, and Tax Expenditur27
VIII. Federal Mandates Statement.....................................27
  IX. Statement of General Performance Goals and Objectives..........27
   X. Duplication of Federal Programs................................27
  XI. Committee Cost Estimate........................................27
 XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits....27
XIII. Advisory Committee Statement...................................28
 XIV. Applicability to Legislative Branch............................28
  XV. Section-by-Section Analysis of the Legislation.................28
 XVI. Changes in Existing Law Made by the Bill, as Reported..........32
XVII. Dissenting Views...............................................81

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

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.

                         I. Purpose and Summary

    H.R. 2339, the ``Reversing the Youth Tobacco Epidemic Act 
of 2019'', was introduced on April 18, 2019, by House Committee 
on Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and 
referred to the Committee on Energy and Commerce. H.R. 2339 
amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to 
strengthen the authority of the Food and Drug Administration 
(FDA) over tobacco products and provide a comprehensive 
approach to address the youth tobacco epidemic, which has 
surged in recent years with the introduction of electronic 
nicotine delivery system (ENDS) products, such as electronic 
cigarettes (e-cigarettes).
    The legislation prohibits the manufacture and sale of all 
flavored tobacco products and requires the removal of all 
flavored ENDS products from the market within 30 days, makes it 
unlawful to market, advertise, or promote ENDS products to 
individuals under the age of 21, and directs the FDA to 
prohibit non-face-to-face sales of certain tobacco products. 
Additionally, H.R. 2339 provides FDA with the authority to 
collect user fees from all classes of tobacco products, 
including ENDS products, and increases the annual user fees 
collected for tobacco products. The bill also requires the 
Federal Trade Commission (FTC) to issue an annual report to 
Congress on the domestic sales, advertising, and promotional 
activities of cigarette, cigar, smokeless tobacco, and ENDS 
manufacturers, in addition to other provisions.
    H.R. 2339 takes the necessary steps to prevent the loss of 
an entirely new generation to a lifetime of nicotine addiction 
by enhancing FDA's regulatory authority to restrict the 
marketing and sale of tobacco products that appeal to young 
people and reverse the epidemic levels of youth tobacco usage.

                II. Background and Need for Legislation

    Tobacco use remains the leading cause of preventable death, 
disability, and disease in the United States.\1\ Each year, 
nearly half a million Americans die prematurely from smoking or 
exposure to secondhand smoke, and another 16 million Americans 
live with a serious illness caused by smoking.\2\ Despite this, 
the Centers for Disease Control and Prevention (CDC) estimates 
that more than 49 million adults in the United States continue 
to use tobacco products, including combustible cigarettes, 
cigars, e-cigarettes, and smokeless tobacco, among others.\3\ 
Even more concerning, in 2019, about 6.2 million U.S. middle 
and high school students were current (past 30 day) users of 
some type of tobacco product.\4\
---------------------------------------------------------------------------
    \1\Centers for Disease Control and Prevention, Smoking & Tobacco 
Use, Data and Statistics (www.cdc.gov/tobacco/data_statistics/
index.htm).
    \2\Id.
    \3\Centers for Disease Control and Prevention, Tobacco Product Use 
and Cessation Indicators Among Adults--United States, 2018 
(www.cdc.gov/mmwr/volumes/68/wr/mm6845a2.htm?s_cid=mm6845a2_w).
    \4\Centers for Disease Control and Prevention, 6.2 Million middle 
and high school students used tobacco products in 2019 (www.cdc.gov/
media/releases/2019/1205-nyts-2019.html).
---------------------------------------------------------------------------
    According to results from the National Youth Tobacco Survey 
(NYTS), an annual survey conducted in collaboration by CDC and 
FDA that tracks youth usage of tobacco products, for the last 
six years, e-cigarettes have been the most commonly used 
tobacco product among middle and high school students.\5\ Based 
on this data, in 2019, more than one out of every four high 
school students are current users of e-cigarettes.\6\ During 
the 2017-2018 period alone, current e-cigarette use by high 
schoolers increased by 78 percent.\7\ CDC attributed this 
significant rise in youth usage of e-cigarettes to the ``recent 
popularity of e-cigarettes shaped like a USB flash drive, such 
as JUUL; these products can be used discreetly, have a high 
nicotine content, and come in flavors that appeal to 
youths.''\8\
---------------------------------------------------------------------------
    \5\Id.
    \6\Id.
    \7\Centers for Disease Control and Prevention, Notes from the 
Field: Use of Electronic Cigarettes and Any Tobacco Product Among 
Middle and High School Students--United States, 2011-2018, Morbidity 
and Mortality Weekly Report (MMWR) (Nov. 16, 2018) (www.cdc.gov/mmwr/
volumes/67/wr/mm6745a5.htm).
    \8\ Id.
---------------------------------------------------------------------------
    The widespread availability and appeal of kid-friendly 
flavors has significantly contributed to the rapid rise in e-
cigarette use by young people, with the availability of flavors 
such as mint, candy, fruit, and chocolate being one of the 
driving reasons why students report using e-cigarettes.\9\ 
Several findings have also shown that youth users also perceive 
flavored tobacco products to be less harmful than non-flavored 
alternatives.\10\ Additionally, data from the Population 
Assessment of Tobacco and Health (PATH) Study found that 79 
percent of youth (age 12 to 17) and 89 percent of young adults 
(age 18 to 24) stated that they used a tobacco product because 
the product ``comes in flavors that I like.''\11\ Evidence has 
also demonstrated that menthol flavored cigarettes contribute 
to increased smoking initiation among young people, as well as 
greater likelihood of addiction.\12\
---------------------------------------------------------------------------
    \9\Food and Drug Administration, Youth Tobacco Use: Results from 
the National Youth Tobacco Survey (www.fda.gov/tobacco-products/youth-
and-tobacco/youth-tobacco-use-results-national-youth-tobacco-survey).
    \10\Huang, L.-L., et al., ``Impact of Non-menthol Flavours in 
Tobacco Products on Perceptions and Use Among Youth, Young Adults and 
Adults: A Systematic Review,'' Tobacco Control, 26(6):709-719, 2017. 
Kowitt, S.D., et al., ``Perceptions and Experiences With Flavored Non-
Menthol Tobacco Products: A Systematic Review of Qualitative Studies,'' 
International Journal of Environmental Research and Public Health, 
14(4):338, 2017. Pepper, JK, et al., ``Adolescents' interest in trying 
flavoured e-cigarettes,'' Tobacco Control, 25: ii62-ii66, published 
online September 15, 2016. Dai, H, et al., ``Flavored electronic 
cigarette use and smoking among youth,'' Pediatrics, 138(6): November 
2016.
    \11\Food and Drug Administration, PATH Study Findings Give Insight 
into Flavored Tobacco, Health Effects of E-Cigarettes, and Adult Use of 
Cigars and Hookah (www.fda.gov/tobacco-products/research/path-study-
findings-give-insight-flavored-tobacco-health-effects-e-cigarettes-and-
adult-use-cigars#references).
    \12\Food and Drug Administration, Preliminary Scientific Evaluation 
of Possible Public Health Effects of Menthol Versus Nonmenthol 
Cigarettes (2013).
---------------------------------------------------------------------------
    In November 2018, FDA acknowledged that the sharp rise in 
e-cigarette use by young people represented an epidemic and 
resulted in an overall uptick in youth tobacco product use 
after several years of decline. These statistics are concerning 
because the use of e-cigarettes, particularly ENDS products 
that contain high levels of nicotine, place young people at 
significant risk for developing nicotine addiction. Nicotine 
exposure harms brain development during adolescence and studies 
have shown that youth who use e-cigarettes are more likely to 
start smoking combustible cigarettes as well.\13\
---------------------------------------------------------------------------
    \13\See Food and Drug Administration, Youth Tobacco Use: Results 
from the National Youth Tobacco Survey (www.fda.gov/tobacco-products/
youth-and-tobacco/youth-tobacco-use-results-national-youth-tobacco-
survey).
---------------------------------------------------------------------------
    Legislation is needed to address the underlying causes of 
this significant rise in youth usage, including the 
availability of flavored e-cigarette and other tobacco 
products, as well as kid-appealing marketing and promotional 
tactics that may influence tobacco use among youth.

                 TITLE I--FOOD AND DRUG ADMINISTRATION

    Title I of H.R. 2339 will reduce child and adolescent 
nicotine addiction and bring regulatory parity to the treatment 
of all tobacco products under FDA's authorities. In order to 
reduce the appeal of tobacco products to kids and eliminate the 
kid-friendly flavors that attract young people to initiate use, 
title I prohibits all characterizing flavors in all tobacco 
products, including menthol, and requires the removal of all 
flavored e-cigarettes from the market within 30 days following 
the enactment of the legislation. Title I also prohibits most 
remote retail sales for tobacco products and directs FDA to 
issue final regulations that require face-to-face sales for 
most tobacco products given the lack of sufficient age 
verification mechanisms that adequately safeguard against 
underage tobacco sales online today.
    This title also extends FDA user fees to all classes of 
tobacco products, including ENDS, and increases the total 
amount of fees collected annually by $100 million. Under 
current law, FDA does not have the authority to assess user 
fees from ENDS manufacturers and importers. In order to bring 
greater alignment to the regulation of all tobacco products and 
ensure FDA has the resources necessary to review tobacco 
products and enforce its regulations, title I would extend user 
fees to these manufacturers for the first time and also 
increase the total amount collected annually. This increase was 
also proposed in the 2020 Trump Administration budget 
request.\14\
---------------------------------------------------------------------------
    \14\A Budget for a Better America, Fiscal Year 2020 Budget of the 
U.S. Government (www.whitehouse.gov/wp-content/uploads/2019/03/budget-
fy2020.pdf).
---------------------------------------------------------------------------
    In addition, title I requires FDA to finalize rulemaking to 
implement graphic health warning label requirements for 
cigarette packages following significant delay and litigation. 
Studies around the world have shown that graphic health 
warnings are an effective way to inform consumers about the 
health risks of smoking and a mechanism to prevent children and 
other nonsmokers from beginning to smoke. Given the lack of 
regulatory clarity, the legislation also instructs FDA to issue 
a rulemaking on the regulation of synthetic nicotine, or 
nicotine that is not made or derived from tobacco. Title I 
extends FDA's advertising and sales regulations that currently 
apply to cigarettes and smokeless tobacco to all tobacco 
products to ensure e-cigarette and other new tobacco product 
manufacturers are held to the same advertising and sales 
requirements that currently apply to traditional cigarettes. 
This includes prohibiting the distribution of non-tobacco 
merchandise that bears a tobacco product brand name or logo; 
prohibiting brand sponsorship of athletic, music, or other 
concert events by tobacco product manufacturers; prohibiting 
offering free gifts in consideration of purchasing a tobacco 
product; and prohibiting advertising or labeling of tobacco 
products in nontraditional mediums without first notifying FDA.
    When introduced, title I also increased the Federal minimum 
age to purchase tobacco products from age 18 to age 21. This 
provision, however, was enacted on December 20, 2019, by 
section 3 of division N of Public Law 116-94, the Further 
Consolidated Appropriations Act of 2020. In order to update the 
public health awareness campaigns underway by FDA, title I 
instructs FDA to modify public health awareness campaigns that 
are designed to educate at-risk individuals about the harmful 
effects of tobacco use, particularly for those between the ages 
of 18 and 21. Title I also requires FDA to provide educational 
materials to health care providers, members of the public, and 
law enforcement officials regarding FDA enforcement authorities 
pertaining to tobacco, including enforcement of the flavor 
prohibition provision. The purpose of this provision is to 
ensure individuals are aware of the new provisions of law set 
in place by H.R. 2339, and to provide proper guidelines for law 
enforcement officials on the scope and limits of authorities 
permitted under Federal law. Finally, title I instructs FDA to 
issue, no later than one year after the date of enactment, 
regulations concerning recordkeeping protocols for the tracking 
and tracing of tobacco products. The requirement that FDA issue 
regulations concerning the tracking and tracing of tobacco 
products, which would establish a system to follow tobacco 
products from the manufacturer to a retail setting, was enacted 
as part of the Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act). This requirement was intended to 
help assist in the investigation of illicit trade and 
diversion, as well as to ensure the integrity of the supply 
chain, however, FDA has yet to issue the required regulations.

                   TITLE II--FEDERAL TRADE COMMISSION

    Evidence has continually shown that tobacco marketing and 
promotional activities have an influence on youth usage of 
tobacco products.\15\ In 2012, the Surgeon General highlighted 
in a report on youth and tobacco use that there is a causal 
relationship between tobacco advertising and promotion and 
increased tobacco use.\16\ In recent years, the proliferation 
in use of social media by young people has changed traditional 
marketing mechanisms as well. One investigation found that 
platforms such as Instagram, which is the second most popular 
social media application among teens, was leveraged to promote 
e-cigarettes to viewers.\17\
---------------------------------------------------------------------------
    \15\See National Cancer Institute, The Role of the Media in 
Promoting and Reducing Tobacco Use. Tobacco Control Monograph No. 19 
(June 2008); Centers for Disease Control and Prevention, Executive 
Summary--Preventing tobacco use among young people: a report of the 
Surgeon General (1994).
    \16\U.S. Health and Human Services, Preventing Tobacco Use Among 
Youth and Young Adults: A Report of the Surgeon General (2012).
    \17\CNN Health, #JUUL: How Social Media Hyped Nicotine for a New 
Generation (Dec. 19, 2018).
---------------------------------------------------------------------------
    For these reasons, title II of H.R. 2339 makes it unlawful 
to market, advertise, or promote any e-cigarette products to 
individuals under the age of 21 or to market, advertise, 
promote, or endorse any e-cigarette product without clearly 
disclosing that the communication is an advertisement. It also 
requires the Federal Trade Commission (FTC) to issue a report 
to Congress annually on the domestic sales, advertising, and 
promotional activities of cigarette, cigar, smokeless tobacco, 
and e-cigarette manufacturers.

                   TITLE III--PUBLIC HEALTH PROGRAMS

    In order to ensure that medically underserved communities 
have the necessary tools to effectively quit smoking and 
successfully undergo tobacco cessation treatment, title III 
requires CDC to provide education and guidance to develop 
evidence-based strategies to prevent tobacco use and for 
smoking cessation. In addition, CDC shall award grants to local 
public health departments that develop and implement evidence-
based strategies for smoking cessation and outreach efforts in 
medically underserved communities, particularly racial and 
ethnic minority populations.

     TITLE IV--NICOTINE OR VAPING ACCESS PROTECTION AND ENFORCEMENT

    H.R. 2339 also ensures FDA has the enforcement authority 
necessary to deter the sale of tobacco products to young people 
by increasing the civil penalties applicable for violations of 
the age restrictions on the sale and distribution of tobacco 
products. This provision would double the civil penalty amounts 
under current law for violations under the Tobacco Control Act.

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 2339:
    The Subcommittee on Health held a legislative hearing on 
October 11, 2019, entitled ``Legislation to Reverse the Youth 
Tobacco Epidemic'' to consider H.R. 2339, the ``Reversing the 
Youth Tobacco Epidemic Act of 2019''. The Subcommittee received 
testimony from the following witnesses:
           Dorian Fuhrman, Co-founder and Parent, 
        Parents Against Vaping e-cigarettes (PAVe);
           Phillip Gardiner, Dr.P.H., Senior Program 
        Officer, Tobacco Related Disease Research Program, 
        University of California Office of the President;
           Matthew L. Myers, President, Campaign for 
        Tobacco-Free Kids;
           Michael Siegel, M.D., M.P.H., Professor, 
        Department of Community Health Sciences, Boston 
        University School of Public Health; and
           Susanne E. Tanski, M.D., M.P.H., Associate 
        Professor of Pediatrics, American Academy of 
        Pediatrics.

                      IV. Committee Consideration

    H.R. 2339, the ``Reversing the Youth Tobacco Epidemic Act 
of 2019'', was introduced on April 18, 2019, by Rep. Frank 
Pallone, Jr. (D-NJ), and referred to the Committee on Energy 
and Commerce. The bill was referred to the Subcommittee on 
Health on April 19, 2019. Following a legislative hearing on 
the bill, the Subcommittee on Health met in open markup session 
on Wednesday, November 13, 2019, on H.R. 2339. An amendment in 
the nature of a substitute (AINS) was offered by Mr. Pallone. 
The Pallone AINS had five amendments offered to it during its 
consideration. An amendment offered by Mr. Burgess relating to 
user fees and reports to Congress was defeated by a record vote 
of 12 yeas to 17 nays (HE-roll call no. 8). Mr. Walden offered 
an amendment that was defeated by a voice vote. An amendment by 
Mr. Butterfield and another offered by Mr. Burgess were both 
agreed to by a voice vote. An amendment offered by Ms. Castor 
was subsequently withdrawn. The Pallone AINS, amended, was 
agreed to by a voice vote. The Subcommittee then agreed to a 
motion by Ms. Eshoo, Chairwoman of the subcommittee, to 
favorably forward H.R. 2339 to the full Committee, amended, by 
a voice vote, a quorum being present.
    The full Committee on Energy and Commerce met, pursuant to 
notice, in open markup session on Tuesday, November 19, 2019, 
to consider H.R. 2339, as amended by the Subcommittee on 
Health. During committee consideration, 11 amendments were 
offered to the bill. A bipartisan amendment by Messrs. Ruiz, 
Bilirakis, and Bucshon was agreed to by a voice vote. Another 
bipartisan amendment by Messrs. Ruiz and Bucshon was withdrawn. 
An amendment offered by Ms. Eshoo and another amendment offered 
by Ms. Clarke of NY were agreed to by a voice vote. An 
amendment by Mr. Walden was defeated by a voice vote. An 
amendment offered by Ms. Castor of FL to exempt certain tobacco 
products from pre-market review under sec. 910 of the Tobacco 
Control Act. Her amendment was agreed to by a record vote of 29 
yeas to 24 nays (roll call no. 49). An amendment by Mr. Burgess 
was defeated by a record vote of 22 yeas to 31 nays (roll call 
no. 48); an amendment by Mr. Hudson was defeated by a record 
vote of 25 yeas to 28 nays (roll call no. 50); an amendment by 
Mr. Griffith was defeated by a record vote of 22 yeas to 31 
nays (roll call no. 47); an amendment by Mr. Burgess was 
defeated by a record vote of 22 yeas to 29 nays (roll call no. 
51); and an amendment offered by Mr. Mullin and Mr. McKinley 
was defeated by a record vote of 25 yeas to 27 nays (roll call 
no. 52). At the conclusion of consideration, Mr. Pallone, 
Chairman of the committee, offered a motion to order H.R. 2339 
reported favorably to the House, amended, which was agreed to 
by a record vote of 28 yeas to 24 nays (roll call no. 53)--
Final Passage--a quorum being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there was one record vote taken on H.R. 
2339 during subcommittee consideration, and there were seven 
record votes taken on H.R. 2339 during full Committee 
consideration, including a motion made by Mr. Pallone ordering 
H.R. 2339 favorably reported to the House, amended. The motion 
on final passage of H.R. 2339 was agreed to by a record vote of 
28 yeas to 24 nays. The following are the record votes taken 
during Committee consideration, including the names of those 
members voting for and against:


                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to enhance 
the Federal regulatory authorities of the FDA to reverse the 
youth tobacco epidemic and protect the next generation from a 
lifetime of nicotine addiction.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 2339 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111--139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 2339 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the short title for this Act may 
be cited as the ``Reversing the Youth Tobacco Epidemic Act of 
2019''.

Sec. 2. Table of contents

    Section 2 provides the Table of Contents for H.R. 2339, 
which includes Title I--Food and Drug Administration; Title 
II--Federal Trade Commission; Title III--Public Health 
Programs; and Title IV--Nicotine or Vaping Access Protection 
and Enforcement.

                 TITLE I--FOOD AND DRUG ADMINISTRATION

Sec. 101. Cigarette graphic health warnings

    Section 101 requires that no 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 
concerning graphic labeling statements for cigarette packaging, 
pursuant to section 4(d) of the Federal Cigarette Labeling and 
Advertising Act. If the Secretary fails to act by March 15, 
2020, the proposed rule entitled ``Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisements'' shall be 
treated as a final rule beginning on March 16, 2020.

Sec. 102. Advertising and sales parity for all deemed tobacco products

    Section 102 requires that no later than one year after the 
date of enactment of H.R. 2339, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, publish a final rule amending current regulations 
concerning advertising and sales under Part 1140 of subchapter 
K of title 21 of the Code of Federal Regulations to apply to 
all tobacco products, as applicable. Such rule shall take 
effect two years after the date of enactment of H.R. 2339.

Sec. 103. Reducing child and adolescent nicotine addiction

    Section 103 amends section 901 of FFDCA to apply to all 
tobacco products to incorporate into the statute FDA's 
authority over all tobacco products, including those that were 
deemed under the authority of FDA pursuant to the 2016 final 
deeming rule issued by FDA. Section 103 also amends section 
906(d) to increase the minimum age to purchase tobacco products 
from 18 to 21. Sec. 103(c) amends section 907(a)(1) of the 
Federal Food, Drug, and Cosmetic Act to prohibit all tobacco 
products from containing a characterizing flavor (including 
menthol, mint, strawberry, grape, orange, clove, cinnamon, 
pineapple, vanilla, coconut, licorice, cocoa, chocolate, 
cherry, or coffee) and amends section 910 to prohibit the 
manufacture and sale of all flavored ENDS product 30 days after 
the date of enactment of H.R. 2339.
    Section 103(c) also states that the Secretary shall not 
issue a marketing order for a flavored ENDS product unless the 
manufacturer has demonstrated that 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 such electronic nicotine delivery system is not more 
harmful to users than an electronic nicotine delivery system 
that does not contain any characterizing flavors.

Sec. 104. Prohibition against remote retail sales

    Section 104 requires that no later than 18 months after the 
date of enactment of H.R. 2339, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, shall publish a final rule prohibiting the retail sale 
of all tobacco products other than retail sales through a 
direct, face-to-face exchange between a retailer and consumer. 
Section 104 includes an exception for certain cigar tobacco 
products but requires FDA to promulgate regulations regarding 
the sale and distribution of excepted cigar tobacco products 
when sold other than through direct, face-to-face exchanges.

Sec. 105. Fees applicable to all tobacco products

    Section 105 increases the total annual amount of user fees 
applicable to tobacco products from $712,000,000 to 
$812,000,000 beginning in fiscal year 2020. For each year 
thereafter, this amount increases by the total percentage 
change in the consumer price index for all urban consumers. In 
addition, section 105 applies user fees to all classes of 
tobacco products and instructs FDA to determine a formula for 
the allocation user fees to be paid by tobacco product 
manufacturers or importers that is equal to the percentage of 
gross domestic sales in the previous calendar year, as reported 
by tobacco product manufacturers to the FDA.

Sec. 106. Regulation of products containing synthetic nicotine

    Section 106 requires that no later than one year after the 
date of enactment of H.R. 2339, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, shall issue an interim final rule on the regulation of 
synthetic nicotine, or nicotine that is not made or derived 
from tobacco. Section 106 then requires that this rule be 
finalized no later than two years after the date of enactment 
of H.R. 2339.

Sec. 107. Update to youth tobacco prevention public awareness campaigns

    Section 107 requires the Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, to 
review all public awareness campaigns designed to educate at-
risk individuals about the harmful effects of tobacco use and 
modify such campaigns, as applicable, to include materials 
designed for individuals aged 18 to 21.

Sec. 108. Exemption from premarket approval of certain tobacco products

    Section 108 amends section 910(a)(2) of FFDCA to exempt 
certain cigar tobacco products from the premarket review 
requirements under section 910 of the Tobacco Control Act 
beginning on the date of enactment of H.R. 2339 and ending on 
September 30, 2028. Section 108 defines these exempted products 
as a tobacco product that 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) is made by combining manually the 
wrapper, filler, and binder and is capped by hand, or 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 and coupons) per cigar of no less than $12 for 
calendar years 2019 and 2020 and indexed to inflation.
    Section 108 states that the Secretary shall withdraw any 
applicable exemption for such cigar products if certain 
conditions are met, including a determination that the use of 
the exempted tobacco product has resulted in an emerging public 
health threat; data from the National Youth Tobacco Survey (or 
successor survey) identifies a rise in youth usage of exempted 
tobacco products; or if the Secretary determines that a tobacco 
product no longer meets the criteria for the exemption.
    Section 108 also requires the Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, to 
enter into an agreement with the National Academies of 
Sciences, Engineering, and Medicine to conduct a study and 
report to Congress on the public health impact of exempting 
certain cigar tobacco products from the requirements under 
section 910 of FFDCA and the youth usage of such products. The 
report shall be submitted to Congress no later than December 
31, 2026.

Sec. 109. Public education

    Section 109 amends section 906 of FFDCA to require that not 
later than six months after the date of enactment of H.R. 2339, 
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 the authority of FDA with 
respect to the enforcement of regulations of tobacco products, 
including the prohibition on characterizing flavors and the 
public health impact of tobacco products with characterizing 
flavors.

Sec. 110. Regulations for recordkeeping concerning tracking and tracing

    Section 110 requires that no later than one year after the 
date of enactment of H.R. 2339, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, shall publish a proposed rule on the recordkeeping 
requirements for tracking and tracing tobacco products under 
section 920(b) of the Federal Food, Drug, and Cosmetic Act. 
Section 110 then requires these regulations to be finalized no 
later than two years after the date of enactment of H.R. 2339.

                   TITLE II--FEDERAL TRADE COMMISSION

Sec. 201. Advertising of tobacco products

    Section 201 makes it unlawful to market, advertise, or 
promote any electronic nicotine delivery system in a manner 
that appeals to an individual under the age of 21 or market, 
advertise, promote, endorse, or 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. Section 201 also 
gives FTC the authority to issue rules under notice-and-comment 
rulemaking to implement these prohibitions. It also allows FTC 
and state attorneys general to enforce the advertising 
prohibitions and seek civil penalties for violations. In 
addition, Section 201 also requires FTC to issue a report to 
Congress within two years, and annually thereafter, on the 
domestic sales, advertising, and promotional activity of 
cigarette, cigar, smokeless tobacco, and e-cigarette 
manufacturers.

                   TITLE III--PUBLIC HEALTH PROGRAMS

Sec. 301. Outreach to medically underserved communities

    Section 301 requires the Secretary to ensure that programs 
at CDC related to outreach to medically underserved 
communities, including racial and ethnic minority populations, 
include efforts to educate and provide guidance on evidence-
based strategies to prevent tobacco, e-cigarette, and nicotine 
addiction, as well as smoking cessation and cessation from the 
use of e-cigarettes and ENDS.

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

    Section 302 directs the CDC to establish a demonstration 
program to award grants to State, local, Tribal, or territorial 
public health departments to support the development of 
improved evidence-based strategies for smoking cessation in 
medically underserved communities, particularly racial and 
ethnic minority populations. Section 302 authorizes to be 
appropriated $3,000,000 for each of fiscal years 2020 through 
2024 for this demonstration program.

     TITLE IV--NICOTINE OR VAPING ACCESS PROTECTION AND ENFORCEMENT

Section 401. Short title

    Section 401 designates that the short title of title IV 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

    Section 402 amends section 103(q)(2) of the Tobacco Control 
Act to increase the civil penalties applicable to certain 
violations of restrictions on sale and distribution of tobacco 
products.

Sec. 403. Study and report on e-cigarettes

    Section 403 requires the Comptroller General of the United 
States to study and issue a report to Congress not later than 
five years after the date of enactment of H.R. 2339 on the 
relationship between e-cigarettes and tobacco cessation; the 
perception of the harmful effects of e-cigarettes; and the 
effects of secondhand exposure to smoke from e-cigarettes.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

             FEDERAL CIGARETTE LABELING AND ADVERTISING ACT



           *       *       *       *       *       *       *
SEC. 4. LABELING.

  (a) Label Requirements.--
          (1) In general.--It shall be unlawful for any person 
        to manufacture, package, sell, offer to sell, 
        distribute, or import for sale or distribution within 
        the United States any cigarettes the package of which 
        fails to bear, in accordance with the requirements of 
        this section, one of the following labels:
                  WARNING: Cigarettes are addictive.
                  WARNING: Tobacco smoke can harm your 
                children.
                  WARNING: Cigarettes cause fatal lung disease.
                  WARNING: Cigarettes cause cancer.
                  WARNING: Cigarettes cause strokes and heart 
                disease.
                  WARNING: Smoking during pregnancy can harm 
                your baby.
                  WARNING: Smoking can kill you.
                  WARNING: Tobacco smoke causes fatal lung 
                disease in nonsmokers.
                  WARNING: Quitting smoking now greatly reduces 
                serious risks to your health.
          (2) Placement; typography; etc.--Each label statement 
        required by paragraph (1) shall be located in the upper 
        portion of the front and rear panels of the package, 
        directly on the package underneath the cellophane or 
        other clear wrapping. Each label statement shall 
        comprise the top 50 percent of the front and rear 
        panels of the package. The word ``WARNING'' shall 
        appear in capital letters and all text shall be in 
        conspicuous and legible 17-point type, unless the text 
        of the label statement would occupy more than 70 
        percent of such area, in which case the text may be in 
        a smaller conspicuous and legible type size, provided 
        that at least 60 percent of such area is occupied by 
        required text. The text shall be black on a white 
        background, or white on a black background, in a manner 
        that contrasts, by typography, layout, or color, with 
        all other printed material on the package, in an 
        alternating fashion under the plan submitted under 
        subsection (c).
          (3) Does not apply to foreign distribution.--The 
        provisions of this subsection do not apply to a tobacco 
        product manufacturer or distributor of cigarettes which 
        does not manufacture, package, or import cigarettes for 
        sale or distribution within the United States.
          (4) Applicability to retailers.--A retailer of 
        cigarettes shall not be in violation of this subsection 
        for packaging that--
                  (A) contains a warning label;
                  (B) is supplied to the retailer by a license- 
                or permit-holding tobacco product manufacturer, 
                importer, or distributor; and
                  (C) is not altered by the retailer in a way 
                that is material to the requirements of this 
                subsection.
  (b) Advertising Requirements.--
          (1) In general.--It shall be unlawful for any tobacco 
        product manufacturer, importer, distributor, or 
        retailer of cigarettes to advertise or cause to be 
        advertised within the United States any cigarette 
        unless its advertising bears, in accordance with the 
        requirements of this section, one of the labels 
        specified in subsection (a).
          (2) Typography, etc.--Each label statement required 
        by subsection (a) in cigarette advertising shall comply 
        with the standards set forth in this paragraph. For 
        press and poster advertisements, each such statement 
        and (where applicable) any required statement relating 
        to tar, nicotine, or other constituent (including a 
        smoke constituent) yield shall comprise at least 20 
        percent of the area of the advertisement and shall 
        appear in a conspicuous and prominent format and 
        location at the top of each advertisement within the 
        trim area. The Secretary may revise the required type 
        sizes in such area in such manner as the Secretary 
        determines appropriate. The word ``WARNING'' shall 
        appear in capital letters, and each label statement 
        shall appear in conspicuous and legible type. The text 
        of the label statement shall be black if the background 
        is white and white if the background is black, under 
        the plan submitted under subsection (c). The label 
        statements shall be enclosed by a rectangular border 
        that is the same color as the letters of the statements 
        and that is the width of the first downstroke of the 
        capital ``W'' of the word ``WARNING'' in the label 
        statements. The text of such label statements shall be 
        in a typeface pro rata to the following requirements: 
        45-point type for a whole-page broadsheet newspaper 
        advertisement; 39-point type for a half-page broadsheet 
        newspaper advertisement; 39-point type for a whole-page 
        tabloid newspaper advertisement; 27-point type for a 
        half-page tabloid newspaper advertisement; 31.5-point 
        type for a double page spread magazine or whole-page 
        magazine advertisement; 22.5-point type for a 28 
        centimeter by 3 column advertisement; and 15-point type 
        for a 20 centimeter by 2 column advertisement. The 
        label statements shall be in English, except that--
                  (A) in the case of an advertisement that 
                appears in a newspaper, magazine, periodical, 
                or other publication that is not in English, 
                the statements shall appear in the predominant 
                language of the publication; and
                  (B) in the case of any other advertisement 
                that is not in English, the statements shall 
                appear in the same language as that principally 
                used in the advertisement.
          (3) Matchbooks.--Notwithstanding paragraph (2), for 
        matchbooks (defined as containing not more than 20 
        matches) customarily given away with the purchase of 
        tobacco products, each label statement required by 
        subsection (a) may be printed on the inside cover of 
        the matchbook.
          (4) Adjustment by secretary.--The Secretary may, 
        through a rulemaking under section 553 of title 5, 
        United States Code, adjust the format and type sizes 
        for the label statements required by this section; the 
        text, format, and type sizes of any required tar, 
        nicotine yield, or other constituent (including smoke 
        constituent) disclosures; or the text, format, and type 
        sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any 
        such label statements or disclosures shall be required 
        to appear only within the 20 percent area of cigarette 
        advertisements provided by paragraph (2). The Secretary 
        shall promulgate regulations which provide for 
        adjustments in the format and type sizes of any text 
        required to appear in such area to ensure that the 
        total text required to appear by law will fit within 
        such area.
  (c) Marketing Requirements.--
          (1) Random display.--The label statements specified 
        in subsection (a)(1) shall be randomly displayed in 
        each 12-month period, in as equal a number of times as 
        is possible on each brand of the product and be 
        randomly distributed in all areas of the United States 
        in which the product is marketed in accordance with a 
        plan submitted by the tobacco product manufacturer, 
        importer, distributor, or retailer and approved by the 
        Secretary.
          (2) Rotation.--The label statements specified in 
        subsection (a)(1) shall be rotated quarterly in 
        alternating sequence in advertisements for each brand 
        of cigarettes in accordance with a plan submitted by 
        the tobacco product manufacturer, importer, 
        distributor, or retailer to, and approved by, the 
        Secretary.
          (3) Review.--The Secretary shall review each plan 
        submitted under paragraph (2) and approve it if the 
        plan--
                  (A) will provide for the equal distribution 
                and display on packaging and the rotation 
                required in advertising under this subsection; 
                and
                  (B) assures that all of the labels required 
                under this section will be displayed by the 
                tobacco product manufacturer, importer, 
                distributor, or retailer at the same time.
          (4) Applicability to retailers.--This subsection and 
        subsection (b) apply to a retailer only if that 
        retailer is responsible for or directs the label 
        statements required under this section except that this 
        paragraph shall not relieve a retailer of liability if 
        the retailer displays, in a location open to the 
        public, an advertisement that does not contain a 
        warning label or has been altered by the retailer in a 
        way that is material to the requirements of this 
        subsection and subsection (b).
  (d) Graphic Label Statements.--[Not later than 24 months 
after the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary] The Secretary shall 
issue regulations that require color graphics depicting the 
negative health consequences of smoking to accompany the label 
statements specified in subsection (a)(1). The Secretary may 
adjust the type size, text and format of the label statements 
specified in subsections (a)(2) and (b)(2) as the Secretary 
determines appropriate so that both the graphics and the 
accompanying label statements are clear, conspicuous, legible 
and appear within the specified area.
  (d)  Change in Required Statements.--The Secretary through a 
rulemaking conducted under section 553 of title 5, United 
States Code, may adjust the format, type size, color graphics, 
and text of any of the label requirements, or establish the 
format, type size, and text of any other disclosures required 
under the Federal Food, Drug, and Cosmetic Act, if the 
Secretary finds that such a change would promote greater public 
understanding of the risks associated with the use of tobacco 
products.
  (e) Tar, Nicotine, and Other Smoke Constituent Disclosure.--
          (1) In general.--The Secretary shall, by a rulemaking 
        conducted under section 553 of title 5, United States 
        Code, determine (in the Secretary's sole discretion) 
        whether cigarette and other tobacco product 
        manufacturers shall be required to include in the area 
        of each cigarette advertisement specified by subsection 
        (b) of this section, or on the package label, or both, 
        the tar and nicotine yields of the advertised or 
        packaged brand. Any such disclosure shall be in 
        accordance with the methodology established under such 
        regulations, shall conform to the type size 
        requirements of subsection (b) of this section, and 
        shall appear within the area specified in subsection 
        (b) of this section.
          (2) Resolution of differences.--Any differences 
        between the requirements established by the Secretary 
        under paragraph (1) and tar and nicotine yield 
        reporting requirements established by the Federal Trade 
        Commission shall be resolved by a memorandum of 
        understanding between the Secretary and the Federal 
        Trade Commission.
          (3) Cigarette and other tobacco product 
        constituents.--In addition to the disclosures required 
        by paragraph (1), the Secretary may, under a rulemaking 
        conducted under section 553 of title 5, United States 
        Code, prescribe disclosure requirements regarding the 
        level of any cigarette or other tobacco product 
        constituent including any smoke constituent. Any such 
        disclosure may be required if the Secretary determines 
        that disclosure would be of benefit to the public 
        health, or otherwise would increase consumer awareness 
        of the health consequences of the use of tobacco 
        products, except that no such prescribed disclosure 
        shall be required on the face of any cigarette package 
        or advertisement. Nothing in this section shall 
        prohibit the Secretary from requiring such prescribed 
        disclosure through a cigarette or other tobacco product 
        package or advertisement insert, or by any other means 
        under the Federal Food, Drug, and Cosmetic Act.
          (4) Retailers.--This subsection applies to a retailer 
        only if that retailer is responsible for or directs the 
        label statements required under this section.

           *       *       *       *       *       *       *

                              ----------                              


                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) The introduction or delivery for introduction into 
interstate commerce of any food, drug, device, tobacco product, 
or cosmetic that is adulterated or misbranded.
  (b) The adulteration or misbranding of any food, drug, 
device, tobacco product, or cosmetic in interstate commerce.
  (c) The receipt in interstate commerce of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded, and the delivery or proffered delivery thereof for 
pay or otherwise.
  (d) The introduction or delivery for introduction into 
interstate commerce of any article in violation of section 404, 
415, 505, or 564.
  (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 417(j), 416, 504, 564, 703, 
704(a), 760, or 761; or the failure to establish or maintain 
any record, or make any report, required under section 412, 
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j), 
(l) or (m), 572(i), 515(f), 519, 564, 760, 761, 909, or 920 or 
the refusal to permit access to or verification or copying of 
any such required record; or the violation of any recordkeeping 
requirement under section 204 of the FDA Food Safety 
Modernization Act (except when such violation is committed by a 
farm).
  (f) The refusal to permit entry or inspection as authorized 
by section 704.
  (g) The manufacture within any Territory of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded.
  (h) The giving of a guaranty or undertaking referred to in 
section 303(c)(2), which guaranty or undertaking is false, 
except by a person who relied upon a guaranty or undertaking to 
the same effect signed by, and containing the name and address 
of, the person residing in the United States from whom he 
received in good faith the food, drug, device, tobacco product, 
or cosmetic; or the giving of a guaranty or undertaking 
referred to in section 303(c)(3), which guaranty or undertaking 
is false.
  (i)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification device authorized or 
required by regulations promulgated under the provisions of 
section 404 or 721.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other thing designed to print, imprint, or reproduce 
the trademark, trade name, or other identifying mark, imprint, 
or device of another or any likeness of any of the foregoing 
upon any drug or container or labeling thereof so as to render 
such drugs a counterfeit drug.
  (3) The doing of any act which causes a drug to be a 
counterfeit drug, or the sale or dispensing, or the holding for 
sale or dispensing, of a counterfeit drug.
  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 414, 505, 510, 512, 
513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708, 
721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any 
method or process which as a trade secret is entitled to 
protection; or the violating of section 408(i)(2) or any 
regulation issued under that section.. This paragraph does not 
authorize the withholding of information from either House of 
Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.
  (k) The alteration, mutilation, destruction, obliteration, or 
removal of the whole or any part of the labeling of, or the 
doing of any other act with respect to, a food, drug, device, 
tobacco product, or cosmetic, if such act is done while such 
article is held for sale (whether or not the first sale) after 
shipment in interstate commerce and results in such article 
being adulterated or misbranded.
  (m) The sale or offering for sale of colored oleomargarine or 
colored margarine, or the possession or serving of colored 
oleomargarine or colored margarine in violation of section 
407(b) or 407(c).
  (n) The using, in labeling, advertising or other sales 
promotion of any reference to any report or analysis furnished 
in compliance with section 704.
  (o) In the case of a prescription drug distributed or offered 
for sale in interstate commerce, the failure of the 
manufacturer, packer, or distributor thereof to maintain for 
transmittal, or to transmit, to any practitioner licensed by 
applicable State law to administer such drug who makes written 
request for information as to such drug, true and correct 
copies of all printed matter which is required to be included 
in any package in which that drug is distributed or sold, or 
such other printed matter as is approved by the Secretary. 
Nothing in this paragraph shall be construed to exempt any 
person from any labeling requirement imposed by or under other 
provisions of this Act.
  (p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a 
notice required by section 510(j)(2) or 905(i)(3).
  (q)(1) The failure or refusal--
          (A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b), 907, 908, or 915;
          (B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 
        904, 909, 919(b)(2)(D), or 920; or
          (C) to comply with a requirement under section 522 or 
        913.
  (2) With respect to any device or tobacco product, the 
submission of any report that is required by or under this Act 
that is false or misleading in any material respect.
  (r) The movement of a device, drug, or tobacco product in 
violation of an order under section 304(g) or the removal or 
alteration of any mark or label required by the order to 
identify the device, drug, or tobacco product as detained.
  (s) The failure to provide the notice required by section 
412(c) or 412(e), the failure to make the reports required by 
section 412(f)(1)(B), the failure to retain the records 
required by section 412(b)(4), or the failure to meet the 
requirements prescribed under section 412(f)(3).
  (t) The importation of a drug in violation of section 
801(d)(1), the sale, purchase, or trade of a drug or drug 
sample or the offer to sell, purchase, or trade a drug or drug 
sample in violation of section 503(c), the sale, purchase, or 
trade of a coupon, the offer to sell, purchase, or trade such a 
coupon, or the counterfeiting of such a coupon in violation of 
section 503(c)(2), the distribution of a drug sample in 
violation of section 503(d) or the failure to otherwise comply 
with the requirements of section 503(d), the distribution of 
drugs in violation of section 503(e), failure to comply with 
the requirements under section 582, the failure to comply with 
the requirements under section 584, as applicable, or the 
failure to otherwise comply with the requirements of section 
503(e).
  (u) The failure to comply with any requirements of the 
provisions of, or any regulations or orders of the Secretary, 
under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
  (v) The introduction or delivery for introduction into 
interstate commerce of a dietary supplement that is unsafe 
under section 413.
  (w) The making of a knowingly false statement in any 
statement, certificate of analysis, record, or report required 
or requested under section 801(d)(3); the failure to submit a 
certificate of analysis as required under such section; the 
failure to maintain records or to submit records or reports as 
required by such section; the release into interstate commerce 
of any article or portion thereof imported into the United 
States under such section or any finished product made from 
such article or portion, except for export in accordance with 
section 801(e) or 802, or with section 351(h) of the Public 
Health Service Act; or the failure to so export or to destroy 
such an article or portions thereof, or such a finished 
product.
  (x) The falsification of a declaration of conformity 
submitted under section 514(c) or the failure or refusal to 
provide data or information requested by the Secretary under 
paragraph (3) of such section.
  (y) In the case of a drug, device, or food--
          (1) the submission of a report or recommendation by a 
        person accredited under section 523 that is false or 
        misleading in any material respect;
          (2) the disclosure by a person accredited under 
        section 523 of confidential commercial information or 
        any trade secret without the express written consent of 
        the person who submitted such information or secret to 
        such person; or
          (3) the receipt by a person accredited under section 
        523 of a bribe in any form or the doing of any corrupt 
        act by such person associated with a responsibility 
        delegated to such person under this Act.
  (z) The dissemination of information in violation of section 
551.
  (aa) The importation of a prescription drug in violation of 
section 804, the falsification of any record required to be 
maintained or provided to the Secretary under such section, or 
any other violation of regulations under such section.
  (bb) The transfer of an article of food in violation of an 
order under section 304(h), or the removal or alteration of any 
mark or label required by the order to identify the article as 
detained.
  (cc) The importing or offering for import into the United 
States of an article of food or a drug by, with the assistance 
of, or at the direction of, a person debarred from such 
activity under section 306(b)(3).
  (dd) The failure to register in accordance with section 415.
  (ee) The importing or offering for import into the United 
States of an article of food in violation of the requirements 
under section 801(m).
  (ff) The importing or offering for import into the United 
States of a drug or device with respect to which there is a 
failure to comply with a request of the Secretary to submit to 
the Secretary a statement under section 801(o).
  (gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited 
under paragraph (2) of such section of false information in an 
inspection report under paragraph (7)(A) of such section; or 
the knowing failure of such a person to include material facts 
in such a report.
  (hh) The failure by a shipper, carrier by motor vehicle or 
rail vehicle, receiver, or any other person engaged in the 
transportation of food to comply with the sanitary 
transportation practices prescribed by the Secretary under 
section 416.
  (ii) The falsification of a report of a serious adverse event 
submitted to a responsible person (as defined under section 760 
or 761) or the falsification of a serious adverse event report 
(as defined under section 760 or 761) submitted to the 
Secretary.
  (jj)(1) The failure to submit the certification required by 
section 402(j)(5)(B) of the Public Health Service Act, or 
knowingly submitting a false certification under such section.
  (2) The failure to submit clinical trial information required 
under subsection (j) of section 402 of the Public Health 
Service Act.
  (3) The submission of clinical trial information under 
subsection (j) of section 402 of the Public Health Service Act 
that is false or misleading in any particular under paragraph 
(5)(D) of such subsection (j).
  (kk) The dissemination of a television advertisement without 
complying with section 503B.
  (ll) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added a drug 
approved under section 505, a biological product licensed under 
section 351 of the Public Health Service Act, or a drug or a 
biological product for which substantial clinical 
investigations have been instituted and for which the existence 
of such investigations has been made public, unless--
          (1) such drug or such biological product was marketed 
        in food before any approval of the drug under section 
        505, before licensure of the biological product under 
        such section 351, and before any substantial clinical 
        investigations involving the drug or the biological 
        product have been instituted;
          (2) the Secretary, in the Secretary's discretion, has 
        issued a regulation, after notice and comment, 
        approving the use of such drug or such biological 
        product in the food;
          (3) the use of the drug or the biological product in 
        the food is to enhance the safety of the food to which 
        the drug or the biological product is added or applied 
        and not to have independent biological or therapeutic 
        effects on humans, and the use is in conformity with--
                  (A) a regulation issued under section 409 
                prescribing conditions of safe use in food;
                  (B) a regulation listing or affirming 
                conditions under which the use of the drug or 
                the biological product in food is generally 
                recognized as safe;
                  (C) the conditions of use identified in a 
                notification to the Secretary of a claim of 
                exemption from the premarket approval 
                requirements for food additives based on the 
                notifier's determination that the use of the 
                drug or the biological product in food is 
                generally recognized as safe, provided that the 
                Secretary has not questioned the general 
                recognition of safety determination in a letter 
                to the notifier;
                  (D) a food contact substance notification 
                that is effective under section 409(h); or
                  (E) such drug or biological product had been 
                marketed for smoking cessation prior to the 
                date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007; or
          (4) the drug is a new animal drug whose use is not 
        unsafe under section 512.
  (mm) The failure to submit a report or provide a notification 
required under section 417(d).
  (nn) The falsification of a report or notification required 
under section 417(d).
  (oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
  (pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of 
section 911.
  (qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification 
device upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other item that is designed to print, imprint, or 
reproduce the trademark, trade name, or other identifying mark, 
imprint, or device of another or any likeness of any of the 
foregoing upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (3) The doing of any act that causes a tobacco product to be 
a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco 
product.
  (rr) The charitable distribution of tobacco products.
  (ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade.
  (tt) Making any express or implied statement or 
representation directed to consumers with respect to a tobacco 
product, in a label or labeling or through the media or 
advertising, that either conveys, or misleads or would mislead 
consumers into believing, that--
          (1) the product is approved by the Food and Drug 
        Administration;
          (2) the Food and Drug Administration deems the 
        product to be safe for use by consumers;
          (3) the product is endorsed by the Food and Drug 
        Administration for use by consumers; or
          (4) the product is safe or less harmful by virtue 
        of--
                  (A) its regulation or inspection by the Food 
                and Drug Administration; or
                  (B) its compliance with regulatory 
                requirements set by the Food and Drug 
                Administration;
        including any such statement or representation 
        rendering the product misbranded under section 903.
                  
  (uu) The operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States 
if the owner, operator, or agent in charge of such facility is 
not in compliance with section 418.
  (vv) The failure to comply with the requirements under 
section 419.
  (ww) The failure to comply with section 420.
  (xx) The refusal or failure to follow an order under section 
423.
  (yy) The knowing and willful failure to comply with the 
notification requirement under section 417(h).
  (zz) The importation or offering for importation of a food if 
the importer (as defined in section 805) does not have in place 
a foreign supplier verification program in compliance with such 
section 805.
  (aaa) The failure to register in accordance with section 
801(s).
  (bbb) The failure to notify the Secretary in violation of 
section 568.
  (ccc)(1) The resale of a compounded drug that is labeled 
``not for resale'' in accordance with section 503B.
  (2) With respect to a drug to be compounded pursuant to 
section 503A or 503B, the intentional falsification of a 
prescription, as applicable.
  (3) The failure to report drugs or adverse events by an 
entity that is registered in accordance with subsection (b) of 
section 503B.
  (ddd)(1) The manufacture or the introduction or delivery for 
introduction into interstate commerce of a rinse-off cosmetic 
that contains intentionally-added plastic microbeads.
  (2) In this paragraph--
          (A) the term ``plastic microbead'' means any solid 
        plastic particle that is less than five millimeters in 
        size and is intended to be used to exfoliate or cleanse 
        the human body or any part thereof; and
          (B) the term ``rinse-off cosmetic'' includes 
        toothpaste.
  (eee) The failure to comply with any order issued under 
section 569D.

           *       *       *       *       *       *       *


                      CHAPTER IX--TOBACCO PRODUCTS

SEC. 900. DEFINITIONS.

   In this chapter:
          (1) Additive.--The term ``additive'' means any 
        substance the intended use of which results or may 
        reasonably be expected to result, directly or 
        indirectly, in its becoming a component or otherwise 
        affecting the characteristic of any tobacco product 
        (including any substances intended for use as a 
        flavoring or coloring or in producing, manufacturing, 
        packing, processing, preparing, treating, packaging, 
        transporting, or holding), except that such term does 
        not include tobacco or a pesticide chemical residue in 
        or on raw tobacco or a pesticide chemical.
          (2) Brand.--The term ``brand'' means a variety of 
        tobacco product distinguished by the tobacco used, tar 
        content, nicotine content, flavoring used, size, 
        filtration, packaging, logo, registered trademark, 
        brand name, identifiable pattern of colors, or any 
        combination of such attributes.
          (3) Cigarette.--The term ``cigarette''--
                  (A) means a product that--
                          (i) is a tobacco product; and
                          (ii) meets the definition of the term 
                        ``cigarette'' in section 3(1) of the 
                        Federal Cigarette Labeling and 
                        Advertising Act; and
                  (B) includes tobacco, in any form, that is 
                functional in the product, which, because of 
                its appearance, the type of tobacco used in the 
                filler, or its packaging and labeling, is 
                likely to be offered to, or purchased by, 
                consumers as a cigarette or as roll-your-own 
                tobacco.
          (4) Cigarette tobacco.--The term ``cigarette 
        tobacco'' means any product that consists of loose 
        tobacco that is intended for use by consumers in a 
        cigarette. Unless otherwise stated, the requirements 
        applicable to cigarettes under this chapter shall also 
        apply to cigarette tobacco.
          (5) Commerce.--The term ``commerce'' has the meaning 
        given that term by section 3(2) of the Federal 
        Cigarette Labeling and Advertising Act.
          (6) Counterfeit tobacco product.--The term 
        ``counterfeit tobacco product'' means a tobacco product 
        (or the container or labeling of such a product) that, 
        without authorization, bears the trademark, trade name, 
        or other identifying mark, imprint, or device, or any 
        likeness thereof, of a tobacco product listed in a 
        registration under section 905(i)(1).
          (7) Distributor.--The term ``distributor'' as regards 
        a tobacco product means any person who furthers the 
        distribution of a tobacco product, whether domestic or 
        imported, at any point from the original place of 
        manufacture to the person who sells or distributes the 
        product to individuals for personal consumption. Common 
        carriers are not considered distributors for purposes 
        of this chapter.
          (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).
          [(8)] (9) Illicit trade.--The term ``illicit trade'' 
        means any practice or conduct prohibited by law which 
        relates to production, shipment, receipt, possession, 
        distribution, sale, or purchase of tobacco products 
        including any practice or conduct intended to 
        facilitate such activity.
          [(9)] (10) Indian country.--The term ``Indian 
        country'' has the meaning given such term in section 
        1151 of title 18, United States Code.
          [(10)] (11) Indian tribe.--The term ``Indian tribe'' 
        has the meaning given such term in section 4(e) of the 
        Indian Self-Determination and Education Assistance Act.
          [(11)] (12) Little cigar.--The term ``little cigar'' 
        means a product that--
                  (A) is a tobacco product; and
                  (B) meets the definition of the term ``little 
                cigar'' in section 3(7) of the Federal 
                Cigarette Labeling and Advertising Act.
          [(12)] (13) Nicotine.--The term ``nicotine'' means 
        the chemical substance named 3-(1-Methyl-2-
        pyrrolidinyl) pyridine or CHN, including any salt or 
        complex of nicotine.
          [(13)] (14) Package.--The term ``package'' means a 
        pack, box, carton, or container of any kind or, if no 
        other container, any wrapping (including cellophane), 
        in which a tobacco product is offered for sale, sold, 
        or otherwise distributed to consumers.
          [(14)] (15) Retailer.--The term ``retailer'' means 
        any person, government, or entity who sells tobacco 
        products to individuals for personal consumption, or 
        who operates a facility where self-service displays of 
        tobacco products are permitted.
          [(15)] (16) Roll-your-own tobacco.--The term ``roll-
        your-own tobacco'' means any tobacco product which, 
        because of its appearance, type, packaging, or 
        labeling, is suitable for use and likely to be offered 
        to, or purchased by, consumers as tobacco for making 
        cigarettes.
          [(16)] (17) Small tobacco product manufacturer.--The 
        term ``small tobacco product manufacturer'' means a 
        tobacco product manufacturer that employs fewer than 
        350 employees. For purposes of determining the number 
        of employees of a manufacturer under the preceding 
        sentence, the employees of a manufacturer are deemed to 
        include the employees of each entity that controls, is 
        controlled by, or is under common control with such 
        manufacturer.
          [(17)] (18) Smoke constituent.--The term ``smoke 
        constituent'' means any chemical or chemical compound 
        in mainstream or sidestream tobacco smoke that either 
        transfers from any component of the cigarette to the 
        smoke or that is formed by the combustion or heating of 
        tobacco, additives, or other component of the tobacco 
        product.
          [(18)] (19) Smokeless tobacco.--The term ``smokeless 
        tobacco'' means any tobacco product that consists of 
        cut, ground, powdered, or leaf tobacco and that is 
        intended to be placed in the oral or nasal cavity.
          [(19)] (20) State; territory.--The terms ``State'' 
        and ``Territory'' shall have the meanings given to such 
        terms in section 201.
          [(20)] (21) Tobacco product manufacturer.--The term 
        ``tobacco product manufacturer'' means any person, 
        including any repacker or relabeler, who--
                  (A) manufactures, fabricates, assembles, 
                processes, or labels a tobacco product; or
                  (B) imports a finished tobacco product for 
                sale or distribution in the United States.
          [(21)] (22) Tobacco warehouse.--
                  (A) Subject to subparagraphs (B) and (C), the 
                term ``tobacco warehouse'' includes any 
                person--
                          (i) who--
                                  (I) removes foreign material 
                                from tobacco leaf through 
                                nothing other than a mechanical 
                                process;
                                  (II) humidifies tobacco leaf 
                                with nothing other than potable 
                                water in the form of steam or 
                                mist; or
                                  (III) de-stems, dries, and 
                                packs tobacco leaf for storage 
                                and shipment;
                          (ii) who performs no other actions 
                        with respect to tobacco leaf; and
                          (iii) who provides to any 
                        manufacturer to whom the person sells 
                        tobacco all information related to the 
                        person's actions described in clause 
                        (i) that is necessary for compliance 
                        with this Act.
                  (B) The term ``tobacco warehouse'' excludes 
                any person who--
                          (i) reconstitutes tobacco leaf;
                          (ii) is a manufacturer, distributor, 
                        or retailer of a tobacco product; or
                          (iii) applies any chemical, additive, 
                        or substance to the tobacco leaf other 
                        than potable water in the form of steam 
                        or mist.
                  (C) The definition of the term ``tobacco 
                warehouse'' in subparagraph (A) shall not apply 
                to the extent to which the Secretary 
                determines, through rulemaking, that regulation 
                under this chapter of the actions described in 
                such subparagraph is appropriate for the 
                protection of the public health.
          [(22)] (23) United states.--The term ``United 
        States'' means the 50 States of the United States of 
        America and the District of Columbia, the Commonwealth 
        of Puerto Rico, Guam, the Virgin Islands, American 
        Samoa, Wake Island, Midway Islands, Kingman Reef, 
        Johnston Atoll, the Northern Mariana Islands, and any 
        other trust territory or possession of the United 
        States.

SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

  (a) In General.--Tobacco products, including modified risk 
tobacco products for which an order has been issued in 
accordance with section 911, shall be regulated by the 
Secretary under this chapter and shall not be subject to the 
provisions of chapter V.
  [(b) Applicability.--This chapter shall apply to all 
cigarettes, cigarette tobacco, roll-your-own tobacco, and 
smokeless tobacco and to any other tobacco products that the 
Secretary by regulation deems to be subject to this chapter.]
  (b) Applicability.--This chapter shall apply to all tobacco 
products.
  (c) Scope.--
          (1) In general.--Nothing in this chapter, or any 
        policy issued or regulation promulgated thereunder, or 
        in sections 101(a), 102, or 103 of title I, title II, 
        or title III of the Family Smoking Prevention and 
        Tobacco Control Act, shall be construed to affect, 
        expand, or limit the Secretary's authority over 
        (including the authority to determine whether products 
        may be regulated), or the regulation of, products under 
        this Act that are not tobacco products under chapter V 
        or any other chapter.
          (2) Limitation of authority.--
                  (A) In general.--The provisions of this 
                chapter shall not apply to tobacco leaf that is 
                not in the possession of a manufacturer of 
                tobacco products, or to the producers of 
                tobacco leaf, including tobacco growers, 
                tobacco warehouses, and tobacco grower 
                cooperatives, nor shall any employee of the 
                Food and Drug Administration have any authority 
                to enter onto a farm owned by a producer of 
                tobacco leaf without the written consent of 
                such producer.
                  (B) Exception.--Notwithstanding subparagraph 
                (A), if a producer of tobacco leaf is also a 
                tobacco product manufacturer or controlled by a 
                tobacco product manufacturer, the producer 
                shall be subject to this chapter in the 
                producer's capacity as a manufacturer. The 
                exception in this subparagraph shall not apply 
                to a producer of tobacco leaf who grows tobacco 
                under a contract with a tobacco product 
                manufacturer and who is not otherwise engaged 
                in the manufacturing process.
                  (C) Rule of construction.--Nothing in this 
                chapter shall be construed to grant the 
                Secretary authority to promulgate regulations 
                on any matter that involves the production of 
                tobacco leaf or a producer thereof, other than 
                activities by a manufacturer affecting 
                production.
  (d) Rulemaking Procedures.--Each rulemaking under this 
chapter shall be in accordance with chapter 5 of title 5, 
United States Code. This subsection shall not be construed to 
affect the rulemaking provisions of section 102(a) of the 
Family Smoking Prevention and Tobacco Control Act.
  (e) Center for Tobacco Products.--Not later than 90 days 
after the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish within 
the Food and Drug Administration the Center for Tobacco 
Products, which shall report to the Commissioner of Food and 
Drugs in the same manner as the other agency centers within the 
Food and Drug Administration. The Center shall be responsible 
for the implementation of this chapter and related matters 
assigned by the Commissioner.
  (f) Office To Assist Small Tobacco Product Manufacturers.--
The Secretary shall establish within the Food and Drug 
Administration an identifiable office to provide technical and 
other nonfinancial assistance to small tobacco product 
manufacturers to assist them in complying with the requirements 
of this Act.
  (g) Consultation Prior to Rulemaking.--Prior to promulgating 
rules under this chapter, the Secretary shall endeavor to 
consult with other Federal agencies as appropriate.

           *       *       *       *       *       *       *


SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

  (a) In General.--Any requirement established by or under 
section 902, 903, 905, or 909 applicable to a tobacco product 
shall apply to such tobacco product until the applicability of 
the requirement to the tobacco product has been changed by 
action taken under section 907, section 910, section 911, or 
subsection (d) of this section, and any requirement established 
by or under section 902, 903, 905, or 909 which is inconsistent 
with a requirement imposed on such tobacco product under 
section 907, section 910, section 911, or subsection (d) of 
this section shall not apply to such tobacco product.
  (b) Information on Public Access and Comment.--Each notice of 
proposed rulemaking or other notification under section 907, 
908, 909, 910, or 911 or under this section, any other notice 
which is published in the Federal Register with respect to any 
other action taken under any such section and which states the 
reasons for such action, and each publication of findings 
required to be made in connection with rulemaking under any 
such section shall set forth--
          (1) the manner in which interested persons may 
        examine data and other information on which the notice 
        or findings is based; and
          (2) the period within which interested persons may 
        present their comments on the notice or findings 
        (including the need therefore) orally or in writing, 
        which period shall be at least 60 days but may not 
        exceed 90 days unless the time is extended by the 
        Secretary by a notice published in the Federal Register 
        stating good cause therefore.
  (c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the 
Secretary's representative under section 903, 904, 907, 908, 
909, 910, 911, or 704, or under subsection (e) or (f) of this 
section, which is exempt from disclosure under subsection (a) 
of section 552 of title 5, United States Code, by reason of 
subsection (b)(4) of that section shall be considered 
confidential and shall not be disclosed, except that the 
information may be disclosed to other officers or employees 
concerned with carrying out this chapter, or when relevant in 
any proceeding under this chapter.
  (d) Restrictions.--
          (1) In general.--The Secretary may by regulation 
        require restrictions on the sale and distribution of a 
        tobacco product, including restrictions on the access 
        to, and the advertising and promotion of, the tobacco 
        product, if the Secretary determines that such 
        regulation would be appropriate for the protection of 
        the public health. The Secretary may by regulation 
        impose restrictions on the advertising and promotion of 
        a tobacco product consistent with and to full extent 
        permitted by the first amendment to the Constitution. 
        The finding as to whether such regulation would be 
        appropriate for the protection of the public health 
        shall be determined with respect to the risks and 
        benefits to the population as a whole, including users 
        and nonusers of the tobacco product, and taking into 
        account--
                  (A) the increased or decreased likelihood 
                that existing users of tobacco products will 
                stop using such products; and
                  (B) the increased or decreased likelihood 
                that those who do not use tobacco products will 
                start using such products.
        No such regulation may require that the sale or 
        distribution of a tobacco product be limited to the 
        written or oral authorization of a practitioner 
        licensed by law to prescribe medical products.
          (2) Label statements.--The label of a tobacco product 
        shall bear such appropriate statements of the 
        restrictions required by a regulation under subsection 
        (a) as the Secretary may in such regulation prescribe.
          [(3) Limitations.--
                  [(A) In general.--No restrictions under 
                paragraph (1) may--
                          [(i) prohibit the sale of any tobacco 
                        product in face-to-face transactions by 
                        a specific category of retail outlets; 
                        or
                          [(ii) establish a minimum age of sale 
                        of tobacco products to any person older 
                        than 18 years of age.
                  [(B) Matchbooks.--For purposes of any 
                regulations issued by the Secretary, matchbooks 
                of conventional size containing not more than 
                20 paper matches, and which are customarily 
                given away for free with the purchase of 
                tobacco products, shall be considered as adult-
                written publications which shall be permitted 
                to contain advertising. Notwithstanding the 
                preceding sentence, if the Secretary finds that 
                such treatment of matchbooks is not appropriate 
                for the protection of the public health, the 
                Secretary may determine by regulation that 
                matchbooks shall not be considered adult-
                written publications.
          [(4) Remote sales.--
                  [(A) In general.--The Secretary shall--
                          [(i) within 18 months after the date 
                        of enactment of the Family Smoking 
                        Prevention and Tobacco Control Act, 
                        promulgate regulations regarding the 
                        sale and distribution of tobacco 
                        products 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 to 
                        individuals who have not attained the 
                        minimum age established by applicable 
                        law for the purchase of such products, 
                        including requirements for age 
                        verification; and
                          [(ii) within 2 years after such date 
                        of enactment, issue regulations to 
                        address the promotion and marketing of 
                        tobacco products that are sold or 
                        distributed through means other than a 
                        direct, face-to-face exchange between a 
                        retailer and a consumer in order to 
                        protect individuals who have not 
                        attained the minimum age established by 
                        applicable law for the purchase of such 
                        products.
                  [(B) Relation to other authority.--Nothing in 
                this paragraph limits the authority of the 
                Secretary to take additional actions under the 
                other paragraphs of this subsection.]
          (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).
          (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).
  (e) Good Manufacturing Practice Requirements.--
          (1) Methods, facilities, and controls to conform.--
                  (A) In general.--In applying manufacturing 
                restrictions to tobacco, the Secretary shall, 
                in accordance with subparagraph (B), prescribe 
                regulations (which may differ based on the type 
                of tobacco product involved) requiring that the 
                methods used in, and the facilities and 
                controls used for, the manufacture, 
                preproduction design validation (including a 
                process to assess the performance of a tobacco 
                product), packing, and storage of a tobacco 
                product conform to current good manufacturing 
                practice, or hazard analysis and critical 
                control point methodology, as prescribed in 
                such regulations to assure that the public 
                health is protected and that the tobacco 
                product is in compliance with this chapter. 
                Such regulations may provide for the testing of 
                raw tobacco for pesticide chemical residues 
                regardless of whether a tolerance for such 
                chemical residues has been established.
                  (B) Requirements.--The Secretary shall--
                          (i) before promulgating any 
                        regulation under subparagraph (A), 
                        afford the Tobacco Products Scientific 
                        Advisory Committee an opportunity to 
                        submit recommendations with respect to 
                        the regulation proposed to be 
                        promulgated;
                          (ii) before promulgating any 
                        regulation under subparagraph (A), 
                        afford opportunity for an oral hearing;
                          (iii) provide the Tobacco Products 
                        Scientific Advisory Committee a 
                        reasonable time to make its 
                        recommendation with respect to proposed 
                        regulations under subparagraph (A);
                          (iv) in establishing the effective 
                        date of a regulation promulgated under 
                        this subsection, take into account the 
                        differences in the manner in which the 
                        different types of tobacco products 
                        have historically been produced, the 
                        financial resources of the different 
                        tobacco product manufacturers, and the 
                        state of their existing manufacturing 
                        facilities, and shall provide for a 
                        reasonable period of time for such 
                        manufacturers to conform to good 
                        manufacturing practices; and
                          (v) not require any small tobacco 
                        product manufacturer to comply with a 
                        regulation under subparagraph (A) for 
                        at least 4 years following the 
                        effective date established by the 
                        Secretary for such regulation.
          (2) Exemptions; variances.--
                  (A) Petition.--Any person subject to any 
                requirement prescribed under paragraph (1) may 
                petition the Secretary for a permanent or 
                temporary exemption or variance from such 
                requirement. Such a petition shall be submitted 
                to the Secretary in such form and manner as the 
                Secretary shall prescribe and shall--
                          (i) in the case of a petition for an 
                        exemption from a requirement, set forth 
                        the basis for the petitioner's 
                        determination that compliance with the 
                        requirement is not required to assure 
                        that the tobacco product will be in 
                        compliance with this chapter;
                          (ii) in the case of a petition for a 
                        variance from a requirement, set forth 
                        the methods proposed to be used in, and 
                        the facilities and controls proposed to 
                        be used for, the manufacture, packing, 
                        and storage of the tobacco product in 
                        lieu of the methods, facilities, and 
                        controls prescribed by the requirement; 
                        and
                          (iii) contain such other information 
                        as the Secretary shall prescribe.
                  (B) Referral to the tobacco products 
                scientific advisory committee.--The Secretary 
                may refer to the Tobacco Products Scientific 
                Advisory Committee any petition submitted under 
                subparagraph (A). The Tobacco Products 
                Scientific Advisory Committee shall report its 
                recommendations to the Secretary with respect 
                to a petition referred to it within 60 days 
                after the date of the petition's referral. 
                Within 60 days after--
                          (i) the date the petition was 
                        submitted to the Secretary under 
                        subparagraph (A); or
                          (ii) the day after the petition was 
                        referred to the Tobacco Products 
                        Scientific Advisory Committee,
                whichever occurs later, the Secretary shall by 
                order either deny the petition or approve it.
                  (C) Approval.--The Secretary may approve--
                          (i) a petition for an exemption for a 
                        tobacco product from a requirement if 
                        the Secretary determines that 
                        compliance with such requirement is not 
                        required to assure that the tobacco 
                        product will be in compliance with this 
                        chapter; and
                          (ii) a petition for a variance for a 
                        tobacco product from a requirement if 
                        the Secretary determines that the 
                        methods to be used in, and the 
                        facilities and controls to be used for, 
                        the manufacture, packing, and storage 
                        of the tobacco product in lieu of the 
                        methods, facilities, and controls 
                        prescribed by the requirement are 
                        sufficient to assure that the tobacco 
                        product will be in compliance with this 
                        chapter.
                  (D) Conditions.--An order of the Secretary 
                approving a petition for a variance shall 
                prescribe such conditions respecting the 
                methods used in, and the facilities and 
                controls used for, the manufacture, packing, 
                and storage of the tobacco product to be 
                granted the variance under the petition as may 
                be necessary to assure that the tobacco product 
                will be in compliance with this chapter.
                  (E) Hearing.--After the issuance of an order 
                under subparagraph (B) respecting a petition, 
                the petitioner shall have an opportunity for an 
                informal hearing on such order.
          (3) Compliance.--Compliance with requirements under 
        this subsection shall not be required before the end of 
        the 3-year period following the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act.
  (f) Research and Development.--The Secretary may enter into 
contracts for research, testing, and demonstrations respecting 
tobacco products and may obtain tobacco products for research, 
testing, and demonstration purposes.
  (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. 907. TOBACCO PRODUCT STANDARDS.

  (a) In General.--
          (1) Special rules.--
                  [(A) Special rule for cigarettes.--Beginning 
                3 months after the date of enactment of the 
                Family Smoking Prevention and Tobacco Control 
                Act, a cigarette or any of its component parts 
                (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 or 
                menthol) or an herb or spice, including 
                strawberry, grape, orange, clove, cinnamon, 
                pineapple, vanilla, coconut, licorice, cocoa, 
                chocolate, cherry, or coffee, that is a 
                characterizing flavor of the tobacco product or 
                tobacco smoke. 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 
                menthol or any artificial or natural flavor, 
                herb, or spice not specified in this 
                subparagraph.]
                  (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) Additional special rule.--Beginning 2 
                years after the date of enactment of the Family 
                Smoking Prevention and Tobacco Control Act, a 
                tobacco product manufacturer shall not use 
                tobacco, including foreign grown tobacco, that 
                contains a pesticide chemical residue that is 
                at a level greater than is specified by any 
                tolerance applicable under Federal law to 
                domestically grown tobacco.
          (2) Revision of tobacco product standards.--The 
        Secretary may revise the tobacco product standards in 
        paragraph (1) in accordance with subsection (c).
          (3) Tobacco product standards.--
                  (A) In general.--The Secretary may adopt 
                tobacco product standards in addition to those 
                in paragraph (1) if the Secretary finds that a 
                tobacco product standard is appropriate for the 
                protection of the public health.
                  (B) Determinations.--
                          (i) Considerations.--In making a 
                        finding described in subparagraph (A), 
                        the Secretary shall consider scientific 
                        evidence concerning--
                                  (I) the risks and benefits to 
                                the population as a whole, 
                                including users and nonusers of 
                                tobacco products, of the 
                                proposed standard;
                                  (II) the increased or 
                                decreased likelihood that 
                                existing users of tobacco 
                                products will stop using such 
                                products; and
                                  (III) the increased or 
                                decreased likelihood that those 
                                who do not use tobacco products 
                                will start using such products.
                          (ii) Additional considerations.--In 
                        the event that the Secretary makes a 
                        determination, set forth in a proposed 
                        tobacco product standard in a proposed 
                        rule, that it is appropriate for the 
                        protection of public health to require 
                        the reduction or elimination of an 
                        additive, constituent (including a 
                        smoke constituent), or other component 
                        of a tobacco product because the 
                        Secretary has found that the additive, 
                        constituent, or other component is or 
                        may be harmful, any party objecting to 
                        the proposed standard on the ground 
                        that the proposed standard will not 
                        reduce or eliminate the risk of illness 
                        or injury may provide for the 
                        Secretary's consideration scientific 
                        evidence that demonstrates that the 
                        proposed standard will not reduce or 
                        eliminate the risk of illness or 
                        injury.
          (4) Content of tobacco product standards.--A tobacco 
        product standard established under this section for a 
        tobacco product--
                  (A) shall include provisions that are 
                appropriate for the protection of the public 
                health, including provisions, where 
                appropriate--
                          (i) for nicotine yields of the 
                        product;
                          (ii) for the reduction or elimination 
                        of other constituents, including smoke 
                        constituents, or harmful components of 
                        the product; or
                          (iii) relating to any other 
                        requirement under subparagraph (B);
                  (B) shall, where appropriate for the 
                protection of the public health, include--
                          (i) provisions respecting the 
                        construction, components, ingredients, 
                        additives, constituents, including 
                        smoke constituents, and properties of 
                        the tobacco product;
                          (ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an 
                        individual basis) of the tobacco 
                        product;
                          (iii) provisions for the measurement 
                        of the tobacco product characteristics 
                        of the tobacco product;
                          (iv) provisions requiring that the 
                        results of each or of certain of the 
                        tests of the tobacco product required 
                        to be made under clause (ii) show that 
                        the tobacco product is in conformity 
                        with the portions of the standard for 
                        which the test or tests were required; 
                        and
                          (v) a provision requiring that the 
                        sale and distribution of the tobacco 
                        product be restricted but only to the 
                        extent that the sale and distribution 
                        of a tobacco product may be restricted 
                        under a regulation under section 
                        906(d);
                  (C) shall, where appropriate, require the use 
                and prescribe the form and content of labeling 
                for the proper use of the tobacco product; and
                  (D) shall require tobacco products containing 
                foreign-grown tobacco to meet the same 
                standards applicable to tobacco products 
                containing domestically grown tobacco.
          (5) Periodic reevaluation of tobacco product 
        standards.--The Secretary shall provide for periodic 
        evaluation of tobacco product standards established 
        under this section to determine whether such standards 
        should be changed to reflect new medical, scientific, 
        or other technological data. The Secretary may provide 
        for testing under paragraph (4)(B) by any person.
          (6) Involvement of other agencies; informed 
        persons.--In carrying out duties under this section, 
        the Secretary shall endeavor to--
                  (A) use personnel, facilities, and other 
                technical support available in other Federal 
                agencies;
                  (B) consult with other Federal agencies 
                concerned with standard setting and other 
                nationally or internationally recognized 
                standard-setting entities; and
                  (C) invite appropriate participation, through 
                joint or other conferences, workshops, or other 
                means, by informed persons representative of 
                scientific, professional, industry, 
                agricultural, or consumer organizations who in 
                the Secretary's judgment can make a significant 
                contribution.
  (b) Considerations by Secretary.--
          (1) Technical achievability.--The Secretary shall 
        consider information submitted in connection with a 
        proposed standard regarding the technical achievability 
        of compliance with such standard.
          (2) Other considerations.--The Secretary shall 
        consider all other information submitted in connection 
        with a proposed standard, including information 
        concerning the countervailing effects of the tobacco 
        product standard on the health of adolescent tobacco 
        users, adult tobacco users, or nontobacco users, such 
        as the creation of a significant demand for contraband 
        or other tobacco products that do not meet the 
        requirements of this chapter and the significance of 
        such demand.
  (c) Proposed Standards.--
          (1) In general.--The Secretary shall publish in the 
        Federal Register a notice of proposed rulemaking for 
        the establishment, amendment, or revocation of any 
        tobacco product standard.
          (2) Requirements of notice.--A notice of proposed 
        rulemaking for the establishment or amendment of a 
        tobacco product standard for a tobacco product shall--
                  (A) set forth a finding with supporting 
                justification that the tobacco product standard 
                is appropriate for the protection of the public 
                health;
                  (B) invite interested persons to submit a 
                draft or proposed tobacco product standard for 
                consideration by the Secretary;
                  (C) invite interested persons to submit 
                comments on structuring the standard so that it 
                does not advantage foreign-grown tobacco over 
                domestically grown tobacco; and
                  (D) invite the Secretary of Agriculture to 
                provide any information or analysis which the 
                Secretary of Agriculture believes is relevant 
                to the proposed tobacco product standard.
          (3) Finding.--A notice of proposed rulemaking for the 
        revocation of a tobacco product standard shall set 
        forth a finding with supporting justification that the 
        tobacco product standard is no longer appropriate for 
        the protection of the public health.
          (4) Comment.--The Secretary shall provide for a 
        comment period of not less than 60 days.
  (d) Promulgation.--
          (1) In general.--After the expiration of the period 
        for comment on a notice of proposed rulemaking 
        published under subsection (c) respecting a tobacco 
        product standard and after consideration of comments 
        submitted under subsections (b) and (c) and any report 
        from the Tobacco Products Scientific Advisory 
        Committee, the Secretary shall--
                  (A) if the Secretary determines that the 
                standard would be appropriate for the 
                protection of the public health, promulgate a 
                regulation establishing a tobacco product 
                standard and publish in the Federal Register 
                findings on the matters referred to in 
                subsection (c); or
                  (B) publish a notice terminating the 
                proceeding for the development of the standard 
                together with the reasons for such termination.
          (2) Effective date.--A regulation establishing a 
        tobacco product standard shall set forth the date or 
        dates upon which the standard shall take effect, but no 
        such regulation may take effect before 1 year after the 
        date of its publication unless the Secretary determines 
        that an earlier effective date is necessary for the 
        protection of the public health. Such date or dates 
        shall be established so as to minimize, consistent with 
        the public health, economic loss to, and disruption or 
        dislocation of, domestic and international trade. In 
        establishing such effective date or dates, the 
        Secretary shall consider information submitted in 
        connection with a proposed product standard by 
        interested parties, including manufacturers and tobacco 
        growers, regarding the technical achievability of 
        compliance with the standard, and including information 
        concerning the existence of patents that make it 
        impossible to comply in the timeframe envisioned in the 
        proposed standard. If the Secretary determines, based 
        on the Secretary's evaluation of submitted comments, 
        that a product standard can be met only by 
        manufacturers requiring substantial changes to the 
        methods of farming the domestically grown tobacco used 
        by the manufacturer, the effective date of that product 
        standard shall be not less than 2 years after the date 
        of publication of the final regulation establishing the 
        standard.
          (3) Limitation on power granted to the food and drug 
        administration.--Because of the importance of a 
        decision of the Secretary to issue a regulation--
                  (A) banning all cigarettes, all smokeless 
                tobacco products, all little cigars, all cigars 
                other than little cigars, all pipe tobacco, or 
                all roll-your-own tobacco products; or
                  (B) requiring the reduction of nicotine 
                yields of a tobacco product to zero,
        the Secretary is prohibited from taking such actions 
        under this Act.
          (4) Amendment; revocation.--
                  (A) Authority.--The Secretary, upon the 
                Secretary's own initiative or upon petition of 
                an interested person, may by a regulation, 
                promulgated in accordance with the requirements 
                of subsection (c) and paragraph (2), amend or 
                revoke a tobacco product standard.
                  (B) Effective date.--The Secretary may 
                declare a proposed amendment of a tobacco 
                product standard to be effective on and after 
                its publication in the Federal Register and 
                until the effective date of any final action 
                taken on such amendment if the Secretary 
                determines that making it so effective is in 
                the public interest.
          (5) Referral to advisory committee.--
                  (A) In general.--The Secretary may refer a 
                proposed regulation for the establishment, 
                amendment, or revocation of a tobacco product 
                standard to the Tobacco Products Scientific 
                Advisory Committee for a report and 
                recommendation with respect to any matter 
                involved in the proposed regulation which 
                requires the exercise of scientific judgment.
                  (B) Initiation of referral.--The Secretary 
                may make a referral under this paragraph--
                          (i) on the Secretary's own 
                        initiative; or
                          (ii) upon the request of an 
                        interested person that--
                                  (I) demonstrates good cause 
                                for the referral; and
                                  (II) is made before the 
                                expiration of the period for 
                                submission of comments on the 
                                proposed regulation.
                  (C) Provision of data.--If a proposed 
                regulation is referred under this paragraph to 
                the Tobacco Products Scientific Advisory 
                Committee, the Secretary shall provide the 
                Advisory Committee with the data and 
                information on which such proposed regulation 
                is based.
                  (D) Report and recommendation.--The Tobacco 
                Products Scientific Advisory Committee shall, 
                within 60 days after the referral of a proposed 
                regulation under this paragraph and after 
                independent study of the data and information 
                furnished to it by the Secretary and other data 
                and information before it, submit to the 
                Secretary a report and recommendation 
                respecting such regulation, together with all 
                underlying data and information and a statement 
                of the reason or basis for the recommendation.
                  (E) Public availability.--The Secretary shall 
                make a copy of each report and recommendation 
                under subparagraph (D) publicly available.
  (e) Menthol Cigarettes.--
          (1) Referral; considerations.--Immediately upon the 
        establishment of the Tobacco Products Scientific 
        Advisory Committee under section 917(a), the Secretary 
        shall refer to the Committee for report and 
        recommendation, under section 917(c)(4), the issue of 
        the impact of the use of menthol in cigarettes on the 
        public health, including such use among children, 
        African-Americans, Hispanics, and other racial and 
        ethnic minorities. In its review, the Tobacco Products 
        Scientific Advisory Committee shall address the 
        considerations listed in subsections (a)(3)(B)(i) and 
        (b).
          (2) Report and recommendation.--Not later than 1 year 
        after its establishment, the Tobacco Product Scientific 
        Advisory Committee shall submit to the Secretary the 
        report and recommendations required pursuant to 
        paragraph (1).
          (3) Rule of construction.--Nothing in this subsection 
        shall be construed to limit the Secretary's authority 
        to take action under this section or other sections of 
        this Act applicable to menthol.
  (f) Dissolvable Tobacco Products.--
          (1) Referral; considerations.--The Secretary shall 
        refer to the Tobacco Products Scientific Advisory 
        Committee for report and recommendation, under section 
        917(c)(4), the issue of the nature and impact of the 
        use of dissolvable tobacco products on the public 
        health, including such use among children. In its 
        review, the Tobacco Products Scientific Advisory 
        Committee shall address the considerations listed in 
        subsection (a)(3)(B)(i).
          (2) Report and recommendation.--Not later than 2 
        years after its establishment, the Tobacco Product 
        Scientific Advisory Committee shall submit to the 
        Secretary the report and recommendations required 
        pursuant to paragraph (1).
          (3) Rule of construction.--Nothing in this subsection 
        shall be construed to limit the Secretary's authority 
        to take action under this section or other sections of 
        this Act at any time applicable to any dissolvable 
        tobacco product.

           *       *       *       *       *       *       *


SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.

  (a) In General.--
          (1) New tobacco product defined.--For purposes of 
        this section the term ``new tobacco product'' means--
                  (A) any tobacco product (including those 
                products in test markets) that was not 
                commercially marketed in the United States as 
                of February 15, 2007; or
                  (B) any modification (including a change in 
                design, any component, any part, or any 
                constituent, including a smoke constituent, or 
                in the content, delivery or form of nicotine, 
                or any other additive or ingredient) of a 
                tobacco product where the modified product was 
                commercially marketed in the United States 
                after February 15, 2007.
          (2) Premarket review required.--
                  (A) New products.--An order under subsection 
                (c)(1)(A)(i) for a new tobacco product is 
                required unless--
                          (i) the manufacturer has submitted a 
                        report under section 905(j); and the 
                        Secretary has issued an order that the 
                        tobacco product--
                                  (I) is substantially 
                                equivalent to a tobacco product 
                                commercially marketed (other 
                                than for test marketing) in the 
                                United States as of February 
                                15, 2007; and
                                  (II) is in compliance with 
                                the requirements of this Act; 
                                [or]
                          (ii) the tobacco product is exempt 
                        from the requirements of section 905(j) 
                        pursuant to a regulation issued under 
                        section 905(j)(3)[.]; or
                          (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.
                  (B) Application to certain post-february 15, 
                2007, products.--Subparagraph (A) shall not 
                apply to a tobacco product--
                          (i) that was first introduced or 
                        delivered for introduction into 
                        interstate commerce for commercial 
                        distribution in the United States after 
                        February 15, 2007, and prior to the 
                        date that is 21 months after the date 
                        of enactment of the Family Smoking 
                        Prevention and Tobacco Control Act; and
                          (ii) for which a report was submitted 
                        under section 905(j) within such 21-
                        month period,
                except that subparagraph (A) shall apply to the 
                tobacco product if the Secretary issues an 
                order that the tobacco product is not 
                substantially equivalent.
                  (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.
          (3) Substantially equivalent defined.--
                  (A) In general.--In this section and section 
                905(j), the term ``substantially equivalent'' 
                or ``substantial equivalence'' means, with 
                respect to the tobacco product being compared 
                to the predicate tobacco product, that the 
                Secretary by order has found that the tobacco 
                product--
                          (i) has the same characteristics as 
                        the predicate tobacco product; or
                          (ii) has different characteristics 
                        and the information submitted contains 
                        information, including clinical data if 
                        deemed necessary by the Secretary, that 
                        demonstrates that it is not appropriate 
                        to regulate the product under this 
                        section because the product does not 
                        raise different questions of public 
                        health.
                  (B) Characteristics.--In subparagraph (A), 
                the term ``characteristics'' means the 
                materials, ingredients, design, composition, 
                heating source, or other features of a tobacco 
                product.
                  (C) Limitation.--A tobacco product may not be 
                found to be substantially equivalent to a 
                predicate tobacco product that has been removed 
                from the market at the initiative of the 
                Secretary or that has been determined by a 
                judicial order to be misbranded or adulterated.
          (4) Health information.--
                  (A) Summary.--As part of a submission under 
                section 905(j) respecting a tobacco product, 
                the person required to file a premarket 
                notification under such section shall provide 
                an adequate summary of any health information 
                related to the tobacco product or state that 
                such information will be made available upon 
                request by any person.
                  (B) Required information.--Any summary under 
                subparagraph (A) respecting a tobacco product 
                shall contain detailed information regarding 
                data concerning adverse health effects and 
                shall be made available to the public by the 
                Secretary within 30 days of the issuance of a 
                determination that such tobacco product is 
                substantially equivalent to another tobacco 
                product.
  (b) Application.--
          (1) Contents.--An application under this section 
        shall contain--
                  (A) full reports of all information, 
                published or known to, or which should 
                reasonably be known to, the applicant, 
                concerning investigations which have been made 
                to show the health risks of such tobacco 
                product and whether such tobacco product 
                presents less risk than other tobacco products;
                  (B) a full statement of the components, 
                ingredients, additives, and properties, and of 
                the principle or principles of operation, of 
                such tobacco product;
                  (C) a full description of the methods used 
                in, and the facilities and controls used for, 
                the manufacture, processing, and, when 
                relevant, packing and installation of, such 
                tobacco product;
                  (D) an identifying reference to any tobacco 
                product standard under section 907 which would 
                be applicable to any aspect of such tobacco 
                product, and either adequate information to 
                show that such aspect of such tobacco product 
                fully meets such tobacco product standard or 
                adequate information to justify any deviation 
                from such standard;
                  (E) such samples of such tobacco product and 
                of components thereof as the Secretary may 
                reasonably require;
                  (F) specimens of the labeling proposed to be 
                used for such tobacco product; and
                  (G) such other information relevant to the 
                subject matter of the application as the 
                Secretary may require.
          (2) Referral to tobacco products scientific advisory 
        committee.--Upon receipt of an application meeting the 
        requirements set forth in paragraph (1), the 
        Secretary--
                  (A) may, on the Secretary's own initiative; 
                or
                  (B) may, upon the request of an applicant,
        refer such application to the Tobacco Products 
        Scientific Advisory Committee for reference and for 
        submission (within such period as the Secretary may 
        establish) of a report and recommendation respecting 
        the application, together with all underlying data and 
        the reasons or basis for the recommendation.
  (c) Action on Application.--
          (1) Deadline.--
                  (A) In general.--As promptly as possible, but 
                in no event later than 180 days after the 
                receipt of an application under subsection (b), 
                the Secretary, after considering the report and 
                recommendation submitted under subsection 
                (b)(2), shall--
                          (i) issue an order that the new 
                        product may be introduced or delivered 
                        for introduction into interstate 
                        commerce if the Secretary finds that 
                        none of the grounds specified in 
                        paragraph (2) of this subsection 
                        applies; or
                          (ii) issue an order that the new 
                        product may not be introduced or 
                        delivered for introduction into 
                        interstate commerce if the Secretary 
                        finds (and sets forth the basis for 
                        such finding as part of or accompanying 
                        such denial) that 1 or more grounds for 
                        denial specified in paragraph (2) of 
                        this subsection apply.
                  (B) Restrictions on sale and distribution.--
                An order under subparagraph (A)(i) may require 
                that the sale and distribution of the tobacco 
                product be restricted but only to the extent 
                that the sale and distribution of a tobacco 
                product may be restricted under a regulation 
                under section 906(d).
          (2) Denial of application.--The Secretary shall deny 
        an application submitted under subsection (b) if, upon 
        the basis of the information submitted to the Secretary 
        as part of the application and any other information 
        before the Secretary with respect to such tobacco 
        product, the Secretary finds that--
                  (A) there is a lack of a showing that 
                permitting such tobacco product to be marketed 
                would be appropriate for the protection of the 
                public health;
                  (B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, 
                or packing of such tobacco product do not 
                conform to the requirements of section 906(e);
                  (C) based on a fair evaluation of all 
                material facts, the proposed labeling is false 
                or misleading in any particular; or
                  (D) such tobacco product is not shown to 
                conform in all respects to a tobacco product 
                standard in effect under section 907, and there 
                is a lack of adequate information to justify 
                the deviation from such standard.
          (3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be 
        practicable, be accompanied by a statement informing 
        the applicant of the measures required to remove such 
        application from deniable form (which measures may 
        include further research by the applicant in accordance 
        with 1 or more protocols prescribed by the Secretary).
          (4) Basis for finding.--For purposes of this section, 
        the finding as to whether the marketing of a tobacco 
        product for which an application has been submitted is 
        appropriate for the protection of the public health 
        shall be determined with respect to the risks and 
        benefits to the population as a whole, including users 
        and nonusers of the tobacco product, and taking into 
        account--
                  (A) the increased or decreased likelihood 
                that existing users of tobacco products will 
                stop using such products; and
                  (B) the increased or decreased likelihood 
                that those who do not use tobacco products will 
                start using such products.
          (5) Basis for action.--
                  (A) Investigations.--For purposes of 
                paragraph (2)(A), whether permitting a tobacco 
                product to be marketed would be appropriate for 
                the protection of the public health shall, when 
                appropriate, be determined on the basis of 
                well-controlled investigations, which may 
                include 1 or more clinical investigations by 
                experts qualified by training and experience to 
                evaluate the tobacco product.
                  (B) Other evidence.--If the Secretary 
                determines that there exists valid scientific 
                evidence (other than evidence derived from 
                investigations described in subparagraph (A)) 
                which is sufficient to evaluate the tobacco 
                product, the Secretary may authorize that the 
                determination for purposes of paragraph (2)(A) 
                be made on the basis of such evidence.
  (d) Withdrawal and Temporary Suspension.--
          (1) In general.--The Secretary shall, upon obtaining, 
        where appropriate, advice on scientific matters from 
        the Tobacco Products Scientific Advisory Committee, and 
        after due notice and opportunity for informal hearing 
        for a tobacco product for which an order was issued 
        under subsection (c)(1)(A)(i), issue an order 
        withdrawing the order if the Secretary finds--
                  (A) that the continued marketing of such 
                tobacco product no longer is appropriate for 
                the protection of the public health;
                  (B) that the application contained or was 
                accompanied by an untrue statement of a 
                material fact;
                  (C) that the applicant--
                          (i) has failed to establish a system 
                        for maintaining records, or has 
                        repeatedly or deliberately failed to 
                        maintain records or to make reports, 
                        required by an applicable regulation 
                        under section 909;
                          (ii) has refused to permit access to, 
                        or copying or verification of, such 
                        records as required by section 704; or
                          (iii) has not complied with the 
                        requirements of section 905;
                  (D) on the basis of new information before 
                the Secretary with respect to such tobacco 
                product, evaluated together with the evidence 
                before the Secretary when the application was 
                reviewed, that the methods used in, or the 
                facilities and controls used for, the 
                manufacture, processing, packing, or 
                installation of such tobacco product do not 
                conform with the requirements of section 906(e) 
                and were not brought into conformity with such 
                requirements within a reasonable time after 
                receipt of written notice from the Secretary of 
                nonconformity;
                  (E) on the basis of new information before 
                the Secretary, evaluated together with the 
                evidence before the Secretary when the 
                application was reviewed, that the labeling of 
                such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not 
                corrected within a reasonable time after 
                receipt of written notice from the Secretary of 
                such fact; or
                  (F) on the basis of new information before 
                the Secretary, evaluated together with the 
                evidence before the Secretary when such order 
                was issued, that such tobacco product is not 
                shown to conform in all respects to a tobacco 
                product standard which is in effect under 
                section 907, compliance with which was a 
                condition to the issuance of an order relating 
                to the application, and that there is a lack of 
                adequate information to justify the deviation 
                from such standard.
          (2) Appeal.--The holder of an application subject to 
        an order issued under paragraph (1) withdrawing an 
        order issued pursuant to subsection (c)(1)(A)(i) may, 
        by petition filed on or before the 30th day after the 
        date upon which such holder receives notice of such 
        withdrawal, obtain review thereof in accordance with 
        section 912.
          (3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary 
        determines there is reasonable probability that the 
        continuation of distribution of a tobacco product under 
        an order would cause serious, adverse health 
        consequences or death, that is greater than ordinarily 
        caused by tobacco products on the market, the Secretary 
        shall by order temporarily suspend the authority of the 
        manufacturer to market the product. If the Secretary 
        issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw such 
        application.
  (e) Service of Order.--An order issued by the Secretary under 
this section shall be served--
          (1) in person by any officer or employee of the 
        department designated by the Secretary; or
          (2) by mailing the order by registered mail or 
        certified mail addressed to the applicant at the 
        applicant's last known address in the records of the 
        Secretary.
  (f) Records.--
          (1) Additional information.--In the case of any 
        tobacco product for which an order issued pursuant to 
        subsection (c)(1)(A)(i) for an application filed under 
        subsection (b) is in effect, the applicant shall 
        establish and maintain such records, and make such 
        reports to the Secretary, as the Secretary may by 
        regulation, or by order with respect to such 
        application, prescribe on the basis of a finding that 
        such records and reports are necessary in order to 
        enable the Secretary to determine, or facilitate a 
        determination of, whether there is or may be grounds 
        for withdrawing or temporarily suspending such order.
          (2) Access to records.--Each person required under 
        this section to maintain records, and each person in 
        charge of custody thereof, shall, upon request of an 
        officer or employee designated by the Secretary, permit 
        such officer or employee at all reasonable times to 
        have access to and copy and verify such records.
  (g) Investigational Tobacco Product Exemption for 
Investigational Use.--The Secretary may exempt tobacco products 
intended for investigational use from the provisions of this 
chapter under such conditions as the Secretary may by 
regulation prescribe.
  (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.

           *       *       *       *       *       *       *


SEC. 919. USER FEES.

  (a) Establishment of Quarterly Fee.--Beginning on the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act, the Secretary shall in accordance with this section assess 
user fees on, and collect such fees from, each manufacturer and 
importer of tobacco products subject to this chapter. The fees 
shall be assessed and collected with respect to each quarter of 
each fiscal year, and the total amount assessed and collected 
for a fiscal year shall be the amount specified in subsection 
(b)(1) for such year, subject to subsection (c).
  (b) Assessment of User Fee.--
          (1) Amount of assessment.--The total amount of user 
        fees authorized to be assessed and collected under 
        subsection (a) for a fiscal year is the following, as 
        applicable to the fiscal year involved:
                  (A) For fiscal year 2009, $85,000,000 
                (subject to subsection (e)).
                  (B) For fiscal year 2010, $235,000,000.
                  (C) For fiscal year 2011, $450,000,000.
                  (D) For fiscal year 2012, $477,000,000.
                  (E) For fiscal year 2013, $505,000,000.
                  (F) For fiscal year 2014, $534,000,000.
                  (G) For fiscal year 2015, $566,000,000.
                  (H) For fiscal year 2016, $599,000,000.
                  (I) For fiscal year 2017, $635,000,000.
                  (J) For fiscal year 2018, $672,000,000.
                  [(K) For fiscal year 2019 and each subsequent 
                fiscal year, $712,000,000.]
                  (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.
          (2) Allocations of assessment by class of tobacco 
        products.--
                  [(A) In general.--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 
                equal to the applicable percentage of each 
                class for the fiscal year multiplied by the 
                amount specified in paragraph (1) for the 
                fiscal year.]
                  (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).
                  (B) Applicable percentage.--
                          (i) In general.--For purposes of 
                        subparagraph (A), the applicable 
                        percentage for a fiscal year for each 
                        of the following classes of tobacco 
                        products shall be determined in 
                        accordance with clause (ii):
                                  (I) Cigarettes.
                                  (II) Cigars, including small 
                                cigars and cigars other than 
                                small cigars.
                                  (III) Snuff.
                                  (IV) Chewing tobacco.
                                  (V) Pipe tobacco.
                                  (VI) Roll-your-own tobacco.
                          (ii) Allocations.--The applicable 
                        percentage of each class of tobacco 
                        product described in clause (i) for a 
                        fiscal year shall be the percentage 
                        determined under section 625(c) of 
                        Public Law 108-357 for each such class 
                        of product for such fiscal year.
                          (iii) Requirement of regulations.--
                        Notwithstanding clause (ii), no user 
                        fees shall be assessed on a class of 
                        tobacco products unless such class of 
                        tobacco products is listed in section 
                        901(b) or is deemed by the Secretary in 
                        a regulation under section 901(b) to be 
                        subject to this chapter.
                          (iv) Reallocations.--In the case of a 
                        class of tobacco products that is not 
                        listed in section 901(b) or deemed by 
                        the Secretary in a regulation under 
                        section 901(b) to be subject to this 
                        chapter, the amount of user fees that 
                        would otherwise be assessed to such 
                        class of tobacco products shall be 
                        reallocated to the classes of tobacco 
                        products that are subject to this 
                        chapter in the same manner and based on 
                        the same relative percentages otherwise 
                        determined under clause (ii).
                  (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) Determination of user fee by company.--
                  (A) In general.--The total user fee to be 
                paid by each manufacturer or importer of a 
                particular class of tobacco products shall be 
                determined for each quarter by multiplying--
                          (i) such manufacturer's or importer's 
                        percentage share as determined under 
                        paragraph (4); by
                          (ii) the portion of the user fee 
                        amount for the current quarter to be 
                        assessed on all manufacturers and 
                        importers of such class of tobacco 
                        products as determined under paragraph 
                        (2).
                  (B) No fee in excess of percentage share.--No 
                manufacturer or importer of tobacco products 
                shall be required to pay a user fee in excess 
                of the percentage share of such manufacturer or 
                importer.
          (4) Allocation of assessment within each class of 
        tobacco product.--The percentage share of each 
        manufacturer or importer of a particular class of 
        tobacco products of the total user fee to be paid by 
        all manufacturers or importers of that class of tobacco 
        products [shall be the percentage determined for 
        purposes of allocations under subsections (e) through 
        (h) of section 625 of Public Law 108-357] shall be the 
        percentage determined by the Secretary.
          [(5) Allocation for cigars.--Notwithstanding 
        paragraph (4), if a user fee assessment is imposed on 
        cigars, the percentage share of each manufacturer or 
        importer of cigars shall be based on the excise taxes 
        paid by such manufacturer or importer during the prior 
        fiscal year.]
          [(6)] (5) Timing of assessment.--The Secretary shall 
        notify each manufacturer and importer of tobacco 
        products subject to this section of the amount of the 
        quarterly assessment imposed on such manufacturer or 
        importer under this subsection for each quarter of each 
        fiscal year. Such notifications shall occur not later 
        than 30 days prior to the end of the quarter for which 
        such assessment is made, and payments of all 
        assessments shall be made by the last day of the 
        quarter involved.
          [(7) Memorandum of understanding.--
                  [(A) In general.--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 the 
                information described in paragraphs (2)(B)(ii) 
                and (4) and 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.
                  [(B) Assurances.--Beginning not later than 
                fiscal year 2015, and for each subsequent 
                fiscal year, the Secretary shall ensure that 
                the Food and Drug Administration is able to 
                determine the applicable percentages described 
                in paragraph (2) and the percentage shares 
                described in paragraph (4). The Secretary may 
                carry out this subparagraph by entering into a 
                contract with the head of the Federal agency 
                referred to in subparagraph (A) to continue to 
                provide the necessary information.]
          (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.
  (c) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance in 
        appropriations Acts, subject to paragraph (2)(D). Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation.
          (2) Availability.--
                  (A) In general.--Fees appropriated under 
                paragraph (3) are available only for the 
                purpose of paying the costs of the activities 
                of the Food and Drug Administration related to 
                the regulation of tobacco products under this 
                chapter and the Family Smoking Prevention and 
                Tobacco Control Act (referred to in this 
                subsection as ``tobacco regulation 
                activities''), except that such fees may be 
                used for the reimbursement specified in 
                subparagraph (C).
                  (B) Prohibition against use of other funds.--
                          (i) In general.--Except as provided 
                        in clause (ii), fees collected under 
                        subsection (a) are the only funds 
                        authorized to be made available for 
                        tobacco regulation activities.
                          (ii) Startup costs.--Clause (i) does 
                        not apply until October 1, 2009. Until 
                        such date, any amounts available to the 
                        Food and Drug Administration (excluding 
                        user fees) shall be available and 
                        allocated as needed to pay the costs of 
                        tobacco regulation activities.
                  (C) Reimbursement of start-up amounts.--
                          (i) In general.--Any amounts 
                        allocated for the start-up period 
                        pursuant to subparagraph (B)(ii) shall 
                        be reimbursed through any appropriated 
                        fees collected under subsection (a), in 
                        such manner as the Secretary determines 
                        appropriate to ensure that such 
                        allocation results in no net change in 
                        the total amount of funds otherwise 
                        available, for the period from October 
                        1, 2008, through September 30, 2010, 
                        for Food and Drug Administration 
                        programs and activities (other than 
                        tobacco regulation activities) for such 
                        period.
                          (ii) Treatment of reimbursed 
                        amounts.--Amounts reimbursed under 
                        clause (i) shall be available for the 
                        programs and activities for which funds 
                        allocated for the start-up period were 
                        available, prior to such allocation, 
                        until September 30, 2010, 
                        notwithstanding any otherwise 
                        applicable limits on amounts for such 
                        programs or activities for a fiscal 
                        year.
                  (D) Fee collected during start-up period.--
                Notwithstanding the first sentence of paragraph 
                (1), fees under subsection (a) may be collected 
                through September 30, 2009 under subparagraph 
                (B)(ii) and shall be available for obligation 
                and remain available until expended. Such 
                offsetting collections shall be credited to the 
                salaries and expenses account of the Food and 
                Drug Administration.
                  (E) Obligation of start-up costs in 
                anticipation of available fee collections.--
                Notwithstanding any other provision of law, 
                following the enactment of an appropriation for 
                fees under this section for fiscal year 2010, 
                or any portion thereof, obligations for costs 
                of tobacco regulation activities during the 
                start-up period may be incurred in anticipation 
                of the receipt of offsetting fee collections 
                through procedures specified in section 1534 of 
                title 31, United States Code.
          (3) Authorization of appropriations.--For fiscal year 
        2009 and each subsequent fiscal year, there is 
        authorized to be appropriated for fees under this 
        section an amount equal to the amount specified in 
        subsection (b)(1) for the fiscal year.
  (d) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  (e) Applicability to Fiscal Year 2009.--If the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act occurs during fiscal year 2009, the following applies, 
subject to subsection (c):
          (1) The Secretary shall determine the fees that would 
        apply for a single quarter of such fiscal year 
        according to the application of subsection (b) to the 
        amount specified in paragraph (1)(A) of such subsection 
        (referred to in this subsection as the ``quarterly fee 
        amounts'').
          (2) For the quarter in which such date of enactment 
        occurs, the amount of fees assessed shall be a pro rata 
        amount, determined according to the number of days 
        remaining in the quarter (including such date of 
        enactment) and according to the daily equivalent of the 
        quarterly fee amounts. Fees assessed under the 
        preceding sentence shall not be collected until the 
        next quarter.
          (3) For the quarter following the quarter to which 
        paragraph (2) applies, the full quarterly fee amounts 
        shall be assessed and collected, in addition to 
        collection of the pro rata fees assessed under 
        paragraph (2).

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           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

DIVISION A--FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

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TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

           *       *       *       *       *       *       *


SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.

  (a) Amendment of Federal Food, Drug, and Cosmetic Act.--
Except as otherwise expressly provided, whenever in this 
section an amendment is expressed in terms of an amendment to, 
or repeal of, a section or other provision, the reference is to 
a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).
  (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
          (1) in subsection (a), by inserting ``tobacco 
        product,'' after ``device,'';
          (2) in subsection (b), by inserting ``tobacco 
        product,'' after ``device,'';
          (3) in subsection (c), by inserting ``tobacco 
        product,'' after ``device,'';
          (4) in subsection (e)--
                  (A) by striking the period after ``572(i)''; 
                and
                  (B) by striking ``or 761 or the refusal to 
                permit access to'' and inserting ``761, 909, or 
                920 or the refusal to permit access to'';
          (5) in subsection (g), by inserting ``tobacco 
        product,'' after ``device,'';
          (6) in subsection (h), by inserting ``tobacco 
        product,'' after ``device,'';
          (7) in subsection (j)--
                  (A) by striking the period after ``573''; and
                  (B) by striking ``708, or 721'' and inserting 
                ``708, 721, 904, 905, 906, 907, 908, 909, or 
                920(b)'';
          (8) in subsection (k), by inserting ``tobacco 
        product,'' after ``device,'';
          (9) by striking subsection (p) and inserting the 
        following:
  ``(p) The failure to register in accordance with section 510 
or 905, the failure to provide any information required by 
section 510(j), 510(k), 905(i), or 905(j), or the failure to 
provide a notice required by section 510(j)(2) or 905(i)(3).'';
          (10) by striking subsection (q)(1) and inserting the 
        following:
  ``(q)(1) The failure or refusal--
          ``(A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b), 907, 908, or 915;
          ``(B) to furnish any notification or other material 
        or information required by or under section 519, 
        520(g), 904, 909, or 920; or
          ``(C) to comply with a requirement under section 522 
        or 913.'';
          (11) in subsection (q)(2), by striking ``device,'' 
        and inserting ``device or tobacco product,'';
          (12) in subsection (r), by inserting ``or tobacco 
        product'' after the term ``device'' each time that such 
        term appears; and
          (13) by adding at the end the following:
  ``(oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
  ``(pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of 
section 911.
  ``(qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification 
device upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  ``(2) Making, selling, disposing of, or keeping in 
possession, control, or custody, or concealing any punch, die, 
plate, stone, or other item that is designed to print, imprint, 
or reproduce the trademark, trade name, or other identifying 
mark, imprint, or device of another or any likeness of any of 
the foregoing upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  ``(3) The doing of any act that causes a tobacco product to 
be a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco 
product.
  ``(rr) The charitable distribution of tobacco products.
  ``(ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade.
  ``(tt) Making any express or implied statement or 
representation directed to consumers with respect to a tobacco 
product, in a label or labeling or through the media or 
advertising, that either conveys, or misleads or would mislead 
consumers into believing, that--
          ``(1) the product is approved by the Food and Drug 
        Administration;
          ``(2) the Food and Drug Administration deems the 
        product to be safe for use by consumers;
          ``(3) the product is endorsed by the Food and Drug 
        Administration for use by consumers; or
          ``(4) the product is safe or less harmful by virtue 
        of--
                  ``(A) its regulation or inspection by the 
                Food and Drug Administration; or
                  ``(B) its compliance with regulatory 
                requirements set by the Food and Drug 
                Administration;
        including any such statement or representation 
        rendering the product misbranded under section 903.''.
  (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is 
amended--
          (1) in paragraph (5)--
                  (A) by striking ``paragraph (1), (2), (3), or 
                (4)'' each place such appears and inserting 
                ``paragraph (1), (2), (3), (4), or (9)'';
                  (B) in subparagraph (A)--
                          (i) by striking ``assessed'' the 
                        first time it appears and inserting 
                        ``assessed, or a no-tobacco-sale order 
                        may be imposed,''; and
                          (ii) by striking ``penalty'' the 
                        second time it appears and inserting 
                        ``penalty, or upon whom a no-tobacco-
                        sale order is to be imposed,'';
                  (C) in subparagraph (B)--
                          (i) by inserting after ``penalty,'' 
                        the following: ``or the period to be 
                        covered by a no-tobacco-sale order,''; 
                        and
                          (ii) by adding at the end the 
                        following: ``A no-tobacco-sale order 
                        permanently prohibiting an individual 
                        retail outlet from selling tobacco 
                        products shall include provisions that 
                        allow the outlet, after a specified 
                        period of time, to request that the 
                        Secretary compromise, modify, or 
                        terminate the order.''; and
                  (D) by adding at the end the following:
  ``(D) The Secretary may compromise, modify, or terminate, 
with or without conditions, any no-tobacco-sale order.'';
          (2) in paragraph (6)--
                  (A) by inserting ``or the imposition of a no-
                tobacco-sale order'' after the term ``penalty'' 
                each place such term appears; and
                  (B) by striking ``issued.'' and inserting 
                ``issued, or on which the no-tobacco-sale order 
                was imposed, as the case may be.''; and
          (3) by adding at the end the following:
  ``(8) If the Secretary finds that a person has committed 
repeated violations of restrictions promulgated under section 
906(d) at a particular retail outlet then the Secretary may 
impose a no-tobacco-sale order on that person prohibiting the 
sale of tobacco products in that outlet. A no-tobacco-sale 
order may be imposed with a civil penalty under paragraph (1). 
Prior to the entry of a no-sale order under this paragraph, a 
person shall be entitled to a hearing pursuant to the 
procedures established through regulations of the Food and Drug 
Administration for assessing civil money penalties, including 
at a retailer's request a hearing by telephone, or at the 
nearest regional or field office of the Food and Drug 
Administration, or at a Federal, State, or county facility 
within 100 miles from the location of the retail outlet, if 
such a facility is available.
  ``(9) Civil Monetary Penalties for Violation of Tobacco 
Product Requirements.--
          ``(A) In general.--Subject to subparagraph (B), any 
        person who violates a requirement of this Act which 
        relates to tobacco products shall be liable to the 
        United States for a civil penalty in an amount not to 
        exceed $15,000 for each such violation, and not to 
        exceed $1,000,000 for all such violations adjudicated 
        in a single proceeding.
          ``(B) Enhanced penalties.--
                  ``(i) Any person who intentionally violates a 
                requirement of section 902(5), 902(6), 904, 
                908(c), or 911(a), shall be subject to a civil 
                monetary penalty of--
                          ``(I) not to exceed $250,000 per 
                        violation, and not to exceed $1,000,000 
                        for all such violations adjudicated in 
                        a single proceeding; or
                          ``(II) in the case of a violation 
                        that continues after the Secretary 
                        provides written notice to such person, 
                        $250,000 for the first 30-day period 
                        (or any portion thereof) that the 
                        person continues to be in violation, 
                        and such amount shall double for every 
                        30-day period thereafter that the 
                        violation continues, not to exceed 
                        $1,000,000 for any 30-day period, and 
                        not to exceed $10,000,000 for all such 
                        violations adjudicated in a single 
                        proceeding.
                  ``(ii) Any person who violates a requirement 
                of section 911(g)(2)(C)(ii) or 911(i)(1), shall 
                be subject to a civil monetary penalty of--
                          ``(I) not to exceed $250,000 per 
                        violation, and not to exceed $1,000,000 
                        for all such violations adjudicated in 
                        a single proceeding; or
                          ``(II) in the case of a violation 
                        that continues after the Secretary 
                        provides written notice to such person, 
                        $250,000 for the first 30-day period 
                        (or any portion thereof) that the 
                        person continues to be in violation, 
                        and such amount shall double for every 
                        30-day period thereafter that the 
                        violation continues, not to exceed 
                        $1,000,000 for any 30-day period, and 
                        not to exceed $10,000,000 for all such 
                        violations adjudicated in a single 
                        proceeding.
                  ``(iii) In determining the amount of a civil 
                penalty under clause (i)(II) or (ii)(II), the 
                Secretary shall take into consideration whether 
                the person is making efforts toward correcting 
                the violation of the requirements of the 
                section for which such person is subject to 
                such civil penalty.''.
  (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
          (1) in subsection (a)(2)--
                  (A) by striking ``and'' before ``(D)''; and
                  (B) by striking ``device.'' and inserting the 
                following: ``device, and (E) Any adulterated or 
                misbranded tobacco product.'';
          (2) in subsection (d)(1), by inserting ``tobacco 
        product,'' after ``device,'';
          (3) in subsection (g)(1), by inserting ``or tobacco 
        product'' after the term ``device'' each place such 
        term appears; and
          (4) in subsection (g)(2)(A), by inserting ``or 
        tobacco product'' after ``device''.
  (e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is 
amended by striking ``section 904'' and inserting ``section 
1004''.
  (f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 
360m(b)(2)(D)) is amended by striking ``section 903(g)'' and 
inserting ``section 1003(g)''.
  (g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) is 
amended--
          (1) by striking ``(a)(1)'' and inserting 
        ``(a)(1)(A)''; and
          (2) by adding at the end the following:
  ``(B)(i) For a tobacco product, to the extent feasible, the 
Secretary shall contract with the States in accordance with 
this paragraph to carry out inspections of retailers within 
that State in connection with the enforcement of this Act.
                  ``(ii) The Secretary shall not enter into any 
                contract under clause (i) with the government 
                of any of the several States to exercise 
                enforcement authority under this Act on Indian 
                country without the express written consent of 
                the Indian tribe involved.''.
  (h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
          (1) by inserting ``tobacco product,'' after the term 
        ``device,'' each place such term appears; and
          (2) by inserting ``tobacco products,'' after the term 
        ``devices,'' each place such term appears.
  (i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
          (1) in subsection (a)(1)--
                  (A) by striking ``devices, or cosmetics'' 
                each place it appears and inserting ``devices, 
                tobacco products, or cosmetics'';
                  (B) by striking ``or restricted devices'' 
                each place it appears and inserting 
                ``restricted devices, or tobacco products''; 
                and
                  (C) by striking ``and devices and subject 
                to'' and all that follows through ``other drugs 
                or devices'' and inserting ``devices, and 
                tobacco products and subject to reporting and 
                inspection under regulations lawfully issued 
                pursuant to section 505 (i) or (k), section 
                519, section 520(g), or chapter IX and data 
                relating to other drugs, devices, or tobacco 
                products'';
          (2) in subsection (b), by inserting ``tobacco 
        product,'' after ``device,''; and
          (3) in subsection (g)(13), by striking ``section 
        903(g)'' and inserting ``section 1003(g)''.
  (j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is 
amended by inserting ``tobacco products,'' after ``devices,''.
  (k) Section 709.--Section 709 (21 U.S.C. 379a) is amended by 
inserting ``tobacco product,'' after ``device,''.
  (l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
          (1) in subsection (a)--
                  (A) by inserting ``tobacco products,'' after 
                the term ``devices,'';
                  (B) by inserting ``or section 905(h)'' after 
                ``section 510''; and
                  (C) by striking the term ``drugs or devices'' 
                each time such term appears and inserting 
                ``drugs, devices, or tobacco products'';
          (2) in subsection (e)(1)--
                  (A) by inserting ``tobacco product'' after 
                ``drug, device,''; and
                  (B) by inserting ``, and a tobacco product 
                intended for export shall not be deemed to be 
                in violation of section 906(e), 907, 911, or 
                920(a),'' before ``if it--''; and
          (3) by adding at the end the following:
  ``(p)(1) Not later than 36 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, and 
annually thereafter, the Secretary shall submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives, a report regarding--
          ``(A) the nature, extent, and destination of United 
        States tobacco product exports that do not conform to 
        tobacco product standards established pursuant to this 
        Act;
          ``(B) the public health implications of such exports, 
        including any evidence of a negative public health 
        impact; and
          ``(C) recommendations or assessments of policy 
        alternatives available to Congress and the executive 
        branch to reduce any negative public health impact 
        caused by such exports.
  ``(2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this 
subsection.''.
  (m) Section 1003.--Section 1003(d)(2)(C) (as redesignated by 
section 101(b)) is amended--
          (1) by striking ``and'' after ``cosmetics,''; and
          (2) inserting ``, and tobacco products'' after 
        ``devices''.
  (n) Section 1009.--Section 1009(b) (as redesignated by 
section 101(b)) is amended by striking ``section 908'' and 
inserting ``section 1008''.
  (o) Section 409 of the Federal Meat Inspection Act.--Section 
409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is 
amended by striking ``section 902(b)'' and inserting ``section 
1002(b)''.
  (p) Rule of construction.--Nothing in this section is 
intended or shall be construed to expand, contract, or 
otherwise modify or amend the existing limitations on State 
government authority over tribal restricted fee or trust lands.
  (q) Guidance and Effective Dates.--
          (1) In general.--The Secretary of Health and Human 
        Services shall issue guidance--
                  (A) defining the term ``repeated violation'', 
                as used in section 303(f)(8) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 
                333(f)(8)) as amended by subsection (c), as 
                including at least 5 violations of particular 
                requirements over a 36-month period at a 
                particular retail outlet that constitute a 
                repeated violation and providing for civil 
                penalties in accordance with paragraph (2);
                  (B) providing for timely and effective notice 
                by certified or registered mail or personal 
                delivery to the retailer of each alleged 
                violation at a particular retail outlet prior 
                to conducting a followup compliance check, such 
                notice to be sent to the location specified on 
                the retailer's registration or to the 
                retailer's registered agent if the retailer has 
                provider such agent information to the Food and 
                Drug Administration prior to the violation;
                  (C) providing for a hearing pursuant to the 
                procedures established through regulations of 
                the Food and Drug Administration for assessing 
                civil money penalties, including at a 
                retailer's request a hearing by telephone or at 
                the nearest regional or field office of the 
                Food and Drug Administration, and providing for 
                an expedited procedure for the administrative 
                appeal of an alleged violation;
                  (D) providing that a person may not be 
                charged with a violation at a particular retail 
                outlet unless the Secretary has provided notice 
                to the retailer of all previous violations at 
                that outlet;
                  (E) establishing that civil money penalties 
                for multiple violations shall increase from one 
                violation to the next violation pursuant to 
                paragraph (2) within the time periods provided 
                for in such paragraph;
                  (F) providing that good faith reliance on the 
                presentation of a false government-issued 
                photographic identification that contains a 
                date of birth does not constitute a violation 
                of any minimum age requirement for the sale of 
                tobacco products if the retailer has taken 
                effective steps to prevent such violations, 
                including--
                          (i) adopting and enforcing a written 
                        policy against sales to minors;
                          (ii) informing its employees of all 
                        applicable laws;
                          (iii) establishing disciplinary 
                        sanctions for employee noncompliance; 
                        and
                          (iv) requiring its employees to 
                        verify age by way of photographic 
                        identification or electronic scanning 
                        device; and
                  (G) providing for the Secretary, in 
                determining whether to impose a no-tobacco-sale 
                order and in determining whether to compromise, 
                modify, or terminate such an order, to consider 
                whether the retailer has taken effective steps 
                to prevent violations of the minimum age 
                requirements for the sale of tobacco products, 
                including the steps listed in subparagraph (F).
          (2) Penalties for violations.--
                  [(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, $0.00 together with 
                                the issuance of a warning 
                                letter to the retailer;
                                  [(II) in the case of a second 
                                violation within a 12-month 
                                period, $250;
                                  [(III) in the case of a third 
                                violation within a 24-month 
                                period, $500;
                                  [(IV) in the case of a fourth 
                                violation within a 24-month 
                                period, $2,000;
                                  [(V) in the case of a fifth 
                                violation within a 36-month 
                                period, $5,000; and
                                  [(VI) in the case of a sixth 
                                or subsequent violation within 
                                a 48-month period, $10,000 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, $250;
                                  [(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, $2,000;
                                  [(V) in the case of a fifth 
                                violation within a 36-month 
                                period, $5,000; and
                                  [(VI) in the case of a sixth 
                                or subsequent violation within 
                                a 48-month period, $10,000 as 
                                determined by the Secretary on 
                                a case-by-case basis.]
                  (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) Training program.--For purposes of 
                subparagraph (A), the term ``approved training 
                program'' means a training program that 
                complies with standards developed by the Food 
                and Drug Administration for such programs.
                  (C) Consideration of state penalties.--The 
                Secretary shall coordinate with the States in 
                enforcing the provisions of this Act and, for 
                purposes of mitigating a civil penalty to be 
                applied for a violation by a retailer of any 
                restriction promulgated under section 906(d), 
                shall consider the amount of any penalties paid 
                by the retailer to a State for the same 
                violation.
          (3) General effective date.--The amendments made by 
        paragraphs (2), (3), and (4) of subsection (c) shall 
        take effect upon the issuance of guidance described in 
        paragraph (1) of this subsection.
          (4) Special effective date.--The amendment made by 
        subsection (c)(1) shall take effect on the date of 
        enactment of this Act.
          (5) Package label requirements.--The package label 
        requirements of paragraphs (3) and (4) of section 
        903(a) of the Federal Food, Drug, and Cosmetic Act (as 
        amended by this division) shall take effect on the date 
        that is 12 months after the date of enactment of this 
        Act. The package label requirements of paragraph (2) of 
        such section 903(a) for cigarettes shall take effect on 
        the date that is 15 months after the issuance of the 
        regulations required by section 4(d) of the Federal 
        Cigarette Labeling and Advertising Act (15 U.S.C. 
        1333), as amended by section 201 of this division. The 
        package label requirements of paragraph (2) of such 
        section 903(a) for tobacco products other than 
        cigarettes shall take effect on the date that is 12 
        months after the date of enactment of this Act. The 
        effective date shall be with respect to the date of 
        manufacture, provided that, in any case, beginning 30 
        days after such effective date, a manufacturer shall 
        not introduce into the domestic commerce of the United 
        States any product, irrespective of the date of 
        manufacture, that is not in conformance with section 
        903(a) (2), (3), and (4) and section 920(a) of the 
        Federal Food, Drug, and Cosmetic Act.
          (6) Advertising Requirements.--The advertising 
        requirements of section 903(a)(8) of the Federal Food, 
        Drug, and Cosmetic Act (as amended by this division) 
        shall take effect on the date that is 12 months after 
        the date of enactment of this Act.

           *       *       *       *       *       *       *


                         XVII. DISSENTING VIEWS

    Reducing youth tobacco use is a shared goal of both 
Republicans and Democrats. A surge in the use of e-cigarettes 
has resulted in a dramatic increase in tobacco utilization by 
minors in recent years.\1\ To combat this epidemic, Republicans 
put forth policy proposals such as ``T21''--a federal 
prohibition on the sale and marketing of tobacco products to 
those under 21 years of age. The Administration also explored 
limiting the sale of electronic nicotine delivery systems 
(ENDS) to age restricted locations. Both policies aim to 
address the issue of ``social sourcing''--when of-age high 
school students buy and resell tobacco products to their 
younger classmates. This is known to be a primary method 
through which minors have been acquiring ENDS products. We also 
supported passage of H.R. 3942, the Preventing Online Sales of 
E-Cigarettes to Children Act. This legislation requires age 
verification by retailers at the time of purchase, as well as 
identification at the point of delivery, and labeling clearly 
indicating that the package contains tobacco products. But H.R. 
2339, the legislation considered before the Energy and Commerce 
Committee in November, goes well beyond the issue of youth 
vaping and takes aim at the entire tobacco industry, including 
products used legally by adults.
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    \1\https.//www.cdc.gov/media/releases/2019/p0211-youth-tobacco-use-
increased.html
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Flavored Tobacco Products
    H.R. 2339 would ban all characterizing flavors for tobacco 
products and, with an exception for ENDS, would not provide any 
process for those products to return to the market.
    Section 907(a)(1)(A) of the Federal Food, Drug, and 
Cosmetics Act (FFDCA) already prohibits the sale and marketing 
of cigarettes containing an artificial or natural flavor (other 
than menthol) that is a characterizing flavor of the tobacco 
product or tobacco smoke. H.R. 2339 would extend this 
prohibition to smokeless tobacco products, cigars, and pipe 
tobacco. These prohibitions amount to excessive government 
overreach and are unnecessary to achieve what is purported to 
be the intent of the legislation--to prevent youth tobacco use.
    Data from the Centers for Disease Control and Prevention 
(CDC) demonstrates the use of these products by minors has been 
stagnant or declined in recent years. Between 2011-2019, the 
only type of tobacco product that contributed to a significant 
rise in youth tobacco utilization were ENDS products.\2\ As 
such, a prohibition on all flavored tobacco products is 
unlikely to lead to substantial reductions in tobacco use by 
children. However, an across the board flavor ban for all 
tobacco products would result in fewer choices for adults who 
legally use them and could encourage consumers to seek out 
illicit products in their absence. The belief that purchases 
will shift to the illicit market is not speculative--this 
marketplace already exists and is thriving. Illicit tobacco 
products already make up approximately 1 of every 10 tobacco 
products consumed globally, according to the World Health 
Organization (WHO).\3\ The risks of the illicit market are seen 
in the recently reported vaping illnesses and deaths that have 
been linked to products containing illicit THC. These products 
often contain dangerous substances, such as heavy metals and 
pesticides, posing increased risks to consumers. H.R. 2339 does 
nothing to combat the ongoing use of illicit products, despite 
many of these illegal THC products being marketed with kid-
friendly flavors.
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    \2\https://www.cdc.gov/tobacco/data_statistics/fact_sheets/
youth_data/tobacco_use/index.htm
    \3\https://www.who.int/news-room/fact-sheets/detail/tobacco
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    Several Republican members also have concerns about the 
legislation's prohibition on menthol combustible cigarettes. 
The Food and Drug Administration (FDA) already has the 
authority to prohibit the sale and marketing of menthol 
cigarettes under section 907(a)(1)(A) and can do so if it 
determines such action is appropriate. These are decisions that 
should be made by the FDA based on sound science, not by 
Congress.
    Finally, the legislation passed out of the Energy and 
Commerce Committee contains a product standard for flavored 
ENDS that differs from the current standard. While the 
legislation would not provide a path forward for the 
authorization of flavored traditional tobacco products, the 
current standard for all tobacco products is whether the 
product is ``appropriate for the protection of the public 
health.'' H.R. 2339 provides an exception to the ban that would 
allow flavored ENDS products to come to market, but it requires 
that a higher bar be met. In order to bring a flavored ENDS 
product to market, the manufacturer must demonstrate to the FDA 
that the use of flavor will increase the likelihood of smoking 
cessation, will not increase the likelihood that individuals 
who do not use tobacco will start, and is not more harmful than 
a non-flavored ENDS product. Republicans do not believe a new 
standard, imposed in statute, is needed for flavored products. 
Unless the science shows that a flavor, in and of itself, is 
unsafe or causes more harm to consumers, Congress should not 
force a science-based regulatory agency to treat it as such. 
Furthermore, FDA has the ability, under section 907(a)(3), to 
adopt additional product standards if the agency finds that 
such standard is ``appropriate for the protection of the public 
health.'' Therefore, if FDA determines that additional 
standards are needed to authorize flavored ENDS products, it 
can determine what the appropriate standard should be. Flavors 
themselves are not inherently dangerous and should not be 
treated as such. The implementation of this new standard in 
statute would make it unlikely that any ENDS products would 
ever be permitted to come to market, even if FDA determines 
authorization may be appropriate for the protection of the 
public health.
User Fees
    The Center for Tobacco Products (CTP) is funded solely by 
the assessment and collection of user fees from tobacco product 
manufacturers and importers. Unlike other user fee programs 
within FDA, the tobacco user fee program is indefinite and does 
not require reauthorization.\4\ The tobacco product user fee 
program does require an annual appropriation from Congress, 
which provides FDA the authority to collect and spend fees. For 
Fiscal Year 2019 and subsequent years, the amount allowed to be 
assessed and collected by CTP is $712 million. Section 
919(b)(2)(B) specifies which tobacco product classes fees may 
be collected from: cigarettes, cigars, snuff, pipe tobacco, 
chewing tobacco, and roll-your-own tobacco. Since these product 
classes are dictated in statute, FDA has determined it does not 
have the statutory authority to collect fees from ENDS 
manufacturers or importers.\5\
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    \4\https://www.crs.gov/Reports/
R45867?source=search&guid=5b14990f90be4d188b6d29fe71b1f8f8&index=0
    \5\21 CFR Part 1150
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    H.R. 2339 aims to give FDA the authority to assess and 
collect user fees from tobacco products outside of the six 
product classes listed in statute. It also proposes increasing 
FDA's user fee authority to $812 million for Fiscal Year 2020 
and includes an inflation adjuster to determine the total 
amount of fees authorized to be collected from all tobacco 
product classes in subsequent years.
    Republicans oppose providing FDA with an additional $100 
million in user fee authority, as well as allowing the fee 
amount to increase with inflation. The CTP is not subject to a 
user fee reauthorization, has avoided Congressional oversight, 
and has ignored statutorily required reporting mandates since 
its creation in the Tobacco Control Act ten years ago. Under 
section 106(a) of the Tobacco Control Act, FDA was required to 
submit a report three years after enactment, followed by 
biennial reports, on the implementation of the Act.\6\ To date, 
the only report that has been submitted to Congress is the 2012 
report required three years after enactment, leaving three 
additional reports unaccounted for. The CTP has been able to 
function while avoiding Congressional oversight because the 
authorization for its user fee program, through which it 
receives all of its funding, does not sunset. All other FDA 
user fee programs are subject to periodic reauthorization by 
Congress, which encourages the agency to be transparent about 
how it uses the fees it collects. We do not believe the CTP 
should receive additional user fee dollars without more 
accountability and transparency to Congress.
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    \6\P.L. 11-31: ``Family Smoking Prevention and Tobacco Control and 
Federal Retirement Reform Act of 2009.''
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Remote Retail Sales Ban
    Some Republicans have also expressed concerns about the 
prohibition of remote retail sales for all tobacco products 
included in the legislation. While most tobacco products are 
sold in gas stations or convenience stores, this prohibition 
would be especially detrimental to the premium cigar industry 
given that most premium cigar products are sold to consumers 
online or through catalog purchases.
    House Republicans have demonstrated a willingness to work 
with Democrats to address the increase in youth vaping through 
policies such as ``T21.'' We have also shown an eagerness to 
investigate and act to stop use of illegal THC vape products 
that have resulted in thousands of illnesses across the 
country. However, we cannot support a policy that results in 
vast government overreach and does not appropriately target the 
problems both sides wish to address.
                                   Greg Walden,
                                           Republican Leader, Committee 
                                               on Energy and Commerce.
                                   Michael C. Burgess, M.D.,
                                           Republican Leader, 
                                               Subcommittee on Health, 
                                               Committee on Energy and 
                                               Commerce.

                                  [all]