Reversing the Youth Tobacco Epidemic Act of 2020

To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale and marketing of tobacco products, and for other purposes. 1. Short title This Act may be cited as the Reversing the Youth Tobacco Epidemic Act of 2020 2. Table of contents The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—Food and Drug Administration Sec. 101. Cigarette graphic health warnings. Sec. 102. Advertising and sales parity for all deemed tobacco products. Sec. 103. Reducing child and adolescent nicotine addiction. Sec. 104. Fees applicable to all tobacco products. Sec. 105. Regulation of products containing synthetic nicotine. Sec. 106. Update to youth tobacco prevention public awareness campaigns. Sec. 107. Public education. 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. Increasing civil penalties applicable to certain violations of restrictions on sale and distribution of tobacco products. Sec. 402. Study and report on e-cigarettes. I Food and Drug Administration 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 the first subsection (d) of section 4 of the Federal Cigarette Labeling and Advertising Act ( 15 U.S.C. 1333 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements (b) Conforming change The first subsection (d) of section 4 of the Federal Cigarette Labeling and Advertising Act ( 15 U.S.C. 1333 Not later than 24 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary The Secretary 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 (or any corresponding similar regulation or ruling)— (1) to apply the provisions of such part 1140 (or any corresponding similar regulation or ruling) to all tobacco products, as applicable, to which chapter IX of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 21 U.S.C. 387a(b) (2) to make such changes as may be necessary for applicability to specific tobacco products and consistency with the amendments made by section 103 of this Act. (b) Effective date The final rule required by subsection (a) shall take effect on the date that is 2 years after the date of enactment of this Act. 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 (b) Applicability This chapter shall apply to all tobacco products. . (2) Rule of construction Section 901(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387a(b) 21 U.S.C. 387 (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) Prohibition against remote retail sales Paragraph (4) of section 906(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387f(d) (4) Prohibition against remote retail sales Not later than 2 years after the date of enactment of the Reversing the Youth Tobacco Epidemic Act of 2020 . (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) (A) Special rules (i) In general 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) Effective date The amendment made by subparagraph (A) shall take effect 1 year after the date of enactment of this Act. (2) Flavored electronic nicotine delivery system Section 910 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387j (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 2020 (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 (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). . 104. 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) (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, adjusted 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 products (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) (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, and the total user fees with respect to each 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 class by the amount specified in paragraph (1) for the fiscal year (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) (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 domestic 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 (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 2, 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) 919(b)(2)(D), 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) 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 (d) Conforming amendments Section 919(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387s(b) (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 so 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 (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 105. Regulation of products containing synthetic nicotine (a) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (1) not later than 1 year after the date of enactment of this Act, issue an interim final rule providing for the regulation of products containing synthetic nicotine under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 (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 106. 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. 107. Public education Section 906 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387f (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 2020 (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 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. . II Federal Trade Commission 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) (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 (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) (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 (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 (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 21 U.S.C. 387 (3) Commission The term Commission (4) Electronic nicotine delivery system The term electronic nicotine delivery system 21 U.S.C. 387 (5) Endorse The term endorse (6) Nicotine The term nicotine 21 U.S.C. 387 (7) Smokeless tobacco The term smokeless tobacco 21 U.S.C. 387 (8) Tobacco product The term tobacco product 21 U.S.C. 321 III Public Health Programs 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 and nicotine addiction; and (2) for smoking cessation and the cessation of the use of electronic nicotine delivery systems, including e-cigarettes. 302. Demonstration grant program to develop strategies for smoking cessation in medically underserved communities (a) In general The Secretary of Health and Human Services, 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 electronic nicotine delivery systems, including e-cigarettes, 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 electronic nicotine delivery systems, including e-cigarettes, 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. IV Nicotine or vaping access protection and enforcement 401. 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 (A) In general The amount of the civil penalty to be applied for violations of section 906(d)(5) or 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 vio6lation 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) 21 U.S.C. 333 21 U.S.C. 387f(d)(5) 402. 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 Congress a report on the results of such study, including recommendations based on such results.

Summary: Reversing the Youth Tobacco Epidemic Act of 2019 This bill revises requirements related to the safety, sale, and advertisement of tobacco products, including electronic nicotine delivery systems (e.g., e-cigarettes, e-hookah, e-cigars, and vape pens). Among other requirements, the bill requires the Food and Drug Administration (FDA) to implement regulations to require color graphics on the labeling of cigarette packages, depicting the negative health consequences of smoking; requires the FDA to apply regulations on tobacco products to all tobacco products, including e-cigarettes; prohibits the retail online sale of tobacco products, including electronic nicotine delivery systems; prohibits flavors other than tobacco in a tobacco product; prohibits the use of flavored products in an electronic nicotine delivery system, except in specified circumstances; increases the user fees that the FDA collects from manufacturers and importers; directs the FDA to regulate products containing synthetic nicotine (not made or derived from tobacco); establishes a demonstration grant program to develop strategies for smoking cessation in medically underserved communities; increases civil penalties for certain violations of restrictions on the sale of tobacco products; and requires the Government Accountability Office to study e-cigarettes. &nbsp;