H.R. 2339 — what changed

changed This Act may be cited as the “Reversing “Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019”.2020”.

“(b) Applicability—This chapter shall apply to all tobacco products.”

removed “(3) Minimum age restrictions

removed “(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.

removed “(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—

removed “(i) subpart B of part 1140 of subchapter K of title 21, Code of Federal Regulations; and

removed “(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).

removed “(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).

removed “(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).”

“(A) Special rules

added “(i) In general—Beginning on the date that is 1 year after the date of enactment of the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020, 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, mango, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee.

removed “(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.

added “(iii) Applicability to certain individuals—Notwithstanding any provision of this Act, no individual who purchases for individual consumption, possesses for individual consumption, or consumes, a tobacco product that is in violation of the prohibition under this subparagraph, including a tobacco product that contains a characterizing flavor of menthol, shall be subject to any criminal penalty under this Act for such purchase, possession, or consumption, nor shall such purchase, possession, or consumption be used as a justification to stop, search, or conduct any other investigative measure against any individual.”

removed “(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.”

“(h) Flavored electronic nicotine delivery systems

added “(1) Restriction—Beginning on the date that is 30 days after the date of enactment of the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020, any flavored electronic nicotine delivery system that is a new tobacco product, including any solution or other component or part (such as a liquid or its aerosol) shall not contain an artificial or natural flavor (other than tobacco) that is a characterizing flavor, including menthol, mint, mango, 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.

removed “(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.”

added “(8) Electronic nicotine delivery system—The term “electronic nicotine delivery system” means a tobacco product that is an 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.”

removed “(8) Electronic nicotine delivery system—The term “electronic nicotine delivery system”—

removed “(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

removed “(B) does not include a product that—

removed “(i) is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose; and

removed “(ii) is marketed and sold solely for a purpose described in clause (i).”

“(4) Prohibition against remote retail sales

changed “(A) Prohibition—Not later than 18 months after the date of enactment of the the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019, 2020, 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).

changed “(ii) Applicable requirements—Not later than 18 months after the date of enactment of the the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019, 2020, 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—

changed “(i) limits the authority of the Secretary to take additional actions under the other paragraphs provisions of this subsection; Act; or

changed “(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 in addition to, or more stringent than, the prohibition under subparagraph (A).”

changed “(K) For fiscal year 2019, years 2019 and 2020, $712,000,000.

changed “(L) For fiscal year 2020, 2021, $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.”

removed “(A) In general

removed “(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.

removed “(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—

removed “(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—

removed “(aa) the amount specified in paragraph (1) for the fiscal year, reduced by

removed “(bb) the total user fees assessed and collected pursuant to subclause (II) for the fiscal year; and

removed “(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).”

removed “(C) Allocation for other tobacco products

removed “(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).

removed “(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.

removed “(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.

removed “(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)—

removed “(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

removed “(II) until the first fiscal year commencing after the finalization of such formula, the exception described in subparagraph (A)(ii)(I) shall not apply.

removed “(v) Revisions by regulation—Any revisions to the formula promulgated pursuant to this subparagraph shall be by regulation.

removed “(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.

removed “(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—

removed “(i) the identification of the manufacturer or importer;

removed “(ii) the class or classes of tobacco products sold by the manufacturer or importer;

removed “(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

removed “(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.”

added “(2) Allocations of assessment by class of tobacco products

added “(A) In general—The total user fees assessed and collected under subsection (a) each fiscal year (beginning with fiscal year 2022) with respect to each class of tobacco products to which this chapter applies 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.

added “(B) Applicable percentage

added “(i) In general—For purposes of subparagraph (A), the applicable percentage for a fiscal year for each class of tobacco product shall be the percentage determined by dividing—

added “(I) the product of the gross domestic volume of the class multiplied by the tax rate applicable to the class under section 5701 of the Internal Revenue Code of 1986; and

added “(II) the sum of the products determined under subclause (I) for all classes of tobacco products.

added “(ii) Definition—For purposes of clause (i), the term “gross domestic volume” means the volume of tobacco products—

added “(I) removed (as defined by section 5702 of the Internal Revenue Code of 1986); and

added “(II) not exempt from tax under chapter 52 of the Internal Revenue Code of 1986 at the time of their removal under that chapter or the Harmonized Tariff Schedule of the United States (19 U.S.C. 1202).”

added “(6) Memorandum of understanding; reporting

added “(A) Transfer of information—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.

added “(B) Reporting

added “(i) Manufacturer reporting—The Secretary may require the manufacturers and importers of each class of tobacco products to which this chapter applies to submit such information, by such time, and in such manner, as the Secretary determines to be necessary to implement this section.

added “(ii) Reports to Congress—For fiscal year 2020 and each subsequent fiscal year for which fees are collected under this section, the Secretary shall, not later than 120 days after the end of the respective fiscal year, submit to the Congress financial and performance reports with respect to such fees.”

removed “(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.”

changed “(iii) subject to subparagraph (C), for the period beginning on the date of the enactment of the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019 2020 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.”

“(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;

changed “(II) data from a National Youth Tobacco Survey (or successor survey) conducted after the date of the enactment of the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019 2020 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.”

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

changed “(1) In general—Not general—Beginning not later than 6 months after the date of the enactment of the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019, 2020, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, Drugs and in consultation with the Surgeon General of the Public Health Service, 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);

changed “(B) the general processes of the Food and Drug Administration for enforcing restrictions on the manufacture and sale of tobacco products;

changed “(C) the general enforcement actions the Food and Drug Administration may take to implement 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;907(a)(1);

“(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—

changed “(A) explanations of key statutory and regulatory terms, including the terms “tobacco product,”“component 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);

changed “(C) general educational 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);

changed “(D) an explanation of information on the health effects of using tobacco products, including those with the characterizing flavors; flavors referred to in section 907(a)(1); and

“(E) information on resources available related to smoking cessation.

“(3) Format—Educational materials provided under paragraph (1) may be—

changed “(A) published in any format, including an Internet internet website, video, fact sheet, infographic, webinar, or other format, as the Secretary determines is appropriate and applicable; and

changed “(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.”appropriate.

added “(4) Funding—To carry out this subsection, there is authorized to be appropriated, and there is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 for each of fiscal years 2021 through 2025. Funds made available by the preceding sentence to carry out this subsection shall be in addition to funds that are derived from fees under section 919 and are otherwise made available to carry out this chapter.”

changed The Secretary shall ensure that programs at Section 399V of 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—Public Health Service Act (42 U.S.C. 280g–11) is amended—

added “(4) to educate and provide guidance to medically underserved communities, particularly racial and ethnic minority populations, regarding effective evidence-based strategies—

added “(A) to prevent tobacco, e-cigarette, and nicotine addiction, including among youth; and

added “(B) for smoking cessation, including cessation of the use of menthol-flavored tobacco products, and the cessation of the use of e-cigarettes and electronic nicotine delivery systems;”

added Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317U (42 U.S.C. 247b–23) the following:

added “317V. Demonstration grant program to develop strategies for smoking cessation in medically underserved communities

added “(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, or Tribal public health departments to support—

added “(1) the development of improved evidence-based strategies for smoking cessation, including cessation of the use of menthol-flavored tobacco products, 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;

added “(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 products, including e-cigarettes and menthol-flavored tobacco products; and

added “(3) improved coordination, access, and referrals to services for tobacco cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems, including tobacco cessation products approved by the Food and Drug Administration and mental health and counseling services.

added “(b) Application—To be eligible to receive a grant under subsection (a), a State, local, or Tribal 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.

added “(c) Authorization of appropriations—To carry out this section, there is authorized to be appropriated, and there is appropriated, out of any funds in the Treasury not otherwise appropriated, $75,000,000 for each of fiscal years 2021 through 2025.”

added “(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:

added “(i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed—

added “(I) in the case of the first violation, $0, together with the issuance of a warning letter to the retailer;

added “(II) in the case of a second violation within a 12-month period, $500;

added “(III) in the case of a third violation within a 24-month period, $1,000;

added “(IV) in the case of a fourth violation within a 24-month period, $4,000;

added “(V) in the case of a fifth violation within a 36-month period, $10,000; and

added “(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.

added “(ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed—

added “(I) in the case of the first violation, $500;

added “(II) in the case of a second violation within a 12-month period, $1,000;

added “(III) in the case of a third violation within a 24-month period, $2,000;

added “(IV) in the case of a fourth violation within a 24-month period, $4,000;

added “(V) in the case of a fifth violation within a 36-month period, $10,000; and

added “(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.”

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

added Not later than 5 years after the date of enactment of this Act, the Comptroller General of the United States shall—

removed “(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:

removed “(i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed—

removed “(I) in the case of the first violation, $0, together with the issuance of a warning letter to the retailer;

removed “(II) in the case of a second violation within a 12-month period, $500;

removed “(III) in the case of a third violation within a 24-month period, $1,000;

removed “(IV) in the case of a fourth violation within a 24-month period, $4,000;

removed “(V) in the case of a fifth violation within a 36-month period, $10,000; and

removed “(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.

removed “(ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed—

removed “(I) in the case of the first violation, $500;

removed “(II) in the case of a second violation within a 12-month period, $1,000;

removed “(III) in the case of a third violation within a 24-month period, $2,000;

removed “(IV) in the case of a fourth violation within a 24-month period, $4,000;

removed “(V) in the case of a fifth violation within a 36-month period, $10,000; and

removed “(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.”