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

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116th CONGRESS
  2d Session
                                H. R. 2339

_______________________________________________________________________

                                 AN ACT

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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting American Lungs and 
Reversing the Youth Tobacco Epidemic Act of 2020''.

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 alternative nicotine.
Sec. 107. Update to youth tobacco prevention public awareness 
                            campaigns.
Sec. 108. Exemption from premarket review 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.
Sec. 303. Public awareness, education, and prevention campaign.
Sec. 304. Tobacco cessation treatment grants to health centers.
Sec. 305. Grants for research.
     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.
          TITLE V--EXCISE TAX ON NICOTINE USED IN VAPING, ETC.

Sec. 501. Imposition of tax on nicotine for use in vaping, etc.
                  TITLE VI--FURTHER HEALTH INVESTMENTS

Sec. 601. Waiving Medicare coinsurance for colorectal cancer screening 
                            tests.
Sec. 602. Safe harbor for high deductible health plans without 
                            deductible for certain inhalers.

                 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, 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.
    (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) 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 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.
                            ``(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 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.''.
                    (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 amendment 
                made to such section 907(a)(1) by this paragraph takes 
                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 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.
            ``(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' 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.''.
            (4) Limitation on enforcement.--A law enforcement officer 
        of a State or political subdivision thereof may not enforce 
        (including by making any stop, search, seizure, or arrest or by 
        pursuing any prosecution, trial, or punishment) any provision 
        of section 907(a)(1)(A) or 910(h) of the Federal Food, Drug, 
        and Cosmetic Act, as amended and added by this subsection.

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 Protecting American Lungs 
                and Reversing the Youth Tobacco Epidemic Act of 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).
                            ``(ii) Applicable requirements.--Not later 
                        than 18 months after the date of enactment of 
                        the Protecting American Lungs and Reversing the 
                        Youth Tobacco Epidemic Act of 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--
                            ``(i) limits the authority of the Secretary 
                        to take additional actions under other 
                        provisions of this Act; or
                            ``(ii) preempts the authority of a State or 
                        local government to establish restrictions on 
                        the retail sale of tobacco products that are in 
                        addition to, or more stringent than, 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 years 2019 and 2020, $712,000,000.
                    ``(L) For fiscal year 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.''.
    (b) Applicability.--
            (1) Fiscal years 2020 and 2021.--Except as amended by 
        subsection (a), for fiscal years 2020 and 2021, section 919 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s) shall 
        apply as in effect on the day before the date of enactment of 
        this Act.
            (2) Subsequent fiscal years.--The amendments made by 
        subsections (c) through (f) apply beginning with fiscal year 
        2022.
    (c) Allocations of Assessment by Class of Tobacco Products.--
Paragraph (2) of section 919(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387s(b)) is amended to read as follows:
            ``(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 
                (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.
                    ``(B) Applicable percentage.--
                            ``(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--
                                    ``(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
                                    ``(II) the sum of the products 
                                determined under subclause (I) for all 
                                classes of tobacco products.
                            ``(ii) Definition.--For purposes of clause 
                        (i), the term `gross domestic volume' means the 
                        volume of tobacco products--
                                    ``(I) removed (as defined by 
                                section 5702 of the Internal Revenue 
                                Code of 1986); and
                                    ``(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).''.
    (d) 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 
allocated on a pro rata basis among the manufacturers and importers of 
each class of tobacco products to which this chapter applies based on 
the percentage share of each manufacturer's or importer's share of 
gross domestic volume within such class on a quarterly basis, based on 
data for the second preceding quarter''.
    (e) Other 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; reporting.--
                    ``(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.
                    ``(B) Reporting.--
                            ``(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.
                            ``(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.''.
    (f) 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)(6)(B),'' before ``or 920''.

SEC. 106. REGULATION OF PRODUCTS CONTAINING ALTERNATIVE 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 alternative 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) Alternative Nicotine.--In this section, the term ``alternative 
nicotine'' means nicotine that is not made or derived from tobacco 
plants and may include nicotine that is chemically synthesized, 
synthesized from recombinant genetic technology, or extracted from non-
tobacco plants.

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

    (a) In General.--The Secretary of Health and Human Services 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 designed 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 REVIEW 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 Protecting American Lungs and 
                        Reversing the Youth Tobacco Epidemic Act of 
                        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.''; 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 Protecting American 
                                Lungs and Reversing the Youth Tobacco 
                                Epidemic Act of 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.''.
    (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), 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.--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 2020, the Secretary 
        of Health and Human Services, acting through the Commissioner 
        of Food and 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);
                    ``(B) the general processes of the Food and Drug 
                Administration for enforcing restrictions on the 
                manufacture and sale of tobacco products;
                    ``(C) the general enforcement actions the Food and 
                Drug Administration may take to implement the 
                prohibition on characterizing flavors in tobacco 
                products under 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--
                    ``(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) 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);
                    ``(D) information on the health effects of using 
                tobacco products, including those with the 
                characterizing 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--
                    ``(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.
            ``(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.''.

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'' 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.
            (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.

    Section 399V of the Public Health Service Act (42 U.S.C. 280g-11) 
is amended--
            (1) in subsection (b)--
                    (A) by redesignating paragraphs (4) and (5) as 
                paragraphs (5) and (6), respectively; and
                    (B) by inserting after paragraph (3) the following:
            ``(4) to educate and provide guidance to medically 
        underserved communities, particularly racial and ethnic 
        minority populations, regarding effective evidence-based 
        strategies--
                    ``(A) to prevent tobacco, e-cigarette, and nicotine 
                addiction, including among youth; and
                    ``(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;'';
            (2) in subsection (d)(1)(B), by inserting ``, including 
        chronic diseases related to and caused by tobacco use'' after 
        ``diseases''; and
            (3) in subsection (j), by striking ``are authorized to be 
        appropriated, such sums as may be necessary to carry out this 
        section for each of fiscal years 2010 through 2014'' and 
        inserting ``is authorized to be appropriated, and there is 
        appropriated, out of any funds in the Treasury not otherwise 
        appropriated, $75,000,000 to carry out this section for each of 
        fiscal years 2021 through 2025''.

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

    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:

``SEC. 317V. 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, or Tribal public health departments to support--
            ``(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;
            ``(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
            ``(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.
    ``(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.
    ``(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.''.

SEC. 303. PUBLIC AWARENESS, EDUCATION, AND PREVENTION CAMPAIGN.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.), as amended by section 302, is further amended by inserting 
after section 317V the following new section:

``SEC. 317W. PUBLIC AWARENESS, EDUCATION, AND PREVENTION CAMPAIGN 
              REGARDING TOBACCO.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in consultation with 
the Surgeon General of the Public Health Service, shall develop and 
implement a national campaign to educate youth and young adults, 
parents, clinicians, health professionals, and others about the harms 
associated with the use by youth and young adults of tobacco products, 
including e-cigarettes.
    ``(b) Requirements.--The campaign under this section shall--
            ``(1) be an evidence-based media and public engagement 
        initiative;
            ``(2) be carried out through competitively bid contracts;
            ``(3) include the development of culturally and 
        linguistically competent resources that may be tailored for 
        communities with high rates of youth tobacco use;
            ``(4) be complementary to, and coordinated with, any other 
        Federal efforts; and
            ``(5) include message testing to identify culturally and 
        linguistically competent and effective messages for behavioral 
        change.
    ``(c) Optional Components.--The campaign under this section may 
include--
            ``(1) the use of--
                    ``(A) television, radio, print, the internet, and 
                other commercial marketing venues; and
                    ``(B) in-person public communications; and
            ``(2) the award of grants to State, local, and Tribal 
        public health departments to encourage partnerships with 
        community organizations and health care providers to develop 
        and deliver evidence-based strategies to prevent youth tobacco 
        use.
    ``(d) Funding.--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, $45,000,000 for each of fiscal 
years 2021 through 2025.''.

SEC. 304. TOBACCO CESSATION TREATMENT GRANTS TO HEALTH CENTERS.

    (a) In General.--Section 330 of the Public Health Service Act (42 
U.S.C. 254b) is amended--
            (1) by redesignating subsections (k) through (r) as 
        subsections (l) through (s), respectively; and
            (2) by adding after subsection (j) the following new 
        subsection:
    ``(k) Tobacco Cessation Grants.--
            ``(1) In general.--The Secretary may award grants to health 
        centers to provide comprehensive tobacco cessation treatment, 
        including counseling and tobacco cessation therapies.
            ``(2) Funding.--For the purpose of carrying out this 
        subsection, in addition to other amounts available for such 
        purpose, there is authorized to be appropriated, and there is 
        appropriated, out of funds in the Treasury not otherwise 
        appropriated, $125,000,000 for each of fiscal years 2021 
        through 2025.''.
    (b) Conforming Changes.--Section 330 of the Public Health Service 
Act (42 U.S.C. 254b) is amended--
            (1) in subsection (c)(3)(B), by striking ``(k)(3)(J)'' and 
        inserting ``(l)(3)(J)'';
            (2) in subsection (e)(1)(B), by striking ``(k)(3)'' each 
        place it appears and inserting ``(l)(3)'';
            (3) in subsection (l)(3)(H), as redesignated, by striking 
        ``or (p)'' and inserting ``or (q)'';
            (4) in subsection (m), as redesignated--
                    (A) by striking ``(k)(3)'' and inserting 
                ``(l)(3)''; and
                    (B) by striking ``(m)'' and inserting ``(n)'';
            (5) in subsection (q), as redesignated, by striking 
        ``(k)(3)(G)'' and inserting ``(l)(3)(G)'';
            (6) in subsection (s)(2)(A), as redesignated--
                    (A) by striking ``(k)(3)'' and inserting 
                ``(l)(3)''; and
                    (B) by striking ``(k)(3)(H)'' and inserting 
                ``(l)(3)(H)''; and
            (7) in subsection (s)(3)(I), as redesignated, by striking 
        ``(q)(4)'' and inserting ``(r)(4)''.
    (c) Technical Corrections.--
            (1) Section 330(h)(5)(B) of the Public Health Service Act 
        (42 U.S.C. 254b(h)(5)(B)) is amended by striking ``substance 
        abuse'' each place it appears and inserting ``substance use 
        disorder''.
            (2) Subclause (II) of subsection (l)(3)(E)(i), as 
        redesignated, of section 330 of the Public Health Service Act 
        (42 U.S.C. 254b) is amended by moving the indentation 2 ems to 
        the left.

SEC. 305. GRANTS FOR RESEARCH.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following new 
section:

``SEC. 399V-7. GRANTS FOR RESEARCH ON PREVENTION, AND CESSATION, OF THE 
              USE OF TOBACCO PRODUCTS.

    ``(a) In General.--The Secretary shall award grants to support--
            ``(1) research to develop and improve effective strategies 
        for prevention, and cessation, of the use of tobacco products, 
        including--
                    ``(A) cessation of the use of flavored combustible 
                cigarettes, including menthol-flavored cigarettes;
                    ``(B) cessation of the use of e-cigarette products; 
                and
                    ``(C) prevention and cessation strategies targeted 
                toward youth; and
            ``(2) research to aid in the development of safe and 
        effective tobacco cessation therapies, including therapies 
        appropriate for populations under the age of 18.
    ``(b) Funding.--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.''.

     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.

    (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 day that is 6 months after the date of enactment of this 
Act. The penalties specified in section 103(q)(2)(A) of the Family 
Smoking Prevention and Tobacco Control Act (21 U.S.C. 333 note), as in 
effect on the day before the date of enactment of this Act, shall 
continue to apply to violations occurring before the day specified in 
the preceding sentence.

SEC. 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 the Congress a report on the results of such 
        study, including recommendations based on such results.

          TITLE V--EXCISE TAX ON NICOTINE USED IN VAPING, ETC.

SEC. 501. IMPOSITION OF TAX ON NICOTINE FOR USE IN VAPING, ETC.

    (a) In General.--Section 5701 of the Internal Revenue Code of 1986 
is amended by redesignating subsection (h) as subsection (i) and by 
inserting after subsection (g) the following new subsection:
    ``(h) Nicotine.--On taxable nicotine, manufactured in or imported 
into the United States, there shall be imposed a tax equal to the 
dollar amount specified in section 5701(b)(1) (or, if greater, $50.33) 
per 1,810 milligrams of nicotine (and a proportionate tax at the like 
rate on any fractional part thereof).''.
    (b) Taxable Nicotine.--Section 5702 of such Code is amended by 
adding at the end the following new subsection:
    ``(q) Taxable Nicotine.--
            ``(1) In general.--Except as otherwise provided in this 
        subsection, the term `taxable nicotine' means any nicotine 
        which has been extracted, concentrated, or synthesized.
            ``(2) Exception for products approved by food and drug 
        administration.--Such term shall not include any nicotine if 
        the manufacturer or importer thereof demonstrates to the 
        satisfaction of the Secretary of Health and Human Services that 
        such nicotine will be used in--
                    ``(A) a drug--
                            ``(i) that is approved under section 505 of 
                        the Federal Food, Drug, and Cosmetic Act or 
                        licensed under section 351 of the Public Health 
                        Service Act; or
                            ``(ii) for which an investigational use 
                        exemption has been authorized under section 
                        505(i) of the Federal Food, Drug, and Cosmetic 
                        Act or under section 351(a) of the Public 
                        Health Service Act; or
                    ``(B) a combination product (as described in 
                section 503(g) of the Federal Food, Drug, and Cosmetic 
                Act), the constituent parts of which were approved or 
                cleared under section 505, 510(k), or 515 of such Act.
            ``(3) Coordination with taxation of other tobacco 
        products.--Cigars, cigarettes, smokeless tobacco, pipe tobacco, 
        and roll-your-own tobacco shall not be treated as containing 
        taxable nicotine solely because the nicotine naturally 
        occurring in the tobacco from which such product is 
        manufactured has been concentrated during the ordinary course 
        of manufacturing.''.
    (c) Taxable Nicotine Treated as a Tobacco Product.--Section 5702(c) 
of such Code is amended by striking ``and roll-your-own tobacco'' and 
inserting ``roll-your-own tobacco, and taxable nicotine''.
    (d) Manufacturer of Taxable Nicotine.--Section 5702 of such Code, 
as amended by subsection (b), is further amended by adding at the end 
the following new subsection:
    ``(r) Manufacturer of Taxable Nicotine.--
            ``(1) In general.--Any person who extracts, concentrates, 
        or synthesizes nicotine shall be treated as a manufacturer of 
        taxable nicotine (and as manufacturing such taxable nicotine).
            ``(2) Application of rules related to manufacturers of 
        tobacco products.--Any reference to a manufacturer of tobacco 
        products, or to manufacturing tobacco products, shall be 
        treated as including a reference to a manufacturer of taxable 
        nicotine, or to manufacturing taxable nicotine, 
        respectively.''.
    (e) Effective Date.--
            (1) In general.--The amendments made by this section shall 
        apply to articles manufactured or imported in calendar quarters 
        beginning more than 90 days after the date of the enactment of 
        this Act.
            (2) Transition rule for permit and bond requirements.--A 
        person which is lawfully engaged in business as a manufacturer 
        or importer of taxable nicotine (within the meaning of 
        subchapter A of chapter 52 of the Internal Revenue Code of 
        1986, as amended by this section) on the date of the enactment 
        of this Act, first becomes subject to the requirements of 
        subchapter B of chapter 52 of such Code by reason of the 
        amendments made by this section, and submits an application 
        under such subchapter B to engage in such business not later 
        than 90 days after the date of the enactment of this Act, shall 
        not be denied the right to carry on such business by reason of 
        such requirements before final action on such application.

                  TITLE VI--FURTHER HEALTH INVESTMENTS

SEC. 601. WAIVING MEDICARE COINSURANCE FOR COLORECTAL CANCER SCREENING 
              TESTS.

    Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)) is 
amended--
            (1) in the second sentence, by striking ``section 1834(0)'' 
        and inserting ``section 1834(o)'';
            (2) by moving such second sentence 2 ems to the left; and
            (3) by inserting the following third sentence following 
        such second sentence: ``For services furnished on or after 
        January 1, 2024, paragraph (1)(Y) shall apply with respect to a 
        colorectal cancer screening test regardless of the code that is 
        billed for the establishment of a diagnosis as a result of the 
        test, or for the removal of tissue or other matter or other 
        procedure that is furnished in connection with, as a result of, 
        and in the same clinical encounter as the screening test.''.

SEC. 602. SAFE HARBOR FOR HIGH DEDUCTIBLE HEALTH PLANS WITHOUT 
              DEDUCTIBLE FOR CERTAIN INHALERS.

    (a) In General.--Section 223(c)(2)(C) of the Internal Revenue Code 
of 1986 is amended--
            (1) by striking ``for preventive care'' and inserting ``for 
        one or more of the following:
                            ``(i) Preventive care'', and
            (2) by adding at the end the following new clause:
                            ``(ii) Inhalers or nebulizers for treatment 
                        of any chronic lung disease (and any medicine 
                        or drug which is delivered through such inhaler 
                        or nebulizer for treatment of such disease).''.
    (b) Conforming Amendment.--The heading for section 223(c)(2)(C) of 
such Code is amended by striking ``preventive care deductible'' and 
inserting ``certain deductibles''.
    (c) Effective Date.--The amendments made by this section shall 
apply to months beginning after the date of the enactment of this Act.

            Passed the House of Representatives February 28, 2020.

            Attest:

                                                                 Clerk.
116th CONGRESS

  2d Session

                               H. R. 2339

_______________________________________________________________________

                                 AN ACT

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