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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Protecting American 

3 Lungs and Reversing the Youth Tobacco Epidemic Act of 

4 2020’’. 

5 SEC. 2. TABLE OF CONTENTS. 

6 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. 
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1 TITLE I—FOOD AND DRUG 

2 ADMINISTRATION 

3 SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS. 

4 (a) ISSUANCE DEADLINES.—Not later than March 

5 15, 2020, the Secretary of Health and Human Services, 

6 acting through the Commissioner of Food and Drugs, 

7 shall publish a final rule pursuant to section 4(d) of the 

8 Federal Cigarette Labeling and Advertising Act (15 

9 U.S.C. 1333(d)). If the Secretary fails to promulgate such 

10 final rule by March 15, 2020, then the proposed rule titled 

11 ‘‘Tobacco Products; Required Warnings for Cigarette 

12 Packages and Advertisements’’ published by the Food and 

13 Drug Administration on August 16, 2019 (84 Fed. Reg. 

14 42754) shall be treated as a final rule beginning on March 

15 16, 2020. 

16 (b) CONFORMING CHANGE.—The first section 4(d) of 

17 the Federal Cigarette Labeling and Advertising Act (15 

18 U.S.C. 1333(d)) (relating to graphic labeling statements) 

19 is amended by striking ‘‘Not later than 24 months after 

20 the date of enactment of the Family Smoking Prevention 

21 and Tobacco Control Act, the Secretary’’ and inserting 

22 ‘‘The Secretary’’. 
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1 SEC. 102. ADVERTISING AND SALES PARITY FOR ALL 

2 DEEMED TOBACCO PRODUCTS. 

3 (a) IN GENERAL.—Not later than 1 year after the 

4 date of enactment of this Act, the Secretary of Health and 

5 Human Services, acting through the Commissioner of 

6 Food and Drugs, shall promulgate a final rule amending 

7 part 1140 of subchapter K of title 21, Code of Federal 

8 Regulations, to apply the provisions of such part 1140 to 

9 all tobacco products, as applicable, to which chapter IX 

10 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 387a et seq.) applies pursuant to section 901(b) of such 

12 Act (21 U.S.C. 387a(b)), as amended by section 103(a) 

13 of this Act. 

14 (b) EFFECTIVE DATE.—The final rule required by 

15 subsection (a) shall take effect on the date that is 2 years 

16 after the date of enactment of this Act. 

17 SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE 

18 ADDICTION. 

19 (a) APPLICABILITY TO ALL TOBACCO PRODUCTS.— 

20 (1) IN GENERAL.—Subsection (b) of section 

21 901 of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 387a) is amended to read as follows: 

23 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 

24 tobacco products.’’. 

25 (2) RULE OF CONSTRUCTION.—Paragraph (1) 

26 and the amendment made thereby shall not be con-
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1 strued to limit the applicability of chapter IX of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 387a et seq.) to— 

4 (A) products that were listed in section 

5 901(b) of such Act as in effect on the day be6 fore the date of enactment of this Act; and 

7 (B) products that were deemed by regula8 tion to be subject to such chapter pursuant to 

9 section 901(b) of such Act as in effect on the 

10 day before the date of enactment of this Act. 

11 (b) PROHIBITING FLAVORING OF TOBACCO PROD12 UCTS.— 

13 (1) PROHIBITION.— 

14 (A) IN GENERAL.—Subparagraph (A) of 

15 section 907(a)(1) of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 387g(a)(1)) is 

17 amended to read as follows: 

18 ‘‘(A) SPECIAL RULES.— 

19 ‘‘(i) IN GENERAL.—Beginning on the 

20 date that is 1 year after the date of enact21 ment of the Protecting American Lungs 

22 and Reversing the Youth Tobacco Epi23 demic Act of 2020, a tobacco product (in24 cluding its components, parts, and acces25 sories, including the tobacco, filter, or 
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1 paper) that is not an electronic nicotine de2 livery system shall not contain, as a con3 stituent (including a smoke constituent) or 

4 additive, an artificial or natural flavor 

5 (other than tobacco) that is a character6 izing flavor of the tobacco product or to7 bacco smoke or an herb or spice, including 

8 menthol, mint, mango, strawberry, grape, 

9 orange, clove, cinnamon, pineapple, vanilla, 

10 coconut, licorice, cocoa, chocolate, cherry, 

11 or coffee. 

12 ‘‘(ii) RULE OF CONSTRUCTION.— 

13 Nothing in this subparagraph shall be con14 strued to limit the Secretary’s authority to 

15 take action under this section or other sec16 tions of this Act applicable to any artificial 

17 or natural flavor, herb, or spice. 

18 ‘‘(iii) APPLICABILITY TO CERTAIN IN19 DIVIDUALS.—Notwithstanding any provi20 sion of this Act, no individual who pur21 chases for individual consumption, pos22 sesses for individual consumption, or con23 sumes, a tobacco product that is in viola24 tion of the prohibition under this subpara25 graph, including a tobacco product that 
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1 contains a characterizing flavor of menthol, 

2 shall be subject to any criminal penalty 

3 under this Act for such purchase, posses4 sion, or consumption, nor shall such pur5 chase, possession, or consumption be used 

6 as a justification to stop, search, or con7 duct any other investigative measure 

8 against any individual.’’. 

9 (B) SAVINGS PROVISION.—Section 

10 907(a)(1) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 387g(a)(1)), as in effect 

12 on the date of enactment of this Act, shall re13 main in effect until the amendment made to 

14 such section 907(a)(1) by this paragraph takes 

15 effect. 

16 (2) FLAVORED ELECTRONIC NICOTINE DELIV17 ERY SYSTEM.—Section 910 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 387j) is amend19 ed by inserting at the end the following: 

20 ‘‘(h) FLAVORED ELECTRONIC NICOTINE DELIVERY

21 SYSTEMS.— 

22 ‘‘(1) RESTRICTION.—Beginning on the date 

23 that is 30 days after the date of enactment of the 

24 Protecting American Lungs and Reversing the 

25 Youth Tobacco Epidemic Act of 2020, any flavored 
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1 electronic nicotine delivery system that is a new to2 bacco product, including any solution or other com3 ponent or part (such as a liquid or its aerosol) shall 

4 not contain an artificial or natural flavor (other than 

5 tobacco) that is a characterizing flavor, including 

6 menthol, mint, mango, strawberry, grape, orange, 

7 clove, cinnamon, pineapple, vanilla, coconut, licorice, 

8 cocoa, chocolate, cherry, or coffee, unless the Sec9 retary has issued a marketing order as described in 

10 paragraph (2). Nothing in this paragraph shall be 

11 construed to limit the Secretary’s authority to take 

12 action under this section or other sections of this 

13 Act applicable to any artificial or natural flavor, 

14 herb, or spice. 

15 ‘‘(2) REVIEW.—The Secretary shall not issue a 

16 marketing order under subsection (c)(1)(A)(i) or a 

17 substantial equivalence order under subsection 

18 (a)(2)(A)(i) for any electronic nicotine delivery sys19 tem, including any liquid, solution, or other compo20 nent or part or its aerosol, that contains an artificial 

21 or natural flavor (other than tobacco) that is a char22 acterizing flavor, unless the Secretary issues an 

23 order finding that the manufacturer has dem24 onstrated that— 

25 ‘‘(A) use of the characterizing flavor— 
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1 ‘‘(i) will significantly increase the like2 lihood of smoking cessation among current 

3 users of tobacco products; and 

4 ‘‘(ii) will not increase the likelihood 

5 that individuals who do not use tobacco 

6 products, including youth, will start using 

7 any tobacco product, including an elec8 tronic nicotine delivery system; and 

9 ‘‘(B) such electronic nicotine delivery sys10 tem is not more harmful to users than an elec11 tronic nicotine delivery system that does not 

12 contain any characterizing flavors.’’. 

13 (3) DEFINITION OF ELECTRONIC NICOTINE DE14 LIVERY SYSTEM.—Section 900 of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 387) is amend16 ed— 

17 (A) by redesignating paragraphs (8) 

18 through (22) as paragraphs (9) through (23), 

19 respectively; and 

20 (B) by inserting after paragraph (7) the 

21 following new paragraph: 

22 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS23 TEM.—The term ‘electronic nicotine delivery system’ 

24 means a tobacco product that is an electronic device 

25 that delivers nicotine, flavor, or another substance 
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1 via an aerosolized solution to the user inhaling from 

2 the device (including e-cigarettes, e-hookah, e-cigars, 

3 vape pens, advanced refillable personal vaporizers, 

4 and electronic pipes) and any component, liquid, 

5 part, or accessory of such a device, whether or not 

6 sold separately.’’. 

7 (4) LIMITATION ON ENFORCEMENT.—A law en8 forcement officer of a State or political subdivision 

9 thereof may not enforce (including by making any 

10 stop, search, seizure, or arrest or by pursuing any 

11 prosecution, trial, or punishment) any provision of 

12 section 907(a)(1)(A) or 910(h) of the Federal Food, 

13 Drug, and Cosmetic Act, as amended and added by 

14 this subsection. 

15 SEC. 104. PROHIBITION AGAINST REMOTE RETAIL SALES. 

16 (a) IN GENERAL.—Paragraph (4) of section 906(d) 

17 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 387f(d)) is amended to read as follows: 

19 ‘‘(4) PROHIBITION AGAINST REMOTE RETAIL

20 SALES.— 

21 ‘‘(A) PROHIBITION.—Not later than 18 

22 months after the date of enactment of the Pro23 tecting American Lungs and Reversing the 

24 Youth Tobacco Epidemic Act of 2020, the Sec25 retary shall promulgate a final regulation pro-
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1 hibiting the retail sale of all tobacco products 

2 other than retail sales through a direct, face-to3 face exchange between a retailer and a con4 sumer. 

5 ‘‘(B) EXCEPTION FOR CERTAIN CIGAR TO6 BACCO PRODUCTS.— 

7 ‘‘(i) EXCEPTION.—The regulation re8 quired by subparagraph (A) shall not apply 

9 to tobacco products described in section 

10 910(a)(2)(A)(iii). 

11 ‘‘(ii) APPLICABLE REQUIREMENTS.— 

12 Not later than 18 months after the date of 

13 enactment of the Protecting American 

14 Lungs and Reversing the Youth Tobacco 

15 Epidemic Act of 2020, the Secretary shall 

16 promulgate regulations regarding the sale 

17 and distribution of tobacco products de18 scribed in section 910(a)(2)(A)(iii) that 

19 occur through means other than a direct, 

20 face-to-face exchange between a retailer 

21 and a consumer in order to prevent the 

22 sale and distribution of tobacco products 

23 described in section 910(a)(2)(A)(iii) to in24 dividuals who have not attained the min25 imum age established by applicable law for 
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1 the purchase of such products, including 

2 requirements for age verification. 

3 ‘‘(C) RELATION TO OTHER AUTHORITY.— 

4 Nothing in this paragraph— 

5 ‘‘(i) limits the authority of the Sec6 retary to take additional actions under 

7 other provisions of this Act; or 

8 ‘‘(ii) preempts the authority of a State 

9 or local government to establish restric10 tions on the retail sale of tobacco products 

11 that are in addition to, or more stringent 

12 than, the prohibition under subparagraph 

13 (A).’’. 

14 (b) APPLICABILITY.—Section 906(d)(4) of the Fed15 eral Food, Drug, and Cosmetic Act, as in effect on the 

16 day before the date of enactment of this Act, shall con17 tinue to apply until the effective date of the regulations 

18 required by section 906(d)(4) of such Act, as amended by 

19 subsection (a). 

20 SEC. 105. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 

21 (a) INCREASE IN TOTAL AMOUNT.—Section 

22 919(b)(1) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 387s(b)(1)) is amended by striking subpara24 graph (K) and inserting the following subparagraphs: 
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1 ‘‘(K) For fiscal years 2019 and 2020, 

2 $712,000,000. 

3 ‘‘(L) For fiscal year 2021, $812,000,000. 

4 ‘‘(M) For each subsequent fiscal year, the 

5 amount that was applicable for the previous fis6 cal year, increased by the total percentage 

7 change that occurred in the Consumer Price 

8 Index for all urban consumers (all items; 

9 United States city average) for the 12-month 

10 period ending June 30 preceding the fiscal 

11 year.’’. 

12 (b) APPLICABILITY.— 

13 (1) FISCAL YEARS 2020 AND 2021.—Except as 

14 amended by subsection (a), for fiscal years 2020 and 

15 2021, section 919 of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 387s) shall apply as in ef17 fect on the day before the date of enactment of this 

18 Act. 

19 (2) SUBSEQUENT FISCAL YEARS.—The amend20 ments made by subsections (c) through (f) apply be21 ginning with fiscal year 2022. 

22 (c) ALLOCATIONS OF ASSESSMENT BY CLASS OF TO23 BACCO PRODUCTS.—Paragraph (2) of section 919(b) of 

24 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

25 387s(b)) is amended to read as follows: 
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1 ‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS

2 OF TOBACCO PRODUCTS.— 

3 ‘‘(A) IN GENERAL.—The total user fees as4 sessed and collected under subsection (a) each 

5 fiscal year (beginning with fiscal year 2022) 

6 with respect to each class of tobacco products 

7 to which this chapter applies shall be an 

8 amount that is equal to the applicable percent9 age of each class for the fiscal year multiplied 

10 by the amount specified in paragraph (1) for 

11 the fiscal year. 

12 ‘‘(B) APPLICABLE PERCENTAGE.— 

13 ‘‘(i) IN GENERAL.—For purposes of 

14 subparagraph (A), the applicable percent15 age for a fiscal year for each class of to16 bacco product shall be the percentage de17 termined by dividing— 

18 ‘‘(I) the product of the gross do19 mestic volume of the class multiplied 

20 by the tax rate applicable to the class 

21 under section 5701 of the Internal 

22 Revenue Code of 1986; and 

23 ‘‘(II) the sum of the products de24 termined under subclause (I) for all 

25 classes of tobacco products. 
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1 ‘‘(ii) DEFINITION.—For purposes of 

2 clause (i), the term ‘gross domestic volume’ 

3 means the volume of tobacco products— 

4 ‘‘(I) removed (as defined by sec5 tion 5702 of the Internal Revenue 

6 Code of 1986); and 

7 ‘‘(II) not exempt from tax under 

8 chapter 52 of the Internal Revenue 

9 Code of 1986 at the time of their re10 moval under that chapter or the Har11 monized Tariff Schedule of the United 

12 States (19 U.S.C. 1202).’’. 

13 (d) ALLOCATION OF ASSESSMENT WITHIN EACH

14 CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 387s(b)(4)) is amended by striking ‘‘shall be the percent17 age determined for purposes of allocations under sub18 sections (e) through (h) of section 625 of Public Law 108– 

19 357’’ and inserting ‘‘shall be allocated on a pro rata basis 

20 among the manufacturers and importers of each class of 

21 tobacco products to which this chapter applies based on 

22 the percentage share of each manufacturer’s or importer’s 

23 share of gross domestic volume within such class on a 

24 quarterly basis, based on data for the second preceding 

25 quarter’’. 
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1 (e) OTHER AMENDMENTS.—Section 919(b) of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 387s(b)) is amended— 

4 (1) by striking paragraph (5); 

5 (2) by redesignating paragraphs (6) and (7) as 

6 paragraphs (5) and (6), respectively; and 

7 (3) by amending paragraph (6), as redesig8 nated, to read as follows: 

9 ‘‘(6) MEMORANDUM OF UNDERSTANDING; RE10 PORTING.— 

11 ‘‘(A) TRANSFER OF INFORMATION.—The 

12 Secretary shall request the appropriate Federal 

13 agency to enter into a memorandum of under14 standing that provides for the regular and time15 ly transfer from the head of such agency to the 

16 Secretary of all necessary information regarding 

17 all tobacco product manufacturers and import18 ers required to pay user fees. The Secretary 

19 shall maintain all disclosure restrictions estab20 lished by the head of such agency regarding the 

21 information provided under the memorandum of 

22 understanding. 

23 ‘‘(B) REPORTING.— 

24 ‘‘(i) MANUFACTURER REPORTING.— 

25 The Secretary may require the manufac-
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1 turers and importers of each class of to2 bacco products to which this chapter ap3 plies to submit such information, by such 

4 time, and in such manner, as the Secretary 

5 determines to be necessary to implement 

6 this section. 

7 ‘‘(ii) REPORTS TO CONGRESS.—For 

8 fiscal year 2020 and each subsequent fiscal 

9 year for which fees are collected under this 

10 section, the Secretary shall, not later than 

11 120 days after the end of the respective 

12 fiscal year, submit to the Congress finan13 cial and performance reports with respect 

14 to such fees.’’. 

15 (f) PROHIBITED ACT.—Section 301(q)(1)(B) of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 331(q)(1)(B)) is amended by inserting ‘‘919(b)(6)(B),’’ 

18 before ‘‘or 920’’. 

19 SEC. 106. REGULATION OF PRODUCTS CONTAINING ALTER20 NATIVE NICOTINE. 

21 (a) IN GENERAL.—The Secretary of Health and 

22 Human Services, acting through the Commissioner of 

23 Food and Drugs, shall— 

24 (1) not later than 1 year after the date of en25 actment of this Act, issue an interim final rule pro-
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1 viding for the regulation of products containing al2 ternative nicotine under the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 301 et seq.); and 

4 (2) not later than 2 years after such date of en5 actment, issue a final rule providing for such regula6 tion. 

7 (b) ALTERNATIVE NICOTINE.—In this section, the 

8 term ‘‘alternative nicotine’’ means nicotine that is not 

9 made or derived from tobacco plants and may include nic10 otine that is chemically synthesized, synthesized from re11 combinant genetic technology, or extracted from non-to12 bacco plants. 

13 SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUB14 LIC AWARENESS CAMPAIGNS. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services shall— 

17 (1) review all public health awareness cam18 paigns of the Department of Health and Human 

19 Services designed to educate at-risk individuals 

20 about the harmful effects of tobacco use, including 

21 the use of e-cigarettes and other electronic nicotine 

22 delivery systems; and 

23 (2) as applicable, modify such campaigns to in24 clude awareness and education materials designed 

25 for individuals who are 18 to 21 years of age. 
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1 (b) CONSULTATION.—In carrying out subsection (a), 

2 the Secretary of Health and Human Services may consult 

3 with medical and public health associations and nonprofit 

4 organizations. 

5 SEC. 108. EXEMPTION FROM PREMARKET REVIEW OF CER6 TAIN TOBACCO PRODUCTS. 

7 (a) IN GENERAL.—Section 910(a)(2) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2)) is 

9 amended— 

10 (1) in subparagraph (A)— 

11 (A) in clause (i)(II), by striking ‘‘or’’; 

12 (B) in clause (ii), by striking the period at 

13 the end and inserting ‘‘; or’’; and 

14 (C) by adding at the end the following: 

15 ‘‘(iii) subject to subparagraph (C), for 

16 the period beginning on the date of the en17 actment of the Protecting American Lungs 

18 and Reversing the Youth Tobacco Epi19 demic Act of 2020 and ending on Sep20 tember 30, 2028, the tobacco product is a 

21 cigar and— 

22 ‘‘(I) is wrapped in whole tobacco 

23 leaf; 

24 ‘‘(II) contains a 100-percent leaf 

25 tobacco binder; 
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1 ‘‘(III) contains primarily long 

2 filler tobacco; 

3 ‘‘(IV) does not have a character4 izing flavor other than tobacco; 

5 ‘‘(V) weighs more than 6 pounds 

6 per 1000 units; 

7 ‘‘(VI) has no filter, tip, or non8 tobacco mouthpiece; 

9 ‘‘(VII)(aa) is made by combining 

10 manually the wrapper, filler, and 

11 binder and is capped by hand; or 

12 ‘‘(bb) has a homogenized tobacco 

13 leaf binder and is made in the United 

14 States using human hands to lay the 

15 100-percent leaf tobacco binder onto 

16 only one machine that bunches, 

17 wraps, and caps each individual cigar; 

18 and 

19 ‘‘(VIII) has a retail price (after 

20 discounts or coupons) per cigar of no 

21 less than— 

22 ‘‘(aa) for calendar years 

23 2019 and 2020, $12; and 

24 ‘‘(bb) for each subsequent 

25 calendar year, $12 multiplied by 
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1 any percent increase in the Con2 sumer Price Index for all urban 

3 consumers (all items; U.S. city 

4 average) since calendar year 

5 2020.’’; and 

6 (2) by adding at the end the following: 

7 ‘‘(C) DETERMINATION OF APPLICA8 BILITY.— 

9 ‘‘(i) IN GENERAL.—The Secretary 

10 shall, notwithstanding subparagraph 

11 (A)(iii) or any determination of substantial 

12 equivalence, if any of the conditions speci13 fied in clause (ii) are met— 

14 ‘‘(I) withdraw any exemption ap15 plicable to a tobacco product or prod16 ucts described in such subparagraph; 

17 ‘‘(II) require that applications for 

18 review under this section be submitted 

19 with respect to such product or prod20 ucts; and 

21 ‘‘(III) require that manufacturers 

22 may only market such tobacco product 

23 after the issuance of an order under 

24 subsection (c)(1)(A)(i) with respect to 

25 such product or products. 
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1 ‘‘(ii) CONDITIONS.—The conditions 

2 specified in this clause are that— 

3 ‘‘(I) the Secretary determines 

4 that the use of a tobacco product or 

5 products described in subparagraph 

6 (A)(iii) has resulted in an emerging 

7 public health threat; 

8 ‘‘(II) data from a National Youth 

9 Tobacco Survey (or successor survey) 

10 conducted after the date of the enact11 ment of the Protecting American 

12 Lungs and Reversing the Youth To13 bacco Epidemic Act of 2020 identifies 

14 a rise in youth usage of tobacco prod15 ucts described in section 

16 910(a)(2)(A)(iii); or 

17 ‘‘(III) the Secretary determines 

18 that a tobacco product or products no 

19 longer meets the criteria specified in 

20 such subparagraph.’’. 

21 (b) NATIONAL ACADEMIES STUDY AND REPORT.— 

22 (1) IN GENERAL.—The Secretary of Health and 

23 Human Services, acting through the Commissioner 

24 of Food and Drugs, shall enter into an agreement 

25 with the National Academies of Sciences, Engineer-
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1 ing, and Medicine under which the National Acad2 emies shall conduct a study on— 

3 (A) the public health impact of having to4 bacco products described in subsection 

5 (a)(2)(A)(iii) of section 910 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 

7 387j), as amended by subsection (a), exempt 

8 from premarket review under such section; 

9 (B) the youth usage of such tobacco prod10 ucts; and 

11 (C) the market share of such products. 

12 (2) REPORT.—The agreement under paragraph 

13 (1) shall include a requirement that the National 

14 Academies of Sciences, Engineering, and Medicine 

15 submit to Congress, not later than December 31, 

16 2026, a report on the findings of the study con17 ducted under such paragraph. 

18 SEC. 109. PUBLIC EDUCATION. 

19 Section 906 of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 387f) is amended by adding at the end 

21 the following: 

22 ‘‘(g) EDUCATION ON TOBACCO PRODUCTS.— 

23 ‘‘(1) IN GENERAL.—Beginning not later than 6 

24 months after the date of the enactment of the Pro25 tecting American Lungs and Reversing the Youth 
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1 Tobacco Epidemic Act of 2020, the Secretary of 

2 Health and Human Services, acting through the 

3 Commissioner of Food and Drugs and in consulta4 tion with the Surgeon General of the Public Health 

5 Service, shall provide educational materials for 

6 health care providers, members of the public, and 

7 law enforcement officials, regarding— 

8 ‘‘(A) the authority of the Food and Drug 

9 Administration with respect to the regulation of 

10 tobacco products (including enforcement of such 

11 regulation); 

12 ‘‘(B) the general processes of the Food and 

13 Drug Administration for enforcing restrictions 

14 on the manufacture and sale of tobacco prod15 ucts; 

16 ‘‘(C) the general enforcement actions the 

17 Food and Drug Administration may take to im18 plement the prohibition on characterizing fla19 vors in tobacco products under section 

20 907(a)(1); 

21 ‘‘(D) the public health impact of tobacco 

22 products with characterizing flavors; and 

23 ‘‘(E) other information as the Secretary 

24 determines appropriate. 
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1 ‘‘(2) CONTENT.—Educational materials pro2 vided under paragraph (1) may include— 

3 ‘‘(A) explanations of key statutory and 

4 regulatory terms, including the terms ‘tobacco 

5 product’, ‘component parts’, ‘accessories’, ‘con6 stituent’, ‘additive’, ‘tobacco product manufac7 turer’, and ‘characterizing flavor’; 

8 ‘‘(B) an explanation of the Food and Drug 

9 Administration’s jurisdiction to regulate tobacco 

10 products, including tobacco products with char11 acterizing flavors under section 907(a)(1); 

12 ‘‘(C) general educational information re13 lated to enforcement tools and processes used 

14 by the Food and Drug Administration for viola15 tions of the prohibition specified in section 

16 907(a)(1); 

17 ‘‘(D) information on the health effects of 

18 using tobacco products, including those with the 

19 characterizing flavors referred to in section 

20 907(a)(1); and 

21 ‘‘(E) information on resources available re22 lated to smoking cessation. 

23 ‘‘(3) FORMAT.—Educational materials provided 

24 under paragraph (1) may be— 
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1 ‘‘(A) published in any format, including an 

2 internet website, video, fact sheet, infographic, 

3 webinar, or other format, as the Secretary de4 termines is appropriate and applicable; and 

5 ‘‘(B) tailored for the unique needs of 

6 health care providers, members of the public, 

7 law enforcement officers, and other audiences, 

8 as the Secretary determines appropriate. 

9 ‘‘(4) FUNDING.—To carry out this subsection, 

10 there is authorized to be appropriated, and there is 

11 appropriated, out of any funds in the Treasury not 

12 otherwise appropriated, $5,000,000 for each of fiscal 

13 years 2021 through 2025. Funds made available by 

14 the preceding sentence to carry out this subsection 

15 shall be in addition to funds that are derived from 

16 fees under section 919 and are otherwise made avail17 able to carry out this chapter.’’. 

18 SEC. 110. REGULATIONS FOR RECORDKEEPING CON19 CERNING TRACKING AND TRACING. 

20 The Secretary of Health and Human Services, acting 

21 through the Commissioner of Food and Drugs, shall pro22 mulgate the regulations required by section 920(b) of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387t) 

24 in accordance with the following schedule: 
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1 (1) Not later than 1 year after the date of en2 actment of this Act, the Secretary shall issue pro3 posed regulations. 

4 (2) Not later than 2 years after the date of en5 actment of this Act, the Secretary shall promulgate 

6 final regulations. 

7 TITLE II—FEDERAL TRADE 

8 COMMISSION 

9 SEC. 201. ADVERTISING OF TOBACCO PRODUCTS. 

10 (a) ADVERTISING OF ELECTRONIC NICOTINE DELIV11 ERY SYSTEMS.— 

12 (1) IN GENERAL.—It shall be unlawful— 

13 (A) to market, advertise, or promote any 

14 electronic nicotine delivery system in a manner 

15 that appeals to an individual under 21 years of 

16 age; or 

17 (B) to market, advertise, promote, or en18 dorse, or to compensate any person for the 

19 marketing, advertising, promotion, or endorse20 ment of, any electronic nicotine delivery system 

21 without clearly disclosing that the communica22 tion is an advertisement, unless the communica23 tion is unambiguously identifiable as an adver24 tisement. 

25 (2) ENFORCEMENT BY COMMISSION.— 
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1 (A) UNFAIR OR DECEPTIVE ACTS OR PRAC2 TICES.—A violation of paragraph (1) shall be 

3 treated as a violation of a regulation under sec4 tion 18(a)(1)(B) of the Federal Trade Commis5 sion Act (15 U.S.C. 57a(a)(1)(B)) regarding 

6 unfair or deceptive acts or practices. 

7 (B) POWERS OF COMMISSION.—The Com8 mission shall enforce paragraph (1) in the same 

9 manner, by the same means, and with the same 

10 jurisdiction, powers, and duties as though all 

11 applicable terms and provisions of the Federal 

12 Trade Commission Act (15 U.S.C. 41 et seq.) 

13 were incorporated into and made a part of this 

14 Act. Any person who violates such paragraph 

15 shall be subject to the penalties and entitled to 

16 the privileges and immunities provided in the 

17 Federal Trade Commission Act. 

18 (3) ENFORCEMENT BY STATE ATTORNEYS GEN19 ERAL.— 

20 (A) IN GENERAL.—If the attorney general 

21 of a State has reason to believe a violation of 

22 paragraph (1) has occurred or is occurring, the 

23 attorney general, in addition to any authority 

24 the attorney general may have to bring an ac25 tion in State court under the law of the State, 
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1 may bring a civil action in any court of com2 petent jurisdiction to— 

3 (i) enjoin further such violation by the 

4 defendant; 

5 (ii) enforce compliance with such 

6 paragraph; 

7 (iii) obtain civil penalties in the same 

8 amount as may be obtained by the Com9 mission in a civil action under section 5(m) 

10 of the Federal Trade Commission Act (15 

11 U.S.C. 45(m)); or 

12 (iv) obtain damages, restitution, or 

13 other compensation on behalf of residents 

14 of the State. 

15 (B) NOTICE.—Before filing an action 

16 under subparagraph (A), the attorney general 

17 of a State shall provide to the Commission a 

18 written notice of such action and a copy of the 

19 complaint for such action. If the attorney gen20 eral determines that it is not feasible to provide 

21 the notice described in this subparagraph before 

22 the filing of the action, the attorney general 

23 shall provide written notice of the action and a 

24 copy of the complaint to the Commission imme25 diately upon the filing of the action. 
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1 (C) AUTHORITY OF FEDERAL TRADE COM2 MISSION.— 

3 (i) IN GENERAL.—On receiving notice 

4 under subparagraph (B) of an action 

5 under subparagraph (A), the Commission 

6 shall have the right— 

7 (I) to intervene in the action; 

8 (II) upon so intervening, to be 

9 heard on all matters arising therein; 

10 and 

11 (III) to file petitions for appeal. 

12 (ii) LIMITATION ON STATE ACTION

13 WHILE FEDERAL ACTION IS PENDING.—If 

14 the Commission has instituted a civil ac15 tion for violation of paragraph (1) (re16 ferred to in this clause as the ‘‘Federal ac17 tion’’), no attorney general of a State may 

18 bring an action under subparagraph (A) 

19 during the pendency of the Federal action 

20 against any defendant named in the com21 plaint in the Federal action for any viola22 tion of such paragraph alleged in such 

23 complaint. 

24 (D) RELATIONSHIP WITH STATE-LAW

25 CLAIMS.— 
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1 (i) PRESERVATION OF STATE-LAW

2 CLAIMS.—Nothing in this section shall pre3 vent the attorney general of a State from 

4 bringing an action under State law for acts 

5 or practices that also violate paragraph 

6 (1). 

7 (ii) ASSERTION IN SAME CIVIL AC8 TION.—If the attorney general of a State 

9 has authority to bring an action under 

10 State law for acts or practices that also 

11 violate paragraph (1), the attorney general 

12 may assert the State-law claim and the 

13 claim for violation of such paragraph in 

14 the same civil action. 

15 (E) ACTIONS BY OTHER STATE OFFI16 CIALS.—In addition to civil actions brought by 

17 attorneys general under subparagraph (A), any 

18 other consumer protection officer of a State 

19 who is authorized by the State to do so may 

20 bring a civil action under such subparagraph, 

21 subject to the same requirements and limita22 tions that apply under this paragraph to civil 

23 actions brought by attorneys general. 

24 (4) RULEMAKING AUTHORITY.—The Commis25 sion may promulgate regulations under section 553 
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1 of title 5, United States Code, to implement para2 graph (1). 

3 (b) REPORT TO CONGRESS ON TOBACCO PRODUCT

4 ADVERTISING.— 

5 (1) IN GENERAL.—Not later than 2 years after 

6 the date of the enactment of this Act, and annually 

7 thereafter, the Commission shall submit to Congress 

8 a report relating to each category of products de9 scribed in paragraph (2) (or a single report a por10 tion of which relates to each such category) that 

11 contains the following: 

12 (A) Information on domestic sales and ad13 vertising and promotional activity by the manu14 facturers that have the largest market shares of 

15 the product category. 

16 (B) Such recommendations for legislation 

17 as the Commission may consider appropriate. 

18 (2) PRODUCT CATEGORIES DESCRIBED.—The 

19 categories of products described in this paragraph 

20 are the following: 

21 (A) Cigarettes. 

22 (B) Cigars. 

23 (C) Smokeless tobacco. 

24 (D) Electronic nicotine delivery systems. 
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1 (c) PRESERVATION OF AUTHORITY.—Nothing in this 

2 section may be construed in any way to limit the Commis3 sion’s authority under any other provision of law. 

4 (d) DEFINITIONS.—In this section: 

5 (1) CIGAR.—The term ‘‘cigar’’ means a tobacco 

6 product that— 

7 (A) is not a cigarette; and 

8 (B) is a roll of tobacco wrapped in leaf to9 bacco or any substance containing tobacco. 

10 (2) CIGARETTE.—The term ‘‘cigarette’’ has the 

11 meaning given such term in section 900 of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 

13 (3) COMMISSION.—The term ‘‘Commission’’ 

14 means the Federal Trade Commission. 

15 (4) ELECTRONIC NICOTINE DELIVERY SYS16 TEM.—The term ‘‘electronic nicotine delivery sys17 tem’’ means a tobacco product that is an electronic 

18 device that delivers nicotine, flavor, or another sub19 stance via an aerosolized solution to the user inhal20 ing from the device (including e-cigarettes, e-hookah, 

21 e-cigars, vape pens, advanced refillable personal va22 porizers, and electronic pipes) and any component, 

23 liquid, part, or accessory of such a device, whether 

24 or not sold separately. 
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1 (5) ENDORSE.—The term ‘‘endorse’’ means to 

2 communicate an advertising message (including a 

3 verbal statement, demonstration, or depiction of the 

4 name, signature, likeness, or other identifying per5 sonal characteristics of an individual or the name or 

6 seal of an organization) that consumers are likely to 

7 believe reflects the opinions, beliefs, findings, or ex8 periences of a party other than the sponsoring ad9 vertiser, even if the views expressed by such party 

10 are identical to those of the sponsoring advertiser. 

11 (6) NICOTINE.—The term ‘‘nicotine’’ has the 

12 meaning given such term in section 900 of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 

14 (7) SMOKELESS TOBACCO.—The term ‘‘smoke15 less tobacco’’ has the meaning given such term in 

16 section 900 of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 387). 

18 (8) TOBACCO PRODUCT.—The term ‘‘tobacco 

19 product’’ has the meaning given such term in section 

20 201 of the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 321). 
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1 TITLE III—PUBLIC HEALTH 

2 PROGRAMS 

3 SEC. 301. OUTREACH TO MEDICALLY UNDERSERVED COM4 MUNITIES. 

5 Section 399V of the Public Health Service Act (42 

6 U.S.C. 280g–11) is amended— 

7 (1) in subsection (b)— 

8 (A) by redesignating paragraphs (4) and 

9 (5) as paragraphs (5) and (6), respectively; and 

10 (B) by inserting after paragraph (3) the 

11 following: 

12 ‘‘(4) to educate and provide guidance to medi13 cally underserved communities, particularly racial 

14 and ethnic minority populations, regarding effective 

15 evidence-based strategies— 

16 ‘‘(A) to prevent tobacco, e-cigarette, and 

17 nicotine addiction, including among youth; and 

18 ‘‘(B) for smoking cessation, including ces19 sation of the use of menthol-flavored tobacco 

20 products, and the cessation of the use of e-ciga21 rettes and electronic nicotine delivery systems;’’; 

22 (2) in subsection (d)(1)(B), by inserting ‘‘, in23 cluding chronic diseases related to and caused by to24 bacco use’’ after ‘‘diseases’’; and 
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1 (3) in subsection (j), by striking ‘‘are author2 ized to be appropriated, such sums as may be nec3 essary to carry out this section for each of fiscal 

4 years 2010 through 2014’’ and inserting ‘‘is author5 ized to be appropriated, and there is appropriated, 

6 out of any funds in the Treasury not otherwise ap7 propriated, $75,000,000 to carry out this section for 

8 each of fiscal years 2021 through 2025’’. 

9 SEC. 302. DEMONSTRATION GRANT PROGRAM TO DEVELOP 

10 STRATEGIES FOR SMOKING CESSATION IN 

11 MEDICALLY UNDERSERVED COMMUNITIES. 

12 Part B of title III of the Public Health Service Act 

13 (42 U.S.C. 243 et seq.) is amended by inserting after sec14 tion 317U (42 U.S.C. 247b–23) the following: 

15 ‘‘SEC. 317V. DEMONSTRATION GRANT PROGRAM TO DE16 VELOP STRATEGIES FOR SMOKING CES17 SATION IN MEDICALLY UNDERSERVED COM18 MUNITIES. 

19 ‘‘(a) IN GENERAL.—The Secretary, acting through 

20 the Director of the Centers for Disease Control and Pre21 vention, shall establish a demonstration program to award 

22 grants to, or contract with, State, local, or Tribal public 

23 health departments to support— 

24 ‘‘(1) the development of improved evidence25 based strategies for smoking cessation, including 
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1 cessation of the use of menthol-flavored tobacco 

2 products, and the cessation of the use of e-cigarettes 

3 and electronic nicotine delivery systems, for popu4 lations in medically underserved communities, par5 ticularly racial and ethnic minority populations; 

6 ‘‘(2) the development of improved communica7 tion and outreach tools to reach populations in medi8 cally underserved communities, particularly racial 

9 and ethnic minority populations, addicted to tobacco 

10 products, including e-cigarettes and menthol-flavored 

11 tobacco products; and 

12 ‘‘(3) improved coordination, access, and refer13 rals to services for tobacco cessation and the ces14 sation of the use of e-cigarettes and electronic nico15 tine delivery systems, including tobacco cessation 

16 products approved by the Food and Drug Adminis17 tration and mental health and counseling services. 

18 ‘‘(b) APPLICATION.—To be eligible to receive a grant 

19 under subsection (a), a State, local, or Tribal public health 

20 department shall submit to the Secretary an application 

21 at such time, in such manner, and containing such infor22 mation as the Secretary may require. 

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To 

24 carry out this section, there is authorized to be appro25 priated, and there is appropriated, out of any funds in 
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1 the Treasury not otherwise appropriated, $75,000,000 for 

2 each of fiscal years 2021 through 2025.’’. 

3 SEC. 303. PUBLIC AWARENESS, EDUCATION, AND PREVEN4 TION CAMPAIGN. 

5 Part B of title III of the Public Health Service Act 

6 (42 U.S.C. 243 et seq.), as amended by section 302, is 

7 further amended by inserting after section 317V the fol8 lowing new section: 

9 ‘‘SEC. 317W. PUBLIC AWARENESS, EDUCATION, AND PRE10 VENTION CAMPAIGN REGARDING TOBACCO. 

11 ‘‘(a) IN GENERAL.—The Secretary, acting through 

12 the Director of the Centers for Disease Control and Pre13 vention and in consultation with the Surgeon General of 

14 the Public Health Service, shall develop and implement a 

15 national campaign to educate youth and young adults, 

16 parents, clinicians, health professionals, and others about 

17 the harms associated with the use by youth and young 

18 adults of tobacco products, including e-cigarettes. 

19 ‘‘(b) REQUIREMENTS.—The campaign under this sec20 tion shall— 

21 ‘‘(1) be an evidence-based media and public en22 gagement initiative; 

23 ‘‘(2) be carried out through competitively bid 

24 contracts; 
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1 ‘‘(3) include the development of culturally and 

2 linguistically competent resources that may be tai3 lored for communities with high rates of youth to4 bacco use; 

5 ‘‘(4) be complementary to, and coordinated 

6 with, any other Federal efforts; and 

7 ‘‘(5) include message testing to identify cul8 turally and linguistically competent and effective 

9 messages for behavioral change. 

10 ‘‘(c) OPTIONAL COMPONENTS.—The campaign under 

11 this section may include— 

12 ‘‘(1) the use of— 

13 ‘‘(A) television, radio, print, the internet, 

14 and other commercial marketing venues; and 

15 ‘‘(B) in-person public communications; and 

16 ‘‘(2) the award of grants to State, local, and 

17 Tribal public health departments to encourage part18 nerships with community organizations and health 

19 care providers to develop and deliver evidence-based 

20 strategies to prevent youth tobacco use. 

21 ‘‘(d) FUNDING.—To carry out this section, there is 

22 authorized to be appropriated, and there is appropriated, 

23 out of any funds in the Treasury not otherwise appro24 priated, $45,000,000 for each of fiscal years 2021 through 

25 2025.’’. 
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1 SEC. 304. TOBACCO CESSATION TREATMENT GRANTS TO 

2 HEALTH CENTERS. 

3 (a) IN GENERAL.—Section 330 of the Public Health 

4 Service Act (42 U.S.C. 254b) is amended— 

5 (1) by redesignating subsections (k) through (r) 

6 as subsections (l) through (s), respectively; and 

7 (2) by adding after subsection (j) the following 

8 new subsection: 

9 ‘‘(k) TOBACCO CESSATION GRANTS.— 

10 ‘‘(1) IN GENERAL.—The Secretary may award 

11 grants to health centers to provide comprehensive to12 bacco cessation treatment, including counseling and 

13 tobacco cessation therapies. 

14 ‘‘(2) FUNDING.—For the purpose of carrying 

15 out this subsection, in addition to other amounts 

16 available for such purpose, there is authorized to be 

17 appropriated, and there is appropriated, out of funds 

18 in the Treasury not otherwise appropriated, 

19 $125,000,000 for each of fiscal years 2021 through 

20 2025.’’. 

21 (b) CONFORMING CHANGES.—Section 330 of the 

22 Public Health Service Act (42 U.S.C. 254b) is amended— 

23 (1) in subsection (c)(3)(B), by striking 

24 ‘‘(k)(3)(J)’’ and inserting ‘‘(l)(3)(J)’’; 

25 (2) in subsection (e)(1)(B), by striking ‘‘(k)(3)’’ 

26 each place it appears and inserting ‘‘(l)(3)’’; 
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1 (3) in subsection (l)(3)(H), as redesignated, by 

2 striking ‘‘or (p)’’ and inserting ‘‘or (q)’’; 

3 (4) in subsection (m), as redesignated— 

4 (A) by striking ‘‘(k)(3)’’ and inserting 

5 ‘‘(l)(3)’’; and 

6 (B) by striking ‘‘(m)’’ and inserting ‘‘(n)’’; 

7 (5) in subsection (q), as redesignated, by strik8 ing ‘‘(k)(3)(G)’’ and inserting ‘‘(l)(3)(G)’’; 

9 (6) in subsection (s)(2)(A), as redesignated— 

10 (A) by striking ‘‘(k)(3)’’ and inserting 

11 ‘‘(l)(3)’’; and 

12 (B) by striking ‘‘(k)(3)(H)’’ and inserting 

13 ‘‘(l)(3)(H)’’; and 

14 (7) in subsection (s)(3)(I), as redesignated, by 

15 striking ‘‘(q)(4)’’ and inserting ‘‘(r)(4)’’. 

16 (c) TECHNICAL CORRECTIONS.— 

17 (1) Section 330(h)(5)(B) of the Public Health 

18 Service Act (42 U.S.C. 254b(h)(5)(B)) is amended 

19 by striking ‘‘substance abuse’’ each place it appears 

20 and inserting ‘‘substance use disorder’’. 

21 (2) Subclause (II) of subsection (l)(3)(E)(i), as 

22 redesignated, of section 330 of the Public Health 

23 Service Act (42 U.S.C. 254b) is amended by moving 

24 the indentation 2 ems to the left. 
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1 SEC. 305. GRANTS FOR RESEARCH. 

2 Part P of title III of the Public Health Service Act 

3 (42 U.S.C. 280g et seq.) is amended by adding at the end 

4 the following new section: 

5 ‘‘SEC. 399V–7. GRANTS FOR RESEARCH ON PREVENTION, 

6 AND CESSATION, OF THE USE OF TOBACCO 

7 PRODUCTS. 

8 ‘‘(a) IN GENERAL.—The Secretary shall award 

9 grants to support— 

10 ‘‘(1) research to develop and improve effective 

11 strategies for prevention, and cessation, of the use of 

12 tobacco products, including— 

13 ‘‘(A) cessation of the use of flavored com14 bustible cigarettes, including menthol-flavored 

15 cigarettes; 

16 ‘‘(B) cessation of the use of e-cigarette 

17 products; and 

18 ‘‘(C) prevention and cessation strategies 

19 targeted toward youth; and 

20 ‘‘(2) research to aid in the development of safe 

21 and effective tobacco cessation therapies, including 

22 therapies appropriate for populations under the age 

23 of 18. 

24 ‘‘(b) FUNDING.—To carry out this section, there is 

25 authorized to be appropriated, and there is appropriated, 

26 out of any funds in the Treasury not otherwise appro-
43 

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1 priated, $75,000,000 for each of fiscal years 2021 through 

2 2025.’’. 

3 TITLE IV—NICOTINE OR VAPING 

4 ACCESS PROTECTION AND 

5 ENFORCEMENT 

6 SEC. 401. INCREASING CIVIL PENALTIES APPLICABLE TO 

7 CERTAIN VIOLATIONS OF RESTRICTIONS ON 

8 SALE AND DISTRIBUTION OF TOBACCO PROD9 UCTS. 

10 (a) PENALTIES.—Subparagraph (A) of section 

11 103(q)(2) of the Family Smoking Prevention and Tobacco 

12 Control Act (21 U.S.C. 333 note) is amended to read as 

13 follows: 

14 ‘‘(A) IN GENERAL.—The amount of the 

15 civil penalty to be applied for violations of re16 strictions promulgated under section 906(d), as 

17 described in paragraph (1), shall be as follows: 

18 ‘‘(i) With respect to a retailer with an 

19 approved training program, the amount of 

20 the civil penalty shall not exceed— 

21 ‘‘(I) in the case of the first viola22 tion, $0, together with the issuance of 

23 a warning letter to the retailer; 
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1 ‘‘(II) in the case of a second vio2 lation within a 12-month period, 

3 $500; 

4 ‘‘(III) in the case of a third viola5 tion within a 24-month period, 

6 $1,000; 

7 ‘‘(IV) in the case of a fourth vio8 lation within a 24-month period, 

9 $4,000; 

10 ‘‘(V) in the case of a fifth viola11 tion within a 36-month period, 

12 $10,000; and 

13 ‘‘(VI) in the case of a sixth or 

14 subsequent violation within a 48- 

15 month period, $20,000 as determined 

16 by the Secretary on a case-by-case 

17 basis. 

18 ‘‘(ii) With respect to a retailer that 

19 does not have an approved training pro20 gram, the amount of the civil penalty shall 

21 not exceed— 

22 ‘‘(I) in the case of the first viola23 tion, $500; 
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1 ‘‘(II) in the case of a second vio2 lation within a 12-month period, 

3 $1,000; 

4 ‘‘(III) in the case of a third viola5 tion within a 24-month period, 

6 $2,000; 

7 ‘‘(IV) in the case of a fourth vio8 lation within a 24-month period, 

9 $4,000; 

10 ‘‘(V) in the case of a fifth viola11 tion within a 36-month period, 

12 $10,000; and 

13 ‘‘(VI) in the case of a sixth or 

14 subsequent violation within a 48- 

15 month period, $20,000 as determined 

16 by the Secretary on a case-by-case 

17 basis.’’. 

18 (b) APPLICABILITY.—The amendment made by sub19 section (a) applies with respect to a violation of a restric20 tion promulgated under section 906(d)(1) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)(1)), as 

22 described in section 103(q)(1) of the Family Smoking Pre23 vention and Tobacco Control Act (21 U.S.C. 333 note), 

24 occurring on or after the day that is 6 months after the 

25 date of enactment of this Act. The penalties specified in 
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1 section 103(q)(2)(A) of the Family Smoking Prevention 

2 and Tobacco Control Act (21 U.S.C. 333 note), as in ef3 fect on the day before the date of enactment of this Act, 

4 shall continue to apply to violations occurring before the 

5 day specified in the preceding sentence. 

6 SEC. 402. STUDY AND REPORT ON E-CIGARETTES. 

7 Not later than 5 years after the date of enactment 

8 of this Act, the Comptroller General of the United States 

9 shall— 

10 (1) complete a study on— 

11 (A) the relationship of e-cigarettes to to12 bacco cessation; 

13 (B) the perception of the harmful effects of 

14 e-cigarettes; and 

15 (C) the effects of secondhand exposure to 

16 smoke from e-cigarettes; and 

17 (2) submit to the Congress a report on the re18 sults of such study, including recommendations 

19 based on such results. 

20 TITLE V—EXCISE TAX ON 

21 NICOTINE USED IN VAPING, ETC. 

22 SEC. 501. IMPOSITION OF TAX ON NICOTINE FOR USE IN 

23 VAPING, ETC. 

24 (a) IN GENERAL.—Section 5701 of the Internal Rev25 enue Code of 1986 is amended by redesignating subsection 
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1 (h) as subsection (i) and by inserting after subsection (g) 

2 the following new subsection: 

3 ‘‘(h) NICOTINE.—On taxable nicotine, manufactured 

4 in or imported into the United States, there shall be im5 posed a tax equal to the dollar amount specified in section 

6 5701(b)(1) (or, if greater, $50.33) per 1,810 milligrams 

7 of nicotine (and a proportionate tax at the like rate on 

8 any fractional part thereof).’’. 

9 (b) TAXABLE NICOTINE.—Section 5702 of such Code 

10 is amended by adding at the end the following new sub11 section: 

12 ‘‘(q) TAXABLE NICOTINE.— 

13 ‘‘(1) IN GENERAL.—Except as otherwise pro14 vided in this subsection, the term ‘taxable nicotine’ 

15 means any nicotine which has been extracted, con16 centrated, or synthesized. 

17 ‘‘(2) EXCEPTION FOR PRODUCTS APPROVED BY

18 FOOD AND DRUG ADMINISTRATION.—Such term 

19 shall not include any nicotine if the manufacturer or 

20 importer thereof demonstrates to the satisfaction of 

21 the Secretary of Health and Human Services that 

22 such nicotine will be used in— 

23 ‘‘(A) a drug— 

24 ‘‘(i) that is approved under section 

25 505 of the Federal Food, Drug, and Cos-
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1 metic Act or licensed under section 351 of 

2 the Public Health Service Act; or 

3 ‘‘(ii) for which an investigational use 

4 exemption has been authorized under sec5 tion 505(i) of the Federal Food, Drug, and 

6 Cosmetic Act or under section 351(a) of 

7 the Public Health Service Act; or 

8 ‘‘(B) a combination product (as described 

9 in section 503(g) of the Federal Food, Drug, 

10 and Cosmetic Act), the constituent parts of 

11 which were approved or cleared under section 

12 505, 510(k), or 515 of such Act. 

13 ‘‘(3) COORDINATION WITH TAXATION OF OTHER

14 TOBACCO PRODUCTS.—Cigars, cigarettes, smokeless 

15 tobacco, pipe tobacco, and roll-your-own tobacco 

16 shall not be treated as containing taxable nicotine 

17 solely because the nicotine naturally occurring in the 

18 tobacco from which such product is manufactured 

19 has been concentrated during the ordinary course of 

20 manufacturing.’’. 

21 (c) TAXABLE NICOTINE TREATED AS A TOBACCO

22 PRODUCT.—Section 5702(c) of such Code is amended by 

23 striking ‘‘and roll-your-own tobacco’’ and inserting ‘‘roll24 your-own tobacco, and taxable nicotine’’. 
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1 (d) MANUFACTURER OF TAXABLE NICOTINE.—Sec2 tion 5702 of such Code, as amended by subsection (b), 

3 is further amended by adding at the end the following new 

4 subsection: 

5 ‘‘(r) MANUFACTURER OF TAXABLE NICOTINE.— 

6 ‘‘(1) IN GENERAL.—Any person who extracts, 

7 concentrates, or synthesizes nicotine shall be treated 

8 as a manufacturer of taxable nicotine (and as manu9 facturing such taxable nicotine). 

10 ‘‘(2) APPLICATION OF RULES RELATED TO

11 MANUFACTURERS OF TOBACCO PRODUCTS.—Any 

12 reference to a manufacturer of tobacco products, or 

13 to manufacturing tobacco products, shall be treated 

14 as including a reference to a manufacturer of tax15 able nicotine, or to manufacturing taxable nicotine, 

16 respectively.’’. 

17 (e) EFFECTIVE DATE.— 

18 (1) IN GENERAL.—The amendments made by 

19 this section shall apply to articles manufactured or 

20 imported in calendar quarters beginning more than 

21 90 days after the date of the enactment of this Act. 

22 (2) TRANSITION RULE FOR PERMIT AND BOND

23 REQUIREMENTS.—A person which is lawfully en24 gaged in business as a manufacturer or importer of 

25 taxable nicotine (within the meaning of subchapter 
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1 A of chapter 52 of the Internal Revenue Code of 

2 1986, as amended by this section) on the date of the 

3 enactment of this Act, first becomes subject to the 

4 requirements of subchapter B of chapter 52 of such 

5 Code by reason of the amendments made by this 

6 section, and submits an application under such sub7 chapter B to engage in such business not later than 

8 90 days after the date of the enactment of this Act, 

9 shall not be denied the right to carry on such busi10 ness by reason of such requirements before final ac11 tion on such application. 

12 TITLE VI—FURTHER HEALTH 

13 INVESTMENTS 

14 SEC. 601. WAIVING MEDICARE COINSURANCE FOR 

15 COLORECTAL CANCER SCREENING TESTS. 

16 Section 1833(a) of the Social Security Act (42 U.S.C. 

17 1395l(a)) is amended— 

18 (1) in the second sentence, by striking ‘‘section 

19 1834(0)’’ and inserting ‘‘section 1834(o)’’; 

20 (2) by moving such second sentence 2 ems to 

21 the left; and 

22 (3) by inserting the following third sentence fol23 lowing such second sentence: ‘‘For services furnished 

24 on or after January 1, 2024, paragraph (1)(Y) shall 

25 apply with respect to a colorectal cancer screening 
51 

•HR 2339 EH

1 test regardless of the code that is billed for the es2 tablishment of a diagnosis as a result of the test, or 

3 for the removal of tissue or other matter or other 

4 procedure that is furnished in connection with, as a 

5 result of, and in the same clinical encounter as the 

6 screening test.’’. 

7 SEC. 602. SAFE HARBOR FOR HIGH DEDUCTIBLE HEALTH 

8 PLANS WITHOUT DEDUCTIBLE FOR CERTAIN 

9 INHALERS. 

10 (a) IN GENERAL.—Section 223(c)(2)(C) of the Inter11 nal Revenue Code of 1986 is amended— 

12 (1) by striking ‘‘for preventive care’’ and insert13 ing ‘‘for one or more of the following: 

14 ‘‘(i) Preventive care’’, and 

15 (2) by adding at the end the following new 

16 clause: 

17 ‘‘(ii) Inhalers or nebulizers for treat18 ment of any chronic lung disease (and any 

19 medicine or drug which is delivered 

20 through such inhaler or nebulizer for treat21 ment of such disease).’’. 

22 (b) CONFORMING AMENDMENT.—The heading for 

23 section 223(c)(2)(C) of such Code is amended by striking 

24 ‘‘PREVENTIVE CARE DEDUCTIBLE’’ and inserting ‘‘CER25 TAIN DEDUCTIBLES’’. 
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1 (c) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to months beginning after the date 

3 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 

bacco products, and for other purposes. Act with respect to the sale and marketing of to-