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 ces-
sation 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 restric-
tions 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 con-
strued 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 be-
fore the date of enactment of this Act; and 
(B) products that were deemed by regula-
tion 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 PROD-
UCTS.— 
(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 enact-
ment of the Protecting American Lungs 
and Reversing the Youth Tobacco Epi-
demic Act of 2020, a tobacco product (in-
cluding its components, parts, and acces-
sories, including the tobacco, filter, or
paper) that is not an electronic nicotine de-
livery system shall not contain, as a con-
stituent (including a smoke constituent) or 
additive, an artificial or natural flavor 
(other than tobacco) that is a character-
izing flavor of the tobacco product or to-
bacco 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 con-
strued to limit the Secretary’s authority to 
take action under this section or other sec-
tions of this Act applicable to any artificial 
or natural flavor, herb, or spice. 
‘‘(iii) APPLICABILITY TO CERTAIN IN-
DIVIDUALS.—Notwithstanding any provi-
sion of this Act, no individual who pur-
chases for individual consumption, pos-
sesses for individual consumption, or con-
sumes, a tobacco product that is in viola-
tion of the prohibition under this subpara-
graph, including a tobacco product that
contains a characterizing flavor of menthol, 
shall be subject to any criminal penalty 
under this Act for such purchase, posses-
sion, or consumption, nor shall such pur-
chase, possession, or consumption be used 
as a justification to stop, search, or con-
duct any other investigative measure 
against any individual.’’. 
(B) 
SAVINGS
PROVISION.—Section 
907(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387g(a)(1)), as in effect 
on the date of enactment of this Act, shall re-
main in effect until the amendment made to 
such section 907(a)(1) by this paragraph takes 
effect. 
(2) FLAVORED ELECTRONIC NICOTINE DELIV-
ERY
SYSTEM.—Section 910 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387j) is amend-
ed 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 to-
bacco product, including any solution or other com-
ponent 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 Sec-
retary 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 sys-
tem, including any liquid, solution, or other compo-
nent or part or its aerosol, that contains an artificial 
or natural flavor (other than tobacco) that is a char-
acterizing flavor, unless the Secretary issues an 
order finding that the manufacturer has dem-
onstrated that— 
‘‘(A) use of the characterizing flavor—
‘‘(i) will significantly increase the like-
lihood 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 elec-
tronic nicotine delivery system; and 
‘‘(B) such electronic nicotine delivery sys-
tem is not more harmful to users than an elec-
tronic nicotine delivery system that does not 
contain any characterizing flavors.’’. 
(3) DEFINITION OF ELECTRONIC NICOTINE DE-
LIVERY SYSTEM.—Section 900 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387) is amend-
ed— 
(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
SYS-
TEM.—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 en-
forcement 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 Pro-
tecting American Lungs and Reversing the 
Youth Tobacco Epidemic Act of 2020, the Sec-
retary shall promulgate a final regulation pro-
hibiting the retail sale of all tobacco products 
other than retail sales through a direct, face-to- 
face exchange between a retailer and a con-
sumer. 
‘‘(B) EXCEPTION FOR CERTAIN CIGAR TO-
BACCO PRODUCTS.— 
‘‘(i) EXCEPTION.—The regulation re-
quired 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 de-
scribed 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 in-
dividuals who have not attained the min-
imum 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 Sec-
retary to take additional actions under 
other provisions of this Act; or 
‘‘(ii) preempts the authority of a State 
or local government to establish restric-
tions 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 Fed-
eral Food, Drug, and Cosmetic Act, as in effect on the 
day before the date of enactment of this Act, shall con-
tinue 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 subpara-
graph (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 fis-
cal 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 ef-
fect on the day before the date of enactment of this 
Act. 
(2) SUBSEQUENT FISCAL YEARS.—The amend-
ments made by subsections (c) through (f) apply be-
ginning with fiscal year 2022. 
(c) ALLOCATIONS OF ASSESSMENT BY CLASS OF TO-
BACCO 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 as-
sessed 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 percent-
age 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 percent-
age for a fiscal year for each class of to-
bacco product shall be the percentage de-
termined by dividing— 
‘‘(I) the product of the gross do-
mestic 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 de-
termined 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 sec-
tion 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 re-
moval under that chapter or the Har-
monized 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 percent-
age determined for purposes of allocations under sub-
sections (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 redesig-
nated, to read as follows: 
‘‘(6) MEMORANDUM OF UNDERSTANDING; RE-
PORTING.— 
‘‘(A) TRANSFER
OF
INFORMATION.—The 
Secretary shall request the appropriate Federal 
agency to enter into a memorandum of under-
standing that provides for the regular and time-
ly transfer from the head of such agency to the 
Secretary of all necessary information regarding 
all tobacco product manufacturers and import-
ers required to pay user fees. The Secretary 
shall maintain all disclosure restrictions estab-
lished 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 manufac-
turers and importers of each class of to-
bacco products to which this chapter ap-
plies 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 finan-
cial 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 ALTER-
NATIVE 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 en-
actment of this Act, issue an interim final rule pro-
viding for the regulation of products containing al-
ternative 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 en-
actment, issue a final rule providing for such regula-
tion. 
(b) ALTERNATIVE NICOTINE.—In this section, the 
term ‘‘alternative nicotine’’ means nicotine that is not 
made or derived from tobacco plants and may include nic-
otine that is chemically synthesized, synthesized from re-
combinant genetic technology, or extracted from non-to-
bacco plants. 
SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUB-
LIC AWARENESS CAMPAIGNS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall— 
(1) review all public health awareness cam-
paigns 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 in-
clude 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 CER-
TAIN 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 en-
actment of the Protecting American Lungs 
and Reversing the Youth Tobacco Epi-
demic Act of 2020 and ending on Sep-
tember 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 character-
izing 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 Con-
sumer 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
APPLICA-
BILITY.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall, 
notwithstanding 
subparagraph 
(A)(iii) or any determination of substantial 
equivalence, if any of the conditions speci-
fied in clause (ii) are met— 
‘‘(I) withdraw any exemption ap-
plicable to a tobacco product or prod-
ucts described in such subparagraph; 
‘‘(II) require that applications for 
review under this section be submitted 
with respect to such product or prod-
ucts; 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 enact-
ment of the Protecting American 
Lungs and Reversing the Youth To-
bacco Epidemic Act of 2020 identifies 
a rise in youth usage of tobacco prod-
ucts 
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, Engineer-
ing, and Medicine under which the National Acad-
emies shall conduct a study on— 
(A) the public health impact of having to-
bacco 
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 prod-
ucts; 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 con-
ducted 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 Pro-
tecting 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 consulta-
tion 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 prod-
ucts; 
‘‘(C) the general enforcement actions the 
Food and Drug Administration may take to im-
plement the prohibition on characterizing fla-
vors 
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 pro-
vided under paragraph (1) may include— 
‘‘(A) explanations of key statutory and 
regulatory terms, including the terms ‘tobacco 
product’, ‘component parts’, ‘accessories’, ‘con-
stituent’, ‘additive’, ‘tobacco product manufac-
turer’, and ‘characterizing flavor’; 
‘‘(B) an explanation of the Food and Drug 
Administration’s jurisdiction to regulate tobacco 
products, including tobacco products with char-
acterizing flavors under section 907(a)(1); 
‘‘(C) general educational information re-
lated to enforcement tools and processes used 
by the Food and Drug Administration for viola-
tions 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 re-
lated 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 de-
termines 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 avail-
able to carry out this chapter.’’. 
SEC. 
110. 
REGULATIONS 
FOR 
RECORDKEEPING 
CON-
CERNING TRACKING AND TRACING. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall pro-
mulgate 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 en-
actment of this Act, the Secretary shall issue pro-
posed regulations. 
(2) Not later than 2 years after the date of en-
actment 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 DELIV-
ERY 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 en-
dorse, or to compensate any person for the 
marketing, advertising, promotion, or endorse-
ment of, any electronic nicotine delivery system 
without clearly disclosing that the communica-
tion is an advertisement, unless the communica-
tion is unambiguously identifiable as an adver-
tisement. 
(2) ENFORCEMENT BY COMMISSION.—
(A) UNFAIR OR DECEPTIVE ACTS OR PRAC-
TICES.—A violation of paragraph (1) shall be 
treated as a violation of a regulation under sec-
tion 18(a)(1)(B) of the Federal Trade Commis-
sion Act (15 U.S.C. 57a(a)(1)(B)) regarding 
unfair or deceptive acts or practices. 
(B) POWERS OF COMMISSION.—The Com-
mission 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 GEN-
ERAL.— 
(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 ac-
tion in State court under the law of the State,
may bring a civil action in any court of com-
petent 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 Com-
mission 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 gen-
eral 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 imme-
diately upon the filing of the action.
(C) AUTHORITY OF FEDERAL TRADE COM-
MISSION.— 
(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 ac-
tion for violation of paragraph (1) (re-
ferred to in this clause as the ‘‘Federal ac-
tion’’), 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 com-
plaint in the Federal action for any viola-
tion of such paragraph alleged in such 
complaint. 
(D) 
RELATIONSHIP
WITH
STATE-LAW 
CLAIMS.—
(i) PRESERVATION
OF
STATE-LAW 
CLAIMS.—Nothing in this section shall pre-
vent 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
AC-
TION.—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
OFFI-
CIALS.—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 limita-
tions that apply under this paragraph to civil 
actions brought by attorneys general. 
(4) RULEMAKING
AUTHORITY.—The Commis-
sion may promulgate regulations under section 553
of title 5, United States Code, to implement para-
graph (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 de-
scribed in paragraph (2) (or a single report a por-
tion of which relates to each such category) that 
contains the following: 
(A) Information on domestic sales and ad-
vertising and promotional activity by the manu-
facturers 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 Commis-
sion’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 to-
bacco or any substance containing tobacco. 
(2) CIGARETTE.—The term ‘‘cigarette’’ has the 
meaning given such term in section 900 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 
(3) COMMISSION.—The term ‘‘Commission’’ 
means the Federal Trade Commission. 
(4) ELECTRONIC
NICOTINE
DELIVERY
SYS-
TEM.—The term ‘‘electronic nicotine delivery sys-
tem’’ means a tobacco product that is an electronic 
device that delivers nicotine, flavor, or another sub-
stance via an aerosolized solution to the user inhal-
ing from the device (including e-cigarettes, e-hookah, 
e-cigars, vape pens, advanced refillable personal va-
porizers, 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 per-
sonal characteristics of an individual or the name or 
seal of an organization) that consumers are likely to 
believe reflects the opinions, beliefs, findings, or ex-
periences of a party other than the sponsoring ad-
vertiser, 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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 
(7) SMOKELESS TOBACCO.—The term ‘‘smoke-
less tobacco’’ has the meaning given such term in 
section 900 of the Federal Food, Drug, and Cos-
metic 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 COM-
MUNITIES. 
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 medi-
cally 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 ces-
sation of the use of menthol-flavored tobacco 
products, and the cessation of the use of e-ciga-
rettes and electronic nicotine delivery systems;’’; 
(2) in subsection (d)(1)(B), by inserting ‘‘, in-
cluding chronic diseases related to and caused by to-
bacco use’’ after ‘‘diseases’’; and
(3) in subsection (j), by striking ‘‘are author-
ized to be appropriated, such sums as may be nec-
essary to carry out this section for each of fiscal 
years 2010 through 2014’’ and inserting ‘‘is author-
ized to be appropriated, and there is appropriated, 
out of any funds in the Treasury not otherwise ap-
propriated, $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 sec-
tion 317U (42 U.S.C. 247b–23) the following: 
‘‘SEC. 317V. DEMONSTRATION GRANT PROGRAM TO DE-
VELOP 
STRATEGIES 
FOR 
SMOKING 
CES-
SATION IN MEDICALLY UNDERSERVED COM-
MUNITIES. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, 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 popu-
lations in medically underserved communities, par-
ticularly racial and ethnic minority populations; 
‘‘(2) the development of improved communica-
tion and outreach tools to reach populations in medi-
cally 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 refer-
rals to services for tobacco cessation and the ces-
sation of the use of e-cigarettes and electronic nico-
tine delivery systems, including tobacco cessation 
products approved by the Food and Drug Adminis-
tration 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 infor-
mation as the Secretary may require. 
‘‘(c) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated, 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 PREVEN-
TION 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 fol-
lowing new section: 
‘‘SEC. 317W. PUBLIC AWARENESS, EDUCATION, AND PRE-
VENTION CAMPAIGN REGARDING TOBACCO. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention 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 sec-
tion shall— 
‘‘(1) be an evidence-based media and public en-
gagement initiative; 
‘‘(2) be carried out through competitively bid 
contracts;
‘‘(3) include the development of culturally and 
linguistically competent resources that may be tai-
lored for communities with high rates of youth to-
bacco use; 
‘‘(4) be complementary to, and coordinated 
with, any other Federal efforts; and 
‘‘(5) include message testing to identify cul-
turally 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 part-
nerships 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 appro-
priated, $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 to-
bacco 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 strik-
ing ‘‘(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 com-
bustible 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 appro-
priated, $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 PROD-
UCTS. 
(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 re-
strictions 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 viola-
tion, $0, together with the issuance of 
a warning letter to the retailer;
‘‘(II) in the case of a second vio-
lation within a 12-month period, 
$500; 
‘‘(III) in the case of a third viola-
tion 
within 
a 
24-month 
period, 
$1,000; 
‘‘(IV) in the case of a fourth vio-
lation within a 24-month period, 
$4,000; 
‘‘(V) in the case of a fifth viola-
tion 
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 pro-
gram, the amount of the civil penalty shall 
not exceed— 
‘‘(I) in the case of the first viola-
tion, $500;
‘‘(II) in the case of a second vio-
lation within a 12-month period, 
$1,000; 
‘‘(III) in the case of a third viola-
tion 
within 
a 
24-month 
period, 
$2,000; 
‘‘(IV) in the case of a fourth vio-
lation within a 24-month period, 
$4,000; 
‘‘(V) in the case of a fifth viola-
tion 
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 sub-
section (a) applies with respect to a violation of a restric-
tion 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 Pre-
vention 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 ef-
fect 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 to-
bacco 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 re-
sults 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 Rev-
enue 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 im-
posed 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 sub-
section: 
‘‘(q) TAXABLE NICOTINE.— 
‘‘(1) IN GENERAL.—Except as otherwise pro-
vided in this subsection, the term ‘taxable nicotine’ 
means any nicotine which has been extracted, con-
centrated, 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 Cos-
metic Act or licensed under section 351 of 
the Public Health Service Act; or 
‘‘(ii) for which an investigational use 
exemption has been authorized under sec-
tion 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.—Sec-
tion 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 manu-
facturing 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 tax-
able 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 en-
gaged 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 sub-
chapter 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 busi-
ness by reason of such requirements before final ac-
tion 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 fol-
lowing 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 es-
tablishment 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 Inter-
nal Revenue Code of 1986 is amended— 
(1) by striking ‘‘for preventive care’’ and insert-
ing ‘‘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 treat-
ment of any chronic lung disease (and any 
medicine or drug which is delivered 
through such inhaler or nebulizer for treat-
ment 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 ‘‘CER-
TAIN 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 to-
bacco products, and for other purposes.