Mr. CASTEN of Illinois, Ms. SA´NCHEZ, Mr. EVANS, Mr. CASTRO of Texas, 
Mr. SWALWELL of California, Mrs. BEATTY, Ms. SPEIER, Ms. BONAMICI, 
Mr. ESPAILLAT, Mr. SERRANO, Ms. SLOTKIN, Mr. SEAN PATRICK MALO-
NEY of New York, Mr. JEFFRIES, Mrs. MCBATH, Miss RICE of New 
York, Mr. NADLER, Ms. GARCIA of Texas, Mr. CARSON of Indiana, Ms. 
WATERS, Mr. GOMEZ, Ms. HAALAND, Mr. THOMPSON of California, Mr. 
LARSON of Connecticut, Mr. VARGAS, Mr. CICILLINE, Mr. FITZPATRICK, 
Mr. CLAY, Mr. LEVIN of Michigan, Ms. JACKSON LEE, and Mr. PHIL-
LIPS 
FEBRUARY 21, 2020 
Reported with an amendment; committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on April 18, 2019] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to the sale and marketing of tobacco products, 
and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Reversing the Youth To-
bacco Epidemic Act of 2019’’. 
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 synthetic nicotine. 
Sec. 107. Update to youth tobacco prevention public awareness campaigns. 
Sec. 108. Exemption from premarket approval 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. 
TITLE IV—NICOTINE OR VAPING ACCESS PROTECTION AND 
ENFORCEMENT 
Sec. 401. Short title. 
Sec. 402. Increasing civil penalties applicable to certain violations of restrictions 
on sale and distribution of tobacco products. 
Sec. 403. Study and report on e-cigarettes. 
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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 Ciga-
rette 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 Advertise-
ments’’ 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 
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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 Regula-
tions— 
(1) 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; and 
(2) to make such changes as may be necessary 
for consistency with the amendments made by section 
103 of this Act, including by updating all references 
to persons younger than 18 years of age in subpart 
B of part 1140 of title 21, Code of Federal Regula-
tions. 
(b) EFFECTIVE DATE.—The final rule required by sub-
section (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: 
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‘‘(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 before 
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) MINIMUM AGE RESTRICTIONS.— 
(1) IN GENERAL.—Section 906(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is 
amended by striking paragraph (3) and inserting the 
following: 
‘‘(3) MINIMUM AGE RESTRICTIONS.— 
‘‘(A) RESTRICTION.—It shall be unlawful 
for any retailer, manufacturer, distributor, 
third-party marketplace, or any other commer-
cial entity to sell a tobacco product to any per-
son younger than 21 years of age. 
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‘‘(B) AGE VERIFICATION.—To ensure com-
pliance with subparagraph (A), a retailer shall, 
at a minimum, verify by means of a govern-
ment-issued photographic identification the age 
of the individual purchasing the product as pre-
scribed in— 
‘‘(i) subpart B of part 1140 of sub-
chapter K of title 21, Code of Federal Regu-
lations; and 
‘‘(ii) successor regulations, including 
the regulation required by section 102 of the 
Reversing the Youth Tobacco Epidemic Act 
of 2019 and any applicable regulation im-
posing restrictions pursuant to paragraph 
(1). 
‘‘(C) REGULATIONS.—Not later than 180 
days after the date of enactment of the Reversing 
the Youth Tobacco Epidemic Act of 2019, the 
Secretary shall promulgate a final regulation to 
implement and enforce subparagraphs (A) and 
(B). 
‘‘(D) TIMING.—Subparagraphs (A) and (B) 
shall take effect on the date that is 180 days 
after the date of enactment of the Reversing the 
Youth Tobacco Epidemic Act of 2019, regardless 
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of whether the Secretary has promulgated the 
final regulations required by subparagraph 
(C).’’. 
(2) PRESERVATION OF STATE AND LOCAL AU-
THORITY.—Nothing in the amendment made by para-
graph (1) shall be construed to affect the preservation 
of State and local authority pursuant to section 916 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387p). 
(c) 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 Reversing the Youth Tobacco 
Epidemic Act of 2019, a tobacco product 
(including 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-
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stituent (including a smoke constituent) or 
additive, an artificial or natural flavor 
(other than tobacco) that is a characterizing 
flavor of the tobacco product or tobacco 
smoke or an herb or spice, including men-
thol, mint, strawberry, grape, orange, clove, 
cinnamon, pineapple, vanilla, coconut, lico-
rice, cocoa, chocolate, cherry, or coffee. 
‘‘(ii) RULE OF CONSTRUCTION.—Noth-
ing in this subparagraph shall be construed 
to limit the Secretary’s authority to take ac-
tion under this section or other sections of 
this Act applicable to any artificial or nat-
ural flavor, herb, or spice. 
‘‘(iii) APPLICABILITY TO CERTAIN IN-
DIVIDUALS.—Notwithstanding any provi-
sion of this Act, no individual who pur-
chases or possess for consumption a tobacco 
product that is in violation of the prohibi-
tion under this subparagraph shall be sub-
ject to any criminal penalty under this Act 
for such purchase or possession, nor shall it 
be used as a justification to stop, search, or 
conduct any other investigative measure 
against any individual.’’. 
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(B) SAVINGS PROVISION.—Section 907(a)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387g(a)(1)), as in effect on the date of en-
actment of this Act, shall remain in effect until 
the amendments made to such section 907(a)(1) 
by this paragraph take effect. 
(2) FLAVORED ELECTRONIC NICOTINE DELIVERY 
SYSTEM.—Section 910 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387j) is amended by insert-
ing 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 Revers-
ing the Youth Tobacco Epidemic Act of 2019, any fla-
vored electronic nicotine delivery system that is a new 
tobacco product, including any liquid, solution, or 
other component or part or its aerosol, shall not con-
tain an artificial or natural flavor (other than to-
bacco) that is a characterizing flavor, including men-
thol, mint, strawberry, grape, orange, clove, cin-
namon, pineapple, vanilla, coconut, licorice, cocoa, 
chocolate, cherry, or coffee, unless the Secretary has 
issued a marketing order as described in paragraph 
(2). Nothing in this paragraph shall be construed to 
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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 demonstrated 
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 electronic 
nicotine delivery system; and 
‘‘(B) such electronic nicotine delivery sys-
tem is not more harmful to users than an elec-
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tronic nicotine delivery system that does not con-
tain 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), re-
spectively; and 
(B) by inserting after paragraph (7) the fol-
lowing new paragraph: 
‘‘(8) ELECTRONIC
NICOTINE
DELIVERY
SYS-
TEM.—The term ‘electronic nicotine delivery sys-
tem’— 
‘‘(A) means any electronic device that deliv-
ers 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 vapor-
izers, and electronic pipes) and any component, 
liquid, part, or accessory of such a device, wheth-
er or not sold separately; and 
‘‘(B) does not include a product that— 
‘‘(i) is approved by the Food and Drug 
Administration for sale as a tobacco ces-
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sation product or for another therapeutic 
purpose; and 
‘‘(ii) is marketed and sold solely for a 
purpose described in clause (i).’’. 
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 the Re-
versing the Youth Tobacco Epidemic Act of 2019, 
the Secretary shall promulgate a final regulation 
prohibiting the retail sale of all tobacco products 
other than retail sales through a direct, face-to- 
face exchange between a retailer and a consumer. 
‘‘(B) EXCEPTION FOR CERTAIN CIGAR 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 
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enactment of the the Reversing the Youth 
Tobacco Epidemic Act of 2019, the Sec-
retary shall promulgate regulations regard-
ing the sale and distribution of tobacco 
products 
described 
in 
section 
910(a)(2)(A)(iii) that occur through means 
other than a direct, face-to-face exchange be-
tween a retailer and a consumer in order to 
prevent the sale and distribution of tobacco 
products 
described 
in 
section 
910(a)(2)(A)(iii) to individuals who have 
not attained the minimum age established 
by applicable law for the purchase of such 
products, including requirements for age 
verification. 
‘‘(C) RELATION TO OTHER AUTHORITY.— 
Nothing in this paragraph— 
‘‘(i) limits the authority of the Sec-
retary to take additional actions under the 
other paragraphs of this subsection; or 
‘‘(ii) preempts the authority of a State 
or local government to establish restrictions 
on the retail sale of tobacco products that 
are at least as restrictive as the prohibition 
under subparagraph (A).’’. 
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(b) APPLICABILITY.—Section 906(d)(4) of the Federal 
Food, Drug, and Cosmetic Act, as in effect on the day before 
the date of enactment of this Act, shall continue to apply 
until the effective date of the regulations required by section 
906(d)(4) of such Act, as amended by subsection (a). 
SEC. 105. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 
(a) INCREASE IN TOTAL AMOUNT.—Section 919(b)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s(b)(1)) is amended by striking subparagraph (K) and 
inserting the following subparagraphs: 
‘‘(K) For fiscal year 2019, $712,000,000. 
‘‘(L) For fiscal year 2020, $812,000,000. 
‘‘(M) For each subsequent fiscal year, the 
amount that was applicable for the previous 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 end-
ing June 30 preceding the fiscal year.’’. 
(b) APPLICATION OF USER FEES TO ALL CLASSES OF 
TOBACCO PRODUCT.— 
(1) IN GENERAL.—Subparagraph (A) of section 
919(b)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387s(b)(2)) is amended to read as fol-
lows: 
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‘‘(A) IN GENERAL.— 
‘‘(i) FISCAL YEARS 2020 AND 2021.—For 
fiscal years 2020 and 2021, user fees shall 
be assessed and collected under subsection 
(a) only with respect to the classes of to-
bacco products listed in subparagraph 
(B)(i), and the total such user fees with re-
spect to each such class shall be an amount 
that is equal to the applicable percentage of 
each such class for the fiscal year multiplied 
by the amount specified in paragraph (1) 
for the fiscal year. 
‘‘(ii) SUBSEQUENT
FISCAL
YEARS.— 
For fiscal year 2022 and each subsequent 
fiscal year, user fees shall be assessed and 
collected under subsection (a) with respect 
to each class of tobacco products to which 
this chapter applies (including tobacco 
products that the Secretary by regulation 
deems to be subject to this chapter), and the 
total user fees with respect to each such 
class shall be— 
‘‘(I) with respect to each class of 
tobacco products listed in subpara-
graph (B)(i), an amount that is cal-
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culated in the same way as the 
amounts calculated for fiscal years 
2020 and 2021 under clause (i), except 
that for purposes of fiscal years 2022 
and subsequent fiscal years, instead of 
multiplying the applicable percentage 
of each such class by ‘the amount speci-
fied in paragraph (1) for the fiscal 
year’, the applicable percentage shall 
be multiplied by— 
‘‘(aa) the amount specified in 
paragraph (1) for the fiscal year, 
reduced by 
‘‘(bb) the total user fees as-
sessed and collected pursuant to 
subclause (II) for the fiscal year; 
and 
‘‘(II) with respect to each class of 
tobacco products to which this chapter 
applies but which is not listed in sub-
paragraph (B)(i), an amount deter-
mined pursuant to a formula under 
subparagraph (C).’’. 
(2) 
OTHER
TOBACCO
PRODUCTS.—Section 
919(b)(2) of the Federal Food, Drug, and Cosmetic 
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Act (21 U.S.C. 387s(b)(2)), as amended by paragraph 
(1), is further amended by adding at the end the fol-
lowing new subparagraphs: 
‘‘(C) ALLOCATION
FOR
OTHER
TOBACCO 
PRODUCTS.— 
‘‘(i) IN GENERAL.—Beginning with fis-
cal year 2022, the total user fees assessed 
and collected under subsection (a) each fis-
cal year with respect to each class of tobacco 
products not listed in subparagraph (B)(i) 
shall be an amount that is determined pur-
suant to a formula developed by the Sec-
retary by regulation using information re-
quired to be submitted under subparagraph 
(D). 
‘‘(ii) ALLOCATION
FOR
OTHER
TO-
BACCO
PRODUCTS.—For each class of to-
bacco products not listed in subparagraph 
(B)(i), the percentage of fees under the for-
mula under clause (i) for the respective fis-
cal year shall be equal to the percentage of 
the gross domestic sales in the previous cal-
endar year that is attributable to such class 
of tobacco products in such calendar year, 
as determined by the Secretary. 
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‘‘(iii) ALLOCATION
OF
ASSESSMENT 
WITHIN EACH CLASS OF OTHER TOBACCO 
PRODUCTS.—The percentage of the total 
user fee to be paid by each manufacturer or 
importer of tobacco products in a class not 
listed in subparagraph (B)(i) shall be deter-
mined by the Secretary, based on the per-
centage of the gross domestics sales of all 
such classes of tobacco products by all man-
ufacturers and importers in the previous 
calendar year that is attributable to such 
manufacturer or importer. 
‘‘(iv) EFFECT OF FAILURE TO FINAL-
IZE FORMULA ON TIME.—If the Secretary 
for any reason fails to finalize by fiscal 
year 2022 the formula required by this sub-
paragraph for the assessment and collection 
of user fees for classes of tobacco products 
not listed in subparagraph (B)(i)— 
‘‘(I) the Secretary shall continue 
to assess and collect fees under sub-
section (a) with respect to each class of 
tobacco products listed in subpara-
graph (B)(i); and 
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‘‘(II) until the first fiscal year 
commencing after the finalization of 
such formula, the exception described 
in subparagraph (A)(ii)(I) shall not 
apply. 
‘‘(v) REVISIONS BY REGULATION.—Any 
revisions to the formula promulgated pursu-
ant to this subparagraph shall be by regula-
tion. 
‘‘(vi) DEFINITION.—In this subpara-
graph, the term ‘gross domestic sales’ means 
the total value in dollars of the sale or dis-
tribution by manufacturers and importers 
of tobacco products in the United States in 
classes not listed in subparagraph (B)(i), as 
determined based on the aggregation of sales 
data from every manufacturer and importer 
of tobacco products that submits sales data 
to the Secretary. 
‘‘(D) INFORMATION REQUIRED TO BE SUB-
MITTED.—Each manufacturer or importer of 
any tobacco product shall submit to the Sec-
retary the information required under this sub-
paragraph by March 1, 2021, for calendar year 
2020, by April 1, 2021, for the period of Janu-
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pamtmann on DSKBC07HB2PROD with BILLS
ary 1, 2021, through March 30, 2021, and 
monthly thereafter. Such information shall in-
clude— 
‘‘(i) the identification of the manufac-
turer or importer; 
‘‘(ii) the class or classes of tobacco 
products sold by the manufacturer or im-
porter; 
‘‘(iii) the full listing of the finished to-
bacco products in a class not listed in sub-
paragraph (B)(i) sold or distributed by the 
manufacturer or importer in the United 
States; and 
‘‘(iv) the gross domestic sales data for 
each class of finished tobacco products sold 
or distributed by the manufacturer or im-
porter in the United States.’’. 
(3) PROHIBITED ACT.—Section 301(q)(1)(B) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331(q)(1)(B)) 
is 
amended 
by 
inserting 
‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 
(c) ALLOCATION
OF
ASSESSMENT
WITHIN
EACH 
CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s(b)(4)) is amended by striking ‘‘shall be the percentage 
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determined for purposes of allocations under subsections (e) 
through (h) of section 625 of Public Law 108–357’’ and in-
serting ‘‘shall be the percentage determined by the Sec-
retary’’. 
(d) CONFORMING AMENDMENTS.—Section 919(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s(b)) is amended— 
(1) by striking paragraph (5); 
(2) by redesignating paragraphs (6) and (7) as 
paragraphs (5) and (6), respectively; and 
(3) by amending paragraph (6), as redesignated, 
to read as follows: 
‘‘(6) MEMORANDUM
OF
UNDERSTANDING.—The 
Secretary shall request the appropriate Federal agen-
cy to enter into a memorandum of understanding 
that provides for the regular and timely transfer from 
the head of such agency to the Secretary of all nec-
essary information regarding all tobacco product 
manufacturers and importers required to pay user 
fees. The Secretary shall maintain all disclosure re-
strictions established by the head of such agency re-
garding the information provided under the memo-
randum of understanding.’’. 
(e) APPLICABILITY.—The amendments made by sub-
sections (b), (c), and (d) apply beginning with fiscal year 
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2022. Subject to the amendment made by subsection (a), 
section 919 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387s), as in effect on the day before the date 
of enactment of this Act, shall apply with respect to fiscal 
years preceding fiscal year 2022. 
(f) REPORT.—For fiscal year 2020 and each subse-
quent fiscal year for which fees are collected under section 
919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s), the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall, by the 
end of the respective fiscal year, submit to the Congress fi-
nancial and performance reports with respect to such fees. 
SEC. 106. REGULATION OF PRODUCTS CONTAINING SYN-
THETIC 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 enact-
ment of this Act, issue an interim final rule pro-
viding for the regulation of products containing syn-
thetic 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. 
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(b) SYNTHETIC NICOTINE DEFINED.—In this section, 
the term ‘‘synthetic nicotine’’ means nicotine that is not 
made or derived from tobacco. 
SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUB-
LIC AWARENESS CAMPAIGNS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of Food 
and Drugs, shall— 
(1) review all public health awareness campaigns 
of the Department of Health and Human Services de-
signed to educate at-risk individuals about the harm-
ful effects of tobacco use, including the use of e-ciga-
rettes and other electronic nicotine delivery systems; 
and 
(2) as applicable, modify such campaigns to in-
clude awareness and education materials designated 
for individuals who are 18 to 21 years of age. 
(b) CONSULTATION.—In carrying out subsection (a), 
the Secretary of Health and Human Services may consult 
with medical and public health associations and nonprofit 
organizations. 
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SEC. 108. EXEMPTION FROM PREMARKET APPROVAL OF 
CERTAIN TOBACCO PRODUCTS. 
(a) IN GENERAL.—Section 910(a)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2)) is 
amended— 
(1) in subparagraph (A)— 
(A) in clause (i)(II), by striking ‘‘or’’; 
(B) in clause (ii), by striking the period at 
the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(iii) subject to subparagraph (C), for 
the period beginning on the date of the en-
actment of the Reversing the Youth Tobacco 
Epidemic Act of 2019 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; 
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‘‘(VI) has no filter, tip, or non-to-
bacco 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 cal-
endar 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 APPLICABILITY.— 
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‘‘(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 prod-
ucts described in subparagraph (A)(iii) 
has resulted in an emerging public 
health threat; 
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‘‘(II) data from a National Youth 
Tobacco Survey (or successor survey) 
conducted after the date of the enact-
ment of the Reversing the Youth To-
bacco Epidemic Act of 2019 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, Engineering, and 
Medicine under which the National Academies 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(a)(2)), 
as amended by subsection (a), exempt from pre-
market review under such section; 
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(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 conducted under 
such paragraph. 
SEC. 109. PUBLIC EDUCATION. 
Section 906 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387f) is amended by adding at the end the 
following: 
‘‘(g) EDUCATION ON TOBACCO PRODUCTS.— 
‘‘(1) IN
GENERAL.—Not later than 6 months 
after the date of the enactment of the Reversing the 
Youth Tobacco Epidemic Act of 2019, the Secretary of 
Health and Human Services, acting through the Com-
missioner of Food and Drugs, shall provide edu-
cational materials for health care providers, members 
of the public, and law enforcement officials, regard-
ing— 
‘‘(A) the authority of the Food and Drug 
Administration with respect to the regulation of 
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tobacco products (including enforcement of such 
regulation); 
‘‘(B) the processes of the Food and Drug 
Administration for enforcing restrictions on the 
manufacture and sale of tobacco products; 
‘‘(C) the prohibition on characterizing fla-
vors in tobacco products and the under section 
907(a)(1) and the exception from such prohibi-
tion under subparagraph (C) of such section; 
‘‘(D) the public health impact of tobacco 
products with characterizing flavors; and 
‘‘(E) other information as the Secretary de-
termines appropriate. 
‘‘(2) CONTENT.—Educational materials provided 
under paragraph (1) may include— 
‘‘(A) explanations of key statutory and reg-
ulatory terms, including the terms ‘tobacco prod-
uct,’ 
‘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); 
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‘‘(C) information related to enforcement 
tools and processes used by the Food and Drug 
Administration for violations of the prohibition 
specified in section 907(a)(1); 
‘‘(D) an explanation of the health effects of 
using tobacco products, including those with 
characterizing flavors; and 
‘‘(E) information on resources available 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 deter-
mines is appropriate and applicable; and 
‘‘(B) tailored for the unique needs of health 
care providers, members of the public, law en-
forcement officers, and other audiences, as the 
Secretary determines appropriate.’’. 
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 
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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 enact-
ment of this Act, the Secretary shall issue proposed 
regulations. 
(2) Not later than 2 years after the date of enact-
ment 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 mar-
keting, advertising, promotion, or endorsement 
of, any electronic nicotine delivery system with-
out clearly disclosing that the communication is 
an advertisement, unless the communication is 
unambiguously identifiable as an advertisement. 
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(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 un-
fair 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 ap-
plicable 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 para-
graph (1) has occurred or is occurring, the attor-
ney general, in addition to any authority the at-
torney general may have to bring an action in 
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State court under the law of the State, may 
bring a civil action in any court of competent 
jurisdiction to— 
(i) enjoin further such violation by the 
defendant; 
(ii) enforce compliance with such para-
graph; 
(iii) obtain civil penalties in the same 
amount as may be obtained by the Commis-
sion in a civil action under section 5(m) of 
the Federal Trade Commission Act (15 
U.S.C. 45(m)); or 
(iv) obtain damages, restitution, or 
other compensation on behalf of residents of 
the State. 
(B) NOTICE.—Before filing an action under 
subparagraph (A), the attorney general of a 
State shall provide to the Commission a written 
notice of such action and a copy of the complaint 
for such action. If the attorney general deter-
mines 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 
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complaint to the Commission immediately 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 action 
for violation of paragraph (1) (referred to 
in this clause as the ‘‘Federal action’’), no 
attorney general of a State may bring an 
action under subparagraph (A) during the 
pendency of the Federal action against any 
defendant named in the complaint in the 
Federal action for any violation of such 
paragraph alleged in such complaint. 
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(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 vio-
late 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 limitations that 
apply under this paragraph to civil actions 
brought by attorneys general. 
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(4) RULEMAKING AUTHORITY.—The Commission 
may promulgate regulations under section 553 of title 
5, United States Code, to implement paragraph (1). 
(b) REPORT TO CONGRESS ON TOBACCO PRODUCT AD-
VERTISING.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of the enactment of this Act, and annually 
thereafter, the Commission shall submit to Congress a 
report relating to each category of products described 
in paragraph (2) (or a single report a portion of 
which relates to each such category) that contains the 
following: 
(A) Information on domestic sales and 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. 
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(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 SYSTEM.— 
The term ‘‘electronic nicotine delivery system’’— 
(A) means any electronic device that deliv-
ers 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 vapor-
izers, and electronic pipes) and any component, 
liquid, part, or accessory of such a device, wheth-
er or not sold separately; and 
(B) does not include a product that— 
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(i) is approved by the Food and Drug 
Administration for sale as a tobacco ces-
sation product or for another therapeutic 
purpose; and 
(ii) is marketed and sold solely for a 
purpose described in clause (i). 
(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 expe-
riences of a party other than the sponsoring adver-
tiser, 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 ‘‘smokeless 
tobacco’’ has the meaning given such term in section 
900 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387). 
(8) TOBACCO
PRODUCT.—The term ‘‘tobacco 
product’’ has the meaning given such term in section 
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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. 
The Secretary shall ensure that programs at the Cen-
ters for Disease Control and Prevention related to outreach 
to medically underserved communities, including racial 
and ethnic minority populations, include efforts to educate 
and provide guidance regarding effective evidence-based 
strategies— 
(1) to prevent tobacco, e-cigarette, and nicotine 
addiction; and 
(2) for smoking cessation and the cessation of the 
use of e-cigarettes and electronic nicotine delivery sys-
tems. 
SEC. 302. DEMONSTRATION GRANT PROGRAM TO DEVELOP 
STRATEGIES FOR SMOKING CESSATION IN 
MEDICALLY UNDERSERVED COMMUNITIES. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall establish a demonstration program to award grants 
to or contract with State, local, Tribal, or territorial public 
health departments to support— 
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(1) the development of improved evidence-based 
strategies for smoking cessation and the cessation of 
the use of e-cigarettes and electronic nicotine delivery 
systems for populations in medically underserved 
communities, particularly racial and ethnic minority 
populations; 
(2) the development of improved communication 
and outreach tools to reach populations in medically 
underserved communities, particularly racial and eth-
nic minority populations, addicted to tobacco and e- 
cigarette products; and 
(3) improved coordination, access, and referrals 
to services for smoking cessation and the cessation of 
the use of e-cigarettes and electronic nicotine delivery 
systems, including smoking cessation products and 
mental health and counseling services. 
(b) APPLICATION.—To be eligible to receive a grant 
under subsection (a), a State, local, Tribal, or territorial 
public health department shall submit to the Secretary an 
application at such time, in such manner, and containing 
such information as the Secretary may require. 
(c) AUTHORIZATION OF APPROPRIATIONS.—There are 
authorized to be appropriated to carry out this section, 
$3,000,000 for each of fiscal years 2020 through 2024. 
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