I 
116TH CONGRESS 
1ST SESSION H. R. 2339 
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
sale and marketing of tobacco products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 18, 2019 
Mr. PALLONE (for himself and Ms. SHALALA) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
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. 
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 
Tobacco 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. 
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Sec. 102. Advertising and sales parity for all deemed tobacco products. 
Sec. 103. Reducing child and adolescent nicotine addiction. 
Sec. 104. Fees applicable to all tobacco products. 
Sec. 105. Regulation of products containing synthetic nicotine. 
TITLE II—FEDERAL TRADE COMMISSION 
Sec. 201. Advertising of tobacco products. 
TITLE I—FOOD AND DRUG 
ADMINISTRATION 
SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS. 
(a) ISSUANCE
DEADLINES.—Not later than 12 
months after the date of enactment of this Act, the Sec-
retary 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 La-
beling and Advertising Act (15 U.S.C. 1333(d)). 
(b) CONFORMING CHANGE.—Section 4(d) of the Fed-
eral Cigarette Labeling and Advertising Act (15 U.S.C. 
1333(d)) is amended by striking ‘‘Not later than 24 
months after the date of enactment of the Family Smok-
ing 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 
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part 1140 of subchapter K of title 21, Code of Federal 
Regulations— 
(1) to apply the provisions of such part 1140 to 
all tobacco products to which chapter IX of the Fed-
eral 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 sec-
tion 103 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 
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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) MINIMUM AGE RESTRICTIONS.—Section 906(d) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387f(d)) is amended by striking paragraph (3) and insert-
ing 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. 
‘‘(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— 
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‘‘(i) subpart B of part 1140 of sub-
chapter K of title 21, Code of Federal Reg-
ulations; 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 
imposing restrictions pursuant to para-
graph (1). 
‘‘(C) 
NON-PREEMPTION.—Subparagraphs 
(A) and (B) shall not be construed to limit the 
authority of a State or political subdivision of 
a State, or the government of an Indian tribe, 
as such authority is described in section 916. 
‘‘(D) REGULATIONS.—Not later than 180 
days after the date of enactment of the Revers-
ing the Youth Tobacco Epidemic Act of 2019, 
the Secretary shall promulgate a final regula-
tion to implement and enforce subparagraphs 
(A) and (B). 
‘‘(E) TIMING.—Subparagraphs (A) and 
(B) shall take effect on the date that is 180 
days after the date of enactment of the Revers-
ing the Youth Tobacco Epidemic Act of 2019, 
regardless of whether the Secretary has promul-
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gated the final regulations required by subpara-
graph (D).’’. 
(c) 
PROHIBITION
AGAINST
REMOTE
RETAIL 
SALES.—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.—Not later than 2 years after the date of en-
actment of the Reversing the Youth Tobacco Epi-
demic Act of 2019, the Secretary shall promulgate 
a final regulation under paragraph (1) prohibiting 
the retail sale of all tobacco products, including elec-
tronic nicotine delivery systems and electronic nico-
tine delivery system accessories, other than retail 
sales through a direct, face-to-face exchange between 
a retailer and a consumer.’’. 
(d) PROHIBITING FLAVORING OF TOBACCO PROD-
UCTS.— 
(1) PROHIBITION.—Subparagraph (A) of sec-
tion 907(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387g(a)(1)) is amended to 
read as follows: 
‘‘(A) SPECIAL
RULE.—Beginning on the 
date that is 1 year after the date of enactment 
of the Reversing the Youth Tobacco Epidemic 
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Act of 2019, except as provided in subpara-
graph (C), a tobacco product or any of its com-
ponent parts or accessories (including the to-
bacco, filter, or paper) shall not contain, as a 
constituent (including a smoke constituent) or 
additive, an artificial or natural flavor (other 
than tobacco) that is a characterizing flavor of 
the tobacco product or tobacco smoke or an 
herb or spice, including menthol, mint, straw-
berry, grape, orange, clove, cinnamon, pine-
apple, vanilla, coconut, licorice, cocoa, chocolate, 
cherry, or coffee. Nothing in this subparagraph 
shall be construed to limit the Secretary’s au-
thority to take action under this section or 
other sections of this Act applicable to any arti-
ficial or natural flavor, herb, or spice.’’. 
(2) EXCEPTION.—Paragraph (1) of section 
907(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387g(a)) is amended by adding at the 
end the following new subparagraph: 
‘‘(C) EXCEPTION
FOR
CHARACTERIZING 
FLAVORS
TO
DECREASE
SMOKING.—Notwith-
standing subparagraph (A), an electronic nico-
tine delivery system product or any component 
or part of such a product may contain, as a 
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constituent (including a smoke constituent) or 
additive, an artificial or natural flavor or an 
herb or spice, that is a characterizing flavor of 
the tobacco product or tobacco smoke so long as 
the Secretary, in coordination with the Commis-
sioner of Food and Drugs, determines that such 
characterizing flavor will be appropriate for the 
protection of public health because it— 
‘‘(i) will significantly increase the like-
lihood of smoking cessation among current 
users of tobacco products; 
‘‘(ii) will not increase the likelihood 
that individuals who do not use tobacco 
products, including youth, will start using 
such products; and 
‘‘(iii) will not increase the likelihood of 
harm to the person using the product.’’. 
(3) 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 enact-
ment of this Act, shall remain in effect until the 
amendments made to such section 907(a)(1) by this 
subsection take effect. 
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SEC. 104. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 
(a) 
INCREASE
IN
TOTAL
AMOUNT.—Section 
919(b)(1)(K) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387s(b)(1)(K)) is amended by striking 
‘‘$712,000,000’’ and inserting ‘‘$812,000,000’’. 
(b) APPLICATION OF USER FEES TO ALL CLASSES 
OF
TOBACCO
PRODUCTS.—Paragraph (2) of section 
919(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387s(b)(2)) is amended to read as follows: 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS 
OF TOBACCO PRODUCTS.—The total user fees as-
sessed and collected under subsection (a) each fiscal 
year with respect to each class of tobacco products 
shall be an amount that is determined pursuant to 
a formula developed by the Secretary. Such formula 
shall ensure that the amount of fees collected is in-
creased by the total percentage change that occurred 
in the Consumer Price Index for all urban con-
sumers (all items; United States city average) for 
the 12-month period ending June 30 preceding the 
fiscal year.’’. 
(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 percent-
age determined for purposes of allocations under sub-
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sections (e) through (h) of section 625 of Public Law 108– 
357’’ and inserting ‘‘shall be the percentage determined 
by the Secretary’’. 
(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 paragraphs (5) and (7); and 
(2) by redesignating paragraph (6) as para-
graph (5). 
(e) APPLICABILITY.—The amendments made by this 
section apply beginning with fiscal year 2022. 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 pre-
ceding fiscal year 2022. 
SEC. 105. 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 en-
actment 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 
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(2) not later than 2 years after such date of en-
actment, issue a final rule providing for such regula-
tion. 
(b) SYNTHETIC NICOTINE DEFINED.—In this sec-
tion, the term ‘‘synthetic nicotine’’ means nicotine that is 
not made or derived from tobacco. 
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.— 
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(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, 
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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. 
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(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.— 
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(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 
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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. 
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