HR 2339 RFS
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— 
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‘‘(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 
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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-
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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 
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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: 
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‘‘(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: 
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‘‘(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. 
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‘‘(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’’. 
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(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-
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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-
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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. 
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