[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2339 Referred in Senate (RFS)]
<DOC>
116th CONGRESS
2d Session
H. R. 2339
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 2, 2020
Received; read twice and referred to the Committee on Finance
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
sale and marketing of tobacco products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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
cessation in medically underserved
communities.
Sec. 303. Public awareness, education, and prevention campaign.
Sec. 304. Tobacco cessation treatment grants to health centers.
Sec. 305. Grants for research.
TITLE IV--NICOTINE OR VAPING ACCESS PROTECTION AND ENFORCEMENT
Sec. 401. Increasing civil penalties applicable to certain violations
of restrictions on sale and distribution of
tobacco products.
Sec. 402. Study and report on e-cigarettes.
TITLE V--EXCISE TAX ON NICOTINE USED IN VAPING, ETC.
Sec. 501. Imposition of tax on nicotine for use in vaping, etc.
TITLE VI--FURTHER HEALTH INVESTMENTS
Sec. 601. Waiving Medicare coinsurance for colorectal cancer screening
tests.
Sec. 602. Safe harbor for high deductible health plans without
deductible for certain inhalers.
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 construed 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 regulation 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 Products.--
(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 enactment of
the Protecting American Lungs and Reversing the
Youth Tobacco Epidemic Act of 2020, a tobacco
product (including its components, parts, and
accessories, including the tobacco, filter, or
paper) that is not an electronic nicotine
delivery system 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,
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 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.
``(iii) Applicability to certain
individuals.--Notwithstanding any provision of
this Act, no individual who purchases for
individual consumption, possesses for
individual consumption, or consumes, a tobacco
product that is in violation of the prohibition
under this subparagraph, including a tobacco
product that contains a characterizing flavor
of menthol, shall be subject to any criminal
penalty under this Act for such purchase,
possession, or consumption, nor shall such
purchase, possession, or consumption be used as
a justification to stop, search, or conduct any
other investigative measure against any
individual.''.
(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 enactment of
this Act, shall remain in effect until the amendment
made to such section 907(a)(1) by this paragraph takes
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 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
tobacco product, including any solution or other component 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 Secretary 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 system, including any liquid,
solution, or other component or part or its aerosol, that
contains an artificial or natural flavor (other than tobacco)
that is a characterizing 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
likelihood 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 system is
not more harmful to users than an electronic nicotine
delivery system that does not contain any
characterizing flavors.''.
(3) Definition of electronic nicotine delivery system.--
Section 900 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387) is amended--
(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 system.--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 enforcement 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 Protecting American Lungs
and Reversing the Youth Tobacco Epidemic Act of 2020,
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 tobacco
products.--
``(i) Exception.--The regulation required
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 described 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 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 Secretary
to take additional actions under other
provisions of this Act; or
``(ii) preempts the authority of a State or
local government to establish restrictions 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 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 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 fiscal 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 effect on the day before the date of enactment of
this Act.
(2) Subsequent fiscal years.--The amendments made by
subsections (c) through (f) apply beginning with fiscal year
2022.
(c) Allocations of Assessment by Class of Tobacco 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 assessed 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
percentage 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 percentage for
a fiscal year for each class of tobacco product
shall be the percentage determined by
dividing--
``(I) the product of the gross
domestic 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
determined 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
section 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 removal
under that chapter or the Harmonized
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 percentage
determined for purposes of allocations under subsections (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 redesignated, to read as
follows:
``(6) Memorandum of understanding; reporting.--
``(A) Transfer of information.--The Secretary shall
request the appropriate Federal agency 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 necessary information
regarding all tobacco product manufacturers and
importers required to pay user fees. The Secretary
shall maintain all disclosure restrictions established
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 manufacturers and
importers of each class of tobacco products to
which this chapter applies 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 financial 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 ALTERNATIVE 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 enactment of
this Act, issue an interim final rule providing for the
regulation of products containing alternative 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 enactment,
issue a final rule providing for such regulation.
(b) Alternative Nicotine.--In this section, the term ``alternative
nicotine'' means nicotine that is not made or derived from tobacco
plants and may include nicotine that is chemically synthesized,
synthesized from recombinant genetic technology, or extracted from non-
tobacco plants.
SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUBLIC AWARENESS
CAMPAIGNS.
(a) In General.--The Secretary of Health and Human Services shall--
(1) review all public health awareness campaigns 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 include
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 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
enactment of the Protecting American Lungs and
Reversing the Youth Tobacco Epidemic Act of
2020 and ending on September 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
characterizing 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
Consumer 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.--
``(i) In general.--The Secretary shall,
notwithstanding subparagraph (A)(iii) or any
determination of substantial equivalence, if
any of the conditions specified in clause (ii)
are met--
``(I) withdraw any exemption
applicable to a tobacco product or
products described in such
subparagraph;
``(II) require that applications
for review under this section be
submitted with respect to such product
or products; 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
enactment of the Protecting American
Lungs and Reversing the Youth Tobacco
Epidemic Act of 2020 identifies a rise
in youth usage of tobacco products
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 tobacco
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 products; 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.--Beginning not later than 6 months after
the date of the enactment of the Protecting 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 consultation 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 products;
``(C) the general enforcement actions the Food and
Drug Administration may take to implement the
prohibition on characterizing flavors 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 provided under
paragraph (1) may include--
``(A) explanations of key statutory and regulatory
terms, including the terms `tobacco product',
`component parts', `accessories', `constituent',
`additive', `tobacco product manufacturer', and
`characterizing flavor';
``(B) an explanation of the Food and Drug
Administration's jurisdiction to regulate tobacco
products, including tobacco products with
characterizing flavors under section 907(a)(1);
``(C) general educational 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) 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 related 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 determines
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 available to
carry out this chapter.''.
SEC. 110. REGULATIONS FOR RECORDKEEPING CONCERNING TRACKING AND
TRACING.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall promulgate 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 enactment of
this Act, the Secretary shall issue proposed regulations.
(2) Not later than 2 years after the date of enactment 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 Delivery 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 endorse, or
to compensate any person for the marketing,
advertising, promotion, or endorsement of, any
electronic nicotine delivery system without clearly
disclosing that the communication is an advertisement,
unless the communication is unambiguously identifiable
as an advertisement.
(2) Enforcement by commission.--
(A) Unfair or deceptive acts or practices.--A
violation of paragraph (1) shall be treated as a
violation of a regulation under section 18(a)(1)(B) of
the Federal Trade Commission Act (15 U.S.C.
57a(a)(1)(B)) regarding unfair or deceptive acts or
practices.
(B) Powers of commission.--The Commission 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 general.--
(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 action in 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
paragraph;
(iii) obtain civil penalties in the same
amount as may be obtained by the Commission 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 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 immediately upon the
filing of the action.
(C) Authority of federal trade commission.--
(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.
(D) Relationship with state-law claims.--
(i) Preservation of state-law claims.--
Nothing in this section shall prevent 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 action.--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 officials.--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.
(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 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 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 advertising
and promotional activity by the manufacturers 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 Commission'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 tobacco or
any substance containing tobacco.
(2) Cigarette.--The term ``cigarette'' has the meaning
given such term in section 900 of the Federal 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'' 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.
(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 personal characteristics of an individual
or the name or seal of an organization) that consumers are
likely to believe reflects the opinions, beliefs, findings, or
experiences of a party other than the sponsoring advertiser,
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 Federal 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 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 COMMUNITIES.
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 medically
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 cessation of
the use of menthol-flavored tobacco products, and the
cessation of the use of e-cigarettes and electronic
nicotine delivery systems;'';
(2) in subsection (d)(1)(B), by inserting ``, including
chronic diseases related to and caused by tobacco use'' after
``diseases''; and
(3) in subsection (j), by striking ``are authorized to be
appropriated, such sums as may be necessary to carry out this
section for each of fiscal years 2010 through 2014'' and
inserting ``is authorized to be appropriated, and there is
appropriated, out of any funds in the Treasury not otherwise
appropriated, $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 section 317U (42 U.S.C. 247b-23)
the following:
``SEC. 317V. 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, 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
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 ethnic minority
populations, addicted to tobacco products, including e-
cigarettes and menthol-flavored tobacco products; and
``(3) improved coordination, access, and referrals to
services for tobacco cessation and the cessation of the use of
e-cigarettes and electronic nicotine delivery systems,
including tobacco cessation products approved by the Food and
Drug Administration 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 information as the Secretary may require.
``(c) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated, 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 PREVENTION 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 following new section:
``SEC. 317W. PUBLIC AWARENESS, EDUCATION, AND PREVENTION CAMPAIGN
REGARDING TOBACCO.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention 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 section shall--
``(1) be an evidence-based media and public engagement
initiative;
``(2) be carried out through competitively bid contracts;
``(3) include the development of culturally and
linguistically competent resources that may be tailored for
communities with high rates of youth tobacco use;
``(4) be complementary to, and coordinated with, any other
Federal efforts; and
``(5) include message testing to identify culturally 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 partnerships 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 appropriated, $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 tobacco 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 striking
``(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 combustible
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 appropriated, $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
PRODUCTS.
(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 restrictions
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
violation, $0, together with the
issuance of a warning letter to the
retailer;
``(II) in the case of a second
violation within a 12-month period,
$500;
``(III) in the case of a third
violation within a 24-month period,
$1,000;
``(IV) in the case of a fourth
violation within a 24-month period,
$4,000;
``(V) in the case of a fifth
violation 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 program, the
amount of the civil penalty shall not exceed--
``(I) in the case of the first
violation, $500;
``(II) in the case of a second
violation within a 12-month period,
$1,000;
``(III) in the case of a third
violation within a 24-month period,
$2,000;
``(IV) in the case of a fourth
violation within a 24-month period,
$4,000;
``(V) in the case of a fifth
violation 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 subsection (a) applies
with respect to a violation of a restriction 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
Prevention 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
effect 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 tobacco
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 results 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 Revenue 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 imposed 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 subsection:
``(q) Taxable Nicotine.--
``(1) In general.--Except as otherwise provided in this
subsection, the term `taxable nicotine' means any nicotine
which has been extracted, concentrated, 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 Cosmetic Act or
licensed under section 351 of the Public Health
Service Act; or
``(ii) for which an investigational use
exemption has been authorized under section
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.--Section 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 manufacturing 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 taxable
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 engaged 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 subchapter 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 business by reason of
such requirements before final action 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 following
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 establishment 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 Internal Revenue Code
of 1986 is amended--
(1) by striking ``for preventive care'' and inserting ``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 treatment
of any chronic lung disease (and any medicine
or drug which is delivered through such inhaler
or nebulizer for treatment 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 ``certain 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:
CHERYL L. JOHNSON,
Clerk.
Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020
#2339 | HR Congress #116
Policy Area: Health
Subjects: Administrative law and regulatory proceduresCancerCardiovascular and respiratory healthChild healthCivil actions and liabilityCongressional oversightConsumer affairsDepartment of Health and Human ServicesDigestive and metabolic diseasesDrug safety, medical device, and laboratory regulationDrug, alcohol, tobacco useFood and Drug Administration (FDA)Government information and archivesGovernment studies and investigationsHealth care costs and insuranceHealth care coverage and accessHealth facilities and institutionsHealth information and medical recordsHealth programs administration and funding
Last Action: Received in the Senate and Read twice and referred to the Committee on Finance. (3/2/2020)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text