[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2339 Introduced in House (IH)]
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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 Representatives 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.
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 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)).
(b) Conforming Change.--Section 4(d) of the Federal 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
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--
(1) to apply the provisions of such part 1140 to all
tobacco products 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.
(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) 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 inserting the following:
``(3) Minimum age restrictions.--
``(A) Restriction.--It shall be unlawful for any
retailer, manufacturer, distributor, third-party
marketplace, or any other commercial entity to sell a
tobacco product to any person younger than 21 years of
age.
``(B) Age verification.--To ensure compliance with
subparagraph (A), a retailer shall, at a minimum,
verify by means of a government-issued photographic
identification the age of the individual purchasing the
product as prescribed in--
``(i) subpart B of part 1140 of subchapter
K of title 21, Code of Federal Regulations; 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 paragraph (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 Reversing the Youth
Tobacco Epidemic Act of 2019, the Secretary shall
promulgate a final regulation 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 Reversing the Youth Tobacco Epidemic
Act of 2019, regardless of whether the Secretary has
promulgated the final regulations required by
subparagraph (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 enactment of the Reversing the
Youth Tobacco Epidemic Act of 2019, the Secretary shall
promulgate a final regulation under paragraph (1) prohibiting
the retail sale of all tobacco products, including electronic
nicotine delivery systems and electronic nicotine 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 Products.--
(1) Prohibition.--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 rule.--Beginning on the date that is
1 year after the date of enactment of the Reversing the
Youth Tobacco Epidemic Act of 2019, except as provided
in subparagraph (C), a tobacco product or any of its
component parts or accessories (including the tobacco,
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, strawberry, grape, orange, clove, cinnamon,
pineapple, vanilla, coconut, licorice, cocoa,
chocolate, cherry, or coffee. 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.''.
(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.--Notwithstanding subparagraph (A), an
electronic nicotine delivery system product or any
component or part of such a product may contain, as a
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 Commissioner 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
likelihood 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 enactment of this Act, shall remain in
effect until the amendments made to such section 907(a)(1) by
this subsection take effect.
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 assessed 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 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.''.
(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
determined for purposes of allocations under subsections (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 paragraph (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
preceding fiscal year 2022.
SEC. 105. REGULATION OF PRODUCTS CONTAINING SYNTHETIC 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 synthetic 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) Synthetic Nicotine Defined.--In this section, 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 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 any roll of tobacco
wrapped in leaf tobacco or in any substance containing tobacco
(other than any roll of tobacco which is a cigarette within the
meaning of paragraph (2)).
(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.--
(A) In general.--The term ``electronic nicotine
delivery system'' means--
(i) an electronic device that--
(I) converts a mixture containing
nicotine or other substances into an
aerosol to be inhaled by the user; and
(II) is a tobacco product; or
(ii) a mixture that--
(I) contains nicotine or other
substances that can be aerosolized and
inhaled by the user; and
(II) is a tobacco product.
(B) Exclusion.--The term ``electronic nicotine
delivery system'' does not include any product that--
(i) has been approved or otherwise
authorized by the Food and Drug Administration
for the purpose of sale as a tobacco cessation
product or for other therapeutic purposes; and
(ii) is marketed and sold solely for such
purpose or purposes.
(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).
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