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(Original Signature of Member)
H. R. ll
116TH CONGRESS
1ST SESSION
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
sale and marketing of tobacco products, and for other purposes.
Mr. PALLONE introduced the following bill; which was referred to the
Committee on llllllllllllll
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to the sale and marketing of tobacco products,
and for other purposes.
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TITLE I—FOOD AND DRUG ADMINISTRATION
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1 Food and Drugs, shall promulgate a final rule amending
2 part 1140 of subchapter K of title 21, Code of Federal
3 Regulations—
4 (1) to apply the provisions of such part 1140 to
5 all tobacco products to which chapter IX of the Fed-
6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387a
7 et seq.) applies pursuant to section 901(b) of such
8 Act (21 U.S.C. 387a(b)), as amended by section
9 103(a) of this Act; and
10 (2) to make such changes as may be necessary
11 for consistency with the amendments made by sec-
12 tion 103 of this Act.
13 (b) EFFECTIVE DATE.—The final rule required by
14 subsection (a) shall take effect on the date that is 2 years
15 after the date of enactment of this Act.
16 SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE
17 ADDICTION.
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1 strued to limit the applicability of chapter IX of the
2 Federal Food, Drug, and Cosmetic Act (21 U.S.C.
3 387a et seq.) to—
4 (A) products that were listed in section
5 901(b) of such Act as in effect on the day be-
6 fore the date of enactment of this Act; and
7 (B) products that were deemed by regula-
8 tion to be subject to such chapter pursuant to
9 section 901(b) of such Act as in effect on the
10 day before the date of enactment of this Act.
11 (b) MINIMUM AGE RESTRICTIONS.—Section 906(d)
12 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
13 387f(d)) is amended by striking paragraph (3) and insert-
14 ing the following:
15 ‘‘(3) MINIMUM AGE RESTRICTIONS.—
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1 of the individual purchasing the product as pre-
2 scribed in—
3 ‘‘(i) subpart B of part 1140 of sub-
4 chapter K of title 21, Code of Federal Reg-
5 ulations; and
6 ‘‘(ii) successor regulations, including
7 the regulation required by section 102 of
8 the Reversing the Youth Tobacco Epidemic
9 Act of 2019 and any applicable regulation
10 imposing restrictions pursuant to para-
11 graph (1).
12 ‘‘(C) NON-PREEMPTION.—Subparagraphs
13 (A) and (B) shall not be construed to limit the
14 authority of a State or political subdivision of
15 a State, or the government of an Indian tribe,
16 as such authority is described in section 916.
17 ‘‘(D) REGULATIONS.—Not later than 180
18 days after the date of enactment of the Revers-
19 ing the Youth Tobacco Epidemic Act of 2019,
20 the Secretary shall promulgate a final regula-
21 tion to implement and enforce subparagraphs
22 (A) and (B).
23 ‘‘(E) TIMING.—Subparagraphs (A) and
24 (B) shall take effect on the date that is 180
25 days after the date of enactment of the Revers-
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1 ing the Youth Tobacco Epidemic Act of 2019,
2 regardless of whether the Secretary has promul-
3 gated the final regulations required by subpara-
4 graph (D).’’.
5 (c) PROHIBITION AGAINST REMOTE RETAIL
6 SALES.—Paragraph (4) of section 906(d) of the Federal
7 Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is
8 amended to read as follows:
9 ‘‘(4) PROHIBITION AGAINST REMOTE RETAIL
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1 ‘‘(A) SPECIAL RULE.—Beginning on the
2 date that is 1 year after the date of enactment
3 of the Reversing the Youth Tobacco Epidemic
4 Act of 2019, except as provided in subpara-
5 graph (C), a tobacco product or any of its com-
6 ponent parts or accessories (including the to-
7 bacco, filter, or paper) shall not contain, as a
8 constituent (including a smoke constituent) or
9 additive, an artificial or natural flavor (other
10 than tobacco) that is a characterizing flavor of
11 the tobacco product or tobacco smoke or an
12 herb or spice, including menthol, mint, straw-
13 berry, grape, orange, clove, cinnamon, pine-
14 apple, vanilla, coconut, licorice, cocoa, chocolate,
15 cherry, or coffee. Nothing in this subparagraph
16 shall be construed to limit the Secretary’s au-
17 thority to take action under this section or
18 other sections of this Act applicable to any arti-
19 ficial or natural flavor, herb, or spice.’’.
20 (2) EXCEPTION.—Paragraph (1) of section
21 907(a) of the Federal Food, Drug, and Cosmetic Act
22 (21 U.S.C. 387g(a)) is amended by adding at the
23 end the following new subparagraph:
24 ‘‘(C) EXCEPTION FOR CHARACTERIZING
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1 standing subparagraph (A), an electronic nico-
2 tine delivery system product or any component
3 or part of such a product may contain, as a
4 constituent (including a smoke constituent) or
5 additive, an artificial or natural flavor or an
6 herb or spice, that is a characterizing flavor of
7 the tobacco product or tobacco smoke so long as
8 the Secretary, in coordination with the Commis-
9 sioner of Food and Drugs, determines that such
10 characterizing flavor will be appropriate for the
11 protection of public health because it—
12 ‘‘(i) will significantly increase the like-
13 lihood of smoking cessation among current
14 users of tobacco products;
15 ‘‘(ii) will not increase the likelihood
16 that individuals who do not use tobacco
17 products, including youth, will start using
18 such products; and
19 ‘‘(iii) will not increase the likelihood of
20 harm to the person using the product.’’.
21 (3) SAVINGS PROVISION.—Section 907(a)(1) of
22 the Federal Food, Drug, and Cosmetic Act (21
23 U.S.C. 387g(a)(1)), as in effect on the date of enact-
24 ment of this Act, shall remain in effect until the
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1 amendments made to such section 907(a)(1) by this
2 subsection take effect.
3 SEC. 104. FEES APPLICABLE TO ALL TOBACCO PRODUCTS.
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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C.
2 387s(b)(4)) is amended by striking ‘‘shall be the percent-
3 age determined for purposes of allocations under sub-
4 sections (e) through (h) of section 625 of Public Law 108–
5 357’’ and inserting ‘‘shall be the percentage determined
6 by the Secretary’’.
7 (d) CONFORMING AMENDMENTS.—Section 919(b) of
8 the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
9 387s(b)) is amended—
10 (1) by striking paragraphs (5) and (7); and
11 (2) by redesignating paragraph (6) as para-
12 graph (5).
13 (e) APPLICABILITY.—The amendments made by this
14 section apply beginning with fiscal year 2022. Section 919
15 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
16 387s), as in effect on the day before the date of enactment
17 of this Act, shall apply with respect to fiscal years pre-
18 ceding fiscal year 2022.
19 SEC. 105. REGULATION OF PRODUCTS CONTAINING SYN-
20 THETIC NICOTINE.
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1 viding for the regulation of products containing syn-
2 thetic nicotine under the Federal Food, Drug, and
3 Cosmetic Act (21 U.S.C. 301 et seq.); and
4 (2) not later than 2 years after such date of en-
5 actment, issue a final rule providing for such regula-
6 tion.
7 (b) SYNTHETIC NICOTINE DEFINED.—In this sec-
8 tion, the term ‘‘synthetic nicotine’’ means nicotine that is
9 not made or derived from tobacco.
10 TITLE II—FEDERAL TRADE
11 COMMISSION
12 SEC. 201. ADVERTISING OF TOBACCO PRODUCTS.
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1 tion is unambiguously identifiable as an adver-
2 tisement.
3 (2) ENFORCEMENT BY COMMISSION.—
22 ERAL.—
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1 attorney general, in addition to any authority
2 the attorney general may have to bring an ac-
3 tion in State court under the law of the State,
4 may bring a civil action in any court of com-
5 petent jurisdiction to—
6 (i) enjoin further such violation by the
7 defendant;
8 (ii) enforce compliance with such
9 paragraph;
10 (iii) obtain civil penalties in the same
11 amount as may be obtained by the Com-
12 mission in a civil action under section 5(m)
13 of the Federal Trade Commission Act (15
14 U.S.C. 45(m)); or
15 (iv) obtain damages, restitution, or
16 other compensation on behalf of residents
17 of the State.
18 (B) NOTICE.—Before filing an action
19 under subparagraph (A), the attorney general
20 of a State shall provide to the Commission a
21 written notice of such action and a copy of the
22 complaint for such action. If the attorney gen-
23 eral determines that it is not feasible to provide
24 the notice described in this subparagraph before
25 the filing of the action, the attorney general
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1 shall provide written notice of the action and a
2 copy of the complaint to the Commission imme-
3 diately upon the filing of the action.
4 (C) AUTHORITY OF FEDERAL TRADE COM-
5 MISSION.—
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1 tion of such paragraph alleged in such
2 complaint.
3 (D) RELATIONSHIP WITH STATE-LAW
4 CLAIMS.—
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1 tions that apply under this paragraph to civil
2 actions brought by attorneys general.
3 (4) RULEMAKING AUTHORITY.—The Commis-
4 sion may promulgate regulations under section 553
5 of title 5, United States Code, to implement para-
6 graph (1).
7 (b) REPORT TO CONGRESS ON TOBACCO PRODUCT
8 ADVERTISING.—
9 (1) IN GENERAL.—Not later than 2 years after
10 the date of the enactment of this Act, and annually
11 thereafter, the Commission shall submit to Congress
12 a report relating to each category of products de-
13 scribed in paragraph (2) (or a single report a por-
14 tion of which relates to each such category) that
15 contains the following:
16 (A) Information on domestic sales and ad-
17 vertising and promotional activity by the manu-
18 facturers that have the largest market shares of
19 the product category.
20 (B) Such recommendations for legislation
21 as the Commission may consider appropriate.
22 (2) PRODUCT CATEGORIES DESCRIBED.—The
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1 (B) Cigars.
2 (C) Smokeless tobacco.
3 (D) Electronic nicotine delivery systems.
4 (c) PRESERVATION OF AUTHORITY.—Nothing in this
5 section may be construed in any way to limit the Commis-
6 sion’s authority under any other provision of law.
7 (d) DEFINITIONS.—In this section:
8 (1) CIGAR.—The term ‘‘cigar’’ means any roll
9 of tobacco wrapped in leaf tobacco or in any sub-
10 stance containing tobacco (other than any roll of to-
11 bacco which is a cigarette within the meaning of
12 paragraph (2)).
13 (2) CIGARETTE.—The term ‘‘cigarette’’ has the
14 meaning given such term in section 900 of the Fed-
15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387).
16 (3) COMMISSION.—The term ‘‘Commission’’
17 means the Federal Trade Commission.
18 (4) ELECTRONIC NICOTINE DELIVERY SYS-
19 TEM.—
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1 (II) is a tobacco product; or
2 (ii) a mixture that—
3 (I) contains nicotine or other
4 substances that can be aerosolized
5 and inhaled by the user; and
6 (II) is a tobacco product.
7 (B) EXCLUSION.—The term ‘‘electronic
8 nicotine delivery system’’ does not include any
9 product that—
10 (i) has been approved or otherwise au-
11 thorized by the Food and Drug Adminis-
12 tration for the purpose of sale as a tobacco
13 cessation product or for other therapeutic
14 purposes; and
15 (ii) is marketed and sold solely for
16 such purpose or purposes.
17 (5) ENDORSE.—The term ‘‘endorse’’ means to
18 communicate an advertising message (including a
19 verbal statement, demonstration, or depiction of the
20 name, signature, likeness, or other identifying per-
21 sonal characteristics of an individual or the name or
22 seal of an organization) that consumers are likely to
23 believe reflects the opinions, beliefs, findings, or ex-
24 periences of a party other than the sponsoring ad-
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1 vertiser, even if the views expressed by such party
2 are identical to those of the sponsoring advertiser.
3 (6) NICOTINE.—The term ‘‘nicotine’’ has the
4 meaning given such term in section 900 of the Fed-
5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387).
6 (7) SMOKELESS TOBACCO.—The term ‘‘smoke-
7 less tobacco’’ has the meaning given such term in
8 section 900 of the Federal Food, Drug, and Cos-
9 metic Act (21 U.S.C. 387).
10 (8) TOBACCO PRODUCT.—The term ‘‘tobacco
11 product’’ has the meaning given such term in section
12 201 of the Federal Food, Drug, and Cosmetic Act
13 (21 U.S.C. 321).
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