I 

115TH CONGRESS 

1ST SESSION H. R. 1136 

To amend the Federal Food, Drug, and Cosmetic Act to provide for a 

certain effective date with respect to deemed tobacco products, to provide 

for the establishment of product standards for vapor product batteries, 

to provide for regulation of vapor products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 16, 2017 

Mr. COLE (for himself and Mr. BISHOP of Georgia) 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 to 

provide for a certain effective date with respect to 

deemed tobacco products, to provide for the establishment of product standards for vapor product batteries, 

to provide for regulation of vapor products, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Deeming Author5 ity Clarification Act of 2017’’. 


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1 SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, 

2 AND COSMETIC ACT TO DEEMED TOBACCO 

3 PRODUCTS. 

4 Section 901(b) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 387a(b)) is amended— 

6 (1) by striking ‘‘This chapter shall apply’’ and 

7 inserting the following: 

8 ‘‘(1) IN GENERAL.—This chapter shall apply’’; 

9 and 

10 (2) by adding at the end the following new 

11 paragraph: 

12 ‘‘(2) DEEMED TOBACCO PRODUCTS.—For each 

13 tobacco product deemed subject to the requirements 

14 of this chapter pursuant to paragraph (1), each ref15 erence in sections 905(j) and 910(a)— 

16 ‘‘(A) to ‘February 15, 2007’, shall be con17 sidered to be a reference to ‘the effective date 

18 of the regulation under which a tobacco product 

19 is deemed subject to the requirements of this 

20 chapter pursuant to section 901(b)’; and 

21 ‘‘(B) to ‘21 months after the date of enact22 ment of the Family Smoking Prevention and 

23 Tobacco Control Act’, shall be considered to be 

24 a reference to the later of— 


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1 ‘‘(i) ‘21 months after the date of en2 actment of the FDA Deeming Authority 

3 Clarification Act of 2017’; and 

4 ‘‘(ii) ‘21 months after the effective 

5 date of such deeming regulation’.’’. 

6 SEC. 3. PRODUCT STANDARDS FOR VAPOR PRODUCT BAT7 TERIES. 

8 (a) APPLICABILITY OF STANDARDS.—Section 907 of 

9 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 387g) and any related provisions of such Act shall apply 

11 with respect to a vapor product battery to the same extent 

12 and in the same manner as such section 907 and related 

13 provisions apply with respect to a component of a tobacco 

14 product. 

15 (b) PROMULGATION OF STANDARDS.— 

16 (1) PROPOSED STANDARDS.—Not later than 12 

17 months after the date of enactment of this Act, the 

18 Secretary of Health and Human Services shall issue 

19 a notice of proposed rulemaking to establish product 

20 standards for vapor product batteries pursuant to 

21 section 907 of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 387g). 

23 (2) FINAL STANDARDS.—Not later than 24 

24 months after the date of enactment of this Act, the 


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1 Secretary shall promulgate the vapor product bat2 tery standards required by this section. 

3 (c) COMPLIANCE WITH FINAL STANDARDS.—For 

4 any vapor product (including those products in test mar5 kets) that has a battery and is commercially marketed in 

6 the United States as of the date by which final standards 

7 are required to be promulgated under subsection (b)(2), 

8 the Secretary of Health and Human Services, based on 

9 any change to the battery for the purpose of conforming 

10 to such final standards, shall not— 

11 (1) require the submission of a report under 

12 section 905(j) of such Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 387e(j)); or 

14 (2) treat such vapor product as a new tobacco 

15 product for which an order is required under section 

16 910(c)(1)(A)(i) of such Act (21 U.S.C. 

17 387j(c)(1)(A)(i)). 

18 (d) DEFINITION.—In this section, the term ‘‘vapor 

19 product’’ has the meaning given to such term in section 

20 921(f) of the Federal Food, Drug, and Cosmetic Act, as 

21 added by section 4 of this Act. 

22 SEC. 4. REGULATION OF VAPOR PRODUCTS. 

23 (a) IN GENERAL.—Chapter IX of the Federal Food, 

24 Drug, and Cosmetic Act is amended by inserting after sec25 tion 920 of such Act (21 U.S.C. 387t) the following: 


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1 ‘‘SEC. 921. VAPOR PRODUCTS. 

2 ‘‘(a) RELATION TO OTHER PROVISIONS.—The au3 thorities vested in the Secretary by this section to regulate 

4 vapor products are in addition to, not in lieu of, the au5 thorities vested in the Secretary by other sections of this 

6 Act to regulate vapor products as tobacco products. 

7 ‘‘(b) ADVERTISING IN PRINT PUBLICATIONS.— 

8 ‘‘(1) IN GENERAL.—The manufacturer, dis9 tributor, or retailer of a vapor product shall not dis10 seminate or cause to be disseminated advertising or 

11 labeling of the vapor product in a newspaper, maga12 zine, periodical or other publication (whether peri13 odic or limited distribution), other than an adult 

14 publication. 

15 ‘‘(2) DEFINITION.—In this subsection, the term 

16 ‘adult publication’ means a newspaper, magazine, 

17 periodical, or other publication— 

18 ‘‘(A) whose readers younger than 18 years 

19 of age constitute 15 percent or less of the total 

20 readership as measured by competent and reli21 able survey evidence; and 

22 ‘‘(B) that is read by fewer than 2 million 

23 persons younger than 18 years of age as meas24 ured by competent and reliable survey evidence. 

25 ‘‘(c) PROHIBIT SELF-SERVICE DISPLAYS OF VAPOR

26 PRODUCTS.— 


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1 ‘‘(1) IN GENERAL.—A retailer may sell vapor 

2 products only in a direct face-to-face exchange. 

3 ‘‘(2) EXCEPTION.—Paragraph (1) does not 

4 apply— 

5 ‘‘(A) to mail order sales; or 

6 ‘‘(B) to sales by means of a vending ma7 chine or self-service display that is located in a 

8 facility where the retailer ensures that no per9 son under 18 years of age is present or per10 mitted to enter at any time. 

11 ‘‘(3) CIVIL PENALTY.—A violation of this sub12 section shall be subject to a civil penalty under sec13 tion 303(f)(9) to the same extent and in the same 

14 manner as a violation of any requirement of this Act 

15 which relates to a tobacco product. 

16 ‘‘(d) LABELING.— 

17 ‘‘(1) IN GENERAL.—Not later than 12 months 

18 after the date of enactment of the FDA Deeming 

19 Authority Clarification Act of 2017, the Secretary 

20 shall promulgate final regulations to require pack21 ages of vapor products to bear a label containing— 

22 ‘‘(A) the phrase ‘Keep Out of Reach of 

23 Children’; 

24 ‘‘(B) the phrase ‘Underage Sale Prohib25 ited’; and 


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1 ‘‘(C) if the vapor product includes nicotine 

2 in a solution or other form at the time of sale, 

3 an accurate statement of the nicotine content. 

4 ‘‘(2) MISBRANDING.—A vapor product whose 

5 label is in violation of paragraph (1) is deemed to 

6 be a misbranded tobacco product under section 903. 

7 ‘‘(e) ANNUAL REGISTRATION REQUIREMENTS FOR

8 VAPOR PRODUCT RETAILERS.— 

9 ‘‘(1) REGISTRATION BY RETAILERS.—Every 

10 person who owns or operates an establishment in 

11 any State engaged in the retail sale of a vapor prod12 uct shall register that establishment with the Sec13 retary by the later of— 

14 ‘‘(A) 60 days after the date of the enact15 ment of the FDA Deeming Authority Clarifica16 tion Act of 2017; and 

17 ‘‘(B) 30 days after first engaging in such 

18 retail sale. 

19 ‘‘(2) EXCLUSION.—The requirements of this 

20 subsection do not apply with respect to any estab21 lishment subject to an active registration or retail li22 cense under— 

23 ‘‘(A) any State law relating to tobacco 

24 products; or 

25 ‘‘(B) section 905. 


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1 ‘‘(3) PUBLIC ACCESS TO REGISTRATION INFOR2 MATION.—The Secretary shall make available for in3 spection, to any person so requesting, any registra4 tion filed under this subsection. 

5 ‘‘(f) VAPOR PRODUCT DEFINED.—In this section: 

6 ‘‘(1) IN GENERAL.—The term ‘vapor product’— 

7 ‘‘(A) means any noncombustible product 

8 that employs a heating element, power source, 

9 electronic circuit, or other electronic, chemical, 

10 or mechanical means, regardless of shape or 

11 size, to produce vapor from nicotine in a solu12 tion or other form; and 

13 ‘‘(B) includes— 

14 ‘‘(i) any electronic cigarette, electronic 

15 cigar, electronic cigarillo, electronic pipe, 

16 or similar product or device that is in17 tended to produce vapor from nicotine in a 

18 solution of other form; and 

19 ‘‘(ii) nicotine in a solution or other 

20 form, whether in a cartridge or container 

21 or otherwise dispensed, that is intended to 

22 be used with or in a product described in 

23 clause (i). 


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1 ‘‘(2) EXCLUSION.—The term ‘vapor product’ 

2 does not include any product regulated as a drug or 

3 device under chapter V.’’. 

4 (b) PROHIBITED ACTS.—Section 301 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend6 ed by adding at the end the following: 

7 ‘‘(eee) The disseminating or causing to be dissemi8 nated, by a manufacturer, distributor, or retailer of a 

9 vapor product, advertising or labeling of the vapor product 

10 in violation of section 921(b). 

11 ‘‘(fff) The failure of a person who owns or operates 

12 an establishment in any State engaged in the retail sale 

13 of a vapor product to register as required by section 

14 921(e).’’. 

Æ 


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