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 establish-
ment of product standards for vapor product batteries, 
to provide for regulation of vapor products, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Deeming Author-
ity Clarification Act of 2017’’. 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, 
AND COSMETIC ACT TO DEEMED TOBACCO 
PRODUCTS. 
Section 901(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387a(b)) is amended— 
(1) by striking ‘‘This chapter shall apply’’ and 
inserting the following: 
‘‘(1) IN GENERAL.—This chapter shall apply’’; 
and 
(2) by adding at the end the following new 
paragraph: 
‘‘(2) DEEMED TOBACCO PRODUCTS.—For each 
tobacco product deemed subject to the requirements 
of this chapter pursuant to paragraph (1), each ref-
erence in sections 905(j) and 910(a)— 
‘‘(A) to ‘February 15, 2007’, shall be con-
sidered to be a reference to ‘the effective date 
of the regulation under which a tobacco product 
is deemed subject to the requirements of this 
chapter pursuant to section 901(b)’; and 
‘‘(B) to ‘21 months after the date of enact-
ment of the Family Smoking Prevention and 
Tobacco Control Act’, shall be considered to be 
a reference to the later of— 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
‘‘(i) ‘21 months after the date of en-
actment of the FDA Deeming Authority 
Clarification Act of 2017’; and 
‘‘(ii) ‘21 months after the effective 
date of such deeming regulation’.’’. 
SEC. 3. PRODUCT STANDARDS FOR VAPOR PRODUCT BAT-
TERIES. 
(a) APPLICABILITY OF STANDARDS.—Section 907 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387g) and any related provisions of such Act shall apply 
with respect to a vapor product battery to the same extent 
and in the same manner as such section 907 and related 
provisions apply with respect to a component of a tobacco 
product. 
(b) PROMULGATION OF STANDARDS.— 
(1) PROPOSED STANDARDS.—Not later than 12 
months after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue 
a notice of proposed rulemaking to establish product 
standards for vapor product batteries pursuant to 
section 907 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387g). 
(2) FINAL
STANDARDS.—Not later than 24 
months after the date of enactment of this Act, the 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
Secretary shall promulgate the vapor product bat-
tery standards required by this section. 
(c) COMPLIANCE WITH FINAL STANDARDS.—For 
any vapor product (including those products in test mar-
kets) that has a battery and is commercially marketed in 
the United States as of the date by which final standards 
are required to be promulgated under subsection (b)(2), 
the Secretary of Health and Human Services, based on 
any change to the battery for the purpose of conforming 
to such final standards, shall not— 
(1) require the submission of a report under 
section 905(j) of such Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387e(j)); or 
(2) treat such vapor product as a new tobacco 
product for which an order is required under section 
910(c)(1)(A)(i) 
of 
such 
Act 
(21 
U.S.C. 
387j(c)(1)(A)(i)). 
(d) DEFINITION.—In this section, the term ‘‘vapor 
product’’ has the meaning given to such term in section 
921(f) of the Federal Food, Drug, and Cosmetic Act, as 
added by section 4 of this Act. 
SEC. 4. REGULATION OF VAPOR PRODUCTS. 
(a) IN GENERAL.—Chapter IX of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 920 of such Act (21 U.S.C. 387t) the following: 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
‘‘SEC. 921. VAPOR PRODUCTS. 
‘‘(a) RELATION TO OTHER PROVISIONS.—The au-
thorities vested in the Secretary by this section to regulate 
vapor products are in addition to, not in lieu of, the au-
thorities vested in the Secretary by other sections of this 
Act to regulate vapor products as tobacco products. 
‘‘(b) ADVERTISING IN PRINT PUBLICATIONS.— 
‘‘(1) IN
GENERAL.—The manufacturer, dis-
tributor, or retailer of a vapor product shall not dis-
seminate or cause to be disseminated advertising or 
labeling of the vapor product in a newspaper, maga-
zine, periodical or other publication (whether peri-
odic or limited distribution), other than an adult 
publication. 
‘‘(2) DEFINITION.—In this subsection, the term 
‘adult publication’ means a newspaper, magazine, 
periodical, or other publication— 
‘‘(A) whose readers younger than 18 years 
of age constitute 15 percent or less of the total 
readership as measured by competent and reli-
able survey evidence; and 
‘‘(B) that is read by fewer than 2 million 
persons younger than 18 years of age as meas-
ured by competent and reliable survey evidence. 
‘‘(c) PROHIBIT SELF-SERVICE DISPLAYS OF VAPOR 
PRODUCTS.— 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
‘‘(1) IN GENERAL.—A retailer may sell vapor 
products only in a direct face-to-face exchange. 
‘‘(2) EXCEPTION.—Paragraph (1) does not 
apply— 
‘‘(A) to mail order sales; or 
‘‘(B) to sales by means of a vending ma-
chine or self-service display that is located in a 
facility where the retailer ensures that no per-
son under 18 years of age is present or per-
mitted to enter at any time. 
‘‘(3) CIVIL PENALTY.—A violation of this sub-
section shall be subject to a civil penalty under sec-
tion 303(f)(9) to the same extent and in the same 
manner as a violation of any requirement of this Act 
which relates to a tobacco product. 
‘‘(d) LABELING.— 
‘‘(1) IN GENERAL.—Not later than 12 months 
after the date of enactment of the FDA Deeming 
Authority Clarification Act of 2017, the Secretary 
shall promulgate final regulations to require pack-
ages of vapor products to bear a label containing— 
‘‘(A) the phrase ‘Keep Out of Reach of 
Children’; 
‘‘(B) the phrase ‘Underage Sale Prohib-
ited’; and 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
‘‘(C) if the vapor product includes nicotine 
in a solution or other form at the time of sale, 
an accurate statement of the nicotine content. 
‘‘(2) MISBRANDING.—A vapor product whose 
label is in violation of paragraph (1) is deemed to 
be a misbranded tobacco product under section 903. 
‘‘(e) ANNUAL REGISTRATION REQUIREMENTS FOR 
VAPOR PRODUCT RETAILERS.— 
‘‘(1) REGISTRATION
BY
RETAILERS.—Every 
person who owns or operates an establishment in 
any State engaged in the retail sale of a vapor prod-
uct shall register that establishment with the Sec-
retary by the later of— 
‘‘(A) 60 days after the date of the enact-
ment of the FDA Deeming Authority Clarifica-
tion Act of 2017; and 
‘‘(B) 30 days after first engaging in such 
retail sale. 
‘‘(2) EXCLUSION.—The requirements of this 
subsection do not apply with respect to any estab-
lishment subject to an active registration or retail li-
cense under— 
‘‘(A) any State law relating to tobacco 
products; or 
‘‘(B) section 905. 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
‘‘(3) PUBLIC ACCESS TO REGISTRATION INFOR-
MATION.—The Secretary shall make available for in-
spection, to any person so requesting, any registra-
tion filed under this subsection. 
‘‘(f) VAPOR PRODUCT DEFINED.—In this section: 
‘‘(1) IN GENERAL.—The term ‘vapor product’— 
‘‘(A) means any noncombustible product 
that employs a heating element, power source, 
electronic circuit, or other electronic, chemical, 
or mechanical means, regardless of shape or 
size, to produce vapor from nicotine in a solu-
tion or other form; and 
‘‘(B) includes— 
‘‘(i) any electronic cigarette, electronic 
cigar, electronic cigarillo, electronic pipe, 
or similar product or device that is in-
tended to produce vapor from nicotine in a 
solution of other form; and 
‘‘(ii) nicotine in a solution or other 
form, whether in a cartridge or container 
or otherwise dispensed, that is intended to 
be used with or in a product described in 
clause (i). 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS
‘‘(2) EXCLUSION.—The term ‘vapor product’ 
does not include any product regulated as a drug or 
device under chapter V.’’. 
(b) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(eee) The disseminating or causing to be dissemi-
nated, by a manufacturer, distributor, or retailer of a 
vapor product, advertising or labeling of the vapor product 
in violation of section 921(b). 
‘‘(fff) The failure of a person who owns or operates 
an establishment in any State engaged in the retail sale 
of a vapor product to register as required by section 
921(e).’’. 
Æ 
VerDate Sep 11 2014 
19:35 Feb 27, 2017
Jkt 069200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6301
E:\BILLS\H1136.IH
H1136
asabaliauskas on DSK3SPTVN1PROD with BILLS