I 
116TH CONGRESS 
1ST SESSION H. R. 5005 
To amend the Federal Food, Drug, and Cosmetic Act to require a recall 
of electronic nicotine delivery systems that have not been subject to 
premarket review, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 8, 2019 
Mr. DESAULNIER 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 
require a recall of electronic nicotine delivery systems 
that have not been subject to premarket review, 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 ‘‘Preventing Vape Use 
Act’’. 
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SEC. 2. INCLUSION OF ENDS IN DEFINITION OF TOBACCO 
PRODUCT. 
(a) CONFIRMATION
OF INCLUSION
OF ENDS IN 
DEFINITION OF TOBACCO PRODUCT.—Section 201(rr)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(rr)(1)) is amended by adding at the end the following: 
‘‘Such term includes an electronic nicotine delivery sys-
tem.’’. 
(b) ENDS DEFINED.—Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amend-
ed by adding at the end the following: 
‘‘(ss) The term ‘electronic nicotine delivery system’ 
means a tobacco product that is an electronic device that 
delivers nicotine, flavor, or another substance via an aero-
solized solution to the user inhaling from the device (in-
cluding e-cigarettes, e-hookah, e-cigars, vape pens, ad-
vanced refillable personal vaporizers, and electronic pipes) 
and any component, liquid, part, or accessory of such a 
device, whether or not sold separately.’’. 
SEC. 3. MANDATORY RECALL OF ENDS PENDING PRE-
MARKET REVIEW. 
Section 908(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387h(c)) is amended by adding at 
the end the following: 
‘‘(4) MANDATORY RECALL OF ENDS PENDING 
PREMARKET REVIEW.— 
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‘‘(A) 
ISSUANCE
OF
ORDER.—Notwith-
standing paragraphs (1) and (2), in the case of 
a tobacco product that is an electronic nicotine 
delivery system with respect to which, as of the 
date of the enactment of this subparagraph, an 
order under section 910(c)(1)(A)(i) has not 
been issued, the Secretary shall, not later than 
60 days after such date of enactment, issue an 
order requiring— 
‘‘(i) the appropriate person (including 
the manufacturers, importers, distributors, 
or retailers of the tobacco product) to im-
mediately cease distribution of such to-
bacco product; and 
‘‘(ii) the recall of such tobacco prod-
uct. 
‘‘(B) HEARING.—The order under sub-
paragraph (A) shall provide the person subject 
to the order with an opportunity for an infor-
mal hearing, to be held not later than 10 days 
after the date of the issuance of the order, on 
the actions required by the order and the terms 
of the recall required by such order. 
‘‘(C) CONTENTS
OF
ORDER.—An order 
issued under subparagraph (A) shall specify a 
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timetable in which the tobacco product recall 
will occur and shall require periodic reports to 
the Secretary describing the progress of the re-
call. 
‘‘(D) NOTICE.—An order under subpara-
graph (A)— 
‘‘(i) shall not include recall of a to-
bacco product from individuals; and 
‘‘(ii) shall provide for notice to per-
sons subject to the risks associated with 
the use of such tobacco product. 
‘‘(E) ASSISTANCE ALLOWED.—In providing 
the notice required by subparagraph (D)(ii), the 
Secretary may use the assistance of retailers 
and other persons who distributed such tobacco 
product. If a significant number of such per-
sons cannot be identified, the Secretary shall 
notify such persons under section 705(b). 
‘‘(F) WITHDRAWAL OF ORDER.—The Sec-
retary may only withdraw an order issued 
under subparagraph (A) with respect to a to-
bacco product described in such subparagraph 
upon 
the 
issuance 
of 
an 
order 
section 
910(c)(1)(A)(i) with respect to that product.’’. 
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SEC. 4. NO EXEMPTIONS ALLOWED FOR ENDS. 
Section 910(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 387j(a)) is amended— 
(1) in paragraph (2), by adding at the end the 
following: 
‘‘(C) APPLICATION
TO
ENDS.—Notwith-
standing clauses (i) and (ii) of subparagraphs 
(A) and (B), beginning on the date that is 60 
days after the date of the enactment of this 
subparagraph— 
‘‘(i) electronic nicotine delivery sys-
tems are deemed to be not substantially 
equivalent to any predicate tobacco prod-
uct; and 
‘‘(ii) the requirement for premarket 
review under subparagraph (A) shall apply 
to a tobacco product that is an electronic 
nicotine delivery system.’’; and 
(2) in paragraph (3)(C)— 
(A) by striking ‘‘equivalent to a predicate’’ 
and inserting the following: ‘‘equivalent— 
‘‘(A) to a predicate’’; 
(B) by striking ‘‘adulterated.’’ and insert-
ing ‘‘adulterated; or’’; and 
(C) by adding at the end the following: 
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‘‘(B) beginning on the date that is 60 days 
after the date of the enactment of this subpara-
graph, if the tobacco product is an electronic 
nicotine delivery system.’’. 
Æ 
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