[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9367 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 9367
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
August 16, 2024
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Preventing Vape Use Act''.
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
system.''.
(b) ENDS Defined.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended 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 aerosolized solution to the user
inhaling from the device (including e-cigarettes, e-hookah, e-cigars,
vape pens, advanced 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 PREMARKET REVIEW.
Section 908(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387h(c)) is amended by adding at the end the following:
``(4) Mandatory recall of ends pending premarket review.--
``(A) Issuance of order.--Notwithstanding
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 a
manufacturer, importer, distributor, or
retailer of the tobacco product) to immediately
cease distribution of such tobacco product; and
``(ii) the recall of such tobacco product.
``(B) Hearing.--The order under subparagraph (A)
shall provide the person subject to the order with an
opportunity for an informal 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 timetable in which the
tobacco product recall will occur and shall require
periodic reports to the Secretary describing the
progress of the recall.
``(D) Notice.--An order under subparagraph (A)--
``(i) shall not include recall of a tobacco
product from individuals; and
``(ii) shall provide for notice to persons
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 persons cannot be identified, the
Secretary shall notify such persons under section
705(b).
``(F) Withdrawal of order.--The Secretary may only
withdraw an order issued under subparagraph (A) with
respect to a tobacco product described in such
subparagraph upon the issuance of an order section
910(c)(1)(A)(i) with respect to that product.''.
SEC. 4. NO EXEMPTIONS ALLOWED FOR ENDS.
Section 910(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387j(a)) is amended--
(1) in paragraph (2), by adding at the end the following:
``(C) Application to ends.--Notwithstanding 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 systems
are deemed to be not substantially equivalent
to any predicate tobacco product; 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 inserting
``adulterated; or''; and
(C) by adding at the end the following:
``(B) beginning on the date that is 60 days after
the date of the enactment of this subparagraph, if the
tobacco product is an electronic nicotine delivery
system.''.
<all>