S.Amdt. 1356

SA 1356. Mr. KAINE submitted an amendment intended to be proposed to
amendment SA 1092 proposed by Mrs. Murray (for herself and Ms. Collins)
to the bill H.R. 4366, making appropriations for military construction,
the Department of Veterans Affairs, and related agencies for the fiscal
year ending September 30, 2024, and for other purposes; which was
ordered to lie on the table; as follows:

At the appropriate place in title VII of division B, insert
the following:
Sec. ___. (a) Not later than 90 days after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall publish a written enforcement plan describing how the
Secretary will remove from the market any disposable flavored
ENDS product--
(1) for which no premarket tobacco application was
submitted to the Secretary pursuant to section 910(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)) on
or before September 9, 2020; or
(2) that is the subject of a denial of a premarket tobacco
application pursuant to section 910(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 387j(c)), unless such
denial is otherwise stayed by the Secretary or through court
order.
(b) The plan under paragraph (1) shall include, at a
minimum, all of the following:
(1) Detailed guidance to wholesalers, distributors, and
retailers on how to identify any disposable flavored ENDS
product described in paragraph (1) or (2) of subsection (a).
(2) Clearly defined and detailed enforcement strategies,
including directed communications regarding a detailed
escalating penalty structure, designed to deter manufacturers
and wholesalers of disposable flavored ENDS products from
manufacturing,

[[Page S5150]]

selling, offering to sell, distributing, or importing for
sale or distribution within the United States any disposable
flavored ENDS product described in paragraph (1) or (2) of
subsection (a).
(3) Detailed plans on how the Secretary will prioritize
enforcement actions directed against manufacturers and
wholesalers that manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the
United States any disposable flavored ENDS product described
in paragraph (1) or (2) of subsection (a).
(4) A plan for how the Secretary will coordinate with the
Attorney General, the Secretary of Homeland Security, and the
Secretary of the Treasury to develop and implement a strategy
to prevent or intercept the importation, smuggling, or
trafficking of any disposable flavored ENDS product described
in paragraph (1) or (2) of subsection (a).
(5) Detailed plans on how and when the Secretary will
implement stronger enforcement procedures and other
activities, and as advisable amend existing procedures and
activities, to more quickly remove from the market any
disposable flavored ENDS product described in paragraph (1)
or (2) of subsection (a).
(c) The Secretary shall, not later than 90 days after the
date of enactment of this Act, publish and maintain on the
website of the Food and Drug Administration, the enforcement
plan specified in subsection (a) and shall provide a copy of
such enforcement plan to the Committee on Appropriations of
the Senate, the Committee on Appropriations of the House of
Representatives, and the Government Accountability Office.
(d) For purposes of this section, the term ``flavored ENDS
product''--
(1) means any non-combustible 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 solution,
where the solution contains a constituent, additive, or
ingredient, an artificial or natural flavor (other than
tobacco) or an herb or spice, that is a characterizing
flavor;
(2) includes any electronic cigarette, electronic cigar,
electronic cigarillo, electronic pipe, or similar product or
device, and includes a consumable nicotine liquid or solution
suitable for use in a flavored ENDS product, whether sold
with the product or separately; and
(3) does not include any product regulated as a drug or
device under chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.).
(e) Beginning 120 days after the date of enactment of this
Act, the Secretary shall submit a report on a quarterly basis
to the Committee on Appropriations of the Senate, the
Committee on Appropriations of the House of Representatives,
and the Government Accountability Office, and post such
report on the website of the Food and Drug Administration,
listing each enforcement action taken in relation to any
disposable flavored ENDS product in the marketplace that is
described in paragraph (1) or (2) of subsection (a). Such
report shall be categorized by manufacturer, wholesaler, and
retailer and shall include the date on which each enforcement
action was initiated, the status of such action, and whether
such disposable flavored ENDS products are continuing to be
sold or distributed despite the enforcement action.
(f) Not later than 180 days after the date of enactment of
this Act, the Secretary shall submit a report to the
Committee on Appropriations of the Senate, the Committee on
Appropriations of the House of Representatives, and the
Government Accountability Office providing specific
recommendations on how to revise or enhance current statutory
and regulatory enforcement authorities to ensure the
expeditious removal from the market of any disposable
flavored ENDS product described in paragraph (1) or (2) of
subsection (a).

____________________