[Congressional Record Volume 170, Number 119 (Tuesday, July 23, 2024)]
[Senate]
[Pages S5220-S5221]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2942. Mr. KAINE submitted an amendment intended to be proposed by
him to the bill S. 4638, to authorize appropriations for fiscal year
2025 for military activities of the Department of Defense, for military
construction, and for defense activities of the Department of Energy,
to prescribe military personnel strengths for such fiscal year, and for
other purposes; which was ordered to lie on the table; as follows:
At the appropriate place in title VI, insert the following:
SEC. 6__. COMBATTING ILLICIT TOBACCO PRODUCTS.
(a) In General.--Beginning not later than 120 days after
the date of the enactment of this Act, no exchange or
commissary store operated by or for a military resale entity
shall offer for sale any ENDS product or oral nicotine
product unless the manufacturer of such product executes and
delivers to the appropriate officer for each military resale
entity a certification form for each ENDS product or oral
nicotine product offered for retail sale at an exchange or
commissary store that attests under penalty of perjury the
following:
(1) The manufacturer has received a marketing granted order
for such product under section 910 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 387j).
(2) The manufacturer submitted a timely filed premarket
tobacco product application for such product, and the
application either remains under review by the Secretary or
has received a denial order that has been and remains stayed
by the Secretary or court order, rescinded by the Secretary,
or vacated by a court.
(b) Failure to Submit Certification.--A manufacturer shall
submit the certification forms required in subsection (a) on
an annual basis. Failure to submit such forms to a military
resale entity as required under the preceding sentence shall
result in the removal of the relevant ENDS product or oral
nicotine product from sale at any exchange or commissary
store operated by or for such military resale entity.
(c) Certification Contents.--
(1) In general.--A certification form required under
subsection (a) shall separately list each brand name, product
name, category (such as e-liquid, power unit, device, e-
liquid cartridge, e-liquid pod, or disposable), and flavor
for each product that is sold offered for sale by the
manufacturer submitting such form.
(2) Other items.--A manufacturer shall, when submitting a
certification under subsection (a), include in that
submission--
(A) a copy of the publicly available marketing order
granted under section 910 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 387j), as redacted by the Secretary
and made available on the agency website;
(B) a copy of the acceptance letter issued under such
section for a timely filed premarket tobacco product
application; or
(C) a document issued by the Secretary or by a court
confirming that the premarket tobacco product application has
received a denial order that has been and remains stayed by
the Secretary or court order, rescinded by the Secretary, or
vacated by a court.
(d) Development of Forms and Publication.--
[[Page S5221]]
(1) In general.--Not later than 60 days after the date of
the enactment of this Act, each military resale entity
shall--
(A) develop and make public the certification form such
entity will require a manfacturer to submit to meet the
requirement under subsection (a); and
(B) provide instructions on how such certification form
shall be submitted to such entity.
(2) Submission in case of failure to publish form.--If a
military resale entity fails to prepare and make public the
certification form required by subsection (a), a manufacturer
may submit information necessary to prove compliance with the
requirements of this section.
(e) Changes to Certification Form.--A manufacturer that
submits a certification form under subsection (a) shall
notify each military resale entity to which such
certification was submitted not later than 30 days after
making any material change to the certification form,
including--
(1) the issuance or denial of a marketing authorization or
other order by the Secretary pursuant to section 910 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j); or
(2) any other order or action by the Secretary or any court
that affects the ability of the ENDS product or oral nicotine
product to be introduced or delivered into interstate
commerce for commercial distribution in the United States.
(f) Directory.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, each military resale entity shall
maintain and make publicly available on its official website
a directory that lists all ENDS product and oral nicotine
product manufacturers and all product brand names, categories
(such as e-liquid, e-liquid cartridge, e-liquid pod, or
disposable), product names, and flavors for which
certification forms have been submitted and approved by the
military resale entity.
(2) Updates.--Each military resale entity shall--
(A) update the directory under paragraph (1) at least
monthly to ensure accuracy; and
(B) establish a process to provide each exchange or
commissary store notice of the initial publication of the
directory and changes made to the directory in the preceding
month.
(3) Exclusions and removals.--An ENDS product or oral
nicotine product shall not be included or retained in a
directory of a military resale entity if the military resale
entity determines that any of the following apply:
(A) The manufacturer failed to provide a complete and
accurate certification as required by this section.
(B) The manufacturer submitted a certification that does
not comply with the requirements of this section.
(C) The information provided by the manufacturer in its
certification contains false information, material
misrepresentations, or omissions.
(4) Notice required.--In the case of a removal of a product
from a directory under paragraph (3), the relevant military
resale entity shall provide to the manufacturer involved
notice and at least 30 days to cure deficiencies before
removing the manufacturer or its products from the directory.
(5) Effect of removal.--The ENDS product or oral nicotine
product of a manufacturer identified in a notice of removal
under paragraph (4) are, beginning on the date that is 30
days after such removal, subject to seizure, forfeiture, and
destruction, and may not be purchased or sold for retail sale
at any exchange or commissary store operated by or for a
military resale entity.
(g) Definitons.--In this section:
(1) ENDS product.--The term ``ENDS product''--
(A) 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;
(B) includes a consumable nicotine liquid solution suitable
for use in such product, whether sold with the product or
separately; and
(C) 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.).
(2) Military resale entity.--The term ``military resale
entity'' means--
(A) the Defense Commissary Agency;
(B) the Army and Air Force Exchange Service;
(C) the Navy Exchange Service Command; and
(D) the Marine Corps Exchange.
(3) Oral nicotine product.--The term ``oral nicotine
product'' means--
(A) means any non-combustible product that contains
nicotine that is intended to be placed in the oral cavity;
and
(B) does not include--
(i) any ENDS product;
(ii) smokeless tobacco (as defined in section 900 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387)); or
(iii) 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.).
(4) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs.
(5) Timely filed premarket tobacco product application.--
The term ``timely filed premarket tobacco product
application'' means an application that was submitted under
section 910 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387j) on or before September 9, 2020, and accepted for
filing with respect to an ENDS product or oral nicotine
product containing nicotine marketed in the United States as
of August 8, 2016.
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