Sec. 1702. Combating illicit tobacco products
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/bill/119/hr/3838/eh/section-1702·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Beginning not later than 120 days after the date of the enactment of this Act, no exchange or commissary 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 that attests under penalty of perjury the following:
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 ). 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by the Secretary or has received a denial order that has been and remains stayed by the Secretary or court order, rescinded by the Secretary, or vacated by a court. 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 such military resale entity. 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. A manufacturer shall, when submitting a certification under subsection (a), include in that submission— a copy of the publicly available marketing granted order 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; a copy of the acceptance letter issued under such section for a timely filed premarket tobacco product application; or a document issued by 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product application has received a denial order that has been and remains stayed by the Secretary or court order, rescinded by the Secretary, or vacated by a court. Not later than 60 days after the date of the enactment of this Act, each military resale entity shall— develop and make public the certification form such resale entity will require a manfacturer to submit to meet the requirement under subsection (a); and provide instructions on how such certification form shall be submitted to the relevant military resale entity. If a military resale entity fails to prepare and make public such certification form, a manufacturer may submit information necessary to prove compliance with the requirements of this section. A manufacturer that submits a certification form under subsection
(a)shall notify each relevant military resale entity to which such certification was submitted not later than 30 days after making any material change to the certification form, including— 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 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. No later than 180 days after 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 relevant military resale entity. Each military resale entity shall— update the directory under paragraph
(1)at least monthly to ensure accuracy; and establish a process to provide each exchange or commissary notice of the initial publication of the directory and changes made to the directory in the prior month. An ENDS product or oral nicotine product shall not be included or retained in a directory of a military resale entity if the relevant military resale entity determines that any of the following apply: The manufacturer failed to provide a complete and accurate certification as required by this section. The manufacturer submitted a certification that does not comply with the requirements of this section. The information provided by the manufacturer in its certification contains false information, material misrepresentations, or omissions. 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. The ENDS product or oral nicotine product of a manufacturer identified in a notice of removal under paragraph
(3)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 operated by or for a military resale entity. In this section: The term ENDS product — 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; includes a consumable nicotine liquid solution suitable for use in such product, whether sold with the product or separately; and 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. ). The term military resale entities means— the Defense Commissary Agency; the Army and Air Force Exchange Service; the Navy Exchange Service Command; and the Marine Corps Exchange. The term oral nicotine product means— means any non-combustible product that contains nicotine that is intended to be placed in the oral cavity; does not include— any ENDS product; smokeless tobacco (as defined in section 900 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 )); or 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. ). The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs. 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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