[Congressional Record Volume 169, Number 175 (Tuesday, October 24, 2023)]
[Senate]
[Pages S5149-S5150]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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).

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