Disposable ENDS Product Enforcement Act of 2023

Subjects: Health, Administrative law and regulatory procedures, Department of Health and Human Services, Drug, alcohol, tobacco use, Food and Drug Administration (FDA), Government information and archives


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 901 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 901

 To require the Food and Drug Administration to prioritize enforcement 
      of disposable electronic nicotine delivery system products.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 9, 2023

   Mrs. Cherfilus-McCormick introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To require the Food and Drug Administration to prioritize enforcement 
      of disposable electronic nicotine delivery system products.

    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 ``Disposable ENDS Product Enforcement 
Act of 2023''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) In April 2020, the Food and Drug Administration issued 
        guidance entitled ``Enforcement Priorities for Electronic 
        Nicotine Delivery System (ENDS) and Other Deemed Products on 
        the Market Without Premarket Authorization''.
            (2) In such guidance, Food and Drug Administration 
        describes how the agency intends to prioritize enforcement 
        against any flavored, cartridge-based electronic nicotine 
        delivery system product (other than a tobacco- or menthol-
        flavored electronic nicotine delivery system product) marketed 
        without authorization from the Food and Drug Administration.
            (3) In defining the term ``cartridge-based ENDS product,'' 
        the guidance cites ``self-contained, disposable products'' as 
        not being with the scope of this prioritized category.
            (4) The guidance explains: ``FDA is continuously evaluating 
        new information and adjusting its enforcement priorities in 
        light of the best available data, and it will continue to do so 
        with respect to these products. FDA will take appropriate 
        action regarding tobacco products that are marketed without 
        premarket authorization, including as warranted based on 
        changed circumstances, new information, or to better address 
        minors' use of those products''.
            (5) In November 2022, the Food and Drug Administration and 
        the Centers for Disease Control and Prevention released the 
        findings from the 2022 National Youth Tobacco Survey. The data 
        shows that self-contained disposable electronic nicotine 
        delivery system products were the most common device type used 
        by minors.

SEC. 3. UPDATED ENFORCEMENT PRIORITIZATION.

    (a) Guidance.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs (referred to in this Act as 
the ``Secretary''), shall not later than 90 days after the date of the 
enactment of this Act, update the final guidance entitled ``Enforcement 
Priorities for Electronic Nicotine Delivery System (ENDS) and Other 
Deemed Products on the Market Without Premarket Authorization'' issued 
in April 2020, to include a description of how the Secretary will also 
prioritize enforcement against disposable ENDS products, including such 
nicotine products not derived from tobacco.
    (b) Enforcement.--Nothing in this section shall be construed as 
preventing the Secretary from prioritizing enforcement against 
disposable ENDS products, including nicotine products not derived from 
tobacco, in advance of updating the guidance referred to in paragraph 
(1), particularly with respect to such products that are targeted to 
minors or whose marketing is likely to promote use of such products by 
minors.
    (c) Inclusion in Tobacco Regulation Activities Annual Report.--The 
Secretary shall include in each annual report required to be submitted 
pursuant to section 112 of subtitle B of title I of division P of the 
Consolidated Appropriations Act, 2022 (Public Law 117-103), the total 
number of compliance and enforcement actions taken with respect to 
disposable ENDS products during the year covered by the report.
    (d) Disposable ENDS Product Defined.--In this Act, the term 
``disposable ENDS product'' means a tobacco product (as defined by 
section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(rr))) that consists of a single unit including the battery and the 
liquid, and the entire device is intended to be disposed of after the 
liquid has been depleted.
                                 &lt;all&gt;
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