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