What This Bill Does
This bill requires the Food and Drug Administration (the federal agency that oversees medicines and food safety) to update its enforcement guidance to prioritize taking action against disposable electronic nicotine delivery system products. The bill aims to address the fact that disposable vaping devices are the most common type of vaping product used by minors, according to a 2022 national survey.
Who It Affects
The Food and Drug Administration and the Secretary of Health and Human Services will be directly responsible for implementing this bill. Manufacturers and sellers of disposable electronic nicotine delivery system products may face increased enforcement actions.
Key Provisions
- The Secretary of Health and Human Services must update the FDA's enforcement guidance within 90 days to include how the agency will prioritize enforcement against disposable electronic nicotine delivery system products, including nicotine products not derived from tobacco (Sec. 3(a))
- The Secretary can begin prioritizing enforcement against disposable products before updating the guidance, particularly targeting products designed for minors or products whose marketing is likely to encourage minor use (Sec. 3(b))
- The Secretary must report annually the total number of compliance and enforcement actions taken against disposable electronic nicotine delivery system products (Sec. 3(c))
What Changes
The FDA will be required to treat disposable vaping devices as a priority enforcement target in its official guidance, whereas previously these products were not included in the agency's stated enforcement priorities.
Important Definitions
Disposable ENDS product: A tobacco product that is one complete unit containing the battery and liquid together, designed to be thrown away after the liquid runs out (Sec. 3(d))
Effective Date
Not specified in bill text
I
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 sys-
tem products.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Disposable ENDS
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Product Enforcement Act of 2023’’.
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SEC. 2. FINDINGS.
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Congress finds the following:
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(1) In April 2020, the Food and Drug Adminis-
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tration issued guidance entitled ‘‘Enforcement Prior-
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ities for Electronic Nicotine Delivery System
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•HR 901 IH
(ENDS) and Other Deemed Products on the Market
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Without Premarket Authorization’’.
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(2) In such guidance, Food and Drug Adminis-
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tration describes how the agency intends to prioritize
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enforcement against any flavored, cartridge-based
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electronic nicotine delivery system product (other
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than a tobacco- or menthol-flavored electronic nico-
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tine delivery system product) marketed without au-
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thorization from the Food and Drug Administration.
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(3) In defining the term ‘‘cartridge-based
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ENDS product,’’ the guidance cites ‘‘self-contained,
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disposable products’’ as not being with the scope of
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this prioritized category.
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(4) The guidance explains: ‘‘FDA is continu-
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ously evaluating new information and adjusting its
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enforcement priorities in light of the best available
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data, and it will continue to do so with respect to
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these products. FDA will take appropriate action re-
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garding tobacco products that are marketed without
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premarket authorization, including as warranted
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based on changed circumstances, new information,
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or to better address minors’ use of those products’’.
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(5) In November 2022, the Food and Drug Ad-
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ministration and the Centers for Disease Control
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and Prevention released the findings from the 2022
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•HR 901 IH
National Youth Tobacco Survey. The data shows
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that self-contained disposable electronic nicotine de-
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livery system products were the most common device
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type used by minors.
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SEC. 3. UPDATED ENFORCEMENT PRIORITIZATION.
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(a) GUIDANCE.—The Secretary of Health and
6
Human Services, acting through the Commissioner of
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Food and Drugs (referred to in this Act as the ‘‘Sec-
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retary’’), shall not later than 90 days after the date of
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the enactment of this Act, update the final guidance enti-
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tled ‘‘Enforcement Priorities for Electronic Nicotine De-
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livery System (ENDS) and Other Deemed Products on the
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Market Without Premarket Authorization’’ issued in April
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2020, to include a description of how the Secretary will
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also prioritize enforcement against disposable ENDS
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products, including such nicotine products not derived
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from tobacco.
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(b) ENFORCEMENT.—Nothing in this section shall be
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construed as preventing the Secretary from prioritizing
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enforcement against disposable ENDS products, including
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nicotine products not derived from tobacco, in advance of
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updating the guidance referred to in paragraph (1), par-
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ticularly with respect to such products that are targeted
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to minors or whose marketing is likely to promote use of
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such products by minors.
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(c) INCLUSION IN TOBACCO REGULATION ACTIVITIES
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ANNUAL REPORT.—The Secretary shall include in each
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annual report required to be submitted pursuant to section
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112 of subtitle B of title I of division P of the Consolidated
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Appropriations Act, 2022 (Public Law 117–103), the total
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number of compliance and enforcement actions taken with
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respect to disposable ENDS products during the year cov-
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ered by the report.
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(d) DISPOSABLE ENDS PRODUCT DEFINED.—In
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this Act, the term ‘‘disposable ENDS product’’ means a
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tobacco product (as defined by section 201(rr) of the Fed-
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eral Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)))
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that consists of a single unit including the battery and
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the liquid, and the entire device is intended to be disposed
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of after the liquid has been depleted.
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Æ
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