[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4997 Introduced in Senate (IS)]
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119th CONGRESS
2d Session
S. 4997
To set forth requirements for the regulation by the Food and Drug
Administration of nitrous oxide products, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 15, 2026
Mr. Wyden (for himself, Mr. Blumenthal, and Mr. Padilla) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To set forth requirements for the regulation by the Food and Drug
Administration of nitrous oxide products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Nitrous Oxide
Inhalation Prevention Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Purpose.
Sec. 3. Requirements with respect to nitrous oxide products.
Sec. 4. Nitrous oxide harm reduction and misuse prevention.
Sec. 5. Rulemaking and interagency coordination.
Sec. 6. Authorization of appropriations.
SEC. 2. PURPOSE.
The purpose of this Act is to prevent misuse of nitrous oxide while
preserving access to such substance for legitimate and essential uses.
SEC. 3. REQUIREMENTS WITH RESPECT TO NITROUS OXIDE PRODUCTS.
(a) In General.--Subchapter E of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following:
``SEC. 569E. REQUIREMENTS WITH RESPECT TO NITROUS OXIDE PRODUCTS.
``(a) In General.--The Secretary shall establish requirements with
respect to nitrous oxide products, consistent with this section. No
person may introduce or deliver for introduction into interstate
commerce, manufacture, sell, or distribute any nitrous oxide product
that does not meet the requirements of this section.
``(b) Nitrous Oxide Product Defined.--
``(1) In general.--For purposes of this section, the term
`nitrous oxide product' means any product containing nitrous
oxide, subject to paragraph (2).
``(2) Exceptions.--
``(A) Exclusion of topping canisters.--Such term
does not include any canister of aerosol whipped cream
or whipped dairy or non-dairy topping, provided that
the product is not marketed, labeled, or distributed in
a manner promoting inhalation for the purpose of
achieving a euphoric, psychoactive, or intoxicating
effect.
``(B) Exclusion for certain regulated products.--
Such term does not include any product regulated by the
Food and Drug Administration as a drug for medical or
dental purposes.
``(c) Packaging and Labeling.--The Secretary shall establish
requirements with respect to the packaging and labeling of nitrous
oxide products, including--
``(1) a prohibition on packaging or labeling of such
products that is brightly colored or contains cartoon
characters or mascots; and
``(2) requiring warning labels on such products, including
each individual 8-gram cartridge containing nitrous oxide,
covering at least 20 percent of the principal display panel,
stating the following: `WARNING: Inhalation of nitrous oxide
for non-medical purposes can cause brain injury, suffocation,
and death. If inhaled, call Poison Control at 1-800-222-1222.'.
``(d) Product Restrictions.--
``(1) Ban on flavoring.--No flavored nitrous oxide product
may be introduced or delivered for introduction in interstate
commerce.
``(2) Size restriction.--No nitrous oxide product for food
use shall contain more than 8 grams of nitrous oxide by weight.
Nothing in this paragraph shall affect nitrous oxide canisters
for any legitimate medical, dental, industrial, or automotive
use.
``(e) Sales Restrictions.--
``(1) Age and time restrictions.--
``(A) In general.--No person may sell or transfer a
nitrous oxide product to any individual under 21 years
of age.
``(B) In-person retailer requirements.--The
Secretary shall promulgate regulations regarding the
sale of nitrous oxide products to consumers in-person,
including requirements that retailers--
``(i) verify the age of consumers through
government-issued photo identification to
ensure that consumers meet the age requirement
under subparagraph (A); and
``(ii) not sell any nitrous oxide products,
except for nitrous oxide products intended for
a legitimate medical, industrial, or automotive
use, at retail stores between the hours of
10:00 p.m. and 5:00 a.m.
``(C) Delivery sellers.--
``(i) In general.--The Secretary shall
promulgate regulations regarding the sale of
nitrous oxide products in accordance with this
subparagraph.
``(ii) Requirements.--A delivery seller who
mails or ships nitrous oxide products--
``(I) shall not sell, deliver, or
cause to be delivered any nitrous oxide
products to a person under the minimum
age required under subparagraph (A);
``(II) shall use a method of
mailing or shipping that requires--
``(aa) the purchaser
placing the delivery sale
order, or an adult who is at
least the minimum age required
under subparagraph (A) for the
sale or transfer of nitrous
oxide products to sign to
accept delivery of the shipping
container at the delivery
address; and
``(bb) the person who signs
to accept delivery of the
shipping container to provide
proof, in the form of a valid,
government-issued
identification bearing a
photograph of the individual,
that the person is at least the
minimum age required under
subparagraph (A) for the legal
sale or transfer of nitrous
oxide products; and
``(III) shall not accept a delivery
sale order from a person without
obtaining the full name, birth date,
and residential address of that person.
``(iii) Limitation.--No database being used
for age and identity verification under clause
(ii)(III) shall be in the possession or under
the control of the delivery seller, or be
subject to any changes or supplementation by
the delivery seller.
``(2) Sales location restrictions.--Each retailer of
nitrous oxide products shall--
``(A) store all such products in a locked or
restricted-access area; and
``(B) ensure that such products are not visible to
the public in any retail stores.
``(3) Limits on purchase amounts.--The Secretary shall
establish a limit on the amount of a nitrous oxide product that
individual consumers may purchase.
``(4) Wholesalers.--Wholesalers of nitrous oxide products
shall not sell such product to individual consumers.''.
(b) Penalties.--Section 303(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)) is amended--
(1) in paragraph (5)--
(A) in subparagraph (A)--
(i) in the first sentence--
(I) by striking ``or (9)'' and
inserting ``(9), or (10)''; and
(II) by inserting ``or no-nitrous-
oxide-product-sale order, as
applicable,'' after ``no-tobacco-sale
order''; and
(ii) in the second sentence, by inserting
``or no-nitrous-oxide-product-sale order''
after ``no-tobacco-sale order'';
(B) in subparagraph (B), in the second sentence, by
inserting ``or nitrous oxide products, as applicable,''
after ``tobacco products'';
(C) by inserting ``or no-nitrous-oxide-product-sale
order'' after ``no-tobacco-sale order'' each place it
appears in subparagraphs (B) and (D); and
(D) in subparagraph (C), by striking ``or (9)'' and
inserting ``(9), or (10)'';
(2) in paragraph (6), by inserting ``or a no-nitrous-oxide-
product-sale order'' after ``no-tobacco-sale order'' each place
it appears; and
(3) by adding at the end the following:
``(10) Penalties for violation of nitrous oxide product
requirements.--
``(A) In general.--In the case of a person who
violates a requirement of section 569E, a civil
monetary penalty described in subparagraph (B) shall be
assessed, or a no-nitrous-oxide-product-sale order may
be imposed by the Secretary by an order made on the
record after opportunity for a hearing provided in
accordance with subparagraph (C) and section 554 of
title 5, United States Code.
``(B) Civil monetary penalties.--
``(i) Manufacturers and distributors.--In
the case of a manufacturer or distributor of a
nitrous oxide product who violates a
requirement of section 569E with respect to
manufacturing, labeling, packaging,
distributing, or introducing into interstate
commerce such a product, such manufacturer or
distributor shall be subject to a civil
monetary penalty in an amount not to exceed
$21,348 for each such violation.
``(ii) Retailers and delivery sellers.--In
the case of a retailer or delivery seller of a
nitrous oxide product who violates a
requirement of section 569E with respect to the
sale or offering for sale of such a product,
such retailer or delivery seller shall be
subject to civil monetary penalties as follows:
``(I) In the case of a first such
violation, no civil monetary penalty
shall apply, and the Secretary shall
issue a warning letter.
``(II) In the case of a second such
violation within any 12-month period,
such retailer or delivery seller shall
be subject to a civil monetary penalty
in an amount not to exceed $356.
``(III) In the case of a third such
violation within any 24-month period,
such retailer or delivery seller shall
be subject to a civil monetary penalty
in an amount not to exceed $709.
``(IV) In the case of a fourth such
violation within any 36-month period,
such retailer or delivery seller shall
be subject to a civil monetary penalty
in an amount not to exceed $2,846.
``(V) In the case of a fifth or
each subsequent such violation within
any 48-month period, such retailer or
delivery seller shall be subject to a
civil monetary penalty in an amount not
to exceed $14,232.
``(VI) No such retailer or delivery
seller shall be subject to a total
amount of civil monetary penalties
under this clause that exceeds
$100,000, for all violations of section
569E adjudicated in a single
proceeding.
``(C) No-nitrous-oxide-product-sale order.--Prior
to the entry of a no-nitrous-oxide-product-sale order
against a manufacturer, distributor, retailer, or
delivery seller under this paragraph, such
manufacturer, distributor, retailer, or delivery seller
shall be entitled to a hearing pursuant to the
procedures established through regulations of the Food
and Drug Administration for assessing civil money
penalties, including, at the request of such person, a
hearing by telephone, or at the nearest regional or
field office of the Food and Drug Administration, or at
a Federal, State, or county facility within 100 miles
from the location of an establishment of the
manufacturer, distributor, retailer, or delivery seller
if such a facility is available.''.
SEC. 4. NITROUS OXIDE HARM REDUCTION AND MISUSE PREVENTION.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399V-8. NITROUS OXIDE HARM REDUCTION AND MISUSE PREVENTION.
``(a) In General.--The Secretary shall award grants to eligible
entities for purposes of carrying out programs to reduce use of nitrous
oxide for the purpose of achieving a euphoric, psychoactive, or
intoxicating effect.
``(b) Eligibility.--To be eligible to receive a grant under this
section, an entity shall--
``(1) be a nonprofit organizations, law enforcement agency,
emergency department, poison control center, school, outreach
program, community center, mental health facility, public
health department, current recipient of Drug-Free Communities
Program funding under section 1032 of the Anti-Drug Abuse Act
of 1988, or other entity, as the Secretary determines
appropriate for the purpose of this section; and
``(2) submit an application to the Secretary, at such time,
in such manner, and containing such information as the
Secretary may require.
``(c) Use of Funds.--Eligible entities may use funds received under
this section to conduct--
``(1) targeted education campaigns warning of the dangers
of use of nitrous oxide for the purpose of achieving a
euphoric, psychoactive, or intoxicating effect;
``(2) community-based prevention and youth outreach
programs; and
``(3) training programs for law enforcement, emergency
departments, and poison control centers on identifying and
responding to nitrous oxide misuse.''.
SEC. 5. RULEMAKING AND INTERAGENCY COORDINATION.
(a) Regulations.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, in consultation with the Consumer
Product Safety Commission and the Federal Trade Commission, shall issue
regulations to carry out section 569E of the Federal Food, Drug, and
Cosmetic Act, as added by section 3.
(b) Annual Reporting.--Not later than October 31, 2027, and
annually thereafter, the Secretary of Health and Human Services, in
consultation with the Commissioner of Food and Drugs, shall submit a
report on enforcement actions, public health outcomes, and
recommendations for policy updates relating to the regulation of
nitrous oxide products, as defined in section 569E of the Federal,
Food, Drug, and Cosmetic Act, as added by section 3, including pursuant
to section 569E of the Federal Food, Drug, and Cosmetic Act (as added
by section 3), to--
(1) the Committee on Health, Education, Labor, and
Pensions, the Committee on Commerce, Science, and
Transportation, and the Committee on the Judiciary of the
Senate; and
(2) the Committee on Energy and Commerce and the Committee
on the Judiciary of the House of Representatives.
SEC. 6. AUTHORIZATION OF APPROPRIATIONS.
To carry out this Act, including the amendments made by this Act,
there are authorized to be appropriated such sums as may be necessary
for each of fiscal years 2027 through 2036.
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