Nitrous Oxide Inhalation Prevention Act
A BILL
To set forth requirements for the regulation by the Food and Drug Administration of nitrous oxide products, and for other purposes.
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
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:
“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.”
Penalties— Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended—
in paragraph (5)—
in subparagraph (A)—
in the first sentence—
by striking “or (9)” and inserting “(9), or (10)”; and
by inserting “or no-nitrous-oxide-product-sale order, as applicable,” after “no-tobacco-sale order”; and
in the second sentence, by inserting “or no-nitrous-oxide-product-sale order” after “no-tobacco-sale order”;
in subparagraph (B), in the second sentence, by inserting “or nitrous oxide products, as applicable,” after “tobacco products”;
by inserting “or no-nitrous-oxide-product-sale order” after “no-tobacco-sale order” each place it appears in subparagraphs (B) and (D); and
in subparagraph (C), by striking “or (9)” and inserting “(9), or (10)”;
in paragraph (6), by inserting “or a no-nitrous-oxide-product-sale order” after “no-tobacco-sale order” each place it appears; and
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:
“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
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.
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—
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
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.