On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory comes in response to a rise in recreational abuse and a growing number of class action lawsuits targeting N2O manufacturers.
Historically regulated by the FDA as a drug when marketed for anesthetic or analgesic purposes, N2O previously was not the subject of targeted enforcement for recreational use. This is changing. The FDA’s advisory alert names 15 recreational N2O brands and warns against these products, as many are brightly packaged, flavored with sweet or fruity additives, and designed to deliver high-volume inhalation doses. These products are widely sold at convenience stores and online retailers, often in the absence of regulatory oversight. The FDA emphasizes the serious health risks associated with the misuse of these products, including neurological damage, injury and death.
Traditional single-use N2O products have expanded into larger, refillable canisters marketed for repeated use. Many of these newer products are among those flagged by the FDA’s recent advisory alert.
Retailers offering these products face heightened exposure to enforcement actions and litigation. Given this shifting regulatory landscape, it is imperative for consumer-facing businesses to review their N2O products and assess their marketing and distribution practices. McGuireWoods’ FDA team closely tracks the evolving N2O market and monitors federal and state legislation. For assistance with product label reviews, regulatory compliance strategies and risk assessments, contact the authors.