Across the United States, nitrous oxide (N2O), also known as laughing gas or nitrous, continues to be sold in convenience stores, gas stations and other easy-to-access locations with limited national enforcement. N2O serves a medical role as an anesthesia and an analgesic. In food preparation, it is used for aeration and to create bubbles in products like whipped cream, beer, seltzer and soft drinks. However, N2O has long been used as a recreational drug due to its ability to create a dissociative state through the modulation and blockage of key receptors in the brain. People suffering from substance abuse may turn to N2O to obtain cheap and convenient small nitrous charger cannisters that are easy to access, use and conceal. Recreational users rely on “crackers” or dispensers to obtain a high from N2O.
Over the past few years, N2O has gone from being available in a standard small “one hit” charger to being sold in large dispensable cannisters. Many are brightly colored, feature fruity or sweet flavors, and are sold with a tip for the user to inhale larger “hits” than with a traditional charger. These products are widely available and often sold by convenience stores due to a lack of regulation. Deaths, hospitalizations and worsening of substance abuse conditions have allegedly been linked to the widespread availability and misuse of N2O products.
On Feb. 6, 2025, a complaint alleging injuries from recreational N2O consumption was filed in the Circuit Court for the Ninth Judicial Circuit in Orange County, Florida. The family of decedent Margaret Caldwell sued several stores and manufacturers of N2O for Caldwell’s death. The plaintiffs filed a claim for strict product liability and alleged violations of Florida’s Deceptive and Unfair Practices Act and unjust enrichment. The defendants, as of the time of writing this article, have not responded to the complaint. Florida Statute 877.11(4) makes it a felony to knowingly distribute or sell more than 16 grams of N2O. Florida has also made it unlawful for any manufacturer to misbrand or adulterate a drug device in a manner that renders it unfit for human use. See Fla. Stat. §499.005(1) and (2).
The FDA considers N2O a drug when claims are made about anesthetic or analgesic effect, but if marketed as a food product N2O generally is recognized as safe. The FDA has not indicated, however, that enforcement against manufacturers is a priority at this time. While the Drug Enforcement Administration remains silent regarding N2O products, companies involved in the manufacturing and sale of N2O are urged to review state and local laws to ensure their N2O products comply with all applicable regulations.
Taking proactive steps to confirm that these products are labeled correctly, sold in the intended retail outlets and packaged in a manner that clearly discourages personal inhalation will be pivotal in preventing future civil litigation against manufacturers of N2O products. Given the recent litigation, consumer retailers of the compound should err on the side of caution when labeling and selling their N2O products in the marketplace. More importantly, it is vital for convenience stores to understand the various state laws and regulations governing the sale of N2O products sold on their shelves.
McGuireWoods’ FDA team monitors federal and state legislation to assist retail clients in mitigating their exposure to the recent rise of N2O-related litigation. Please contact the authors for product label reviews and consultations.