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FDA Wants Public Input On International Scheduling Of Nitrous Oxide And Other Drugs Ahead Of WHO Meeting



The Food and Drug Administration (FDA) is seeking comment on whether a series of drugs—including nitrous oxide, as well as a ketamine-like substance, a synthetic opioid and other drugs—should be placed under international control.

In a notice published in the Federal Register on Monday, FDA said it is inviting input on the potential international scheduling of the drugs ahead of an October meeting of the the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD).

Nitrous oxide—which is medically used as an anesthetic and recreationally used as an inhalant, commonly in small canisters known as “whippits”—is currently unscheduled at the international level, as well as at the federal level in the U.S. However, certain countries like the U.K. have moved to ban the drug, drawing criticism from experts who had recommended against prohibition.

“Nitrous oxide (N2 O) is an inhalable gas that is also known by the common names, laughing gas, nitrous, whippets, NOS, or hippy-crack,” FDA said in the notice. “N2O was first used in the late 1700s as an analgesic for dental and surgical operations. It is approved by FDA as a medical gas but has seen increasing use around the world for its subjective effects.”

For the purposes of the WHO ECDD meeting, member states will be considering whether the drug should go through a pre-review process, which would determine whether it goes through a formal “critical” review that could result in a scheduling action. Another drug, the muscle relaxant carisoprodol, is also being considered for pre-review.

Six other substances—the benzodiazepines bromazolam and flubromazepam, the synthetic opioid butonitazene, the stimulants 3-Chloromethcathinone (3-CMC) and dipentylone and the dissociative 2-fluorodeschloroketamine (2-FDCK)—will also be up for critical review.

None of the eight drugs are currently listed under international control.

FDA said that any comments it receives on the substances “will be considered by [the U.S. Department of Health and Human Services] when it prepares a scientific and medical evaluation for drug substances that is responsive to the WHO Questionnaire for these drug substances.”

“HHS will forward such evaluation of these drug substances to WHO, for WHO’s consideration in deciding whether to recommend international control/decontrol of any of these drug substances,” FDA said. “Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain record-keeping requirements on them.”

While FDA is soliciting comments that will be considered as part of an HHS evaluation of the drugs, it said it will not be making a scheduling recommendation to WHO until after the body makes its own recommendation to the United National (UN) Commission on Narcotic Drugs in late 2023. Public comments will be accepted through August 24.

The federal government has welcomed comment on a number of prospective scheduling considerations by the WHO committee, receiving tens of thousands of responses when ECDD when it was looking into international scheduling of kratom in 2021, for example. The UN panel subsequently rejected a ban on the substance.

In 2020, the UN commission also voted in favor of a proposal to remove marijuana from the strictest international schedule, though it remains controlled under a separate treaty. During that same meeting, the UN rejected a WHO recommendation to clarify that CBD containing up to 0.2 percent THC is uncontrolled.

Meanwhile, a UN coalition of “special rapporteurs” appointed by the Human Rights Council recently called for an end to the global war on drugs.

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Via Wikimedia/GreenZeb.

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