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FDA wants public input on international scheduling of nitrous oxide and other drugs ahead of WHO meeting

August 8, 2023 by Kyle Jaeger

The Food and Drug Administration is looking for comments on whether or not a number of drugs, including nitrous dioxide, as well a ketamine like substance, a synthesized opioid and other drugs, should be placed under international controls.

In a Federal Register notice published on Monday, FDA invited input on potential international scheduling for the drugs in advance of a meeting of the World Health Organization’s Expert Committee on Drug Dependence.

Currently, nitrous oxide, which is used medically as an anesthetic, and recreationally as an inhalant in small canisters called “whippits”, is not scheduled at both the federal and international levels in the U.S. Nevertheless, some countries, such as the U.K., have banned the drug, despite the fact that experts had advised against its prohibition.

The FDA’s notice stated that “nitrous oxide (N 2O) is a gas which is commonly known as laughing gas, nitrous gas, whippets or NOS. The FDA stated that “N 2O has been used as an analgesic since the late 1700s for dental and surgical procedures.” FDA has approved it as a medical gas, but its subjective effects have seen an increase in use worldwide.

In order to determine whether a drug will undergo a “critical” formal review, that could lead to a scheduling decision, the member states of the WHO ECDD will consider whether the drug needs a pre-review. Pre-review is also being considered in the case of another drug, muscle relaxant, carisoprodol.

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.

Currently, none of the eight drugs is listed as a controlled substance under international law.

FDA stated that any comments received on these substances “will [be considered by the U.S. Department of Health and Human Services] in preparing a scientific and a medical evaluation of drug substances that responds to the WHO Questionnaire.”

FDA stated. This control could, for example, limit the import/export of these drugs and impose record-keeping obligations.

The FDA will accept public comments until August 24. These comments will be used to inform the HHS evaluation. However, the FDA will not make a recommendation for scheduling to WHO until the UN Commission on Narcotic Drugs has made its recommendation. will accept public comments through August 24, 2018.

The Federal Government has received tens and thousands of comments from the WHO Committee when they were looking at international scheduling for kratom 2021. then rejected the ban on the substance.

In 2020, the UN Commission also voted to remove cannabis from the strictest schedule. However, it is still controlled by a separate agreement. The UN also rejected a WHO proposal to clarify that CBD with up to 0.2 per cent THC was uncontrolled.

A coalition of UN “special reporteurs” recently appointed by the Human Rights Council has called for the end to the global drug war .


DeSantis’s Florida Law Bans Marijuana Ads That Are ‘Recreational,’ While Restricting Industry Workers

Via Wikimedia/GreenZeb.

The post FDA wants public input on international scheduling of nitrous oxide and other drugs ahead of WHO meeting appeared initially on Marijuana Moment.

Kyle Jaeger
Author: Kyle Jaeger

About Kyle Jaeger

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