FDA Suggests CBD be Changed to Schedule 5 Substance

In a newly released memo, the U.S. Food and Drug Administration said that cannabidiol (CBD) should be removed from the Controlled Substances Act (CSA); however, international drug treaties require the regulation of cannabis, including CBD.

The 27-page memo was written to advise the U.S. Drug Enforcement Agency (DEA) that CBD has “negligible potential for abuse,” “currently accepted medical use in treatment,” and that any abuse “may lead to limited physical dependence.”

Based on the FDA’s recommendation, the DEA rescheduled CBD under its least restrictive category, Schedule 5. Drugs in this category are considered to have a low potential for abuse and include over-the-counter medications like cough syrup containing codeine.

The FDA considered eight factors when making its scheduling recommendation and concluded that CBD “could be removed from control.”

“We reach this conclusion because we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA.”

Although CBD doesn’t meet the criteria for even a Schedule 5 substance, the FDA ultimately recommended categorizing it as Schedule 5 because of a letter from Robert W. Patterson, the Acting Administrator of the DEA, “asserted that the United States would not be able to keep obligations under the 1961 Single Convention on Narcotic Drugs if CBD were decontrolled under the CSA.”

However, in the memo, the FDA notes that “if treaty obligations do not require control of CBD, or if the international controls on CBD change in the future, this recommendation will need to be promptly revisited.”

The DEA announced last Friday that FDA-approved cannabis drugs with no more than 0.1 THC would be considered Schedule 5. Currently, that only includes the recently approved epilepsy medication Epidiolex.

Canada, who is also a signatory to the Single Convention on Narcotic Drugs of 1961, will officially legalize marijuana on October 17. The International Narcotics Board, “an independent, quasi-judicial expert body” established during the 1961 treaty agreement has expressed “deep concern” over cannabis legalization. It’s not clear if Canada will withdraw from the treaty.

 

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