The U.S. Food and Drug Administration noted that cannabidiol shouldn’t be a controlled substance, but international treaties require the United States to treat it as one, the federal agency said in a 27-page memo written after it approved the first drug made with CBD earlier this year.
“CBD has negligible potential for abuse,” wrote Dr. Brett Giroir, the assistant secretary for health in the U.S. Health and Human Services Department, FDA’s parent agency.
Giroir noted that CBD doesn’t meet the description of even the least-restrictive class of controlled substances, Schedule 5, but that international drug treaties require the nation to control the cannabis extract.
If those treaties were to change, he added, “the above recommendation … would need to be revised promptly.”
The letter was written to advise the U.S. Drug Enforcement Agency about how to classify CBD. Before then, the DEA considered cannabis extracts to be in the most restrictive class of drugs, Schedule 1.
The letter was dated May 16 but made public Friday, after the DEA announced that FDA-approved cannabis drugs with no more than 0.1% THC could be classified as Schedule 5. Currently, that definition only applies to Epidiolex.
The DEA said that cannabis extracts with more than 0.1% THC will remain on Schedule 1.
Epidiolex is manufactured and sold by London-based GW Pharmaceuticals, which derives the extract from marijuana and trades on the Nasdaq as GWPH.
