The FDA’s Center for Drug Evaluation and Research has produced guidelines for research into cannabis-related ingredients that may make potential drugs.
The document covers the drug review and approval process, including clinical trials, that must be followed by research teams working with cannabis compounds. Botanical raw materials, extracts and highly purified substances of botanical origin are included within the scope of the new guidelines. However fully synthetic versions of substances that occur in cannabis are not included, as these are already regulated the same as other fully synthetic drugs.
The guidelines also lay out the approved sources of cannabis that investigators are allowed to use. For cannabis containing more than 0.3 percent of the psychoactive ingredient THC, the FDA confirm that this must be sourced from the National Institute on Drug Abuse’s (NIDA) Drug Supply Program (DSP), which is still the only domestic federally legal source. However the 2018 Farm Bill legalized hemp plants containing less than 0.3 percent THC, so researchers can now access hemp that meet this specification from any manufacturer.
Though the new guidelines offer useful clarity for researchers investigating cannabis compounds as drug candidates, they are still notable for their absence of any guidance on CBD oil. Already a big sales ticket item across the US, CBD exists in some sort of semi-legal limbo land.
While the Farm Bill legalized hemp, it did not legalize CBD, moving its enforcement from the Drug Enforcement Administration to the FDA. When the FDA approved the epilepsy drug Epidiolex, which contains CBD, it subsequently told companies that they cannot not add the ingredient to food or drink or make health claims for its use in topicals.
The FDA is currently in an open-ended consultation period over CBD that should result in the agency finally issuing regulations for its legal marketing.
“There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence,” an FDA spokesperson told website MarketWatch in written comments.
The FDA has issued warnings in situations where companies marketing CBD as supplements made unauthorized claims about cancer, arthritis and other diseases.