While FDA approved the first drug containing cannibidiol (CBD), it is cracking down on certain other CBD products marketed as supplements.
In July, FDA cleared Epidiolex (GW Pharmaceuticals), which contains a purified drug substance (CBD) derived from marijuana. The new drug is indicated for seizures associated with rare forms of childhood epilepsy.
However, FDA is cracking down on certain CBD supplements that make claims of treating certain diseases or conditions.
The agency recently warned Phoenix, Ariz.-based Signature Formulations, about its manufacturing violations as well as marketing CBD-containing products as drugs.
For example, Signature claims that that its Herbal Muscle Gel and Herbal Muscle Mist helps reduce inflammation, arthritis, and back pain, and can be used to treat fibromyalgia, Carpal Tunnel Syndrome, sciatica and other conditions.
The 2 products are drugs, because they are intended to be used in the diagnosis, cure, mitigation, treatment, or prevention of disease, FDA said in its warning letter. “Specifically, these products are intended for use as external analgesics and for the treatment of other diseases (including but not limited to gout, cold, and flu),” the agency said.
In addition, Signature Formulations’ facilities had several Current Good Manufacturing Practices (CGMP) violations, including releasing OTC topical pain relief drug products (Herbal Muscle Gel, CBD Muscle Gel, and Herbal Muscle Mist) “without testing to determine conformance with their assay specifications or active ingredient label claims,” according to the warning letter.
This is not the first warning letter from FDA on CBD-containing products, and is likely not to be the last. When FDA approved Epidiolex, FDA Commissioner Scott Gottlieb, MD, emphasized that it was “not an approval of marijuana or all of its components,” he said in an FDA statement.
“This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”