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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.
In an interesting move, FDA sent out eight warning letters on Feb. 4, 2016 to various makers of a dietary supplement called cannabidiol, which is derived from the Cannabis plant. Cannabidiol, which is also known as CBD oil, is described as a nonpsychoactive (no THC) dietary supplement that is purported to have numerous benefits, including anti-inflammatory and antiemetic properties. The oils are also advertised as being able to reduce depression, combat cancer, shrink tumors, facilitate wound healing, and treat other serious, chronic conditions, such as rheumatoid arthritis, schizophrenia, diabetes, lupus, and Crohn's disease, among others.
The companies that received warning letters about the claims associated with cannabidiol include Sana Te, PainBomb, Morguetorium, LLC, Michigan Herbal Remedies, HealthyHempOil.com, Dose of Nature, Green Garden Gold, and ABC Productions. FDA reviewed the websites, Etsy stores, and Facebook pages of the companies, and concluded the companies were selling products marketed as new drugs. FDA said the CBD oil products are being marketed as medications and have not been adequately tested to prove they are safe and effective. The agency wrote, “drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA.”
To FDA, CBD products are excluded from the dietary supplement definition, as CBD oil is already being investigated for its medicinal benefits in clinical trials. The agency pointed out that CBD oil is currently undergoing clinical investigation, citing GW Pharmaceuticals’ studies in the United States of the products Sativex and Epidiolex for the treatment of cancer pain and a form of epilepsy called Dravet Syndrome, respectively. The agency says that unless a clinical investigation meets the limited criteria in that particular regulation, an investigational new drug (IND) application is required for all other clinical investigations of products. Thus, any manufacturers of CBD oil making claims about clinical efficacy for the treatment of disease must file an IND with the agency and have scientific data to back up their claims.
It should be noted that in Canada, GW Pharmaceuticals’ Sativex was approved by authorities in 2005 to alleviate pain associated with spasticity in patients with multiple sclerosis. In 2007, the company got marketing authorization for the medication to treat patients who suffer from pain as a result of advanced cancer. The product is distributed in Canada by Bayer. Unlike the products marketed strictly as CBD oil, Sativex also contains the active ingredient THC.
FDA can legally issue warnings to these retailers as a result of a technicality. Interestingly, if the products by these retailers had been sold as dietary supplements prior to the issuance of GW Pharmaceuticals’ IND, there would be no problem. FDA writes in the letters, "There is an exception if the substance [CBD oil] was 'marketed as' a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD."
In an interesting news twist, a prominent seller of CBD oil is Wu-Tang Clan member Ghostface Killah, who is not related to the companies named in any of FDA’s warning letters. In a video response to Martin Shkreli, former CEO of Turing who became infamous for raising the price of Daraprim, Ghostface scolded the pharma bad boy. In the second half of the response video, the rapper used the platform and his current media notoriety to hawk Wu Goo Oil, his new CBD oil venture. Ghostface even invited his family members to give informal testimonials about the effectiveness of his new product-his sister claimed the oil helped her survive after a tumor was removed from her brain.
Sources: FDA, Mashable, Health Canada