The U.S. Food and Drug Administration issued warning letters to four CBD companies Oct. 31, stating that companies selling products and making unsubstantiated claims to cure or treat cancer are in violation of the Federal Food, Drug and Cosmetic Act.
The FDA issued warning letters to Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC.
The letters cited an FDA investigation that probed into the companies’ websites and social media for claims “regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases,” according to an FDA release.
The FDA is interested in seeing more substantiated, clinical research on cannabinoid medicines, however.
“We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website,” FDA Commissioner Scott Gottlieb said. “We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”
Gottlieb said, “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products.”
The warning letters mentioned existing clinical investigations into CBD and cannabinoid medicines that the FDA considers legitimate.
“The existence of substantial clinical investigations regarding CBD has been made public,” they wrote to Stanley Brothers Social Enterprises. “For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. Under FDA’s regulations [21 CFR § 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND [Investigational New Drug application] is required for all clinical investigations of products that are subject to section 505 of the Act.”
“FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue.” The FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.
“We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,”Gottlieb said.