As part of its efforts to shield consumers from health fraud, FDA this week sent warning letters to four companies accused of illegally selling products online to treat diseases including cancer without evidence to substantiate their marketing claims.
The products subject to the warning letters dated Oct. 31 contain cannabidiol (CBD), a substance derived from cannabis subject to clinical trials by biopharmaceutical company GW Pharmaceuticals plc., which has sought FDA approval for a drug to treat rare forms of epilepsy.
According to FDA, the activity flagged by the agency not only violates the Federal Food, Drug and Cosmetic Act (FDCA), it threatens patients because the products have not been proven effective or safe.
“The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases," the agency proclaimed in a Nov. 1 news release, announcing the warning letters.
One of the most well-known players in the CBD industry—Stanley Brothers Social Enterprises LLC, doing business as CW Botanicals and CW Hemp—received one of the four warning letters from FDA. The others were Green Roads of Florida LLC, Natural Alchemist (Alurent Inc.) and That’s Natural! Marketing & Consulting. None of the companies immediately provided comments in response to emailed requests from INSIDER.
Among the claims flagged by FDA in the warning letters: “Combats tumor and cancer cells;" “CBD makes cancer cells commit ‘suicide’ without killing other cells;" and “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer."
“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors," FDA Commissioner Scott Gottlieb, M.D., said in a statement. “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."
This isn’t the first time FDA has sent warning letters to companies selling CBD. In February 2016, for example, the public health agency advised companies that they were making claims of preventing, diagnosing, treating or curing diseases.
In citing evidence in the recent warning letters that the companies’ products are intended for use as drugs, FDA referenced website claims related to such ailments as Alzheimer’s disease, autism, bipolar disorder, cancer and heart disease.
FDA also reiterated its view that CBD products are excluded from the definition of a dietary supplement because CBD has been authorized for investigation as a new drug and meets other criteria specified in the FDCA.
GW’s CBD drug Epidiolex® has been tested to treat Lennox-Gastaut syndrome and Dravet syndrome, two forms of childhood-onset epilepsy difficult to manage. On Oct. 30, GW and its U.S. subsidiary Greenwich Biosciences announced completing rolling submission of a New Drug Application (NDA) to FDA for its CBD drug.
London-based GW anticipates FDA drug approval and launch of Epidiolex in 2018.
Stephen Schultz, vice president of investor relations with GW, did not immediately respond to a request for comment on FDA’s warning letters.