Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products sold online that allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication.
These actions were not surprising given FDA Commissioner Scott Gottlieb’s recent testimony before Congress, during which he addressed the Agency’s role in cracking down on such claims and said that FDA would “have some answers…soon because I think we do bear some responsibility to start to address these questions,” a development we covered in one of our weekly cannabis roundup posts.
The companies receiving the Warning Letters made claims regarding their products preventing, reversing or curing cancer, killing/inhibiting cancer cells or tumors, or other similar anti-cancer claims. More specifically, the companies said about their products:
- “Combats tumor and cancer cells;”
- "CBD makes cancer cells commit ‘suicide’ without killing other cells;”
- “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
- “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer."
Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.
This is not the first time the Agency has taken enforcement action against firms selling CBD products with unsubstantiated claims (see, e.g., here). However, FDA’s recent actions will no doubt have a chilling effect on marketing efforts in the rapidly-expanding medical marijuana industry. Leaving no doubt about what industry can expect, Commissioner Gottlieb said that “[w]e 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 Agency is not alone in addressing cannabis product marketing practices. For example, in September 2017, the Office of the Attorney General (OAG) of Washington State sent a letter to marijuana retailers in which OAG reminded industry of the State’s ban on making curative or therapeutic claims in marijuana advertisements, including on websites. In the letter, Shannon Smith, Senior Assistant Attorney General and Chief of the Consumer Protection Division, said that despite the State’s prohibition, her office has investigated several marijuana retailers for making medical claims on their websites.
As noted above, FDA has not approved marijuana, a Schedule I controlled substance, for any indication. However, the Agency has approved Marinol® and Syndros™ for therapeutic uses, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol® and Syndros™ include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of marijuana. Another FDA-approved drug, Cesamet™, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived. Moreover, FDA has indicated that it supports access to investigational drugs derived from marijuana. For example, the Agency granted an investigational new drug application (IND) for a Phase II/III clinical trial of Epidiolex® (cannabidiol) in the treatment of Dravet Syndrome. Earlier this week, GW Pharmaceuticals announced that it completed its rolling new drug application (NDA) submission to FDA for Epidiolex® (cannabidiol) as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy.