Cannabidiol, commonly known as CBD, is currently high on the FDA’s priority list. As many of my readers will know, the FDA sent out official Warning Letters on February 4, 2016 to several retailers of CBD products. All of the letters were similar and later published on the FDA’s website. Click here to read the letters. A question that I often get is whether the FDA has banned CBD.
Medical claims cannot be made about CBD products, nor can they be marketed as dietary supplements. The FDA (short for “Food and Drug Administration”) is responsible for protecting public health in the USA by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the food supply, cosmetics, and products that emit radiation. Click here to read the FDA’s official statement about its activities and mandate, called “What We Do.” CBD has gotten the attention of the FDA for at least a few reasons. Primarily, the FDA is concerned about CBD suppliers making health claims. Additionally, and for reasons I’ll discuss below, the FDA contends that CBD cannot be marketed as a dietary supplement. Finally, the FDA has concerns about how much, if any, CBD is in any given batch of product being marketed and sold as CBD.
The thrust of the February Warning Letters was that the claims made by the CBD retailers established that “that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“the FDA Act”) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Despite enormous evidence that CBD offers a wide range of health benefits, this warning was pretty non-controversial. You cannot market a substance as treating any specific disease or symptom without FDA approval. As much as many of us think the FDA is overly-influenced by large pharmaceutical companies who are driven more by the profit motive than the desire to help treat disease and alleviate suffering, the fact is that we are better off having oversight as to what types of health claims can be made about particular products. The FDA does an imperfect job (at best) at this task, but the job itself is useful and beneficial to society. I’d like to see CBD approved to treat specific diseases; however, until that time comes it cannot and should not be marketed as a treatment for any specific disease or ailment.
Additionally, in the Warning Letters the FDA claimed that the retailers were illegally marketing their products as “dietary supplements” because CBD products are excluded from the definition of dietary supplement under section 201(ff)(3)(B)(ii) of the FDA Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. This is more controversial. The FDA asserted that if an article, such as CBD, has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. The FDA contends that substantial clinical investigations have been made public by virtue of GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. The problem, and hence the controversy, is that there are credible claims that CBD was being used as a dietary supplement prior to the initiation of the clinical investigations, claims which if true would make them “grandfathered” in and allowable as dietary supplements. The FDA’s position is currently firm on the matter. If you have specific information about CBD being used as a dietary supplement prior to the GW Pharmaceutical trials, I encourage you to contact the FDA. It may be that CBD is ultimately accepted as a dietary supplement by the FDA. Until such time, it would be irresponsible of me to recommend that anyone market their CBD products as such.
The FDA has not banned CBD. Based on the current state of the law, CBD products do not violate the FDA Act so long as they do not make medical claims and/or are marketed as dietary supplements. And, of course, products that are marketed as CBD but which contain little to no CBD may be violating any number of laws. Fortunately, there is a growing number of quality-driven CBD companies, many of whom I represent, who voluntarily obtain lab testing and willingly publish the results. This is a good practice because self-regulation and a focus on quality will help the growing hemp, cannabis, and CBD industry thrive.
I am a business lawyer who provides legal representation to CBD businesses, laboratories, and other legitimate businesses in the cannabis and hemp industries. If you have questions about hemp law, CBD law, or cannabis law please do not hesitate to contact me. I’d love to hear from you. Thank you for reading my blog.
Posted June 14, 2016.