The U. S. Food and Drug Administration (FDA) has approved a drug, Epidiolex, containing a highly purified form of cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in people aged one year or older. This is the only plant-based drug approved by the FDA that contains CBD.
The Federal Food, Drug, and Cosmetic Act (FDCA) prohibits the sale of foods or dietary supplements that contain an “approved drug ingredient” without explicit approval from the FDA. When the FDA approved Epidiolex, a seizure medication containing CBD, it became an approved pharmacological ingredient. This measure makes the use of CBD in most products illegal without FDA approval. Ingredients derived from parts of the cannabis plant that do not contain tetrahydrocannabinol (THC) or CBD could fall outside the scope of this exclusion and could therefore be marketed as dietary supplements.
The FDA has not approved any human or animal product containing CBD, except for a prescription drug, to treat rare and severe forms of epilepsy in children. Proponents of bills related to CBD argue that there needs to be federal legislation or for the FDA to take more steps to clarify the treatment of CBD products under federal law. The FDA has released some non-binding guidance documents related to CBD products, but there are no regulations yet. With regard to products labeled as containing hemp and which may also contain THC or CBD, it is prohibited to introduce or deliver for introduction into interstate commerce any animal feed to which THC or CBD has been added.
Some studies have concluded that CBD mitigates ailments such as anxiety, insomnia, chronic pain and addiction to substances such as nicotine and heroin. There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). The FDA is conducting research to provide evidence on whether an ingredient in a drug should be approved for use in food products and currently, research into the benefits of CBD is contradictory. Limits to the FDA's research budget have posed problems for as long as the FDA has had CBD-related issues on its agenda.
EPIDIOLEX is the first and only prescription cannabidiol (CBD) approved by the FDA to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients aged 1 year or older. The FDA is now taking action with respect to unapproved and potentially unsafe products containing THC or CBD to help protect animals and the safety of the food supply.
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