Cannabidiol (CBD) is a compound derived from cannabis that has been gaining popularity in recent years due to its potential therapeutic benefits. There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including CBD. However, the US Food and Drug Administration (FDA) has not approved any applications for the marketing of cannabis or cannabis-derived products for the treatment of any disease or condition. The FDA has approved one cannabis-derived drug and three cannabis-related drugs, all of which are only available with a prescription from a licensed healthcare provider.
Epidiolex, which contains a purified form of the drug substance CBD, has been approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. Marinol and Syndros, which contain the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC), have been approved for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS. Cesamet, which contains the active ingredient nabilone, has also been approved. The FDA remains concerned about the proliferation of products that claim to contain CBD and are marketed for therapeutic or medical purposes, even though they have not been approved by the FDA.
Selling unapproved products with baseless therapeutic claims is not only a violation of the law, but it can also put patients at risk, as these products have not been proven to be safe or effective. This misleading marketing of unproven treatments also poses significant public health problems, since patients and other users can be influenced not to use approved therapies to treat serious and even fatal illnesses. The FDA has several resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other interested parties have access to these resources in a centralized place. The agency is committed to protecting public health and, at the same time, to taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. The FDA knows that several states have passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so.
It is important to conduct medical research on the safety and efficacy of cannabis products through adequate and well-controlled clinical trials. The FDA will continue to facilitate the work of companies interested in properly marketing safe, effective and quality products, including science-based research on the medicinal uses of cannabis. The National Institutes of Health, in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), provide additional information on research on the medical use of cannabis. The FDA also encourages interested parties to submit evidence related to this issue. In conclusion, while there are no other FDA-approved drugs that contain CBD, there are several resources available that address cannabis and cannabis-derived products such as CBD. The FDA is committed to protecting public health by taking steps to improve the efficiency of regulatory channels for legal marketing of appropriate cannabis and cannabis-derived products.