The federal government is committed to protecting public health and taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. 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 health care provider. The FDA has also concluded that products containing THC and CBD are excluded from the definition of a dietary supplement under section 201 (ff) (B) of the Federal Food, Drug and Cosmetic Act (Act FD&C). The FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds, such as CBD, may offer and is committed to ensuring that consumers and other interested parties have access to resources in a centralized place.
To date, the agency has not approved an application for the marketing of cannabis for the treatment of any disease or condition. However, the FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. Epidiolex has also been approved for the treatment of seizures associated with the tuberous sclerosis complex in patients aged 1 year and older. The FDA has also approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC) that is considered the psychoactive component of cannabis.
Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived. 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. Unlike FDA-approved drugs, products that have not been reviewed by the FDA as part of the drug approval process have not been evaluated to determine if they work, what the appropriate dose may be, if they work, how they might interact with other drugs, or if they have dangerous secondary or other safety issues. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as wasting associated with AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy. 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 (NIH), 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 agency is also open to speaking with states that are considering supporting medical research on cannabis and its derivatives. Information on reports of adverse events related to cannabis use is extremely limited; however, general information on possible adverse effects may come from clinical trials that have been published or from spontaneously reported adverse events sent to the FDA. Additional information is needed on the safety and efficacy of cannabis and its components. Cannabis clinical trials conducted under an IND request could gather this important information as part of the drug development process. We welcome interested parties to submit any evidence they consider related to this issue.
Our continuous review of available evidence has not led us to change our conclusions that products containing THC and CBD are excluded from the definition of a dietary supplement under section 201 (ff) (B) of Act FD&C.
