The U. S. government is committed to protecting public health and taking steps to improve the efficiency of regulatory pathways for the legal marketing of appropriate cannabis and cannabis-derived products, including cannabidiol (CBD). The FDA has not yet approved any applications for the marketing of cannabis for the treatment of any disease or condition, but has approved one cannabis-derived drug and three cannabis-related drugs.
These approved products are only available with a prescription from a licensed healthcare provider. The FDA is also concerned about the proliferation of products that claim to contain CBD and are marketed for therapeutic or medical uses, although they have not been approved by the FDA. These products are often sold online and have not been proven to be safe or effective. The FDA wants to ensure that consumers and other interested parties have access to resources in a centralized location regarding cannabis and cannabis-derived products, such as CBD.
The agency has approved Epidiolex, which contains a purified form of the drug CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. It has also approved Epidiolex for the treatment of seizures associated with the tuberous sclerosis complex in patients aged 1 year or older. Marinol and Syndros, which include the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC) that is considered the psychoactive component of cannabis, have also been approved by the FDA for therapeutic uses in the United States. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is obtained synthetically. The FDA remains committed to facilitating the work of companies interested in properly marketing safe, effective, and quality products derived from 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 agency also welcomes opportunities to talk to states that are considering supporting medical research on cannabis and its derivatives. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as wasting caused by AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy. However, selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law but can also put patients at risk since these products have not been proven to be safe or effective. The FDA encourages interested parties to submit evidence related to this topic. Clinical trials on cannabis conducted under an IND request could collect important information as part of the drug development process.
The agency is also open to discussing any evidence that could challenge its current findings that THC and CBD products are excluded from the definition of dietary supplement under section 201 (ff) (B) of Act FD&C.