CBD is one of the hundreds of components found in marijuana, and it does not cause euphoria on its own. The US government has recognized the potential of cannabis and its components, including cannabidiol (CBD), for therapeutic and consumer products. The FDA is committed to protecting public health and taking steps to improve the efficiency of regulatory pathways for the legal marketing of cannabis-derived products. To date, the FDA has not approved any applications for the marketing of cannabis for the treatment of any disease or condition.
However, the FDA 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 has also issued warnings about companies that market products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (Act FD&C). The FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and wants to ensure that consumers and other interested parties have access to these resources in a centralized location.
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 tuberous sclerosis complex in patients aged 1 year or older. Marinol and Syndros have been approved for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS. Marinol and Syndros contain 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 obtained synthetically. The FDA remains concerned about companies that market products claiming to contain CBD and that are marketed for therapeutic or medical uses without being approved by the FDA. These products have not been proven to be safe or effective, and can put patients at risk. This misleading advertising of unproven treatments also raises significant public health problems since patients can be influenced not to use approved therapies to treat serious diseases.
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. The FDA depends on applicants and scientific researchers to conduct its research on safety and efficacy of cannabis products through appropriate and well-controlled clinical trials. The agency's role is to review data submitted to it in an application for approval to ensure that the drug meets legal approval standards. The FDA will continue to facilitate work of companies interested in properly marketing safe, effective and quality products including science-based research on medicinal uses of cannabis.
The National Institutes of Health provide additional information on research on medical use of cannabis. The FDA knows that several states have passed laws that remove state restrictions on medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research on safety and efficacy of cannabis products through appropriate clinical trials. The agency welcomes opportunity to talk to states that are considering supporting medical research on cannabis and its derivatives so that it can provide information on federal regulations.
Information in reports of adverse events related to cannabis use is extremely limited; however, general information on possible adverse effects may come from published clinical trials as well as from spontaneously reported adverse events sent to the FDA.
