The federal government's official website often ends in .gov or .mil, so it's important to make sure you're on a legitimate site before sharing sensitive information. There is a great deal of interest in the potential of cannabis and its components, such as cannabidiol (CBD), to create therapies and other consumer products. The Food and Drug Administration (FDA) recognizes this potential and is committed to protecting public health while also improving the efficiency of regulatory channels for the legal marketing of appropriate cannabis-derived products. To that end, the FDA has compiled a list of frequently asked questions and answers about hemp and its legality at the federal level.
To date, the FDA has not approved any applications for the marketing of cannabis for the treatment of any disease or condition. However, the agency 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. Epidiolex, which contains a purified form of CBD, has been approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged one year and older, as well as for the treatment of seizures associated with tuberous sclerosis complex in patients aged one year and older.
This means that the FDA has determined that this particular drug is safe and effective for its intended use. 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 contain dronabinol, a synthetic form of delta-9-tetrahydrocannabinol (THC), which is considered to be the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains nabilone, which has a chemical structure similar to THC and is synthetically derived.
The FDA is concerned about products that claim to contain CBD and are marketed for therapeutic or medical purposes without having been reviewed by the agency as part of the drug approval process. These products are often sold online and can put patients at risk since they have not been proven to be safe or effective. Additionally, this misleading marketing of unproven treatments can lead to significant public health problems if patients are influenced not to use approved therapies to treat serious illnesses. Unlike FDA-approved drugs, products that have not been reviewed by the FDA have not been evaluated to determine if they work, what dose may be appropriate, how they may interact with other drugs, or if they have dangerous secondary effects 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 AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy. The FDA will continue to facilitate research into safe, effective, and quality products derived from cannabis, including research into its medicinal uses. The National Institutes of Health (NIH), particularly the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), provide additional information on research into medical uses of cannabis. The agency also welcomes opportunities to speak with states that are considering supporting medical research on cannabis and its derivatives in order to provide information on federal regulations and scientific standards.
Information on reports of adverse events related to cannabis use is limited; most reports come from approved products. General information on possible adverse effects from using cannabis or its components may come from clinical trials that have been published or from spontaneously reported adverse events sent to the FDA. Additional information is needed on safety and efficacy of cannabis and its components; clinical trials conducted under an Investigational New Drug (IND) request could provide this important information as part of the drug development process.
