The term “hemp” refers to the plant Cannabis sativa L. and is officially recognized by the federal government. There is a great deal of interest in the development of therapies and other consumer products derived from cannabis and its components, such as cannabidiol (CBD). The Food and Drug Administration (FDA) is committed to protecting public health while also taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. To date, the FDA has not approved any requests to commercialize 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. The FDA has approved Epidiolex, which contains a purified form of CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year or older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or 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 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 that of THC and is synthetically derived. The FDA remains concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses, even though they have not been approved by the FDA. These products are often sold online and are therefore available across the country. Selling unapproved products with unfounded therapeutic claims is not only illegal but can also put patients at risk since these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health problems since patients and other consumers can be influenced not to use approved therapies to treat serious and even fatal diseases.
Unlike drugs approved by the FDA, products that have not been reviewed by the agency as part of the drug approval process have not been evaluated to determine if they work, what the appropriate dose might be if they work, how they might interact with other drugs, or if they have dangerous side effects or other safety problems. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions such as emaciation associated with AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy. The agency relies on applicants and scientific researchers to conduct research on these products. The FDA will continue to facilitate the work of companies interested in adequately bringing safe, effective and quality products to the market, including scientifically based research on the medicinal uses of cannabis. The National Institutes of Health (NIH), particularly the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), can provide additional information on research on medical use of cannabis. It is important to conduct medical research on the safety and efficacy of cannabis products through appropriate and well-controlled clinical trials. The FDA knows that several states have passed laws that eliminate state restrictions on medical use of cannabis and its derivatives or are considering doing so. The agency's role is to review data submitted in an approval request to ensure that it meets legal approval standards.
The FDA will continue to facilitate work of companies interested in bringing safe, effective and quality products to market, including scientifically based research on medicinal uses of cannabis. The FDA is not aware of any evidence that could challenge its current findings that products containing THC and CBD are excluded from definition of dietary supplement under section 201 (ff) (B) of Act FD&C. Interested parties may submit evidence related to this issue. The agency's continuous review of information has shown that there is an exception to section 201 (ff) (B) if substance was marketed as dietary supplement or conventional food before drug was approved or before new pharmacological research was authorized.