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 facilitate the legal marketing of appropriate cannabis-derived products.
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 stakeholders have access to these resources in a centralized location. 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 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 without being approved by the agency. These products are often sold online and can put patients at risk since they have not been proven to be safe or effective.
Selling unapproved products with unfounded therapeutic claims is not only illegal but can also raise significant public health problems since patients may 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 AIDS wasting, 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's role is to review data submitted in an approval request to ensure that the drug meets legal approval standards. The agency will continue to facilitate the work of companies interested in bringing safe, effective, and quality products to market including scientifically based research on the medicinal uses of cannabis. The National Institutes of Health (NIH), particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA), can provide additional information on research on medical use of cannabis. The FDA knows that several states have passed laws eliminating 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 and well-controlled clinical trials. The agency welcomes opportunities to speak with states considering supporting medical research on cannabis and its derivatives so that it can provide information on federal and scientific standards. Information on reports of adverse effects from cannabis use is limited; the FDA primarily receives adverse event reports for approved products. General information on possible adverse effects from use of cannabis and its components may come from published clinical trials as well as from spontaneously reported adverse events sent to the FDA. Additional information is needed on safety and effectiveness of cannabis and its components. Clinical trials with cannabis conducted pursuant to an Investigational New Drug (IND) application could collect this important information as part of drug development process. 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 as appropriate.
However, based on available evidence, FDA has concluded this is not case with THC or CBD. The FDA is not aware of any evidence challenging its current findings that products containing THC and CBD are excluded from definition of dietary supplement under section 201(ff)(B) of Food Drug & Cosmetic Act (FD&C). Interested parties may submit evidence they consider related to this issue.