The FDA has not approved any human or animal product containing CBD, except for a drug prescribed to treat severe and rare forms of epilepsy in children. Therefore, all other CBD products intended to be used as a medicine are considered unapproved drugs and are illegal for sale. There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). The FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and recognizes the strong interest in these possibilities.
However, the FDA knows that some companies market products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (Act FD&C) and that may jeopardize the health and safety of consumers. The agency is committed to protecting public health and, at the same time, to taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. The FDA has several resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other interested parties have access to these resources in a centralized place. To date, the FDA has not approved an application 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 health care provider. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. Epidiolex has also been approved for the treatment of seizures associated with the tuberous sclerosis complex in patients aged 1 year and older.
That means that the FDA has concluded that this particular drug is safe and effective for its intended use. The agency 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 include 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 that claim to contain CBD and are marketed for therapeutic or medical purposes, even though they have not been approved by the FDA. Often, these products are sold online and are therefore available everywhere. Selling unapproved products with baseless therapeutic claims is not only a violation of the law, but it can also put patients at risk, as these products have not been proven to be safe or effective. This misleading marketing of unproven treatments also poses significant public health problems, since patients and other users can be influenced not to use approved therapies to treat serious and even fatal illnesses.
Unlike FDA-approved drugs, products that have not been reviewed by the FDA as part of the drug approval process have not been evaluated to determine if they work, what the appropriate dose may be, if they work, how they might interact with other drugs, or if they have side effects hazardous or other safety factors concerns. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as wasting associated with AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy. The FDA relies on applicants and scientific researchers to conduct research. The agency's role is to review data submitted to it in an approval request to ensure that the drug meets legal approval standards.
The FDA will continue to facilitate the 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 adequate and well-controlled clinical trials.
The agency welcomes opportunity to speak with states that are considering supporting medical research on cannabis and its derivatives in order to provide information on federal and scientific regulations. Information on reports of adverse events related to cannabis use is extremely limited; however, general information on possible adverse effects may come from clinical trials published as well as from spontaneously reported adverse events sent to FDA.
