The FDA has a clear stance on CBD derived from hemp plants: it is not yet approved for use in medicines or food and beverage products. The agency recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer, but also 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). The FDA has several 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. To date, the FDA has not approved an application 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 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.
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.
The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as the wasting of AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy. The agency's role is to review data submitted to the FDA 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 the medicinal uses of cannabis. The FDA is not aware of any evidence that could question its current findings that products containing THC and CBD are excluded from the definition of a dietary supplement under section 201 (ff) (B) of Act FD&C.
Interested parties can submit to the agency any evidence they consider related to this issue. Our continuous review of the information that has been presented so far indicates that THC and CBD products are excluded from this definition.
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