The FDA has not approved any over-the-counter (OTC) drugs that contain CBD and none of these products meet the requirements to be legally marketed without an approved new drug application. The agency is aware that some companies are marketing products that contain cannabis and cannabis-derived compounds in forms that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may jeopardize the health and safety of consumers. The FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds can offer and recognizes the strong interest in these possibilities. To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. However, the FDA has approved a drug derived from cannabis and three cannabis-related products.
These approved products are only available with a prescription from an authorized healthcare 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 1 year of age or older. Epidiolex has also been approved for the treatment of seizures associated with the 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 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 claiming to contain CBD that are marketed for therapeutic or medical uses, even if they have not been approved by the FDA. Often, these products are sold online and are therefore available throughout. Selling unapproved products with unsubstantiated 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 deceptive marketing of unproven treatments also poses significant public health problems, as patients and other users can be influenced not to use approved therapies to treat serious and even fatal diseases. Unlike FDA-approved drugs, products that have not undergone FDA review as part of the drug approval process have not been evaluated to determine if they work, what the appropriate dose may be if they do, how they might interact with other drugs, or if they have side effects dangerous or other type of security worries. The FDA is aware that unapproved cannabis or cannabis-derived products are used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy.
The agency's role is to review data submitted to the FDA in a request for approval 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 scientific research on the medicinal uses of cannabis. The FDA is aware that several states have passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research on the safety and efficacy of cannabis products through appropriate and well-controlled clinical trials. We welcome the opportunity to speak with states considering supporting medical research into cannabis and its derivatives. Additional information on possible adverse effects of cannabis use and its components may come from published clinical trials, as well as spontaneously reported adverse effects submitted to the FDA.
Additional information is needed on the safety and efficacy of cannabis and its components. Cannabis clinical trials conducted under an IND request could collect this important information as part of the drug development process. An exception to section 201 (ff) ((B) exists if the substance was marketed as a dietary supplement or as a conventional food before the drug was approved or before new drug investigations were authorized, as appropriate. However, based on available evidence, the FDA has concluded that this is not the case for THC or CBD. The FDA is not aware of any evidence that would challenge its current findings that THC and CBD products are excluded from the definition of a dietary supplement under section 201 (ff) ((B) of the FD&C Act. Our ongoing review of the information that has been submitted thus far has not called our conclusions into question.
Interested parties may submit to the agency any evidence they believe relates to this topic.
