The FDA is aware of the potential opportunities that cannabis or cannabis-derived compounds, such as cannabidiol (CBD), can offer. However, the agency is committed to protecting public health and taking steps to improve the efficiency of regulatory pathways for the legal marketing of cannabis and appropriate cannabis-derived products. To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. 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 agency 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.
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. 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. 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.
The agency welcomes the opportunity to speak with states considering supporting medical research into cannabis and its derivatives, so that it can provide information on federal and scientific standards. Additional information on research on the medical use of cannabis is available from the National Institutes of Health, in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA). Information from reports of adverse events related to cannabis use is extremely limited; FDA mainly receives adverse event reports for approved products. General 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. 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. Interested parties may submit to the agency any evidence they believe relates to this topic. Our ongoing review of the information that has been presented so far has not led us to change our conclusions.
