The FDA has repeatedly stated that it cannot establish any regulations for over-the-counter hemp products due to lack of data to prove their safety. Additionally, since CBD is an active ingredient in a prescription drug, Epidiolex, the agency cannot regulate non-pharmaceutical CBD. 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 compounds derived from cannabis may offer and is committed to protecting public health while taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products.
To date, the agency has not approved a request to commercialize 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 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 aged 1 year or older.
It has also approved Epidiolex for the treatment of seizures associated with the tuberous sclerosis complex in patients 1 year of age or older. Marinol and Syndros have also been approved for therapeutic uses in the United States, including for 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 though they have not been approved by the FDA. Often, these products are sold online and are therefore available across the country.
Selling unapproved products with unfounded 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 raises significant public health problems, since patients and other consumers can be influenced not to use approved therapies to treat serious and even fatal diseases. The FDA relies on applicants and scientific researchers to conduct research on cannabis and its derivatives. The agency will continue to facilitate the work of companies interested in adequately bringing safe, effective and quality products to the market, including scientifically based research on the medicinal uses of cannabis. The National Institutes of Health, in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), can obtain additional information on research on the medical use of cannabis. It is important to conduct medical research on the safety and efficacy of cannabis products through appropriate and well-controlled clinical trials.
The FDA welcomes the opportunity to speak with states that are considering supporting medical research on cannabis and its derivatives, so that they can provide information on federal and scientific standards. Information on reports of adverse effects on cannabis use is extremely limited; however, general information on possible adverse effects may come from published clinical trials as well as from spontaneously reported adverse events sent to the FDA. The FDA knows that several states have passed laws that eliminate state restrictions on the medical use of cannabis and its derivatives or are considering doing so. Interested parties may submit to the agency any evidence they consider related to challenge its current findings that products containing THC and CBD are excluded from the definition of dietary supplement under section 201 (ff) (B) of Act FD&C.
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