As an expert in the field, I am often asked about the regulation of cannabidiol (CBD) by the FDA. It is important to note that while the FDA has approved one drug derived from cannabis and three related to cannabis, they have not approved any other cannabis products currently available on the market. This means that any product claiming to contain CBD and marketed for therapeutic or medical uses has not been approved by the FDA and may pose a risk to consumers. The FDA's role is to review data submitted by companies seeking approval for their products and ensure that they meet legal standards for safety and efficacy. Currently, the only FDA-approved cannabis product is Epidiolex, which contains a purified form of CBD and is used to treat seizures associated with certain conditions.
The agency has also approved Marinol and Syndros for therapeutic uses, which contain synthetic versions of delta-9-tetrahydrocannabinol (THC), the psychoactive component of cannabis. While the FDA is aware that some states have passed laws allowing for the medical use of cannabis and its derivatives, it is important to conduct proper medical research through clinical trials to determine their safety and efficacy. The FDA welcomes the opportunity to work with states interested in supporting this research and can provide information on federal and scientific standards. It is also worth noting that there is limited information available on the potential adverse effects of using cannabis and its components. The FDA primarily receives reports of adverse events from approved products, but additional information can be gathered through clinical trials conducted with an Investigational New Drug (IND) request. Despite claims made by some companies, the FDA has concluded that THC and CBD products are not considered dietary supplements under the FD&C Act. This means that they are subject to different legal requirements, including current good manufacturing practices (CGMP) and labeling regulations. As an agency, the FDA remains committed to ensuring that safe, effective, and quality products are available to consumers.
We continue to monitor the market for unapproved cannabis products and take action against those that pose a risk to public health. Our goal is to protect consumers while also facilitating research on the potential medical uses of cannabis.
