Cannabidiol (CBD) is a compound derived from cannabis that has gained significant interest in recent years due to its potential therapeutic benefits. The FDA has taken steps to ensure that consumers and other interested parties have access to resources related to cannabis and cannabis-derived products, such as CBD. The FDA has not approved any applications for the marketing of cannabis for the treatment of any disease or condition, but 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 also concluded that products containing THC and CBD are excluded from the definition of dietary supplements according to the Federal Food, Drug and Cosmetic Act (Act FD&C). The FDA is committed to protecting public health and taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. To this end, the agency has several resources available that address cannabis and cannabis-derived products, such as CBD. The FDA wants to ensure that consumers and other interested parties have access to these resources in a centralized place. 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. The agency is aware that some states have passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. The FDA encourages research into the safety and efficacy of cannabis and its components through adequate and well-controlled clinical trials. The agency also welcomes the opportunity to speak with states that are considering supporting medical research on cannabis and its derivatives. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as wasting associated with AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy.
However, information on reports of adverse events related to cannabis use is extremely limited; the FDA mainly receives reports of adverse events from approved products. In conclusion, based on the available evidence, the FDA has concluded that products containing THC and CBD are excluded from the definition of dietary supplements according to Act FD&C. The agency is committed to protecting public health by taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products.
