Cannabidiol (CBD) is a compound derived from hemp that has been gaining significant interest in recent years due to its potential therapeutic and medical benefits. To be federally legal, CBD must contain no more than 0.3% THC and be derived from hemp. The US Food and Drug Administration (FDA) has not yet approved any cannabis-derived products for therapeutic or medical use, but they have approved one drug containing CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients over 1 year of age. They have also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older, as well as Marinol and Syndros for therapeutic uses in the US, including the treatment of anorexia associated with weight loss in patients with AIDS.
The FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (Act FD&C) and that may endanger the health and safety of consumers. The agency is committed to protecting public health and, at the same time, taking steps to improve the efficiency of regulatory pathways for the legal marketing of cannabis and appropriate cannabis-derived products. The FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and they want to ensure that consumers and other stakeholders have access to these resources in a centralized location. They are also 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.
The FDA is encouraging companies interested in properly marketing safe, effective, and quality products, including science-based research on the medicinal uses of cannabis, to submit applications for approval. They are also encouraging clinical trials to be conducted on the safety and effectiveness of cannabis products. The FDA remains concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses, although they have not been approved by the FDA. Often, these products are sold online and are therefore available throughout.
The sale of unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but may also put patients at risk, as these products have not been shown to be safe or effective. The FDA is aware that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis and cancer and nausea induced by chemotherapy. They are also aware that there is an exception to section 201 (ff) (B) if the substance was marketed as a dietary supplement or as a conventional food before the medicinal product was approved or before research on new drugs was authorized. The FDA is not aware of any evidence questioning its current findings that THC and CBD products are excluded from the definition of dietary supplement under section 201 (ff) (B) of the FD&C Act. Interested parties may submit to the agency any evidence they believe is relevant to this issue. In conclusion, while CBD is not yet federally legal, there is significant interest in its development for therapeutic and medical purposes. The FDA is committed to protecting public health while taking steps to improve the efficiency of regulatory pathways for legal marketing of cannabis and appropriate cannabis-derived products.
