What Does the FDA Say About CBD?

The Food and Drug Administration (FDA) has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). The FD&C Act prohibits the sale of foods or dietary supplements containing an “approved drug ingredient” without explicit FDA approval. When the FDA approved Epidiolex, a CBD drug for seizures, CBD became an approved drug ingredient. This measure makes the use of CBD in most products illegal without FDA approval, but the FDA has not issued a regulation that establishes a clear line between approved and unapproved uses of CBD in other products.

At the same time, the agency has repeatedly dismissed industry-funded research into the safety of CBD products as insufficient. The sale of these products is illegal under federal law imposed by the FDA, but because the FDA cannot crack down on all sales of food products or dietary supplements containing CBD, companies continue to sell CBD products. At a minimum, the potential harm of CBD seems to require a balance between the costs and benefits of specific products. However, the FDA has warned consumers that CBD can have potentially harmful side effects, such as liver injury. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved application for a new drug.

These products are still available for purchase, but the Cannafyl website now contains a disclaimer stating that its CBD products “are not intended to diagnose, treat, cure or prevent any disease.”For CBD data collection and analysis efforts to have maximum scientific impact, they must be designed to address the most important practical and scientific challenges in this area. Those who produce and sell CBD products and those seeking access to them will likely strive to ensure favorable changes in the law. The FDA has approved a drug, Epidiolex, containing a highly purified form of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or the tuberous sclerosis complex (TSC) in people aged one year and older. Leongini's prediction that Tuesday's meeting will not immediately break FDA's resistance to CBD without a prescription reflects what several industry experts told MJBizDaily. It is clear that understanding what the FDA says about CBD is essential for anyone interested in using it.

While there are still many unanswered questions about its safety and efficacy, it is important to be aware of what is currently known about its regulation.