The Food and Drug Administration (FDA) has identified potential risks associated with cannabidiol (CBD) use, based on limited safety data. The agency has noted that there are “data gaps on the toxicity of CBD” and that some of the available data raises concerns about potential harm. Animal studies have shown that CBD may interfere with the development and function of testicles and sperm, lower testosterone levels, and alter sexual behavior in men. Questions also remain about the cumulative use of CBD and its impacts on vulnerable populations, such as children and pregnant or breastfeeding women. The FDA has sent warning letters to companies that illegally sold CBD products in interstate commerce, claiming to prevent, diagnose, mitigate, treat, or cure serious diseases such as cancer.
These products violated the Federal Food, Drug and Cosmetic Act (FD&C). The letters also described how companies used online stores and social media to market CBD products in ways that violated the FD&C. Consumers may also postpone obtaining important medical care due to unfounded claims related to CBD products. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. On the same day that it issued the warning letters, the FDA also released a revised consumer update detailing safety issues related to CBD products more broadly. Today's actions come at a time when the FDA continues to explore possible avenues to legally market several types of CBD products.
There are many unanswered questions and data gaps about the toxicity of CBD, and some of the available data raises serious concerns about the potential harms of CBD. The FDA cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. In addition to the fact that it has been shown to be effective in prescription form for two rare forms of epilepsy, there is no justification for CBD to be added to chocolates, candies, coffee capsules, cosmetics, pet treats, tinctures, dietary supplements, vaporizers or other products. Consumers should be aware of potential risks associated with CBD use and should consult their healthcare provider before using any CBD product.