This week, FDA issued warning letters to 15 companies for selling products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). The covered products include pet products, topicals, dietary supplements, and conventional foods (including peanut butter, water and gummies).
As we have written about [here], 2019 has seen a flurry of enforcement actions against companies marketing CBD-containing products. In this latest batch of warning letters, FDA alleges that these companies marketed CBD products in ways that violate the FD&C Act by making claims that CBD products could prevent or cure diseases in humans and/or animals, and marketing CBD products as a dietary supplement or a food additive. Significantly, this is the first time FDA has clearly stated that CBD cannot be in a dietary supplement because it is a drug.
In surveying these companies’ websites and social media, FDA cited claims such as:
- CBD product has “anti-inflammatory” properties” and can be “applied topically for temporary relief to treat pain and discomfort from arthritis, muscle strain, bruises, sprains, joint aches and backaches”.
- “CBD lowers incidence of diabetes”
- “Little known uses for CBD – CBD for opioid addiction”
- “Our treats and oil can help your dog and cat with anxiety, skin conditions, arthritis, and more”
- “What Does Conditions May CBD Be Effective For? [sic] IBS; Migraine headaches; Seizure disorders; MRSA; Cancer; Depression; PTSD; Autism; Parkinson’s; Alzheimer’s”
Some of the products cited by FDA are specifically marketed for infants and children and one product is intended for food-producing animals. These warning letters indicate that FDA remains concerned about products marketed for vulnerable populations, like infants and children, that may be at greater risk for adverse reactions, and that FDA continues to be focused on the safety of human food products.
Earlier this week, FDA also published a Consumer Update detailing its underlying safety concerns about CBD, stating that “CBD has the potential to harm you, and harm can happen even before you become aware of it.” Further, based on the lack of scientific information supporting the safety of CBD, FDA has indicated that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. This is significant because without the GRAS designation, CBD would need to be the subject of an approved food additive regulation before it could legally be used in human or animal food.
These warning letters signal that FDA may be taking a more aggressive approach with increased scrutiny of CBD products. Our food and dietary supplement lawyers regularly advise clients on the status of CBD in FDA-regulated products. If you have any questions about this Alert, or are considering marketing or selling CBD products, contact our Food and Dietary Supplement regulatory team.