FDA Enforcement Continues Against Companies Making CBD Product Claims
By Catie Wightman, Ariane Beckman
Aug 11, 2022
In June 2022, the U.S. Food and Drug Administration (FDA) issued several warning letters to companies selling food products and dietary supplements containing CBD. These letters are an important reminder that the FDA still takes the position that CBD is not a legal ingredient in foods and dietary supplements and that enforcement continues to prioritize companies marketing their products with unlawful drug claims.
These latest warning letters were sent to Young Living Essential Oils, New Sun Inc., and H2 Beverages. The FDA found several violations, including that some companies were making drug or disease claims about the products in marketing materials, on their websites, on product labels, and/or on social media. The FDA reasoned that the presence of these claims rendered the products unapproved and also misbranded new drugs. Notably, one letter focused on products marketed as safe for children, emphasizing FDA’s stated safety concerns and enforcement prioritization of products marketed or intended for use by children and other vulnerable populations.
Some examples of unlawful product claims cited by the FDA are:
- “May assist with neurological disorders,”
- “[m]ay relieve pain and inflammation, and aid with anxiety and depression,”
- “CBD Gummies may help relieve pain, inflammation, anxiety, and depression,”
- “What does CBD oil support?...addiction...Alzheimer’s...anxiety...chronic pain...depression...diabetes...drug withdrawal...epilepsy...glaucoma...inflammation...insomnia...Parkinson’s...sleep disorders...plus more!...Coming Soon, Young Living CBD Oil,”
- ““Hemp Seed Oil (CBD) is a dietary supplement, and is safe to be consumed on a daily basis by adults as well as children.”
The FDA takes the position that CBD may not be added to food or marketed as a dietary supplement. However, the FDA has historically limited enforcement to companies making drug and disease claims about such products. Under the Federal Food, Drug, and Cosmetic Act, products that are not approved as drugs by the FDA are prohibited from claiming they can diagnose, cure, treat, mitigate, or prevent a disease in humans or animals. These claims are prohibited from being included on product labels and any associated marketing materials, including websites and social media. Simply linking to a blog post about how CBD may treat a health condition is considered by FDA to be a prohibited claim, even if the claim is not about a particular product. In addition, customer reviews that include information about how a product was helpful for a particular health condition may be considered prohibited claims, even if it was posted by a customer and not the company itself.
CBD companies should ensure that labels, websites, social media pages, and customer reviews, including endorsements from third parties, do not contain any drug or disease claims. In addition, all products should meet FDA labeling requirements including a complete list of ingredients using standard ingredient names, accurate serving sizes, and proper label formatting. These letters also cited labeling violations unrelated to the legality of the CBD ingredients.
If you have any questions about your company’s compliance regarding the sale of CBD products, please reach out to the Vicente Sederberg LLP Hemp & Cannabinoids team for assistance.