14/15 June 2021
The U.S. Food and Drug Administration (FDA) recently issued several warning letters to U.S. companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, the agency published a revised Consumer Update detailing safety concerns about CBD products more broadly. "Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food", the agency says.
CBD is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. As reported before, the FDA works quickly to further clarify FDA´s regulatory approach for products containing cannabis and cannabis-derived compounds like CBD. Therefore the agency will "continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns."
According to FDA, there are a number of questions remaining regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals. In addition, the revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and mood changes.
In total, the agency sent warning letters to 15 companies. The FDA has previously sent warning letters to other companies illegally selling CBD products. Some of these products were in further violation of regulations because CBD was added to food, and some of the products were also marketed as dietary supplements. However, according to FDA, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations may promptly result in legal action, including product seizure and / or injunction.
For more detailed information please read FDA´s News Release "FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns".