FDA has sent warning letters to four companies for selling “unapproved animal drugs containing cannabidiol (CBD)” that are marketed for use in food-producing animals.
The U.S. Food and Drug Administration (FDA) has sent warning letters to four companies for selling “unapproved animal drugs containing cannabidiol (CBD)” that are marketed for use in food-producing animals. The companies subject to the warning letters are: Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. According to FDA, CBD is not a lawful dietary supplements due to the drug preclusion clause of the Food Drug and Cosmetics Act. CBD was investigated as a new drug and approved as Epidiolex for the treatment of epilepsy in children, therefore CBD cannot be marketed as a dietary ingredient. As a results, the products marketed by the aforementioned companies are being treated as unapproved drugs.
Claims made by the companies for the CBD products in questions include helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….”
The agency is concerned about the use of CBD in food-producing animals because of the safety risk to the animals, and the lack of data demonstrating the safety of the food products, such as meat, milk, and eggs, sourced from animals that consume CBD. The companies were given 15 working days from the date of the letter (May 26, 2022) to address the violations and prevent their reoccurrence.