FDA Issues Warning Letters to Four Companies Selling Unapproved CBD Products for Food-Producing Animals

On May 26, 2022, FDA issued warning letters to Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest, alleging, among other things, that the companies were illegally selling unapproved animal drugs with cannabidiol (CBD) intended to be used in food-producing animals. While some of the companies claim that the drugs are used to “[help] farm animals with stress [and] anxiety,” these drugs have not been reviewed by the FDA to evaluate their safety and effectiveness with respect to the animals themselves, as well as the potential risks raised by the presence of CBD in human food derived from these animals.

FDA further challenged the positioning of some of these companies’ products as human dietary supplements, noting that they do not meet the definition of dietary supplements under the Dietary Supplement Health and Education Act. The agency also noted its concern that animal owners will rely to their detriment on unsubstantiated claims of alleviating anxiety in animals instead of seeking professional medical care when their animals are in distress.