July 2, 2022

Volume XII, Number 183

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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.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 147
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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