FDA warns 4 companies for illegally selling CBD products intended for use in food-producing animals

The US Food and Drug Administration (FDA) sent warning letters to 4 businesses selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food animals. According to a statement released by the FDA, the companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest.¹

To date, the FDA has not approved products containing CBD for humans or animals, except for one prescription drug product to treat rare, severe forms of epilepsy in children.² All other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell under the Federal Food, Drug, and Cosmetic (FD&C) Act.³

The aforementioned companies made health claims, enumerated in the warning letters, such as 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 FDA said these statements establish the product as drugs, and therefore in violation of the FD&C Act.¹

“While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply,” read an FDA press release.

The FDA said the concern regarding these CBD products is twofold: First, there is a lack of data on the safety, efficacy, and proper dosage with respect to the health of the animal consuming the CBD products. Second, there is a lack of data about the safety of the human food products (meat, milk and eggs) derived from the animals that have consumed said CBD products.¹

“In addition, the manufacturing processes of unapproved CBD drug products have not been reviewed by the FDA as part of the human or animal drug approval processes,” said the FDA in a press release. “The FDA has received reports of some CBD products containing contaminants such as pesticides and heavy metals, thus introducing additional concerns for the use of CBD products.”

All of the letters were co-signed by FDA’s Center for Food Safety and Nutrition and the Center for Drug Evaluation and Research.

References

1. FDA warns four companies for illegally selling CBD products intended for use in food-producing animals. News release. US Food and Drug Administration. May 26, 2022. Accessed May 26, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-warns-four-companies-illegally-selling-cbd-products-intended-use-food-producing-animals
2. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. News release. US Food and Drug Administration. June 25, 2018. Accessed May 26, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms
3. Federal Food, Drug, and Cosmetic Act (FD&C Act). US Food and Drug Administration. Accessed May 26, 2022. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act