The FDA says CBD products violate federal food, drug, and cosmetic law.
The US Food and Drug Administration (FDA) has sent warning letters to 4 companies selling unapproved cannabidiol (CBD) animal drugs 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 any products containing CBD for humans or animals, with the exception of a prescription drug to treat rare and severe forms of epilepsy in children.2 All other CBD products intended for use as drugs are considered unapproved drugs and their sale is illegal under the Federal Food, Drug, and Cosmetic (FD&C) Act.3
The aforementioned companies made health claims, listed in the warning letters, such as helping “farm animals suffering from stress, anxiety, pain, inflammation, injury…” and providing “a support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response…. The FDA said these statements establish the product as a drug, and therefore in violation of FD&C law.1
“While the FDA does not know the current extent of CBD use in food-producing animals, the agency is now taking action regarding these unapproved and potentially dangerous products to help protect animals and safety. of the food supply,” read an FDA press release.
The FDA has stated that the concern with 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 on the safety of human food products (meat, milk, and eggs) derived from animals that have consumed said CBD products.1
“Furthermore, the manufacturing processes of unapproved CBD pharmaceutical products have not been reviewed by the FDA as part of human or animal drug approval processes,” the FDA said in a press release. . “The FDA has received reports of certain CBD products containing contaminants such as pesticides and heavy metals, thereby introducing additional concerns for the use of CBD products.”
All letters were co-signed by the FDA’s Center for Food Safety and Nutrition and the Center for Drug Evaluation and Research.
- FDA warns four companies for illegally selling CBD products for use in food-producing animals. Press 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 – animal-producers
- FDA approves first drug with active ingredient derived from marijuana to treat rare and severe forms of epilepsy. Press 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 – grave-forms
- 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