USA—The U.S. Food and Drug Administration (FDA) has issued warning letters to Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest, alleging, that the companies were illegally selling unapproved animal drugs with cannabidiol (CBD) intended for use in food-producing animals.
While some of the companies claim that the drugs are used to “[help] farm animals with stress [and] anxiety,” anxiety in animals can be a signal of a range of medical conditions requiring veterinary care from a licensed professional.
Therefore, the FDA is concerned that consumers may put off seeking professional medical care for their animals, such as getting a proper diagnosis, treatment and supportive care, because they are relying on unproven claims associated with unapproved CBD products.
The announcement said that, “The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children.”
In addition to potential safety risks for the animals consuming them, the FDA announcement also mentioned the lack of data regarding the safety of human food products—such as meat, milk and eggs—that are produced from the animals that have consumed the CBD products in question.
Although hemp and hemp-derived products containing no more than 0.3 percent THC by dry weight were legalized under the 2018 Farm Bill, the FDA has yet to enact regulations allowing for the marketing of such products in the human or animal food supply.
In addition to the CBD products marketed for food-producing animals, Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest also sell CBD-containing unapproved new drugs for humans and adulterated human foods.
Some of the products were also marketed as dietary supplements even though CBD-containing products do not meet the definition of a dietary supplement under the Dietary Supplement Health and Education Act.
The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to which, they FDA may pursue legal action against them, including product seizure and/or injunction.
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