Under the US Federal Food, Drug, and Cosmetic (FD&C) Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.
The US Food and Drug Administration (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. Therefore, it stressed that all other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell.
The regulatory body noted some of the claims made by the companies sent the warning letters refer to 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….’
“These claims, among others, establish the intended use of the products as drugs,” said the FDA.
The agency said it has not evaluated such drugs to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.
It is concerned about these CBD products for use in farmed animals not only because CBD could pose a safety risk for the animals themselves, but also because of lack of data about the safety of the meat, milk and eggs derived from animals that would have consumed such products.
To date, there is a lack of data on the residues that may result when food-producing animals consume CBD products, said the FDA. There is also a lack of data on what levels of potential residues are safe for a person consuming the foods that come from CBD-treated animals, it noted.
In addition, said the watchdog, it has not reviewed the manufacturing processes of unapproved CBD drug products as part of the human or animal drug approval processes. It also said it had received reports of some CBD products containing contaminants such as pesticides and heavy metals, thus introducing additional concerns for the use of CBD products.
Companies could face legal action
In addition to the CBD products marketed for food-producing animals, the FDA said 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.”
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 promptly address the violations may result in legal action, including product seizure and/or injunction, it said.