Cannabidiol (CBD) products for farm animals aren’t legal, the U.S. Food and Drug Administration reiterated on Thursday.
The FDA also sent warning letters to four companies, taking aim at companies’ claims that CBD products help “farm animals with stress, anxiety, pain, inflammation, injuries,” for example, and could provide “support to help manage normal stress, promote a calming effect, maintain a healthy gut,” the FDA noted.
“These claims, among others, establish the intended use of the products as drugs,” the Administration wrote in its announcement. The companies that received warning letters are: Haniel Concepts (dba Free State Oils); Hope Botanicals; Plantacea LLC (dba Kahm CBD); and Kingdom Harvest. The four companies that received warning letters now have 15 days to respond with plans to address the “violations and prevent their recurrence,” otherwise the FDA could seek legal action and seizure.
“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,” the Administration noted.
While the 2018 Farm Bill legalized hemp, defined as cannabis plants with .3% THC or less, the FDA hasn’t yet released rules to guide the booming CBD industry. Today, unregulated CBD products are sold for human consumption in places like gas stations and grocery stores, and unregulated CBD products are also increasingly showing up in food and other products meant for animals.
Under the Federal Food, Drug, and Cosmetic (FD&C) Act, a product “intended to affect the structure or function of the body of humans or animals” is considered a drug. The FDA has “not approved any human or animal products containing CBD” as drugs, other than Epidiolex, which is intended for people with seizures.
“Therefore, all other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell,” the FDA noted in their notice about the warning letters.
There are two nuanced issues related to CBD in animal feed. The first is that CBD could “pose a safety risk for the animals themselves,” the FDA noted. But also, animals are part of the food system for human consumption, and what happens when a human eats an animal that has previously consumed CBD?
There’s a “lack of data about the safety of the human food products (meat, milk and eggs) from the animals that have consumed these CBD products,” the FDA highlighted.
“After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system,” the FDA’s warning letter announcement read. “Part of the animal drug approval process includes setting a withdrawal period to establish the minimum amount of time between the last dose of a drug and the slaughter or harvesting of food products from the treated animals.”
Additionally, the Administration said that it has received reports of CBD products that contain pesticides and heavy metals, creating additional “concerns.”
While the companies targeted in Thursday’s FDA warning letters were related to animal feed, even major chain pet stores are increasingly selling non-feed CBD products to treat, for example, anxiety and pain.
“Anxiety in animals can be a signal of a range of medical conditions requiring veterinary care from a licensed professional,” the FDA noted, adding that another layer of concern is that pet and animal owners might delay professional medical care and a “proper diagnosis” because they are “relying on unproven claims associated with unapproved CBD products.”
Hemp for animal feed and pet products is a topic of repeated interest at conferences and in state legislatures, as Cannabis Wire has reported. The National Cattlemen’s Beef Association, for example, recently registered to lobby at the national level. Their issue? “Request for further research on Hemp in animal ag feed” and “Hemp as livestock feed,” as Cannabis Wire first reported.
And at the University of Tennessee Institute of Agriculture’s 2021 Hemp Products and Animal Health Conference, Charlotte Conway, Deputy Director in the FDA’s Division of Animal Feeds, said that hemp has “accidentally” become an area of her focus over the past couple of years.
“This is something that I’ve spent a lot of hours talking to people about, and I’m getting very hopeful that we’re headed down the road to seeing some hemp-derived ingredients approved for use in animal food,” Conway said, as Cannabis Wire reported. “One of our big, big data gaps is the potential for residues to accumulate in food producing animals.”
The topic was also the focus of a panel this week hosted by the Food and Drug Law Institute, as Cannabis Wire reported.