The warnings from the US Food and Drug Administration (FDA) highlighted the safety concerns from sales of a range of products – like feed pellets – that contained cannabidiol. The agency released the warning letters last week.
The cannabidiol (CBD) containing products were found to be in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act), the agency said.
“These particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals,” the FDA said. “Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.”
The warning letters were sent as part of an effort to clarify the agency’s regulatory approach regarding products that contain cannabis and cannabis-derived ingredients like CBD, said Amy Abernethy, FDA principal deputy commissioner.
Most CBD products have not been approved by the FDA.
“Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food,” it added.
Companies have 15 working days to tell the FDA the steps they are taking to respond to the violations and how they intend to prevent it from being repeated. If steps to address the comments in the letters are not taken, the firms in question may face legal action.
Warnings for feed use
Among the companies sent warning letters by the FDA, Oregon-based Apex Hemp Oil LLC was cited for several CBD-inclusive products including its Apex CBD livestock pellets.
After receiving the warning letter, JT Taylor, owner of Apex Hemp Oil, said the company has already taken steps to address concerns raised in the letter. It is planning to amend its labels and the wording on its products to adhere to FDA rules.
The company has removed the product listing on its website for its CBD livestock pellets, which were labeled for several species including cows, pigs, chickens and horses.
However, Taylor told us he would like to see more funding for research to explore the use of hemp or hemp-derived ingredients in livestock feed. He said hemp seed contains livestock industry-relevant vitamins and minerals along with an amount of protein and fat.
CBD use in feed products is prohibited
The inclusion of CBD in animal feed is prohibited by the FD&C Act, the agency said. “There is no animal food additive regulation that authorizes the use of CBD."
The product and those for companion animals are considered to be “unapproved new animal drugs” and to be adulterated according to the FD&C Act, the FDA said. The products are called drugs because they are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in animals and/or intended to affect the structure or any function of the body of animals.”
To be sold legally, a new animal drug has to have an approved or conditionally approved new drug application or have an index listing, the agency said. The products also have not been “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.”
“We are not aware of any basis to conclude that CBD is GRAS for use in animal foods,” the FDA continued. “The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food. We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958.”
Instead, there is a lack of data needed to support the use of CBD in animal feed and some literature reports raise safety questions for animals consuming the ingredient, the agency said. There are questions about the potential for liver toxicity and male reproductive toxicity. More information is needed, especially regarding the use of CBD with animals and livestock that produce meat, milk or eggs for human consumption, it stressed.
The FDA said it is continuing to seek ways for products with CBD to be sold lawfully. That effort includes tracking andanalyzing information on the safety of such products.