FDA has been very clear that CBD is not approved for any uses in food or as a dietary supplement, and it has approved only one human prescription drug use. In May, the agency made it just as clear that CBD is not approved in drugs that are intended for use in food-producing animals through its issuance of warning letters to four companies. As stated in the FDA update, “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 issuance was followed by an FDA tweet stating, “CBD products for food-producing animals are of particular concern to the FDA.” While the agency expressed concern about the safety risk that CBD could pose for the animals themselves, it also noted the lack of data about the safety of the human food products (meat, milk and eggs) from the animals that have consumed these CBD products.
When a food-producing animal is treated with a drug, residues can remain in the animal’s milk, eggs, or meat if the drug is not completely out of the animal’s system when the food is harvested (e.g., milking, egg collection) or the animal slaughtered. It is for this reason that withdrawal periods are established for drugs when they are approved, with a minimum period between last dose and slaughter/food harvesting. But because CBD is not an approved animal drug, there has been no assessment of the length of time the CBD may stay in the animal’s system to enable the establishment of a safe withdrawal period. Thus, there is a lack of data on the residues that may result when food-producing animals consume CBD products and the resulting safety of the person who consumes products from that animal.
Other FDA concerns about CBD in food-producing animals include the lack of data on efficacy, proper dosage, the potential of dangerous side effects or other safety concerns, and the potential that the reliance on an unproven CBD claim may cause an animal owner to postpone medical care for the animal. Additionally, because CBD inclusion is not legal, the animal food or drug manufacturing processes have not been reviewed or approved, and the products may contain higher than acceptable levels of pesticides, heavy metals or not have been safely produced.
FDA continues to state that it recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant public interest in these possibilities. However, until the agency’s questions are satisfactorily answered about the science, safety, and quality of products containing cannabis and CBD, it is unlikely that approvals for use in foods or by food-producing animals will be given. And, until then, the agency will continue to warn companies to cease sales of and remove from market any such CBD products “to help protect animals and the safety of the food supply.” Since CBD is still relatively new, it may take some time before the FDA will be able to make a determination regarding its safety. Additionally, the European Food Safety Authority’s (EFSA) recent citing of data gaps and uncertainties about the potential hazards related to consumption of CBD as the reason it cannot make an accurate safety determination for CBD as a novel food does not bode well for a speedy resolution by the FDA.