The AVMA has produced an updated and comprehensive guide to cannabis and cannabidiol (CBD) that includes current scientific research and an overview of federal regulation. The complete document is available in the AVMA members only section.
The publication reaffirms information previously shared by OVMA and others regarding FDA direction on CBD products. Key points include:
Drug Classification
“With respect to cannabidiol (CBD), the FDA states ‘any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than food) and any product that is intended to affect the structure or functions of the body of humans or animals is a drug.’ The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.”
Inclusion in Food
“Analogous to a new animal drug application, an approved food additive petition is needed for the food additive to legally enter the marketplace.” To date, it is reported that “no applications for cannabis-derived substances to be approved in pet food or animal feed as food additives have been submitted.”
Dietary Supplements
“FDA indicates that DSHEA (Dietary and Health Supplement and Health Education Act) only applies to products for use in humans. Therefore, if a product is marketed as a dietary supplement intended for animals, it is regulated by the FDA as either a drug or a food: there is no statutory language that defines ‘dietary supplements’ for use in animals.”
FDA Enforcement Actions
Finally, to reaffirm previously reported FDA enforcement action, the AVMA document reports: “At the end of November 2019, the FDA had sent at least 22 warning letters to companies illegally selling CBD products, because the companies claimed they could prevent, diagnose, treat or cure disease. Fifteen of these warning letters included mention of products targeted towards animals.
“In some cases, there were additional violations of the FDCA because these products were marketed as dietary supplements or because they involved the addition of CBD to food. In some cases, letters were co-signed by the Federal Trade Commission because of concerns about unsubstantiated advertising which is a violation of the Federal Trade Commission Act.”
