FDA Requests Input From Veterinarians on Use of CBD Products
The U.S. Food and Drug Administration’s Center for Veterinary Medicine has requested public comments, particularly from veterinarians, on the use of cannabis-derived products (CDPs) for animals. The emphasis is on CBD products and information ranging from the benefits of use to toxicological concerns.
Veterinarians are asked to help the FDA better understand how they are using CDPs for animals and the effects they have seen as a result. Their experiences and insights are crucial in shaping the FDA’s understanding and potential regulation of these products. The focus is on hemp-derived products, meaning the cannabinoids like CBD are extracted from Cannabis sativa L. These products would have no more than 0.3% THC on a dry weight basis.
Currently, there are no animal drugs containing CBD that are FDA-approved. Under the Animal Medicinal Drug Use Clarification Act of 1994, veterinarians are allowed to prescribe approved human drugs for animals. Numerous CBD products for animals claim they treat various conditions and diseases or promote wellness. However, the FDA has not approved them, thus the Request for Information (RFI).
The FDA wants to know if veterinarians are using or recommending hemp-derived cannabis products and if they have prescribed or dispensed the only approved cannabis-based drugs for humans: Epidiolex, Marinol and Syndros. Explanations about the effects of cannabis-derived products, drug interactions, preferred brands, labeling issues and factors influencing the decision to use cannabis-derived products are some of the additional information requested.
When an animal’s health is threatened, or the animal is suffering, or at risk of death without treatment, veterinarians are permitted to prescribe extra label uses of human and animal drugs when certain conditions are met. An extra label means the drug is used in a way that is not in accordance with approved label directions. Extra label use of a human drug in an animal-producing food is only allowed when an animal drug approved for use cannot be used.
The catch is that if there is no scientific information about the safety of using an approved human drug in a food-producing animal, the veterinarian must ensure the animal and its food products do not become part of the human food supply. That places a responsibility on the veterinarian that may be difficult to manage.
The RFI says,
“FDA is seeking a better understanding of what veterinarians are experiencing related to CDPs in their patients, such as general patterns of use ( i.e., animal species, brands, formulations, doses, indications for use), quality standards, benefits of use, potential drug interactions, adverse events and safety problems, and toxicological concerns.”
The goal is to establish regulations for the CBD market. However, the agency has been struggling with evaluating and regulating the CBD market for humans for years despite significant research data now available.
The RFI is intended to collect data on the use of CDPs in animals, but it also says the same thing the agency says about human use of CBD. “…further research is necessary to assess the safety and effectiveness of these products.” It is unlikely there will be regulatory changes in the near future.
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