FDA requests Information on the Use of Cannabis Products in Animals

The market for cannabis-derived products (CDPs) has grown significantly in recent years since the US government lifted certain restrictions related to specific aspects of cannabis use and distribution. As a result, the US Food and Drug Administration (FDA) is seeking comments related to the use of cannabis-derived products (CDPs) in animals, with a focus on cannabidiol (CBD) products.

Companies marketing CBD products for use in animals often make claims related to a variety of diseases or conditions. Some products also claim to improve general wellbeing and promote longevity. These products are marketed in many different formulations, such as tinctures/oils, treats/chews, pellets, capsules, and sometimes as food toppers or infused into food. There are also topical products such as balms and shampoos. However, there are currently no FDA-approved, conditionally approved, or indexed veterinary drugs containing CBD. In terms of human drugs, the FDA has approved one cannabis-derived drug (EPIDIOLEX (CBD)), and the following three synthetic cannabis-related drugs:

  • MARINOL (Dronabinol),
  • SYNDROS (Dronabinol), and
  • CESAMET (Nabilone).

Under certain conditions, veterinarians can legally prescribe approved human medicines for use in animals (off-label use).

Questions to Consider

The FDA's Center for Veterinary Medicine (CVM) has issued a Request for Information (RFI) seeking comments from the public, particularly veterinarians, on the use of CDPs in animals. The agency is particularly interested in input on 10 questions regarding veterinarians' experiences with CDPs in their animal patients. The questions focus on general trends related to CDPs, such as

  • Information on usage trends (e.g., product selection, indications, etc.),
  • Quality standards,
  • Benefits of use,
  • Potential drug interactions,
  • Adverse events and safety issues, and
  • Toxicological concerns.

According to the FDA, the information received will increase "the FDA’s knowledge of potential safety signals associated with CDPs and improve the FDA’s understanding of veterinarians’ experiences related to the use of CDPs in their animal patients".

The comment period for this RFI ends on 16 April 2025. For more information please see FDA Solicits Public Comments on Use of Cannabis-Derived Products in Veterinary Medicine.

Go back

NEWSLETTER

Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.