Request for Information: FDA Inquires Public Commentary on the Usage of Cannabis-Derived Products in Veterinary Practice

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The FDA is seeking commentary from the public regarding the use of cannabis-derived products such as CBD, in veterinary practice.

Image | adobe.stock/New Africa

Image | adobe.stock/New Africa

The Food and Drug Administration (FDA) announced in a recent press release the publication of a request for information (RFI) notice (1,2) seeking public commentary on the usage of cannabis-derived products (CDPs) in veterinary practice. According to there release (1), “The focus of this RFI is on cannabidiol (CBD) products and other products derived from hemp. The FDA is interested in general trends associated with these products, such as information about usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug interactions, adverse events and safety problems, and toxicological concerns.”

The RFI (2) mentions that the information will help enlighten the Center for Veterinary Medicine regarding possible safety concerns. “Firms marketing CBD products for use in (non-human) animals often make claims regarding a wide variety of diseases or conditions," explains the RFI. "Some products are also purported to enhance general wellness and promote longevity. Products are marketed in many different formulations, such as tinctures/oils, treats/chews, pellets for large animals, capsules, and sometimes as food toppers or infused in foods such as peanut butter; topical products infused with CBD, such as balms and shampoos, are also available for pets," (2).

At this current time, there aren’t any FDA-approved drugs containing CBD (2). In humans, Epidiolex, Marinol, Syndros, and Cesamet are FDA-approved medications that are produced from cannabis or created synthetically. There are some gaps in data, says the agency, and research regarding the use of cannabis-derived products in animals and the commentary period will hopefully help bring some clarification as to how veterinarians are utilizing products, such as CBD, in their animal patients.

The RFI reported that the FDA is particularly interested in responses to the following 10 questions (2):

1. Are you a veterinarian licensed to practice veterinary medicine in the United States? If so, in which State(s) do you hold an active license? Please indicate how many years of experience, as a practicing veterinarian, you have. Please indicate the type of community (For example, urban, suburban, or rural) that best describes where you work.

2. Are you in clinical practice, meaning, do you have physical contact with client-owned animals? If so, what species does your practice see (For example, food-producing species such as cattle, poultry, etc., and/or nonfood-producing species such as dogs, cats, etc.)?

3. Have clients asked you about using products derived from cannabis in their animals? If so, please describe approximately how often (weekly, monthly, quarterly, annually) your clients ask and describe for which animal species and for what indications your clients are using (or are interested in using) cannabis-derived products.

4. When clients ask about products derived from cannabis, do they generally distinguish between products derived from hemp versus those derived from marijuana (For example, do they ask about hemp products, marijuana products, or do they not specify)? What brands (if known) and formulations or types of products do clients ask about (For example, tinctures, treats, capsules, topical products, etc.)?

5. Have you prescribed or dispensed EPIDIOLEX, MARINOL, SYNDROS, or CESAMET for use in any of your patients? If so, which drug(s) for what species, and what was the reason or indication for which you prescribed or dispensed these drugs for animal patients?

6. Do you use or recommend hemp-derived cannabis products for your animal patients? If so, are you confident that the products you use or recommend are labeled accurately (For example, concentration, ingredients, etc.)? What factors influence your decision on which brand of hemp-derived cannabis product to use or recommend (For example, certificate of analysis, research, continuing education lectures, etc.)? What CBD:THC cannabinoid ratio in hemp-derived cannabis products do you use or recommend for your animal patients (if known)?

7. Describe your practices surrounding recommendations of hemp-derived cannabis products for your animal patients including: for what indications do you use or recommend hemp-derived cannabis products; for which species; and which dosage forms (For example, oral, topical, inhalation), dose, brand, and cannabinoid(s) do you prefer? What information sources do you use to make these treatment decisions (continuing education, specialist recommendations, industry recommendations, etc.)? Describe any benefits of use related to hemp-derived cannabis products in your patients.

8. Related to hemp-derived cannabis products only: Have clients reported to you, or have you observed, adverse effects following an animal being administered a hemp- derived cannabis product (For example, after a client intentionally administered a hemp-derived cannabis product, not accidental ingestion of adult recreational use products)? If so, please describe each event(s) including animal species, clinical signs and severity of the adverse event, product/dose/route of exposure (if known), whether veterinary intervention was needed, and whether the animal recovered, or the adverse event resulted in death. Did you report any adverse events to FDA?

9. Do you have questions or concerns about drug interactions between hemp-derived cannabis products and other medications? For purposes of this information request, we are interested in interactions with any product used for medical purposes, including FDA-approved drugs, United States Department of Agriculture-licensed biologics, and other products, such as veterinary nutraceuticals and veterinary phytotherapy (plant-derived) products. Are you concerned about, or have you seen potential drug interactions (For example, reduction in the effectiveness, safety margin, or both, of either the hemp-derived cannabis products or the other medications) between hemp-derived cannabis products and other medications?

10. If you do not use or recommend hemp-derived cannabis products for your animal patients, what factors have influenced your decision (For example, legal issues surrounding cannabis, safety concerns, effectiveness concerns, product quality concerns, not found a need, etc.)? If you do not use or recommend hemp-derived cannabis products for your animal patients for reasons other than effectiveness concerns, are there any indications and species for which you believe they could be effective and why?

To learn more about how to provide feedback to the FDA, please click here (2).

The comment period regarding the FDA’s request for information notice (1) will be open for 90 days and will close on April 16, 2025.

References

  1. Medicine, C. for V. FDA seeks veterinarian input on cannabis-derived products in animals https://www.fda.gov/animal-veterinary/cvm-updates/fda-solicits-public-comments-use-cannabis-derived-products-veterinary-medicine (accessed Jan 20, 2025).
  2. The Federal Register https://www.federalregister.gov/documents/2025/01/16/2025-00945/use-of-cannabis-derived-products-including-cannabidiol-in-veterinary-practice-request-for (accessed Jan 20, 2025).
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