Executive Summary
On January 16, 2025, the U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) issued a Request for Information (RFI) to obtain information from the public, particularly veterinarians, on the use of cannabis-derived products (CDPs) in animals, principally cannabidiol (CBD) products, and associated general usage trends. CVM states that this information will enhance its knowledge of potential safety signals associated with CDPs, and it will aid CVM’s understanding of veterinarians’ experiences related to the use of CDPs for their animal patients. The comment period closes April 16, 2025.
Background
The Agricultural Improvement Act of 2018 eased longstanding federal restrictions on the cultivation of hemp[1] by (1) allowing interstate commerce of hemp, (2) removing hemp from the Controlled Substances Act’s statutory definition of marijuana, and (3) expressly preserving FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FDCA).[2]
Since 2018, FDA has undertaken a series of activities pursuant to this authority mainly within the context of products intended for humans. In May 2019, the Agency held a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis[3] or cannabis-derived compounds.[4] Between 2019 and 2022, FDA received and reviewed three citizen petitions requesting that the Agency conduct rulemaking to allow the marketing of CBD products as human dietary supplements.[5] In January 2023, FDA denied these citizen petitions and concluded that then-existing regulatory frameworks for human and animal food and dietary supplements were not appropriate for the use of CBD in those products.[6] At the same time, the Agency has issued multiple warning letters to firms that illegally market CDPs for use in humans and non-human animals.[7]
FDA has approved one cannabis-derived human drug (Epidiolex) and three synthetic cannabis-derived human drug products (Marinol, Syndros, and Cesamet) since 2018. While FDA has not approved, conditionally approved, or indexed any animal drugs containing CBD, the Animal Medicinal Drug Use Act and its implementing regulations[8] permit veterinarians lawfully to prescribe approved human drugs for use in animals in an extralabel manner (subject to certain conditions).
Request for Information
CVM seeks input from practicing veterinarians related to the use of CDPs in their animal patients to help inform FDA of the use and effect of CDPs in animals. Specifically, CVM requests information regarding 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 RFI poses ten questions for comment, which span six topics:
- Veterinarians’ scope of practice, including species treated and communities served;
- Clients’ interest in using hemp- or marijuana-derived products for their animals, including the particular formulations or types of products requested;
- Veterinarians’ prescribing and dispensing trends for FDA approved cannabis-derived human drugs including whether veterinarians prescribe or dispense Epidiolex, Marinol, Syndros, and Cesamet to their animal patients and, if so, for what indications;
- Veterinarians’ approach to recommending hemp-derived cannabis products for animal patients, as well as the factors influencing such recommendations;
- Adverse effects following the administration of hemp-derived cannabis products to animals, including clinical signs and severity of the adverse event and subsequent reporting to FDA; and
- Veterinarians’ questions or concerns about drug interactions between hemp-derived cannabis products and other medications.
Deadline for Comments
Comments for the RFI on the use of CDPs in veterinary practice are due on or before April 16, 2025.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
[1] “Hemp” means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. The Agricultural Act of 2014, 7 U.S.C. § 5940.
[3] “Cannabis” refers to plants that can be further defined as either “hemp” or “marijuana,” depending on their delta-9 THC concentration. 90 Fed. Reg. 4746, 4747 (Jan. 16, 2025).
[4] 84 Fed. Reg. 12969; Docket No: FDA-2019-N-1482.
[8] See 21 C.F.R. Part 530.
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