Regulatory distinctions between animal and human health products shape development timelines, compliance strategies, and commercial risk. Jurisdictional lines, intended use, and claims discipline determine whether products fall under the Food and Drug Administration (FDA) or the U.S. Department of Agriculture (USDA), and how those determinations affect speed to market. Regulatory strategy is not an afterthought, but a core design decision.
Distinct Regulatory Frameworks for Animal Health
In a recent Venable webinar, the presenters explained that animal health products operate under a patchwork of statutes administered by FDA and USDA, with oversight divided largely between FDA's Center for Veterinary Medicine and USDA's Animal and Plant Health Inspection Service. Unlike human medical products, veterinary offerings exist in an environment with a higher tolerance for risk, particularly when products do not implicate the human food supply. As partner Justin Coen noted, "there's just a much greater tolerance for animal health risk, whereas on the human side there's very little tolerance," a difference that underpins lighter pre-market controls with heavier reliance on post-market enforcement. The speakers stressed that intended use and claims—rather than technology alone—drive jurisdiction, classification, and the level of scrutiny a product will face.
Speed to Market Through Veterinary Devices
A central focus of the discussion was veterinary medical devices, which stand apart from their human counterparts because they lack a formal statutory classification system and generally face no pre-market review. Partner Todd Harrison highlighted the commercial implications of this gap, stating, "with medical devices for animals there's no pre-market review at all," making devices one of the fastest paths to commercialization when the primary mode of action is physical or mechanical. The presenters cautioned, however, that the absence of pre-market approval shifts responsibility squarely onto manufacturers to substantiate safety and performance through internal documentation. FDA engagement, they explained, is typically reactive, triggered by complaints, inspections, or adverse events rather than routine submissions.
Claims, Labeling, and Post-Market Enforcement
The panelists paid significant attention to labeling and promotional practices, which function as the primary regulatory levers in a post-market enforcement model. The speakers underscored that websites, testimonials, and marketing materials are treated as labeling and can reclassify a product if claims exceed its regulatory category. Coen warned that "the claims that are made for the products…drive the classification, and it's also going to drive the oversight of those products," emphasizing that disease claims or mechanistic assertions can convert a device or supplement into a drug. Robust complaint handling, recall readiness, and right-sized quality systems were presented as essential defenses in an environment where manufacturers "own the safety case."
Managing Risk Across Agencies and Product Types
The session concluded by addressing complex scenarios involving biologics, combination products, and food-producing animals, where regulatory tolerance narrows, and oversight intensifies. Products involving immune mechanisms or residues in edible tissues face more rigorous controls, longer timelines, and greater coordination between agencies. Harrison and Coen advised companies to evaluate the primary mode of action early and, when necessary, seek formal jurisdictional determinations to avoid costly misclassification. The overarching message was that disciplined claims, aligned evidence, and early regulatory planning allow companies to leverage the comparative advantages of veterinary regulatory schemes while managing enforcement and liability risk.
If you or your organization have questions about veterinary regulatory schemes, please contact one of the speakers or any attorney in Venable's Animal Health and Agribusiness Law Group.