Manufacturers of pet supplements and treats are navigating one of the most complex regulatory environments in the category's history, according to Todd Harrison, partner at Venable LLP, who works with companies across the animal health supplement space and serves as legal counsel for the National Animal Supplement Council (NASC).
At the heart of the challenge is a fragmented system in which federal expectations, state requirements and evolving industry practices frequently conflict. "The regulatory system has not fully caught up with the evolution of the animal supplement marketplace," Harrison said. "Until there is a more clearly defined and uniformly applied category, manufacturers will continue to face friction at the intersection of labeling, claims and ingredient requirements."
Labeling: Two frameworks, one label
Among the most persistent pain points is labeling. Harrison described a landscape in which manufacturers must simultaneously satisfy two fundamentally different regulatory paradigms — federal expectations favoring greater transparency and consumer-friendly disclosure, and state-level requirements rooted in feed-based constructs that were never designed for supplement-type products with non-nutritional health benefits.
"A label designed to communicate supplement-type information in a clear, consumer-friendly way may not fit within traditional feed-labeling constructs, and vice versa," Harrison said. "That tension often leads to inefficiencies, including the need for multiple label versions, additional internal review and, in some cases, inconsistent labeling across jurisdictions."
He also pointed to the absence of a standardized Product Facts panel for animal health supplements as a significant structural gap. Unlike human dietary supplements, which have a well-established format, animal supplement manufacturers must interpret general principles and apply them without a uniform framework.
“While NASC has stepped in to bring uniformity amongst its members, it does not have the authority to compel the use of Product Facts labeling,” Harrison noted.
The "functional treat" problem
Harrison flagged the proliferation of so-called “functional” treats as a growing regulatory flashpoint. From a regulatory standpoint, he said, no such category exists. Products are generally treated as either feed, which includes treats, or supplements, and that classification has sweeping compliance consequences.
"If a product is marketed as a treat, it is typically regulated as feed and must comply with feed requirements, such as guaranteed analysis and the use of approved feed ingredients," Harrison said. "If a product is positioned as a supplement, however, it should be marketed accordingly and not described as a 'treat.'"
That distinction, he added, determines the entire compliance framework that applies — and companies that blur the line do so at their regulatory peril.
Claims: Net impression matters
Managing product claims remains equally fraught. Harrison said companies are working to stay on the permissible side of the line between structure/function language and unapproved drug claims, but that line is rarely clear in the animal context.
"FDA and state regulators look at the totality of the presentation — including imagery, testimonials, product names and even videos," he said. "In many cases, visual content can carry more weight than text."
Harrison cited examples such as depicting a dog that appears lame and then running normally, or suggesting a pet no longer needs prescription drugs, as the kind of implied disease claims that can trigger enforcement action even without explicit language. He offered three guiding principles for companies navigating this landscape:
- Focus on underlying science and mechanisms rather than treatment outcomes.
- Evaluate claims holistically, including visuals and branding.
- Recognize that there is no anecdotal exception — even truthful statements can become a regulatory problem if they imply disease treatment.
"The biggest risk is not a single claim, but the cumulative impression that a product is intended to diagnose, treat, cure or prevent disease," Harrison said. "That is what can transform a supplement into an unapproved new animal drug subject to enforcement action."
Ingredients under the microscope
On the ingredient side, Harrison identified several categories drawing heightened scrutiny in 2026.
- Functional treats containing unapproved feed ingredients or approved ingredients used for unapproved purposes are drawing active state enforcement, including red tags.
- Novel and bioengineered ingredients without a clear history of useIngredients that are also the subject of drug development, where FDA is evaluating whether products are being positioned in a way that overlaps with therapeutic use.
- Microbial-based ingredients, including probiotics and postbiotics, continue to face questions around characterization, stability and consistency.
FDA's Center for Veterinary Medicine is the primary federal body involved, Harrison said, but state feed control officials also play a significant role in how ingredients are classified and labeled.
Federal vs. state: A layered system
For manufacturers operating across multiple states, the interplay between federal oversight and state enforcement adds another layer of operational complexity. Harrison described a system in which AAFCO's model regulations carry substantial practical weight as many states adopt or rely on them.
“It’s important to understand that AAFCO itself does not have independent regulatory authority,” Harrison explained. “However, its model regulations, ingredient definitions and policy interpretations are highly influential because many states adopt or rely on them. As a result, AAFCO’s positions often shape how state regulators approach labeling, ingredient status and product classification.”
Despite AAFCO’s attempts to achieve consistency amongst the states as a practical matter, this simply isn’t happening. State requirements vary widely, and this inconsistency is becoming increasingly problematic for a national industry, added Harrison. In states with more active enforcement postures, companies may need to maintain multiple label versions, complete additional state-level registration steps and absorb higher compliance costs.
“To manage this, companies are increasingly adopting internal compliance frameworks that aim to meet the most stringent applicable standard across jurisdictions, while also engaging proactively with regulators and industry groups to stay ahead of evolving expectations,” he said.
NASC, Harrison noted, plays a distinct but complementary role by providing practical guidance, quality standards and post-market surveillance tools that help companies manage an inconsistent regulatory landscape. Many manufacturers, he said, use NASC standards as a baseline for compliance and best practices.
Legislative watch: The Animal Health Supplement Act
Looking ahead, Harrison identified three areas industry stakeholders are watching most closely: federal legislative activity, FDA's enforcement posture on intended use, and ongoing state-level developments.
At the federal level, he pointed to the Animal Health Supplement Act — advanced by NASC — as an effort to establish the kind of statutory clarity the category currently lacks. Unlike human dietary supplements, animal health supplements have no defined statutory category governing ingredient status, permissible claims or labeling standards.
"The objective is not to reduce oversight but to create a framework that is predictable, transparent and appropriately tailored to the category, rather than continuing to rely on regulatory models developed for feed or pharmaceuticals," Harrison said.
He said the most meaningful development for the industry would be a uniform federal framework that distinguishes animal health supplements from drugs based on intended use, provides science-based rules for ingredient and claim evaluation, aligns labeling expectations with supplement-type products, and reduces fragmentation between federal and state requirements.
“Companies may need to adjust labeling, ingredient sourcing or product positioning to meet state-specific expectations, increasing complexity and cost,” Harrison said. “Greater alignment — or at least clearer delineation — between federal and state requirements would significantly improve the compliance landscape and reduce these inefficiencies.”
This is precisely the gap the Animal Health Supplement Act aims to address, said Harrison.
“By establishing a defined statutory category and a tailored regulatory framework, proposals such as the Animal Health Supplement Act aim to replace the current uncertainty with a system that serves regulators, industry and consumers alike,” he explained. "Greater clarity would allow companies to spend less time navigating regulatory ambiguity and more time focusing on product quality, safety and innovation, while still ensuring appropriate oversight and consumer protection.”
