The FDA Enforces Pet Food Selectively. Here's What Actually Gets Attention

The FDA investigated grain-free dog food for four years. They examined thousands of reports linking certain diets to heart disease. Then in December 2022, they closed the case without establishing a definitive link.

That investigation tells you everything you need to know about how the FDA actually regulates pet food. They respond to safety signals. They investigate serious problems. But proving causation is hard, resources are finite, and most of what happens in the pet food industry happens without FDA involvement.

For founders who've read the regulatory basics, the natural next question is: what does FDA oversight actually look like in practice? The answer involves fewer inspections, more recalls, and a much narrower enforcement focus than most people assume.

What the FDA Actually Controls

FDA pet food authority comes from the Federal Food, Drug, and Cosmetic Act. Under that law, all pet food sold in the United States must be safe, produced under sanitary conditions, free of harmful substances, and truthfully labeled.

What that doesn't mean: the FDA does not approve pet food products before they go to market. There's no certification process. No testing requirement. No FDA stamp of approval. You can launch a pet food brand tomorrow without any direct FDA interaction.

What it does mean: if your product causes harm, contains adulterants, or makes false claims, the FDA has authority to act. The distinction matters. FDA oversight is reactive, not proactive. They're not reviewing your label before launch. They're responding to problems after they occur.

The relationship to AAFCO and state regulators adds complexity. AAFCO sets nutritional standards. States enforce through registration requirements. The FDA handles safety at the federal level. For a detailed breakdown of how these three layers interact, see our pet food regulations guide. For this article, the key point is simpler: the FDA focuses on safety. Everything else is largely someone else's problem.

Where FDA Enforcement Actually Happens

The data tells a clear story about FDA enforcement priorities.

In 2024, there were 17 pet food recalls. The primary drivers were Salmonella and Listeria contamination. This wasn't an unusual year. A comprehensive analysis of 3,691 dog and cat product recalls from 2003 through 2022 found that biological contamination accounted for 35% of recalls, chemical contamination for 32%, and current Good Manufacturing Practice violations for 8%.

Salmonella alone drove 23% of all recalls over that 20-year period. Of those Salmonella recalls, 94% were classified as Class I, meaning they posed a serious health hazard.

The pattern is unmistakable. FDA enforcement concentrates on pathogen contamination. If your product tests positive for Salmonella, expect immediate action. If your label has a minor compliance issue, expect silence.

Raw pet food illustrates the risk distribution. Industry analysis shows raw products face 20 times higher pathogen recall rates than conventional products. For raw brand founders, this isn't a regulatory nuisance. It's an existential business risk. One contamination event can destroy consumer trust faster than years of marketing can build it.

The Enforcement Priority Hierarchy

Not all regulatory issues receive equal attention. Understanding the hierarchy helps founders allocate compliance resources appropriately.

Safety issues get immediate response. Pathogen contamination triggers recalls. Foreign material in products prompts investigation if consumer reports accumulate. Anything that causes documented harm to animals or humans becomes an FDA priority.

Adulteration matters but moves slower. Chemical contamination, undeclared ingredients, and ingredient quality issues get attention, but the timeline is longer. These problems often surface through routine testing rather than acute illness reports.

Labeling violations fall to states. The FDA technically has authority over misleading labels, but in practice, state agriculture departments handle most labeling enforcement. Unless your label makes therapeutic claims (which invokes drug regulations) or contains obviously false statements, the FDA is unlikely to act.

Marketing claims are largely unenforced. Claims like "natural," "premium," or "human-grade" have no federal definitions and minimal enforcement. The FTC technically has authority over pet food advertising, but in 1999 the agency rescinded its marketing guidelines for cat and dog food, deferring to AAFCO regulations. Since then, the FTC has been largely silent on pet food marketing claims.

The practical implication: founders should prioritize food safety and manufacturing controls above all else. Labeling compliance matters for state registration and retailer relationships. Marketing claim purity is mostly a brand integrity decision, not a regulatory survival question.

The DCM Investigation Shows How FDA Actually Works

In July 2018, the FDA announced it was investigating a potential link between certain diets and canine dilated cardiomyopathy (DCM). The investigation centered on grain-free diets high in peas, lentils, and other legumes.

The signal seemed strong. Over 90% of reported products were grain-free. 93% contained peas and/or lentils as main ingredients. Reports came from breeds not typically predisposed to DCM, including Golden Retrievers and Labrador Retrievers.

Then in December 2022, the FDA closed the investigation without establishing a definitive causal link. Their conclusion: this was "a complex scientific issue involving multiple factors," potentially including genetics, diet adequacy, and individual nutrient synthesis.

The DCM case reveals several truths about FDA oversight.

First, the FDA responds to adverse event reports. The investigation launched because veterinarians and pet owners filed reports. Without that signal, there would have been no investigation.

Second, correlation isn't causation, and the FDA knows it. Grain-free diets dominated the reports, but that could reflect market share, reporting bias, or actual causation. The FDA couldn't prove which.

Third, investigations take years and may not produce answers. Four years of work, hundreds of reports, multiple updates, and the outcome was "we're not sure."

Fourth, the market moved anyway. Whether or not grain-free diets actually cause DCM, many brands reformulated. Consumer perception shifted. Retailers asked questions. The FDA investigation changed the market even without a definitive finding.

For founders, the lesson isn't that regulations are toothless. It's that FDA attention creates consequences regardless of eventual conclusions. Being the subject of an investigation hurts, even if you're ultimately cleared.

FSMA Requirements for Pet Food Manufacturers

The Food Safety Modernization Act (FSMA) represents the most significant food safety regulation in decades, and it applies to pet food.

The Preventive Controls for Animal Food rule requires pet food manufacturers to implement hazard analysis and risk-based preventive controls. In practice, this means documented food safety plans, identified hazards, preventive control measures, monitoring procedures, corrective actions, and verification activities.

Current Good Manufacturing Practice (cGMP) requirements under FSMA mandate sanitary facility design, employee hygiene protocols, equipment maintenance standards, and pest control programs. These aren't suggestions. They're legal requirements for commercial pet food manufacturing.

The Foreign Supplier Verification Program (FSVP) adds requirements for imported ingredients. If your supply chain includes ingredients from outside the United States, you need documented verification that foreign suppliers meet FDA food safety standards.

Small businesses have exemptions based on size. The FDA defines a small business as one with fewer than 500 full-time equivalent employees. Qualified facilities with average annual sales plus inventory value under $2.5 million have modified requirements. Very small businesses selling primarily direct-to-consumer may qualify for additional exemptions. But most commercial pet food operations with retail or wholesale distribution fall under full FSMA requirements.

The practical impact of FSMA: if you're using a co-packer, they should already be FSMA compliant. If you're building your own manufacturing operation, FSMA compliance is foundational infrastructure, not optional paperwork. Work with your formulator and manufacturing partners to ensure food safety plans are in place from day one.

What This Means for Small Brands

FDA resources are finite. The agency oversees human food, animal food, drugs, medical devices, cosmetics, and tobacco products. Pet food is one piece of a massive regulatory portfolio.

Inspection frequency varies dramatically by facility type and risk profile. High-risk facilities see more frequent visits. Small operations producing standard products may go years between inspections. This isn't a guarantee of immunity. It's a statistical reality of resource allocation.

Warning letters to pet food companies happen but focus almost exclusively on food safety violations. Recent examples include Mid America Pet Food in November 2024 following Salmonella contamination linked to a multi-state outbreak, and Primal Pet Foods in February 2023 after 49 products tested positive for Listeria or Salmonella. The pattern is consistent: warning letters follow pathogen detection, not labeling issues or marketing claims.

The triggers that increase FDA attention: adverse event reports from consumers or veterinarians, competitor complaints, retailer pressure following consumer issues, and routine sampling programs that detect contamination. A single pathogen-positive test can cascade into full facility investigation.

For small brands, the practical approach is straightforward. Invest heavily in food safety controls. Pathogen testing, sanitation protocols, supplier verification, and documented procedures are the core of FDA compliance. Document everything. Maintain clean records that you can produce if asked. If something goes wrong, you want a paper trail showing you followed appropriate procedures.

Don't worry about the FDA reviewing your Instagram marketing or parsing your label language for minor issues. Do worry about Salmonella in your product. The enforcement priority is that clear.

FDA pet food oversight is narrower than most founders assume. The agency focuses on safety. Pathogen contamination drives recalls. Manufacturing standards under FSMA set the baseline. Everything else largely happens at the state level or not at all.

The DCM investigation is the template for understanding FDA attention. Reports trigger investigation. Investigation takes time. Conclusions may not come. But attention itself creates market consequences.

For founders building pet food brands, the regulatory strategy writes itself. Nail food safety. Document your processes. Partner with FSMA-compliant manufacturers. And recognize that FDA enforcement, while real, concentrates on a predictable set of issues. Know which ones matter.

For the full picture of pet food regulatory compliance, including AAFCO requirements and state registration, see our comprehensive regulatory guide.

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