What Pet Food Founders Get Wrong About Regulations

Most founders treat pet food regulations like a checkbox. File some paperwork, slap "complete and balanced" on the label, move on to the interesting parts of building a business.

Then they discover that "some paperwork" means registering in dozens of states with different forms, different fees, and different deadlines. That the FDA and AAFCO just ended a 17-year partnership, creating two separate ingredient approval pathways. That the regulatory consultant they're paying $300 an hour could have been avoided if they'd understood which requirements actually matter versus which ones just exist.

Pet food regulations aren't complicated because the rules are hard to understand. They're complicated because nobody explains which rules actually get enforced, which ones are changing, and which decisions you need to make versus delegate. This is that explanation.

The Regulatory Basics

Pet food regulations in the United States operate on three levels, and understanding who does what prevents most of the confusion founders experience.

The FDA sets the federal floor. Under the Federal Food, Drug, and Cosmetic Act, pet food must be safe, produced under sanitary conditions, free of harmful substances, and truthfully labeled. No premarket approval is required. You don't need FDA permission to launch a pet food product. You need to comply with their rules, which is a different thing entirely.

AAFCO provides the standards that make compliance concrete. The Association of American Feed Control Officials develops model regulations and nutrient profiles that define what "complete and balanced" actually means. For adult dog maintenance, that's a minimum of 22% crude protein on a dry matter basis. For adult cats, it's 26%. AAFCO doesn't regulate, test, or certify products. They write the standards that states adopt.

States enforce through their agriculture departments. This is where compliance gets expensive. Each state that adopts AAFCO's model regulations becomes a separate jurisdiction with its own registration requirements, fees, and timelines. Your product isn't legal to sell in Texas until Texas says it is, regardless of what the FDA or AAFCO think.

The relationship works like this: FDA sets safety requirements, AAFCO defines nutritional standards, and states use both to determine what you can sell where. Most founders focus on FDA and AAFCO because they're the visible players. The smarter ones focus on state registration because that's where products actually get blocked.

For operators building a brand, the regulatory landscape connects directly to supply chain decisions. Ingredient choices, manufacturing partners, and distribution strategy all carry regulatory implications. Understanding the basics prevents expensive surprises downstream.

The 2024 Split That Changed Everything

On October 1, 2024, the FDA and AAFCO ended a 17-year memorandum of understanding that had governed how new pet food ingredients got approved. For founders planning products with novel ingredients, this changes the playbook.

Here's what happened. Under the old system, AAFCO ran an ingredient definition process. If you wanted to use a new ingredient in pet food, you submitted to AAFCO, their scientific review team evaluated it, and if approved, it became part of the AAFCO Official Publication. State regulators accepted AAFCO-defined ingredients, and the FDA exercised enforcement discretion.

That pathway no longer exists.

New ingredients now go through the FDA directly, either via GRAS (Generally Recognized as Safe) determination, a Food Additive Petition, or the new Animal Food Ingredient Consultation (AFIC) process. AAFCO has partnered with Kansas State University to provide scientific review, targeting a 9-month approval timeline, but this new pathway lacks the automatic acceptance that the old AAFCO process provided.

The good news: existing ingredients aren't affected. Anything in the 2024 AAFCO Official Publication remains usable. The FDA has stated it will continue exercising enforcement discretion for these legacy ingredients in interstate commerce. If you're formulating with standard ingredients, the split doesn't change your day-to-day.

The complication: if you're building a brand around a novel ingredient, the regulatory path just got less predictable. The FDA pathway requires more extensive safety data. State regulators may or may not accept FDA-cleared ingredients without separate AAFCO recognition. International markets have their own questions about U.S. approval processes.

The practical implication: if novel ingredients are central to your product strategy, build in regulatory timeline uncertainty. If you're using standard formulations, the split is mostly background noise. Either way, the regulatory consultant conversation should now include a specific question: "How does the FDA/AAFCO split affect my ingredient strategy?"

State Registration Reality

Almost every state requires pet food registration before you can legally sell there. The requirements vary so much that multi-state distribution becomes a compliance project in itself.

Here's what state registration actually looks like.

New York charges $100 per product per year. If you have a line of six SKUs, that's $600 annually just for New York. Texas charges $75 per year. California registers manufacturers rather than products, with different fee structures. Florida bases fees on tonnage: $40 for companies selling up to 25 tons, scaling to $3,500 for volumes over 5,000 tons.

The variation goes beyond fees. Different states have different forms. Different renewal dates. Different label review requirements. Some states require tonnage reporting quarterly. Some annually. Some not at all. Missing a deadline can result in late penalties, stop-sale orders, or forced product removal from retail shelves.

For a brand selling in 25 states, compliance means tracking 25 different registration schedules, 25 different fee structures, and 25 different label approval processes. The cost isn't just the fees themselves. It's the operational overhead of managing the complexity.

E-commerce adds another layer of uncertainty. If you sell online and ship to customers in 50 states, do you need registration in all 50? The answer is technically yes. The enforcement reality is murkier. Some states actively pursue online-only brands. Others don't have the resources. The conservative approach is full registration everywhere you ship. The practical approach is registration in states where you have retail distribution plus the states known for active enforcement.

FDA registration sits on top of all this. All pet food manufacturers must register with the FDA at the federal level, with re-registration required every two years. This is separate from state registration. You need both.

The bottom line: budget for state registration as a line item, not an afterthought. For multi-state distribution, expect registration costs to reach five figures annually when you factor in fees, label reviews, and the time required to manage the process. Build this into your unit economics before you set your price point.

Formulation vs. Feeding Trials

To make a "complete and balanced" claim on your label, you need to substantiate it through one of two methods: formulation or feeding trials. Both support the same claim. They differ in cost, timeline, and what they actually prove.

The formulation method is paper-based. You demonstrate that your recipe meets AAFCO nutrient profiles through lab analysis of ingredients. Your formulator calculates the nutrient content, you get the finished product tested, and if the numbers hit AAFCO minimums and maximums, you can make the claim. This is faster and cheaper. It's how the majority of pet food products are substantiated.

Feeding trials are animal tests conducted according to AAFCO protocols. You feed the test diet exclusively to at least 8 healthy animals for 26 weeks, monitoring intake, body weight, and physical condition. At the end, blood parameters (hemoglobin, packed cell volume, serum alkaline phosphatase, albumin) are checked. If no more than 2 animals are removed for non-dietary reasons and no deficiency signs appear, the diet passes.

The decision framework is simpler than the regulatory language suggests.

Choose formulation when: you're using standard ingredients with established nutrient profiles, your formulator has experience with similar products, and your timeline and budget favor speed. This is the right choice for most brands.

Consider feeding trials when: you're using novel ingredients where bioavailability is uncertain, your marketing positioning depends on "proven" nutrition claims, or you're targeting veterinary channels where trials carry credibility weight. Some brands also use trials to validate recipes they've developed through formulation, adding a layer of real-world verification.

The catch with formulation: it's theoretical. Lab analysis tells you the nutrients are present. It doesn't tell you whether the animal can actually absorb and use them. Interactions between ingredients, processing effects, and individual variation don't show up in a spreadsheet. For standard formulations with well-understood ingredients, this rarely matters. For novel approaches, it might.

The catch with feeding trials: they're expensive and time-consuming, and the protocol is minimal. Blood tests only happen at the end. Weight gain (not just maintenance) is acceptable. The 26-week duration may not catch long-term issues. Critics argue the protocol is outdated for modern nutrition science.

Most founders should choose formulation and move on. The exceptions: if your entire brand proposition rests on novel nutrition claims, feeding trials might be worth the investment in credibility. Discuss the tradeoffs with your formulator. For a deeper look at the formulation decision itself, see our pet food formulation guide.

What Actually Gets Enforced

Regulations on paper and regulations in practice are different things. Understanding where enforcement actually happens helps you prioritize compliance efforts.

Labeling violations are the most common enforcement issue. The FDA and state regulators review labels for compliance with naming conventions, guaranteed analysis format, ingredient lists, and nutritional adequacy statements. A labeling mistake doesn't just risk enforcement action. It can delay product launch, require reprinting packaging, and damage retailer relationships. Get your label right before you print 50,000 bags.

Recalls tell you where safety enforcement focuses. In 2025, the FDA oversaw 13 pet food recalls totaling over 166,000 pounds. The primary drivers: Salmonella (157,000+ pounds), avian flu (5,200+ pounds), and foreign objects (3,600 pounds). The pattern is clear. Pathogen contamination dominates recall activity.

Raw pet food carries dramatically higher risk. Industry analysis shows raw products face 20 times higher pathogen recall rates than conventional products. If you're building a raw brand, food safety protocols aren't optional extras. They're existential requirements.

Adverse event data adds context. FOIA disclosures from 2024 showed Purina with 1,705 reports of sick pets and 206 deaths, Mars with 119 sick and 6 deaths, Hill's with 31 sick and 2 deaths. These numbers need interpretation. Scale matters. The largest manufacturers receive more reports because they sell more product. A high absolute number doesn't mean a higher incident rate. For small brands, the takeaway isn't "big companies have more problems." It's "if something goes wrong at scale, the numbers get big fast."

What this means for small brands: enforcement resources are finite. The FDA isn't reviewing every label from every startup. But that doesn't mean non-compliance is safe. State regulators vary in aggressiveness. Retailers increasingly require documentation of compliance. One competitor complaint or customer incident can trigger attention you don't want.

The practical approach: nail the basics (labeling, manufacturing standards, state registration), maintain clean documentation, and if you're in a higher-risk category like raw, over-invest in food safety.

The Legislation to Watch

The regulatory landscape is shifting. Two pieces of pending legislation could significantly change how pet food compliance works.

The PURR Act (Pet Food Uniform Regulatory Reform Act) is the big one. Introduced in Congress and backed by the Pet Food Institute, it would establish federal preemption over state pet food labeling. Instead of 50 different state label review processes, you'd have one federal standard.

If passed, PURR Act would: codify AAFCO definitions at the federal level, set FDA timelines for GRAS reviews, allow certain structure/function claims (like "supports dental health") without pre-approval, and eliminate the state-by-state registration patchwork for labeling purposes.

For operators, this would dramatically simplify compliance. One label approval process instead of dozens. Clearer timelines for ingredient review. Reduced regulatory overhead for multi-state distribution.

The Innovative FEED Act addresses ingredient innovation, creating a new category for "zootechnical" additives with specific labeling provisions. This matters less for mainstream formulations but signals regulatory openness to novel ingredients.

Neither has passed. Legislation timelines are unpredictable. But both indicate the direction of regulatory thinking: simplification, federal consistency, and faster pathways for innovation.

How to monitor without becoming a regulatory obsessive: follow Pet Food Institute updates, check FDA announcements quarterly, and have a regulatory consultant who flags changes relevant to your product category. You don't need to track every draft guidance. You need to know when something changes that affects your business.

For now, comply with the current system. Build your compliance infrastructure assuming state-by-state registration continues. If federal preemption passes, you'll have simplified operations. If it doesn't, you'll already be compliant.

Pet food regulations reward founders who understand priorities. The basics matter, but most brands clear that bar. The advantage goes to those who understand where the system is changing, where enforcement actually bites, and which decisions deserve their attention versus their consultant's.

Build compliance infrastructure early. Budget for state registration costs. Match your ingredient strategy to your regulatory tolerance. And when the rules change, adapt faster than competitors who weren't paying attention.

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