If you make, sell, process, or distribute food in the United States, you answer to a federal regulator. But which one? That’s where things get confusing  because the U.S. doesn’t have a single food safety agency. It has two primary ones, dividing jurisdiction in ways that aren’t always intuitive.

Getting this wrong isn’t just an academic mistake. The agency that regulates your product determines which rules you follow, which inspections you’re subject to, what your labels need to say, and what compliance programs you must have in place. Wrong agency, wrong compliance program  and you’re exposed.

The Two Agencies, In Plain Terms

The USDA oversees meat, poultry, and certain egg products, while the FDA is responsible for virtually everything else  which accounts for about 80% of the food supply. eathealthy365

That 80/20 split surprises most people. The USDA feels like the bigger, more visible presence in food  but it’s actually the FDA that touches the vast majority of what Americans eat every day.

The FDA, an agency within the Department of Health and Human Services, is responsible for enforcing the Food Safety Modernization Act (FSMA), which focuses on preventing foodborne illness rather than just responding to outbreaks. The agency sets standards for food production, labeling, and processing and conducts inspections of food facilities to ensure compliance.

The USDA, through its Food Safety and Inspection Service (FSIS), regulates the remaining 20% of the food supply  but this includes some of the most heavily consumed items: meat, poultry, and processed egg products. oftlaw

What the USDA Regulates

The Food Safety and Inspection Service, part of USDA, regulates meat from the livestock species named in the Federal Meat Inspection Act  cattle, swine, sheep, and goats and, under that same Act, fish of the order Siluriformes such as catfish — poultry under the Poultry Products Inspection Act, and processed egg products under the Egg Products Inspection Act. federalpolicymonitor

A key threshold to know: the USDA regulates products with over 3% raw meat or 2% cooked meat or poultry. This matters enormously if you’re producing combination foods  soups, sauces, frozen meals, deli products  where meat content determines which agency governs your operation. foodready

One notable exception most people don’t know: USDA is responsible for regulating meat and poultry, processed egg products, and catfish. Catfish shifted to USDA jurisdiction through the 2008 Farm Bill  making it the only seafood species not regulated by the FDA. usda

What the FDA Regulates

The FDA oversees essentially all other food in the U.S. food supply  produce, seafood other than Siluriformes, dairy, packaged and processed foods, dietary supplements, bottled water, and food additives  under the Federal Food, Drug, and Cosmetic Act.

FDA regulates facilities processing non-USDA regulated foods, including seafood, dairy, and dietary supplements, as well as imported food products, requiring compliance with the Foreign Supplier Verification Program (FSVP) to ensure safety. fooddocs

If your product doesn’t contain meat or poultry above the thresholds above, there’s a strong chance you’re in FDA territory  which means FSMA compliance, facility registration, and potentially a Food Safety Plan developed by a PCQI.

The Confusing Middle Ground

This is where even experienced food professionals get tripped up. Some foods split jurisdiction in ways that seem completely arbitrary until you understand the regulatory history behind them.

Eggs are the classic example. An egg in its shell is under FDA jurisdiction, but once it’s cracked and processed, it falls under USDA rules. The FDA regulates egg processing plants that wash, sort, and pack shell eggs. The USDA regulates egg product processing plants that break and pasteurize eggs into liquid, frozen, or dried form. oftlaw

Pizza is another one that catches businesses off guard. The USDA regulates pepperoni pizzas with meat, while the FDA regulates cheese pizzas. Same product category, two different federal agencies  determined entirely by meat content. oftlaw

Combination foods follow the meat percentage rule. When foods contain both meat and non-meat ingredients, the agency with the dominant regulatory interest takes the lead  determined by the quantity of meat or poultry involved, the nature of the food, and how the product is processed and sold. ensureiq

Imported foods add another layer. Imported foods may require dual regulation, where meat shipments must meet USDA standards, and accompanying non-meat items are evaluated by the FDA. ensureiq

Key Differences in How Each Agency Operates

Understanding which agency regulates you also shapes how you’ll be regulated — and the differences are significant.

Inspection frequency:
The USDA’s FSIS operates with continuous, on-site inspection for slaughter facilities and regular inspection for processing plants. The USDA’s focus on meat, poultry, and eggs stems from the origins of food regulation, where concerns over contamination in slaughterhouses led to stricter, continuous inspections. The FDA, on the other hand, oversees food products where risks tend to be lower, and inspections are less frequent but still systematic. ensureiq

Labeling requirements:
The FDA focuses on nutrition facts, ingredient lists, and health claims. The USDA requires pre-approval for labels on meat and poultry, ensuring accuracy before the product hits shelves. FDA-regulated products do not require pre-approval of labels — but they must comply with FDA’s labeling regulations at the time of sale. oftlaw

FDA’s requirements for allergen labeling are more detailed than USDA’s, particularly regarding warning statements and advisory labeling. ofwlaw

Compliance programs:
FDA-regulated facilities subject to FSMA must maintain a written Food Safety Plan, developed by a PCQI, with documented hazard analysis, preventive controls, and monitoring procedures. USDA-regulated facilities operate under HACCP plans specific to meat and poultry processing, enforced by FSIS.

Quick Reference: FDA vs. USDA by Food Category

Why This Matters for Your Business

Knowing your regulatory home isn’t just a compliance checkbox  it determines everything about how you structure your food safety program. The wrong assumption can leave you under-prepared for an inspection, missing required registrations, or operating with a compliance program built for the wrong set of rules.

The complexity of FDA and USDA food labeling and compliance requirements doesn’t mean compliance is impossible — it means businesses need structured approaches that account for which agency regulates their products and where enforcement risks concentrate. ofwlaw

If you’re launching a new product, expanding into a new category, or acquiring a food business and aren’t certain which agency has jurisdiction, get a professional determination before you build your compliance program around the wrong framework. The cost of clarifying this upfront is always less than the cost of restructuring after an inspection.

Not sure whether FDA or USDA regulates your product? Afya Food Safety & Sanitation provides regulatory determination, FSMA compliance consulting, and HACCP plan development for food businesses navigating both agencies. Contact us.