Posted on November 11th, 2025  

One of the first—and most critical—questions a new food business owner or processor must answer is: "Am I regulated by the USDA or the FDA?"  

Getting this wrong can lead to failed inspections, labeling rejection, and costly operational delays. In the United States, two primary federal agencies manage the safety of our food supply, but they each have distinct jurisdictions, regulatory requirements, and even different philosophies on inspection.  

Understanding the difference isn't just about compliance; it's about knowing which food safety system (HACCP or FSMA's Preventive Controls) you must implement, how often you'll be inspected, and what documentation you need.  

The Great Divide: A Simple Rule of Thumb  

The split in jurisdiction boils down to specific types of agricultural products. While it can get complex, the initial distinction is straightforward:  

The FDA (Food and Drug Administration)  

The FDA is the larger of the two agencies in terms of the sheer volume of food it regulates, covering approximately 80% of the U.S. food supply.   

• Jurisdiction: "Everything else"—all food products not under USDA's primary mandate.  
• Key Products:  
• Produce (Fruits, Vegetables)  
• Dairy (Fluid Milk, Yogurt, Cheese, Ice Cream)  
• Seafood (Fish, Shellfish, and all non-catfish items)  
• Eggs (Shell eggs)  
• Packaged & Processed Foods (Cereal, bread, snacks, frozen meals, bottled water)    
• Regulatory System: Primarily the Food Safety Modernization Act (FSMA). This requires most facilities to develop a Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan, which is a broader system than traditional HACCP.  
• Inspection: Inspections are periodic and risk-based. They do not require a full-time, on-site inspector.  

The USDA (United States Department of Agriculture)  

The USDA's regulatory arm, the Food Safety and Inspection Service (FSIS), focuses on the nation's high-risk animal products.   

• Jurisdiction: Meat, Poultry, and Processed Egg Products.  
• Key Products:  
• Meat (Beef, Pork, Lamb, Goat, etc.)  
• Poultry (Chicken, Turkey, Duck, etc.)  
• Processed Egg Products (Liquid, frozen, or dried eggs)  
• Catfish    
• Regulatory System: HACCP (Hazard Analysis Critical Control Point), as mandated by the Federal Meat Inspection Act and Poultry Products Inspection Act.  
• Inspection: Inspections are continuous. FSIS inspectors are often physically present in the establishment during all hours of slaughter and processing.  

When the Rules Overlap: The "Mixed Product" Confusion  

This is where many businesses get into trouble. What happens when your product contains ingredients regulated by both agencies?  

The answer is based on the percentage of meat or poultry in the finished product.  

Product Type   

Regulatory Agency   

Key Component Threshold       

Soup or Stew   

FDA   

Contains less than 2% cooked meat/poultry     

Soup or Stew   

USDA   

Contains 2% or more cooked meat/poultry     

Pizza   

FDA   

Cheese pizza (no meat topping)     

Pizza   

USDA   

Pepperoni pizza, sausage pizza, or any with meat topping    

The Egg Conundrum   

• Intact Shell Eggs (still in the shell): FDA  
• Processed Egg Products (liquid, frozen, dried): USDA  

If you run an egg-breaking facility to make liquid egg whites, you are regulated by the USDA. If you are selling eggs by the dozen, you are regulated by the FDA.  

The Labeling Difference  

The difference extends to your packaging and market entry.   

• FDA: Focuses on the accuracy of the Nutrition Facts, ingredients, and allergen declarations. Labels are not generally pre-approved.  
• USDA: Requires pre-market generic label approval for no small claim label or prior approval from the FSIS for label with special claim.   

Why This Regulatory Split is Critical for Your Business  

Choosing the wrong food safety system or ignoring the proper inspection requirements can lead to immediate shutdown.   

1. HACCP vs. HARPC: If you are a meat processor and only have a HARPC (FSMA) plan, you are non-compliant with the USDA. If you are a juice company (FDA) and only have a basic HACCP plan, you may be missing the required preventive control steps mandated by FSMA.  
2. Continuous vs. Periodic Inspection: USDA facilities must be ready for constant oversight, requiring a different operational mindset than an FDA-regulated facility, which prepares for scheduled and surprise inspections.  
3. Hiring the Right Expert: The expertise required to draft a USDA-compliant HACCP Plan and a FSMA-compliant Food Safety Plan (HARPC) are different. Make sure your consultant is qualified for your agency.  

Are you a new food producer unsure if your blended product (e.g., a savory pastry, a meat sauce, or a specialty jerky) falls under the stricter USDA HACCP rules or the broader FDA FSMA rules?  

Contact us and let us help you analyze your product and ingredients and give you a definitive answer on whether your path is USDA-FSIS or FDA-FSMA, saving you thousands in potential non-compliance fines.