What You Need to Know:

Contents

Determining USDA Jurisdiction
Examples of Business Regulation
Examples of Food Product Regulation
Meat Products
Egg-Related Products
FAQ

• The USDA regulates the production of meat, poultry and egg products. USDA-regulated businesses are required to have a USDA inspector onsite at all times.

• The FDA regulates the production of everything else (non-meat foods, unusual meats, and fish products). No inspector is required onsite during production.

• A business that conducts activities falling under both umbrellas is regulated by both agencies.

• Food produced and sold in a retail environment (i.e. restaurant, deli) is not typically regulated by either the USDA or the FDA.

“How to determine food business jurisdiction: Start with USDA. If you can’t positively identify how it falls under USDA jurisdiction, then it’s regulated by the FDA.”

Determining USDA Jurisdiction

The USDA typically regulates the following business types:

• Slaughterhouses

• Meat Processors*

• Poultry Processors*

• Egg Processors

• Food processors whose products contain meat*

Food products with the following characteristics are regulated by the USDA.

• Contains >2% cooked meat

• Contains >3% raw meat

• Contains >2% cooked poultry meat

• Contains >10% cooked poultry skins

*For more detail, see the tables below

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Examples of Business Regulation

Business	Description of Operations	Federal Jurisdiction
Meat Product Processor	Producer of frozen meat pies, bone broth, steak delivered via mail	USDA
Poultry Product Processor	Poultry processor	USDA
"Egg Product" Processor	Producers dried, frozen, or liquid eggs	USDA
Egg processing plant	Egg washing, sorting, packing	FDA
Slaughterhouse	Slaughter and processing of carcasses for sale. *Slaughter for personal consumption is not regulated by the USDA	USDA
Commissary for retail outlets	A commissary produces deli meats to sell at multiple delis, all owned by the same company. Products are shipped ready-to-eat.	FDA
Restaurants and retail establishments	Retail establishment that sells meat to typical consumers in retail quantities.	Not typically regulated by the federal government

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Examples of Food Product Regulation

Misc Products	Regulator
Spaghetti Sauce (2% meat)	FDA
Sliced Egg sandwich (closed face)	FDA
Shrimp flavored instant noodles	FDA
Venison Jerky	FDA
Closed Face Sandwiches	FDA
Open face sandwiches	USDA
Pork Sandwich (open faced)	USDA
Corndogs	USDA
Frozen Beef pot pie	USDA

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Meat Products	Regulator
Cow	USDA
Sheep	USDA
Pig	USDA
Horse	USDA
Mules	USDA
Goat	USDA
Domesticated Birds (chicken, turkey, ducks, geese, guineas, geese)	USDA
Wild Birds	FDA
Rabbit	FDA
Bison	FDA
Game animals	FDA
Deer, Elk, Moose	FDA
Zoo animals	FDA

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Egg Related Products	Regulator
Dried Eggs	USDA
Frozen Eggs	USDA
Liquid Eggs	USDA
Egg Substitutes	FDA
Dried Custard Mixes	FDA
Egg Nog Recipes	FDA
Egg Noodles	FDA
Milk and Egg Dip	FDA
Cake Mixes	FDA
French toast Sandwiches Containing Egg	FDA
Products containing egg	FDA

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FAQ

What does the USDA inspector do?

The USDA inspector inspects:

• Slaughtered animals to confirm they were healthy

• Sanitation conditions of a plant

• Operations to confirm that they align with the firm’s HACCP plan

• Product is correctly labeled and packaged to be transported

What it FSIS?

The Food Safety and Inspection Service (FSIS) is the inspection arm of the USDA. So if you see the term FSIS, think USDA.

This article applies to you if…

∆ You are unsure whether your product is regulated by the FDA or the USDA.

References

USDA Inspection Requirements Overview

FDA vs. USDA Jurisdiction Guide

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More About Supply Chain

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It’s not always clear where  the FDA has jurisdiction when it comes to food businesses. This table provides an overview of FDA Jurisdiction. Specific examples are provided below.

Regulated By the FDA	Not Regulated By the FDA
Foods that enter interstate commerce	Food Service Establishments
Most packaged foods	Restaurants
Most foods solid online	Restaurant Chain
Human and animal food	Food Truck
Imported Foods	Caterer
Farms (if they grow and process food)	Grocery Stores
	Food Bank
	Cafeterias / Institutions
	Markets
	Home-Food Processor
	Alcoholic Beverages
	Butcher Shop
	Slaughterhouses (USDA)
	Farms (if they only grow food)

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*Note: Domestic food processors of any kind must still register as a Food Facility even if their products do not enter interstate commerce. This is free and purely for record keeping purposes (it will not subject a business to FDA inspections or oversight)

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Examples of FDA Jurisdiction Businesses

FDA Jurisdiction	Examples
Food products that enter interstate commerce (i.e. businesses whose foods leave the state)	Most foods sold online
	Most non-meat products that are made and sold in a package
	A central kitchen that prepares and distributes foods to locations in multiple states
	A transporter that distributes food nationwide
	Any business that processes, packs, transports, distributes, receives, or holds food which crosses state lines.
Imported Foods	Food distributor that imports foods and sells it
	Food importer that warehouses food

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Businesses Not Under FDA Jurisdiction

Not FDA Jurisdiction	Example	Who typically regulates
Restaurant (Individual)	Fast Food Restaurant	Local/State health dept.
Restaurant (Chain)	Chain of frozen yogurt restaurants	Each would be regulated individually by its respective local or state health department
Restaurant (Delivery only)	Meals are ordered via app/web and delivered hot to the consumer	Local/State health dept.*
Food Truck	Korean food truck	Local/State health dept. *
Caterer	Facility where a caterer prepares food for immediate service	Local/State health dept.*
Grocery Store	Grocery store that also serves some hot food or includes a deli	Local/State health dept.
Food Bank	Food bank that accepts food donations and distributes that food locally	Local/State health dept.
Cafeteria / Institution	Hospital cafeteria, School lunch cafeteria	Local/State health dept.
Farmers Market	Weekly market that offers various prepared foods and ingredients for sale	Local / State Health Dept
Seafood Market	Retail market that supplies seafood products to consumers	Local / State Health Dept
Alcoholic Beverage Producer, Importer, Distributor, Wholesaler	Winery, Brewery, Distillery	State Health Dept / TTB (Note that alcoholic beverages <7% ABC are subjected to FDA labeling standards)
Butcher Shop	Retail market that butchers and retails meat for consumers	Local/State Health Dept. OR USDA. (This depends on what level of processing is being done to the meat before it is sold)
Home Food Processor	Business conducted from the home that involves making food	Local / State – Note that many cities and states prohibit or specifically regulate home processing
Meat Product Processor	Frozen meat pies, Bone broth, High-quality cuts of steak delivered via mail	USDA
Poultry Product Processor	Frozen buffalo wings, Roast Chickens	USDA
Processed Egg Products	Frozen omelets, Egg whites	USDA

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*If you serve or prepare food in multiple areas you may have to license with the local health department for each of those jurisdictions. If the food is crossing state lines, then FDA regulation would apply.

Still Unsure Whether Your Business is Regulated by the FDA?

Ask a question in the comments and I’ll answer it

Try using this dichotomous key

What’s Next?

Understand about Registering a Food Facility with the FDA

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Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

What is Interstate Commerce?

If a product crosses state lines between the start of the manufacturing process and when it is received by the individual who purchases it, then it has entered "interstate commerce".

Additionally, if the product is composed of ingredients from out-of-state, then it is considered to be a part of "interstate commerce" -- even if the product was created and consumed in state.

The technical definition of interstate commerce is:

"(1) commerce between any State or Territory and any place outside thereof,

and

(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."

FD&C Act [21 U.S.C. 321(b)] 

Examples of food that enters interstate commerce:

• A frozen pizza business that has a website and ships to buyers nationwide.

• A food processing facility that operates in New York and supplies cookies to bakeries in New Jersey.

• A distributor that holds food products created by local food producers in a warehouse and distributes them to a local retailer who, in turn, sells them in several states

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How Does Interstate Commerce  Relate to the FDA?

Whether a product enters interstate commerce is a major factor in determining whether a food business falls under FDA Jurisdiction. The other major factor is what type of food business it is. 

However, it is worth noting that all domestic facilities that engage in food processing, production, packing, or holding, must register as a Food Facility.

Additionally, the FDA may regulate any product that is adulterated or misbranded, even if that product doesn't enter interstate commerce.

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Sources

Learn more about interstate commerce in US Code Title 21 §331

More About Jurisdiction

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References

Learn more about interstate commerce in US Code Title 21 §331