Does the FDA Regulate My Food Business?

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?

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What’s Next?

Understand about Registering a Food Facility with the FDA

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