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FDA or USDA: which agency regulates your food label

Before you design a single label, you need to know which federal agency regulates your product — because the FDA and USDA don't just have different rules, they have different processes. Most packaged foods answer to the FDA. But add enough meat or poultry and your product crosses into USDA territory, where labels must be approved before you can sell.

Updated August 6, 2026 · 4 min read · Sourced from FDA guidance

Two agencies, one grocery shelf

The FDA regulates roughly 80% of the U.S. food supply — packaged foods, produce, seafood, shell eggs, bottled water, and dietary supplements — under the Federal Food, Drug, and Cosmetic Act. The USDA's Food Safety and Inspection Service (FSIS) regulates meat (cattle, pigs, sheep, goats), poultry (chicken, turkey), and processed egg products (liquid, frozen, or dried eggs), under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. FSIS also covers catfish (order Siluriformes), even though other seafood stays with the FDA.

The 3% / 2% meat rule

For a mixed product, the dividing line is how much meat or poultry it contains by weight. A product with more than 3% raw meat or poultry, or more than 2% cooked meat or poultry, is regulated by USDA FSIS. At or below those amounts, it usually stays under the FDA. This is why two similar products can follow different rulebooks: a cheese pizza or a pasta sauce with a trace of meat is typically an FDA product, while a pepperoni pizza or a beef chili is a USDA product. A closed-face (ready-to-eat) meat sandwich falls under the FDA; an open-faced one falls under FSIS.

Common products and their usual regulator
ProductUsual agency
Packaged snacks, produce, most seafood, bottled waterFDA
Shell eggsFDA
Cheese pizza; ≤3% raw / <2% cooked meatFDA
Dietary supplementsFDA
Meat & poultry (beef, pork, chicken, turkey)USDA FSIS
Processed egg products (liquid, frozen, dried)USDA FSIS
Catfish (Siluriformes)USDA FSIS
>3% raw or >2% cooked meat/poultryUSDA FSIS

Why it changes everything: label pre-approval

The biggest practical difference is timing. USDA requires label pre-approval — every label for a meat, poultry, or egg product must be reviewed and approved by FSIS before the product can be sold. (Many standard labels qualify for 'generic' approval without individual submission, but special claims must be sent in.) The FDA does not pre-approve labels — with narrow exceptions such as infant formula and certain health claims — so you are responsible for getting it right, and the agency enforces after the fact.

Important

Special claims — 'natural,' 'no antibiotics ever,' 'grass-fed,' 'organic' — on a USDA product must be documented and approved by FSIS before use. On an FDA product you follow the FDA's definitions, but there is no pre-approval step. Don't assume a claim that is fine on an FDA label automatically clears on a USDA one.

What USDA labels carry that FDA labels don't

  • The USDA mark of inspection (the inspection legend) with the establishment number.
  • Safe handling instructions on raw or partially cooked meat and poultry.
  • Meat and poultry serving sizes still use the older 1990 reference amounts, not the FDA's 2016 RACC updates — see serving sizes and RACC.

If you're an FDA product

Most small food businesses — bakers, jam and sauce makers, snack and beverage brands — are FDA-regulated, which means no pre-approval and you build the Nutrition Facts panel yourself. The Nutrition Facts label generator produces the FDA 2016 format, and the Supplement Facts generator handles dietary supplements. Start with the required label elements and the small-business labeling guide.

Note

These tools build FDA-format labels. If your product is USDA-regulated, the panel is similar but you must go through FSIS label approval — begin at the FSIS labeling resources rather than publishing directly.

Frequently asked questions

Does the FDA or USDA regulate my food product?
Most packaged foods, produce, seafood, and shell eggs are regulated by the FDA. Meat, poultry, and processed egg products are regulated by USDA FSIS. A mixed product with more than 3% raw or 2% cooked meat or poultry by weight falls under USDA.
What is the 3% / 2% meat rule?
A product containing more than 3% raw meat or poultry, or more than 2% cooked meat or poultry, by weight is regulated by USDA FSIS. At or below those thresholds it is usually an FDA product.
Does the FDA approve food labels before I can sell?
No. The FDA does not pre-approve food labels, except for infant formula and certain health claims. USDA FSIS does require label approval for meat, poultry, and egg products before they enter commerce.
Who regulates eggs — the FDA or USDA?
Shell eggs are regulated by the FDA. Processed egg products such as liquid, frozen, or dried eggs are regulated by USDA FSIS under the Egg Products Inspection Act.
Can I keep my product under FDA rules?
Sometimes. Keeping meat or poultry at or below the 3% raw / 2% cooked thresholds, or using plant-based proteins, keeps a product under FDA oversight. You should never mislabel meat content to avoid jurisdiction.

Sources

Related tools & guides

This guide is general educational information, not legal advice, and labeling rules can change. Your obligations depend on your specific products, claims, sales, and state. Verify your situation against the current FDA guidance and eCFR linked above, or consult a qualified food-labeling professional, before printing a label.