USDA vs FDA: Which Agency Regulates Your Food Label?

Last verified 16 Sep 2026 · Sources

Whether FDA or USDA regulates your label depends on what’s in the product, not your business type. Meat, poultry, and their products above roughly 3% raw meat or 2% cooked meat or poultry content fall under USDA’s Food Safety and Inspection Service (FSIS), governed by 9 CFR parts 317 and 381, not FDA’s 21 CFR 101. Egg products (not shell eggs) fall under FSIS too, under 9 CFR part 590. Alcohol at 0.5% ABV or more falls under the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) instead of either food agency. Everything else defaults to FDA.

Quick facts	USDA vs FDA Jurisdiction
Regulation	9 CFR 317.309, 9 CFR 381.409, 9 CFR 412; 21 CFR 101.9; 27 CFR part 7
Applies to	Any product containing meat, poultry, egg products, or alcohol, deciding which federal agency's labeling rules govern it
Key numbers	FSIS jurisdiction threshold: roughly 3% raw meat / 2% cooked meat or poultry; TTB jurisdiction: beverages ≥0.5% ABV

The rule

FDA’s authority comes from the Food, Drug, and Cosmetic Act and shows up in the Nutrition Facts rules at 21 CFR 101. USDA’s authority over meat and poultry comes from a different set of statutes (the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act), carried out by FSIS. The nutrition-labeling content rules FSIS applies sit at 9 CFR 317.309 (meat) and 9 CFR 381.409 (poultry); both track FDA’s 21 CFR 101.9 approach closely, including a similar compliance tolerance: 9 CFR 381.409 states that Class II (naturally occurring) nutrients are compliant at “at least equal to 80 percent of the value for that nutrient declared on the label,” and that calories, sugars, total fat, saturated fat, cholesterol, and sodium are misbranded if the composite exceeds the declared value “by more than 20 percent.”

The line for a mixed product (one with some meat or poultry, not a straight cut of it) turns on how much meat or poultry is in the formula. FSIS’s 2007 Federal Register notice, “FSIS Jurisdiction Over Flavor Products Containing Meat or Poultry” (72 FR 3779), states that products “with greater than 3 percent raw meat or poultry, or 2 percent or more cooked meat or poultry, in their formulation are amenable to FSIS jurisdiction,” describing the amount of meat or poultry used as one basis for determining amenability. The open-face-versus-closed-face sandwich distinction is a classic rule-of-thumb example of the same line, drawn from FSIS’s Food Standards and Labeling Policy Book.

Egg products (dried, frozen, or liquid eggs, with or without added ingredients) fall under continuous USDA inspection at 9 CFR part 590. Shell eggs are treated more lightly: packers with 3,000 or fewer layers are exempt from that part’s temperature and labeling requirements. Alcohol beverages sit outside both food agencies once they cross 0.5% ABV: 27 CFR part 7 sets TTB’s malt beverage labeling rules at that threshold and directs beverages that don’t meet the FAA Act’s definitions of malt beverage, wine, or distilled spirits back to “the applicable labeling regulations for foods issued by the U.S. Food and Drug Administration,” the relevant line for kombucha and similar fermented beverages.

The numbers

Product	Governing agency	Key citation
Jerky above the raw/cooked meat threshold	USDA-FSIS	9 CFR 317.309 / 381.409
Soup with meat above the threshold; plain soup	FSIS / FDA	9 CFR 317.309; 21 CFR 101.9
Kombucha under / at or above 0.5% ABV	FDA / TTB	21 CFR 101.9; 27 CFR part 7
Cheese, pasta (no meat filling), hot sauce, granola, protein bars	FDA	21 CFR 101.9
Pasta with meat filling above the threshold	USDA-FSIS	9 CFR 317.309
Liquid or frozen egg products / shell eggs	USDA-FSIS / state & USDA-AMS	9 CFR part 590
Dog treats containing meat	FDA’s Center for Veterinary Medicine, alongside state feed control officials under the AAFCO model; pet food sits outside 21 CFR 101 human labeling, and FSIS does not regulate it	Not listed

On the label

A beef jerky and a plain pasta can look similar on paper (both from small makers, both selling into the same regional grocery co-op), but they answer to different rulebooks. If you make the jerky, your panel has to meet 9 CFR 317.309’s format and compliance-tolerance rules and typically needs a USDA mark of inspection; if your label makes any claim (“natural,” a health claim, “no antibiotics”), it needs FSIS sketch approval under 9 CFR part 412, not the generic no-submission path available to a plain mandatory-features label. If you make the pasta, with no meat filling, you build your panel entirely under 21 CFR 101.9 and never touch FSIS: no mark of inspection, no sketch approval.

Mistakes we see

Assuming any product with “meat” or “poultry” in the ingredient list needs a USDA label, without checking the actual percentage against the threshold.
Treating a fermented beverage’s ABV as fixed at the recipe stage, when bottled ABV can drift and needs checking against the 0.5% TTB threshold.
Launching a claims-bearing meat or poultry label without FSIS sketch approval, assuming generic approval covers it.
Not distinguishing shell eggs from egg products when sourcing a liquid egg ingredient, even though the finished product stays under FDA.
Guessing at pet-treat labeling rules by analogy to human food labeling instead of checking the applicable feed-control framework.

Related rules

A product that turns out to be FSIS-regulated still needs many of the same underlying calculations. See database analysis vs lab testing for how FSIS applies a similar compliance-tolerance structure. If you’re unsure whether your product needs any nutrition panel before sorting out which agency governs it, start with when is nutrition labeling required. Larger soup or pasta packages should also check dual column: when required.

When jurisdiction gets complicated, get a system for it

Knowing which rulebook each product answers to lets you plan approvals and print runs with no surprises at the co-op. If you run SKUs that might sit on different sides of the FDA/USDA/TTB line (a jerky line alongside a hot sauce line, say), the Studio plan ($299 a year: every product you make, plus the compliance binder and PDF reports) keeps each product’s compliance path organized with AI spec-sheet import, allergen and cross-contact tools, a spec-sheet review calendar, and change history, so a formula shift that moves a product across a jurisdictional threshold doesn’t get missed; the Co-packer plan ($1,199 a year: everything in the Studio plan plus client folders and white-label documents) fits a consultant managing several brands at once. For one product you already know is FDA-regulated, enter your recipe, then see your label: your calories, the claims you qualify for and your allergen line are free, no card required, every other value and %DV stays hidden until you unlock, and Single Product ($29) unlocks every other nutrient value and %DV, every FDA format your product qualifies for, and your ingredient statement and allergen declaration. See pricing or build your label free to see the free preview first.

FAQ

How do I know if my product is FDA or USDA-regulated?

It comes down to what's in it. Per FSIS's 2007 Federal Register notice (72 FR 3779), products with greater than 3 percent raw meat or poultry, or 2 percent or more cooked meat or poultry, in their formulation are amenable to FSIS jurisdiction; most other packaged foods fall under FDA.

Does a sandwich with meat automatically need a USDA label?

Not always. This is the classic open-face vs. closed-face distinction FSIS and FDA have historically used to sort jurisdiction, per FSIS's Food Standards and Labeling Policy Book: a closed-face sandwich is FSIS-regulated, an open-face sandwich is FDA-regulated.

Do shell eggs need a USDA nutrition label?

Shell eggs are treated differently from processed egg products under 9 CFR part 590; shell egg packers with 3,000 or fewer layers are exempt from certain temperature and labeling requirements that apply to larger packers.

At what alcohol content does TTB take over from FDA?

27 CFR part 7 treats 0.5% alcohol by volume as the line for TTB's malt beverage labeling requirements; beverages below that threshold, or that don't meet the FAA Act's definitions for wine, beer, or spirits, are referred back to FDA's food labeling rules.

Does USDA require pre-approval of every meat or poultry label?

No. Most labels qualify for generic approval without a submission if they carry only mandatory features and no special claims; labels with claims like \"natural,\" health claims, or animal-raising statements need FSIS sketch approval before use, under 9 CFR part 412.

← All labeling rules

USDA vs FDA: Which Agency Regulates Your Food Label?

The rule

The numbers

On the label

Mistakes we see

Related rules

When jurisdiction gets complicated, get a system for it

FAQ

Related rules

Sources

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