Free FDA Label Requirement Checklist
Every element a US package is legally required to carry, cited to the section of 21 CFR that requires it. Answer five questions, tick what is already on your artwork, and see exactly what is missing.
Missing 4: Statement of identity, Net quantity of contents, Name and place of business, Nutrition Facts panel.
-
The common or usual name of the food, on the front. Brand names and invented product names do not satisfy this on their own.
Principal display panel · 21 CFR § 101.3
-
How much is in the package, in both US customary and metric units, placed in the lower 30% of the front panel.
Principal display panel · 21 CFR § 101.7
-
Manufacturer, packer or distributor, with a street address unless the firm is listed in a current city or telephone directory.
Information panel · 21 CFR § 101.5
-
The panel itself, in an FDA-recognised format, with values rounded to the rules in § 101.9(c).
Information panel · 21 CFR § 101.9
These depend on facts this tool cannot see, so they are not ticked off - they are looked up.
-
Minimum type sizes
Required statements have minimum type sizes that depend on the area of your panel, so they cannot be judged from the label alone. Work it out →
21 CFR § 101.2
This checklist covers the elements required on a US retail food or supplement package. It is not legal advice, and a product can carry every element here and still be misbranded for a reason specific to it - a claim it is not entitled to make, or a standard of identity it does not meet. Read the cited section before you print.
Common questions
What must every US food label carry?
Five things: a statement of identity naming the food, the net quantity of contents, an ingredient list, the name and place of business of the manufacturer, packer or distributor, and the Nutrition Facts panel. Allergen declaration sits alongside the ingredient list. Missing any one of them makes the product misbranded, however good the rest of the label is.
What goes on the principal display panel versus the information panel?
The principal display panel is the part of the package a shopper is most likely to see on the shelf, and it carries the statement of identity and the net quantity of contents. Everything else required, including the nutrition panel, the ingredient list and the manufacturer name and address, goes on the information panel, which is the panel immediately to the right of the PDP.
Is my small business exempt from the Nutrition Facts panel?
Possibly. FDA provides a small-business exemption based on employee numbers and units sold, claimed by filing a notice, and a separate exemption for low-volume products. The exemption is lost the moment you make a nutrient content claim or a health claim on the package. Confirm eligibility rather than assuming it, and re-confirm as volume grows.
Does country of origin have to appear?
Imported products must declare country of origin, and separate country-of-origin labelling rules apply to certain commodities. This is administered partly by Customs and Border Protection rather than FDA alone, which is why it is easy to overlook when working from an FDA-only checklist.
Does passing this checklist mean my label is compliant?
No. It confirms the required elements are present and correctly placed. It cannot verify that your nutrient values are accurate, that your serving size reflects the product, that your claims are substantiated, or that a state or category-specific rule does not apply on top. Treat it as the structural pass, not the final sign-off.