FDA 21 CFR Part 101

FDA Label Requirements for Imported Food

Imported food products are subject to the same FDA labeling requirements as food made in the United States. The FDA does not have a separate, relaxed standard for imports — your label must meet U.S. law before your product can be sold.

The Same Rules Apply to Imports

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all food offered for sale in the United States — regardless of origin — must meet FDA labeling requirements. This means a product made in France, Japan, Mexico, or anywhere else must carry the same label elements as a domestically produced equivalent.

Important: The FDA inspects imported food labels at the border. Products with non-compliant labels can be detained, refused entry, or required to be relabeled before sale — at the importer's expense.

The required elements on an FDA-compliant label for imported food include: a statement of identity, net quantity of contents, Nutrition Facts panel, ingredient list, allergen declaration, and the name and address of a U.S. responsible party.

Key Requirements for Imported Food Labels

English language: All mandatory label information must be in English. Bilingual labels are allowed but English must be equally prominent
U.S. Nutrition Facts format: The FDA's Nutrition Facts panel layout, required nutrients, and daily value percentages must be used — not EU, Canadian, or other formats. See FDA Nutrition Facts label format
Ingredient list in English: Ingredients listed in descending order by weight using their English common names. See FDA ingredient list requirements
9 major allergens declared: Milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame must all be declared. Sesame was added in 2023. See FDA allergen labeling requirements
Net weight in dual units: Net quantity must be declared in both U.S. customary units (oz, lb, fl oz) and metric units (g, kg, mL). See FDA net weight requirements
U.S. responsible party address: A U.S. importer, distributor, or agent address must appear on the label
Minimum font size: All mandatory text must meet FDA minimum type size rules. See FDA font size requirements

What Happens If Your Import Label Fails

When the FDA identifies a labeling violation on an imported shipment, it can take several actions:

Detention without physical examination (DWPE): If your facility has a history of violations, future shipments can be automatically detained
Refusal of admission: The shipment is refused entry and must be re-exported or destroyed
Voluntary relabeling: In some cases the FDA allows the importer to relabel the product in a bonded facility before it enters commerce — at the importer's cost

Labeling violations are among the most common reasons for import refusals. Getting your label right before you ship is significantly cheaper than correcting it at the port.

Common Mistakes on Imported Food Labels

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Using a home-country nutrition panel instead of the FDA Nutrition Facts format
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Label is entirely in a foreign language with no English
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Missing sesame allergen declaration — added as a U.S. major allergen in January 2023
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Net weight in metric only — both metric and U.S. customary units are required
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No U.S. distributor or importer address on the label
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Ingredient list not in descending order by weight

Related Guides

U.S. food label requirements for exporters — full element-by-element breakdown
FDA compliance for imported food products
Export food to USA requirements