FDA 21 CFR Part 101

US Food Label Requirements for Exporters

Every food product imported into the United States must carry a label that meets FDA requirements — regardless of what country it was made in. Your home country's label format is not sufficient. Here is exactly what must appear on a U.S.-compliant label.

Mandatory Label Elements

Under 21 CFR Part 101, the following elements are required on all food labels sold in the U.S.:

Statement of Identity

The common or usual name of the product must appear on the principal display panel (the front of the package) in bold type. Example: "Whole Wheat Crackers" or "Extra Virgin Olive Oil."

Net Quantity of Contents

The net weight or volume must appear in the bottom 30% of the principal display panel in both U.S. customary units (oz, fl oz, lb) and metric units (g, mL, kg). See FDA net weight requirements.

Nutrition Facts Panel

A Nutrition Facts label formatted to FDA standards is required for most packaged foods. The U.S. format differs significantly from EU, Canadian, and other international formats — including serving size calculations, required nutrients, and layout. See FDA Nutrition Facts label format.

Ingredient List

All ingredients must be listed in descending order by weight using their common or usual names in English. Sub-ingredients in compound ingredients must be listed in parentheses. See FDA ingredient list requirements.

Allergen Declaration

The U.S. recognizes 9 major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Each must be declared — either in the ingredient list using common names or in a separate "Contains:" statement. See FDA allergen labeling requirements.

Name and Address of Manufacturer or Distributor

The label must include the name and place of business of the manufacturer, packer, or U.S. distributor. Foreign manufacturers must typically include a U.S. distributor's address. See FDA manufacturer address requirements.

Language Requirements

All mandatory label information must appear in English. You may include translations in other languages, but the English information must be at least as prominent. Bilingual labels are permitted — and common for products sold in multicultural markets — as long as the English is not obscured.

Using only your home country's language (French, Italian, Spanish, Mandarin, etc.) is not compliant, even if the product is otherwise correctly labeled.

How U.S. Labels Differ from EU and International Labels

Nutrition panel layout: The U.S. Nutrition Facts format is distinct — different nutrients, different daily value percentages, and a specific visual layout mandated by the FDA
Serving size: U.S. serving sizes must be based on FDA Reference Amounts Customarily Consumed (RACC), not manufacturer choice or EU equivalents
Allergens: Sesame was added as a 9th U.S. allergen in 2023 — it is not a major allergen in the EU or most other markets
Net weight units: Both U.S. customary and metric units are required — metric only (as used in the EU) is not sufficient
Font size: Minimum type size requirements apply to every mandatory label element — see FDA font size requirements

Common Mistakes for Exporters

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Assuming an EU or Codex-compliant label also meets FDA requirements — the formats are fundamentally different
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Using only metric units on net weight — U.S. customary units (oz, lb) are required alongside metric
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Omitting sesame from allergen declarations — sesame became a U.S. major allergen in January 2023
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Listing a foreign manufacturer address without a U.S. distributor address — the FDA requires a U.S. place of business on the label
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Using a home-country nutrition label format instead of the FDA Nutrition Facts panel
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Printing labels before checking compliance — reprints are expensive and cause launch delays

Related Guides

Export food to USA requirements — registration, prior notice, and importer requirements
FDA label requirements for imported food
FDA compliance for imported food products