FDA Food Labeling Requirements for Foreign Exporters: A Complete Compliance Guide

Labeling is the number one reason food shipments from foreign manufacturers are detained at US ports. Not contamination, not documentation — labels. The FDA's labeling requirements are detailed, prescriptive, and different from the labeling rules in almost every other country. A label that passes inspection in the EU, Japan, or Australia will almost certainly not comply with US rules without significant modification. Foreign exporters who treat US labeling as a translation exercise — simply converting their existing label to English — will face refusals, delays, and costly re-labeling at the port or, worse, in a US warehouse.

The Nutrition Facts panel

Every packaged food product sold in the United States must carry a Nutrition Facts panel that follows the FDA's specific format, updated in 2016. The panel must display serving size (based on Reference Amounts Customarily Consumed, not the manufacturer's suggested serving), calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium. The format, font sizes, line spacing, and bold/non-bold designations are all specified in the regulation. The daily values used in the panel must be the current FDA daily values — not the values used by any other country's regulatory system. A European label that lists energy in kilojoules and protein in a different position on the panel does not comply. A Japanese label that uses different reference serving sizes does not comply. The panel must be recalculated and reformatted for the US market.

Ingredient list requirements

The ingredient list must appear on the label in descending order of predominance by weight. Each ingredient must be listed by its common or usual name as recognized in the United States — not by trade names, chemical names, or names used in other regulatory systems. Colors must be listed by their FDA-approved names (for example, FD&C Red No. 40, not Allura Red AC or E129). Ingredients that serve a technical function must be identified by both the ingredient name and a description of the function (for example, sodium benzoate (preservative)). Sub-ingredients of multi-component ingredients must be declared either in the main ingredient list or in parentheses following the multi-component ingredient name.

Allergen declarations under FALCPA and the FASTER Act

The Food Allergen Labeling and Consumer Protection Act (FALCPA) and the FASTER Act require that labels clearly identify the presence of nine major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. The allergen declaration must use the specific allergen name (for example, milk, not casein or whey without identifying the source). The declaration can appear as a separate Contains statement immediately after the ingredient list or can be incorporated into the ingredient list using parenthetical references. Many foreign labels declare allergens using their local regulatory framework, which may cover a different set of allergens (the EU lists 14) or use different declaration formats. These do not satisfy US requirements.

Net quantity, country of origin, and responsible party

The label must state the net quantity of contents in both metric and US customary units (for example, 500 g (17.6 oz)). The country of origin must be declared in English in a conspicuous location — this is both an FDA and a US Customs requirement under 19 CFR 134. The label must also include the name and address of the manufacturer, packer, or distributor. For foreign products, this is typically the US distributor or importer, not the foreign manufacturer. If the name on the label is not the manufacturer, the label must include a qualifying phrase such as manufactured for or distributed by.

Common labeling mistakes by foreign exporters

The most common mistakes include using the wrong Nutrition Facts format (old US format, EU format, or Codex format instead of the current US format), listing allergens according to EU or ASEAN rules instead of US rules, omitting sesame as an allergen (mandatory since January 2023), using metric-only net weight without US customary units, declaring colors by E-numbers instead of FDA-approved names, and omitting the added sugars line from the Nutrition Facts panel. Each of these individually is sufficient for the FDA to detain a shipment.

How FDABridge handles label compliance

FDABridge provides label compliance review for foreign food exporters as part of our registration services. We review your existing labels against current FDA requirements, identify every element that needs to change, and provide specific guidance on corrections. We do not design labels — we ensure the regulatory content on your label meets US requirements before your products ship. Visit fdabridge.com/food to learn about our food export services.