Every food product imported into the United States must meet the same labeling requirements as domestically produced food. There are no exceptions for imported products, no transition period for foreign suppliers, and no pre-approval process from FDA. If your product's label does not comply with U.S. rules at the time it arrives at the port, it is considered misbranded under the Federal Food, Drug, and Cosmetic Act, and FDA can detain and refuse it. The problem for importers is that U.S. labeling rules differ from virtually every other country's rules in ways that foreign suppliers do not know about, do not understand, or assume do not apply to them. Here is exactly where U.S. rules differ from international norms, what your supplier is most likely getting wrong, and a label review checklist you can send before production starts.
Key Takeaways
Imported food must meet identical labeling requirements as U.S.-produced food. There are no waivers for foreign products.
A food product with a noncompliant label is "misbranded" under the FD&C Act and subject to detention, refusal, and destruction.
The U.S. requires declaration of 9 major allergens (the "Big 9"): milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. Many countries require fewer allergens or use different declaration formats.
The U.S. Nutrition Facts panel has a specific format, specific nutrients, specific units, and specific serving size methodology that differs from nearly every other country's nutrition label.
All required label information must be in English. Bilingual labels are permitted, but English is mandatory.
FDA updated its food labeling compliance program in 2025 to incorporate the sesame allergen requirement and updated Nutrition Facts formatting. In 2026, FDA is using this updated program as the primary reference during inspections, increasing citations for legacy labels.
Correcting labels at the port is expensive, slow, and often impossible for perishable products. The time to fix labeling is before the product ships, not after it arrives.
What Must Appear on a U.S. Food Label?
Every packaged food product sold in the United States must display five mandatory elements.
| Required Element | What It Must Include | Where It Appears |
|---|---|---|
| Statement of identity | The common or usual name of the food (not a brand name or trade name alone) | Principal Display Panel (front of package), in bold type at least half the size of the largest text |
| Net quantity of contents | The weight, volume, or count of the food product in both metric and U.S. customary units | Principal Display Panel, in the lower 30% of the panel |
| Ingredient statement | All ingredients listed in descending order by weight, using common names | Information panel (typically back or side), near the Nutrition Facts label |
Allergen declaration
Declaration of any of the 9 major allergens present, either in parentheses within the ingredient list or in a separate "Contains" statement
With or immediately following the ingredient statement
Name and place of business
The name and address (including street, city, state, and ZIP) of the manufacturer, packer, or distributor
Information panel
Most packaged foods must also include a Nutrition Facts label (discussed below). Exemptions exist for very small businesses (under $500,000 in annual food sales and under $50,000 in sales of the specific product) and certain product categories.
Where Do U.S. Rules Differ From International Norms?
This is the section that matters most for importers. Your foreign supplier produces labels that comply with their domestic market. Those labels almost certainly do not comply with U.S. rules. Here are the most common differences.
Allergen Declaration
The U.S. requires declaration of 9 major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. This list was expanded to include sesame by the FASTER Act of 2021, effective January 1, 2023.
| Requirement | United States | European Union | Codex Alimentarius |
|---|---|---|---|
| Number of major allergens | 9 | 14 | 8 |
| Sesame required? | Yes (since 2023) | Yes | Yes |
| Celery required? | No | Yes | No |
| Mustard required? | No | Yes | No |
| Lupin required? | No | Yes | No |
| Mollusks required? | No | Yes | No |
| Declaration format | Parenthetical in ingredients OR separate "Contains" statement | Emphasized (bold, italic, or CAPS) within ingredients | Varies by country |
| "May contain" (cross-contact) | Voluntary, not regulated by FDA | Voluntary, being harmonized | Varies |
The importer's risk: A product labeled for the EU market may declare 14 allergens but use the wrong format for the U.S. A product labeled for an Asian or Latin American market may declare fewer allergens than the U.S. requires. In both cases, the label is noncompliant.
Nutrition Facts Panel
The U.S. Nutrition Facts panel has a specific format codified at 21 CFR 101.9. It differs from the nutrition information panels used in the EU, Canada, Australia, and most other markets.
| Requirement | United States | European Union | Canada |
|---|---|---|---|
| Panel name | "Nutrition Facts" | "Nutrition Information" or "Nutrition Declaration" | "Nutrition Facts" (similar but not identical format) |
| Energy units | Calories (kcal) | kJ and kcal | Calories |
| Serving size basis | Reference Amounts Customarily Consumed (RACC) set by FDA | Per 100g/100ml (and optionally per serving) | Serving size based on Schedule M |
| Added sugars | Required (separately from total sugars) | Not required separately | Required |
| Vitamin D | Required | Not required on standard label | Required |
| Potassium | Required | Not required on standard label | Required |
| % Daily Value basis | Based on U.S. Daily Reference Values | Based on EU Reference Intakes | Based on Canadian Daily Values |
| Format | Specific FDA tabular format with bold dividers | Tabular or linear, less prescriptive | Specific Health Canada format |
The importer's risk: A label designed for any market other than the U.S. will almost certainly have the wrong nutrition panel format, the wrong serving size methodology, missing nutrients (added sugars, Vitamin D, potassium), and different % Daily Value calculations. This label cannot be used in the United States.
Ingredient Naming
The U.S. requires ingredients to be listed using their common or usual names as defined in 21 CFR. Many ingredients have different names in different countries.
Common mismatches include "colour" vs. "color," "flavour" vs. "flavor," "maize" vs. "corn," "courgette" vs. "zucchini," "caster sugar" vs. "sugar," and using E-numbers (E330, E412) instead of the U.S. common names (citric acid, guar gum). FDA does not accept E-number designations. Each additive must be listed by its U.S. common or usual name.
Language Requirements
All mandatory label information must be in English. A label entirely in Spanish, French, Mandarin, or any other language without English translations of all required elements is noncompliant.
Bilingual or multilingual labels are permitted, but the English text must include all required elements. If a label has ingredient lists in both English and Spanish, both versions must be complete and accurate.
Net Weight and Measurement
The U.S. requires net quantity of contents in both metric and U.S. customary units (e.g., "Net Wt. 16 oz (454 g)"). Many foreign labels display only metric units, which does not meet U.S. requirements.
Country of Origin
Imported food products must bear a country of origin statement (e.g., "Product of Thailand" or "Made in Mexico"). This is a CBP requirement under the Tariff Act, enforced at import. Many foreign suppliers omit this because it is not required in their domestic market.
The 8 Most Common Labeling Violations on Imported Food
| # | Violation | Why It Happens | Consequence |
|---|---|---|---|
| 1 | Missing or incorrect allergen declaration | Supplier uses home-country allergen list (fewer allergens, different format), sesame not declared | Misbranded: detention and refusal. Undeclared allergens trigger recalls. |
| 2 | Wrong Nutrition Facts format | Supplier uses EU, Canadian, or APAC nutrition panel design | Misbranded: label does not meet 21 CFR 101.9 format requirements |
| 3 | Missing added sugars on Nutrition Facts | Supplier's home market does not require added sugars declaration | Noncompliant with updated Nutrition Facts requirements |
| 4 | No English text on label | Supplier produces labels for domestic or regional markets in local language only | Misbranded: all required elements must be in English |
| 5 | E-numbers instead of ingredient names | EU-format ingredient list uses E-number codes for additives | Noncompliant: FDA requires U.S. common or usual names |
| 6 | Missing country of origin | Supplier's domestic market does not require origin statement | CBP and FDA violation: product must state country of manufacture |
| 7 | Net weight in metric only | No U.S. customary equivalent (ounces, pounds) | Noncompliant with Fair Packaging and Labeling Act |
| 8 | Unauthorized health or nutrient claims | Supplier makes claims on label that do not meet FDA standards for structure/function, nutrient content, or health claims | Misbranded: unauthorized claims can trigger warning letters and detention |
The Label Review Checklist for Foreign Suppliers
Send this checklist to every foreign food supplier before they produce labels for U.S.-destined products.
Statement of identity: Does the front of the package display the common or usual name of the food in English, in bold type, at a size at least half the largest text on the panel?
Net quantity: Is the net weight or volume displayed in both metric and U.S. customary units (e.g., "Net Wt. 12 oz (340 g)") in the lower 30% of the front panel?
Ingredient statement: Are all ingredients listed in descending order by weight, using U.S. common or usual names (not E-numbers), in English, in type at least 1/16 inch tall?
Allergen declaration: Are all 9 major U.S. allergens (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, sesame) declared either in parentheses within the ingredient list or in a separate "Contains" statement?
Nutrition Facts panel: Does the panel use the exact U.S. "Nutrition Facts" format per 21 CFR 101.9, including calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, Vitamin D, calcium, iron, and potassium, with correct serving sizes based on FDA Reference Amounts Customarily Consumed?
Name and place of business: Does the label include the name and full address (street, city, state, ZIP) of the manufacturer, packer, or distributor? If the named entity is not the manufacturer, does it include a qualifying phrase ("manufactured for," "distributed by," etc.)?
Country of origin: Does the label include a country of origin statement (e.g., "Product of [country]")?
Language: Is all mandatory label text in English? If the label is bilingual, are both language versions complete and consistent?
No unauthorized claims: Does the label avoid health claims, nutrient content claims, or structure/function claims that have not been reviewed for U.S. compliance?
Color additive compliance: Does the ingredient list use U.S. names for color additives, and does it avoid any revoked additives (FD&C Red No. 3 after January 15, 2027)?
Frequently Asked Questions
Do imported food products have to meet the same labeling rules as domestic products?
Yes. There are no exceptions, waivers, or transition periods for imported food. Every product offered for import must comply with U.S. labeling requirements at the time of arrival.
What happens if my product label does not comply?
The product is considered misbranded under the FD&C Act. FDA can detain and refuse it. The importer must either recondition (relabel) the product under FDA supervision or export or destroy it.
Can I relabel at the port?
Sometimes, but it is expensive, slow, and not always possible. For perishable products with limited shelf life, the time lost to relabeling at the port can render the product unsaleable. The cost of port-side relabeling typically includes labor, materials, FDA supervision, and additional storage charges during the process. It is far more cost-effective to produce U.S.-compliant labels before the product ships.
How many allergens must be declared in the U.S.?
Nine: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. Sesame was added by the FASTER Act of 2021.
Does the U.S. accept E-numbers on ingredient lists?
No. FDA requires that food additives be listed by their U.S. common or usual names. E-number designations used in the EU and other markets are not accepted.
Must the label be in English?
Yes. All mandatory label elements must be in English. Bilingual labels are permitted but English is required.
What is the correct format for the U.S. Nutrition Facts panel?
The format is specified at 21 CFR 101.9. It uses "Nutrition Facts" as the title, lists calories and specific nutrients in a prescribed order, uses serving sizes based on FDA Reference Amounts Customarily Consumed, and requires declaration of added sugars, Vitamin D, calcium, iron, and potassium. Nutrition panels from other countries (including Canada, the EU, and Australia) do not meet U.S. format requirements.
Does FDA pre-approve food labels?
No. FDA does not pre-approve or certify labels before products are sold. It is the importer's responsibility to ensure compliance before offering the product for import. FDA can take enforcement action against noncompliant labels at any time.
Is country of origin labeling required on imported food?
Yes. All imported food must bear a country of origin statement under the Tariff Act. This is enforced by CBP at import.
What changed in FDA's labeling enforcement in 2025 and 2026?
FDA updated its general food labeling compliance program in 2025 to incorporate the sesame allergen requirement and the updated Nutrition Facts format (including added sugars, Vitamin D, potassium). In 2026, FDA is using this updated program as the primary inspection reference, increasing the likelihood that legacy labels and transitional SKUs will be cited.
How do I ensure my foreign supplier produces a compliant label?
Send them the label review checklist in this article before production. Require a label proof for review against U.S. requirements before final printing. Have a U.S.-based regulatory consultant or your customs broker review the proof for compliance before the product ships.
This guide reflects FDA food labeling requirements, the updated labeling compliance program, and common international labeling differences as of April 3, 2026. Food labeling regulations are codified at 21 CFR Part 101 and enforced by FDA and CBP. Importers should verify current requirements through FDA.gov and the FDA Food Labeling Guide. For related topics, see our guides on prior notice filing, FSVP compliance, FDA holds on perishable food, FDA import alerts, Red No. 3 reformulation, and choosing a customs broker for food imports.
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