Food companies that manufacture, distribute, or import food products into the United States must comply with strict food labeling regulations established by the U.S. Food and Drug Administration (FDA). One of the most important labeling requirements involves the disclosure of major food allergens.

Consumers rely on allergen labeling to identify ingredients that may trigger serious allergic reactions. Because of this, the FDA requires food manufacturers to clearly declare certain ingredients known to cause the majority of food allergies.

If your company produces or imports food products for the U.S. market, understanding FDA allergen labeling requirements is essential to remain compliant and avoid costly regulatory issues.

FDA Registration Assistance helps food manufacturers, exporters, and importers ensure their products meet FDA labeling and compliance requirements before entering the U.S. market.

The 9 Major Food Allergens According to the FDA

Under U.S. food labeling law, the FDA recognizes nine major food allergens that must be declared on food labels when present in a product.

These allergens are responsible for the vast majority of serious allergic reactions in the United States.

The nine major allergens are:

• Milk
• Eggs
• Fish
• Crustacean shellfish
• Tree nuts
• Peanuts
• Wheat
• Soybeans
• Sesame

These allergens were originally identified under the Food Allergen Labeling and Consumer Protection Act (FALCPA), with sesame added later through the FASTER Act, which became effective in 2023.

Any food product containing one of these allergens must clearly disclose it on the label.

What Is Considered a Major Food Allergen?

A major food allergen is an ingredient that is known to cause significant allergic reactions in sensitive individuals. Even small amounts of these allergens can trigger serious symptoms, including life-threatening reactions such as anaphylaxis.

Because of these risks, the FDA requires that the presence of major allergens be clearly communicated on food labels to help consumers make safe dietary choices.

Food manufacturers must carefully review their ingredients to ensure proper allergen disclosure when any of the nine major allergens are present.

FDA Allergen Labeling Requirements

When a food product contains one of the FDA’s major allergens, the allergen must be declared in one of two ways.

1. Ingredient List Declaration

The allergen may be listed directly within the ingredient statement.

Example:

Ingredients: Wheat flour, sugar, cocoa butter, milk, salt

2. “Contains” Allergen Statement

Manufacturers may include a separate allergen declaration immediately after the ingredient list.

Example:

Contains: Milk, Wheat, Soy

This format helps consumers easily identify allergens without needing to interpret complex ingredient names.

What Counts as a Tree Nut Allergen?

Tree nuts are one of the major allergen categories recognized by the FDA. However, the FDA requires that the specific tree nut be identified, rather than simply listing “tree nuts.”

Examples of tree nuts include:

• almonds
• walnuts
• pecans
• cashews
• pistachios
• hazelnuts
• macadamia nuts
• brazil nuts

For example, if a product contains almonds, the label must identify “almonds” rather than simply stating “tree nuts.”

Why Accurate Allergen Labeling Is Critical

Proper allergen labeling is essential for protecting consumers with food allergies. Even trace amounts of an allergen can trigger severe reactions.

For food manufacturers and importers, incorrect allergen labeling may lead to serious regulatory consequences, including:

• FDA warning letters
• product recalls
• shipment detention at U.S. ports
• refusal of entry by the FDA

Ensuring that allergen declarations are accurate and compliant with FDA regulations is a key part of food safety and regulatory compliance.

FDA Compliance for Food Manufacturers and Importers

Companies exporting food products to the United States must comply with multiple FDA requirements beyond allergen labeling.

These requirements may include:

• FDA Food Facility Registration
• FDA U.S. Agent designation for foreign facilities
• Foreign Supplier Verification Program (FSVP) compliance
• FDA labeling compliance

FDA Registration Assistance helps companies navigate these regulatory requirements and avoid costly compliance issues.

Why Companies Work With FDA Registration Assistance

Food manufacturers, importers, and exporters around the world rely on FDA Registration Assistance for regulatory guidance and compliance support.

Global Experience

We support companies in more than 135 countries with FDA registration and regulatory compliance.

Complete FDA Compliance Services

Our services include:

• FDA Food Facility Registration
• FDA U.S. Agent services
• FSVP Agent services
• FDA label review and compliance consulting

Responsive Regulatory Support

Our team provides fast and reliable guidance for companies navigating FDA regulations.

Frequently Asked Questions

1. What are the nine major food allergens recognized by the FDA?

The FDA recognizes milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame as the nine major food allergens that must be declared on food labels.

2. Why does the FDA require allergen labeling?

The FDA requires allergen labeling to help consumers with food allergies easily identify ingredients that may cause allergic reactions.

3. What law established FDA allergen labeling requirements?

The Food Allergen Labeling and Consumer Protection Act (FALCPA) established allergen labeling requirements, with the FASTER Act later adding sesame as a major allergen.

4. Do food manufacturers always need to declare allergens?

Yes. If a product contains one of the nine major allergens, the allergen must be clearly declared on the food label.

5. How should allergens be listed on food labels?

Allergens may appear in the ingredient list or in a separate “Contains” statement following the ingredient list.

6. What happens if allergen labeling is incorrect?

Incorrect allergen labeling can lead to product recalls, FDA enforcement actions, or import refusals.

7. Are coconut and mustard considered FDA major allergens?

No. Coconut and mustard are not included among the FDA’s nine major food allergens, although they may be regulated differently in other countries.

8. Do importers need to verify allergen labeling?

Yes. Importers must ensure that products entering the United States comply with FDA food labeling requirements.

9. Can FDA Registration Assistance review food labels?

Yes. FDA Registration Assistance provides label review services to help companies ensure their food labels meet FDA regulatory requirements.

10. Why work with FDA Registration Assistance?

FDA Registration Assistance provides expert regulatory guidance, responsive support, and comprehensive FDA compliance services for companies exporting food products to the United States.

Need Help With FDA Food Labeling or Registration?

If your company exports food products to the United States, ensuring proper allergen labeling and regulatory compliance is essential.

FDA Registration Assistance helps food manufacturers and importers navigate FDA regulations, including food facility registration, labeling compliance, and import requirements.

Contact FDA Registration Assistance today to ensure your products meet FDA requirements.