【Food Labels in the US】How to Correctly Label the Allergens

Food allergies occur when the immune system reacts to certain proteins in food. The severity of food allergic reactions can vary, ranging from mild symptoms like hives and swelling of the lips to more severe, life-threatening symptoms such as difficulty breathing and anaphylactic shock. To ensure consumer safety, the U.S. Food and Drug Administration (FDA) mandates that food labels must list allergens as required by law.

Major Food Allergens in the United States

The Food Allergen Labeling and Consumer Protection Act of 2004 identifies eight major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research Act added sesame to the list, making it the ninth major food allergen.

Fig. Nine major food allergens in the United States (Source: FDA official website)

Food labels requiring the disclosure of major food allergens

The FDA enforces the requirement for the labeling of major food allergens on most packaged foods, including dietary supplements. However, this requirement does not apply to the following:

• Most meat, poultry, and certain egg products regulated by the U.S. Department of Agriculture (USDA);
• Alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) under its labeling rules;
• Fresh agricultural products;
• Highly refined oils (21 USC 321(qq)(2));
• Most foods sold at retail or food service establishments that are not pre-labeled.

Correctly labeling of food allergens

• Name of the food source from which the major food allergen is derived

The Federal Food, Drug, and Cosmetic Act (21 USC 343(w)) requires that food labels must include the name of the food source from which the major food allergen is derived. These allergens are as follows:

• Milk;
• Egg;
• The specific species of fish (e.g., bass, flounder, tilapia, salmon or cod);
• The specific species of Crustacean shellfish (e.g., crab, lobster, or shrimp);
• The specific type of tree nut (e.g., almond, pecans, or walnuts);
• Wheat;
• Peanuts;
• Soybeans; and
• Sesame.

Major food allergens also include ingredients derived from the proteins of these nine substances (21 USC 321(qq)(2)). The food source names can use both singular and plural forms, as well as reasonable synonyms, such as “soybeans/soy/soya” for soy-related allergens. When the allergen in a product is from tree nuts, fish, or shellfish, the specific name of the allergen should be listed. For example, instead of just “tree nuts”, it should specify “almonds”. (21 USC 343(w)(2)).

In special cases, such as genetically engineered or fermented milk proteins produced through the use of the DNA sequence of a major food allergen, these proteins may be sufficiently similar to those from the original milk source and could trigger allergic reactions in individuals sensitive to milk proteins. In such cases, these food ingredients must also be labeled as allergens. The labeling should be clear enough to indicate the relationship to the source allergen. For instance, such an ingredient could be labeled as “Contains milk-derived protein.”

• Labeling Methods for Major Food Allergens

If the common name of an ingredient already indicates the food source of the allergen, such as “milk” or “sesame”, there is no need for additional allergen labeling. However, if an ingredient contains a major food allergen but the common name does not specify the food source of the allergen, the allergen must be clearly labeled on the food package using one of the following two methods (21 USC 343(w)(1)):

a. Food source name in parentheses after the ingredient name, for example:

Ingredients: lecithin (soy), egg, whey (milk) and spices (sesame).

b. “Contains” statement must list all the major food allergens present in the product, placed immediately after or next to the ingredient list, in a font size no smaller than the font used for the ingredient list.

For example:

Ingredients: lecithin, egg, whey and spices.

Contains soy, egg, milk and sesame.

• “ may contain [allergen]” statement

When a facility uses shared equipment or produces multiple products containing different allergens on the same production line, there is a possibility of cross-contact due to inadequate cleaning or the presence of allergen-containing dust or aerosols. A “may contain [allergen]” statement is not mandatory but can be used to indicate potential cross-contact. However, this claim is only appropriate if the manufacturer adheres to current good manufacturing practices and has taken all reasonable precautions to prevent cross-contact.

Other Allergens

• Gluten

Gluten refers to proteins naturally present in gluten-containing grains (wheat, rye, barley, or any hybrid grains). Gluten can have adverse health effects for people with celiac disease. U.S. federal regulations stipulate that if a food does not contain gluten or if the unavoidable gluten content is less than 20 parts per million (ppm), the food may be labeled “gluten-free”, using terms like “no gluten”, “free of gluten” or “without gluten” (21 CFR 101.91).

• Food Additives

Some individuals may have hypersensitivity reactions to food colorings. For example, "FD&C Yellow No. 5" may cause itching and hives in sensitive people, and "cochineal extract" and "carmine" have been identified as allergens. The FDA requires that foods containing these color additives must list the specific names on the label (21 CFR 74.705(d)(2), 21 CFR 73.100(d)(2)).

Various sulfur dioxide agents, including sodium bisulfite, may cause adverse reactions (e.g., asthma) in sensitive individuals. When sulfur dioxide is present in a concentration of 10 ppm or more, even if it is introduced into the food as an ingredient for processing but does not remain in the final product, it must be labeled on the packaging (21 CFR 101.100(a)(4)).

Conclusion

If a food label lacks or incorrectly lists allergen information, the FDA may take enforcement actions, such as recalls or refusing imports, depending on the specific circumstances. Manufacturers should thoroughly understand their product ingredients and correctly label allergen information to protect consumers. If you have any questions or need assistance with U.S. food labeling, feel free to contact the Food Division of CIRS Group.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Reference

1. Food Allergies
2. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
3. The FASTER Act: Sesame Is the Ninth Major Food Allergen
4. Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
5. 21 USC (United States Code)-CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT
6. 21 CFR (Code of Federal Regulations)

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