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Food Allergen Labeling Law

Food Allergen Labeling and Consumer Protection Act of 2004


Updated January 26, 2011

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires manufacturers to clearly list the eight most common food allergens on product labels. Commonly referred to as the FDA food labeling law, it requires manufacturers to use the “common or usual name” of the allergen. For example, “egg” must be used instead of “ovoalbumin.” The warning must be listed in the same size type as the rest of the ingredients on the label. The common name must appear:

  • In parentheses after the ingredient name. For example: “ovoalbumin (egg),” or
  • After or next to the ingredient list, with the word “Contains.” For example: “Contains: egg”


There are, of course, some exceptions to the law.

Soy Ingredients: There are two exceptions to FALCPA that are specific to soy: manufacturers do not have to label a product "contains soy" if it only contains refined soy oil, or if it contains soy lecithin that has been used as a release agent.Research shows that soy proteins are present in soybean oil and soy lecithin. However, it is not clear if there is enough soy protein in these ingredients to cause a reaction in most people with soy allergies. Some people are more sensitive to soy than others, so follow your doctor's advice about these ingredients.

Raw agricultural commodities: In addition, FLCPA does not apply to "raw agricultural commodities" - fruits and vegetables in their natural state. It also does not cover eggs, milk, or meat, which are regulated by the USDA. Raw fruits and vegetables may be sprayed with pesticides that contain allergens (most commonly, soy oil.) Raw chicken may be processed in water or broth that contains major allergens (once again, most commonly, soy). Manufacturers are not required to print allergy warnings on raw chicken.

Mollusks: FALCPA defines crustacean shellfish as one of the big eight allergens, but not mollusks. This means that manufacturers are not required to list the presence of clams, oysters, mussels, scallops or other mollusks in ingredient lists. If you are allergic to crustacean shellfish, there is a likelihood that you may have a sensitivity to mollusks as well.

What does “May Contain” Mean?

If you see the following statements on a label, the food may be cross-contaminated with a big eight food allergen. These warnings are voluntary, so some manufacturers may not include this information. The only way to know if there is a chance of cross-contamination is to call the manufacturer of the product.

  • "may contain…"
  • "produced on shared equipment with…"
  • "produced in a facility that also processes…"

More Questions about FALCPA?


U.S. Food and Drug Administration. Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act. Accessed 1/22/2011. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059065.htm

U.S. Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance. October 2006. Accessed 1/22/2011. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm

U.S. Food and Drug Administration. Food Allergies: What You Need to Know. Accessed 1/22/2011. http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm

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