What Does the U.S. Food Allergen Labeling Law Really Require?

Manufacturers must clearly list eight common allergens.

Nut allergy warning on packaging
Nut allergy warning on packaging. Getty Images/Peter Dazeley/Photographer's Choice

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 Food and Drug Administration (FDA) food labeling law, it also requires manufacturers to use the “common or usual name” of the allergen. For example, “egg” must be called "egg" on food labels instead of “ovalbumin.” The warning must be listed in the same size type as the rest of the ingredients on the label.

The common name must appear either:

  • in parentheses after the ingredient name. For example: “ovalbumin (egg),” or
  • after or next to the ingredient list, with the word “contains.” For example: “Contains: egg”

Exceptions to FALCPA

There are some exceptions to the law involving specific allergens.

Soy Ingredients: There are two exceptions to FALCPA that are specific to soy: manufacturers do not have to label a product "contains soy" if the product 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: FALCPA does not apply to "raw agricultural commodities" — fruits and vegetables in their natural state (as you would find them loose in the produce section, for example).

Therefore, these do not need to be labeled.

The law also does not cover eggs, milk, or meat, which are regulated by the U.S. Department of Agriculture, rather than by the FDA.

Because of these loopholes, 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, but also possibly wheat).

Manufacturers are not required to print allergy warnings on raw chicken.

Mollusks: FALCPA defines crustacean shellfish as one of the big eight allergens, but does not include mollusks. This means 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, it's likely 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