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FDA Allergen Labeling Rules

According to the United States Food and Drug Administration (FDA), "approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies." In 2004 the FDA enacted the Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II) to identify major food allergens and outline specific regulations for their labeling on all manufactured food products.

  1. Eight Major Food Allergens

    • The FDA declared that all manufactured foods which contain one or more of the eight major food allergens must carry labels alerting consumers to the danger. As listed in Section 201(qq)(1) these allergens are "milk, egg, fish (e.g., bass, flounder or cod), crustacean shellfish (e.g., crab, lobster or shrimp), tree nuts (e.g., almonds, pecans or walnuts), wheat, peanuts and soybeans."

    Spell It Out

    • The manufacturer does not need to include any additional labeling if the major allergen is spelled out in the ingredient list. For example, if the ingredient lists "cheese", for no additional labeling to occur, the ingredient list must correctly contain "cheese (milk)."

    Alternative Labeling

    • If the manufacture chooses to not spell out the major allergen source in the ingredieant list, it must then include an additional label below or adjacent to the ingredient list in a type no smaller than that of the ingredient list using the words "May Contain (Allergen)."

    Oily Exception

    • Anything containing a protein from a major allergen must be labeled except in the case of highly refined oils such as soybean or peanut oil.

    Gluten-Free

    • Though currently a voluntary rule, the FDA encourages manufacturers to identify "gluten-free" products. This comes in response to the rise in diagnosed cases of celiac disease, an autoimmune sensitivity to gluten. Gluten commonly appears in wheat products, though it may appear in other foods as well.

    Cross Contamination

    • The FDA does not legally require manufacturers to report if a food may have become contaminated with an allergen due to production on shared equipment. Some manufacturers include a warning like, "May contain wheat and soy" or "Manufactured on equipment that may have also processed peanuts." Unfortunately, the FDA requires no standardization of the language as of 2010, though it is currently working on the issue.

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