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Is It, or Isn’t It? Should FDA Add Other Food Allergens to the Major Food Allergen List for Labeling?

On Tuesday, April 19, the U.S. Food & Drug Administration (FDA) published a draft guidance titled Evaluating the Public Health Importance of Food Allergens Outside of the Official List of Major Food Allergens Listed in the Federal Food, Drug, & Cosmetic Act, outlining FDA’s stance when evaluating food allergens that are not one of the major allergens that require declaration on food product labels.


The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 amended the Food, Drug, & Cosmetic (FD&C) Act to define the list of major food allergens that require declaration on all food product labels: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. At the time, these eight food groups accounted for roughly 90% of documented food-based allergic reactions in the U.S. (out of a group of 160 identified food allergens). This gave FDA authority to require a declaration of known common allergens, while other regulations also gave FDA the authority to require declarations of additive allergens, including spices, colorings, and flavorings.


Since then, FDA has received multiple citizen petitions to evaluate other food allergens to be included in the list of major allergens. In April of 2021, in response to one such petition, the FD&C Act was amended to include sesame as one of the major food allergens, requiring it to be declared clearly on all products that contain sesame as an ingredient. In the case of sesame, significant amounts of data were submitted citing a prevalence of food products with undisclosed sesame ingredients, with these undeclared sesame food products causing allergic reactions. This information led FDA to the conclusion that sesame needed to be added to the major list of food allergens.


Not all petitions end in amended legislation; FDA has rejected petitions in the past for barley, rye, and garlic. In these three cases, insufficient data was provided to suggest these caused a significant number of allergic reactions. In the case of garlic, it was already required to be declared as an ingredient in any product where included, FDA found that elevating it to the status of a major food allergen was not only unnecessary, but the claim was not evidentially supported.


FDA is requesting allergen data from the industry to assess whether any food allergens have increased in prevalence and would necessitate additional legislation for the sake of public health. Data submissions are voluntary and will help FDA make regulatory determinations about food allergen labeling in the future. Interested private entities and food manufacturers should submit any relevant data to FDA.

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