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Sesame Allergen Labeling Becomes Law

 Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the label of a food that contains an ingredient that is or contains protein from a “major food allergen” must declare the presence of the allergen in the manner described by the law.  Until last week, there were eight major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, designated by FALCPA in 2004 for special food allergy labeling because they account for over 90 percent of all documented food allergies in the U.S. and represents the foods most likely to result in severe or life-threatening reactions.

On April 23, 2021, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, making sesame the ninth allergen that must be declared in specific allergen labeling.  This change will apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.  The new law (discussed here) also requires that FDA collect data on the prevalence of food allergies and prepare a report to Congress on the development of effective food allergy diagnostics, the prevention of food allergies, and the scientific criteria for defining a food or food ingredient as a “major food allergen.”  In this regard, while FDA has the authority to issue regulations requiring the disclosure of additives, such as spices and flavorings, that are, or contain, allergens other than the major food allergens, and a Citizen Petition was filed in November 2014, requesting that sesame be regulated similarly to other major allergens, by the end of last year, FDA had not yet moved beyond issuing a draft guidance, discussed here, for the voluntary disclosure of sesame as an allergen.

Consumer groups hope the FASTER Act of 2021 will lead to quicker expansion of the list of “major food allergens” the next time it becomes clear that an allergy is severe and prevalent in the U.S., and food that contains the allergen would not otherwise be required to disclose it as an ingredient.  According to a response from the Food Allergy Research & Education (FARE) organization, nearly 1.6 million Americans are allergic to sesame and will now be at less risk for death from accidental ingestion of food with sesame that was not listed on the food label.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 116
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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