September 27, 2021

Volume XI, Number 270

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September 24, 2021

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Sesame – the Ninth “Major Food Allergen”?

As our many of readers will know, food labels must declare the presence of an ingredient that is or that contains a protein from one of the “major food allergens” as defined in the Federal, Food, Drug and Cosmetic Act (FD&C Act). Currently, eight major food allergens are defined in the FD&C Act: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Absent from this list (and therefore not required to be disclosed in food allergy labeling) is sesame, which 49% of the U.S. population (or approximately 1.6 million people) report having an allergy to.  In November 2020, FDA issued a Draft Guidance indicating that sesame should be voluntarily declared on the food label.  But without legislative action FDA cannot amend the list of major food allergens and officially include sesame as a major food allergen.

In response to this issue, on February 22, 2021, the Food Allergy Safety, Treatment, Education and Research (FASTER) Act (H.R.1202) was introduced to the U.S. House of Representatives. Foremost among the bill’s goals is the addition of sesame as a “major food allergen.” Furthermore, the bill would require the Secretary of Health and Human Services to collect data on the prevalence of food allergies and make periodic reports to Congress. The bill also establishes a risk-based scientific process and framework for determining future major food allergens that will trigger mandatory allergen labeling.  The bill was originally introduced to the House in 2019 (see H.R.2117), where it was unanimously passed. And although a similar bill was passed by the Senate (see S.3541), the legislative session expired before the House could consider the revised bill.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 61
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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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