Congress Makes Sesame the Ninth Major Food Allergen

On April 14, 2021, the U.S. House of Representatives passed the Food Allergy Safety, Treatment, Education and Research (“FASTER”) Act of 2021 (S. 578), which makes sesame a major food allergen under the Federal Food, Drug, and Cosmetic Act (“FDCA”).  The U.S. Senate passed the bill last month and it is now headed to President Biden’s desk where it is expected to be signed into law. 

Sesame as a Major Food Allergen

The Food Allergen Labeling And Consumer Protection Act (“FALCPA”) amended the FDCA to establish eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.[1] Under the FASTER Act, sesame will become the ninth major food allergen.  Any ingredient that contains a major food allergen must declare the allergen source on the label.  The declaration can be made either using a “Contains” statement, e.g. “Contains Sesame,” or in the ingredient list with a parentheses following the name of the ingredient, e.g. “Tahini (sesame).”[2]

In addition to mandatory labeling requirements, the Food Safety Modernization Act (“FSMA”) requires a food allergen to be controlled for if it is identified as a hazard.  Under the preventative controls for human food rule, manufacturers are required to have procedures, practices, and processes that minimize or prevent allergen cross-contact during the storage, handling, and use of the allergen and that ensure the finished food product is properly labeled.[3] Manufacturers will need to have controls in place for sesame if it is identified as a hazard.

The FASTER Act also requires the Secretary of Health and Human Services to submit a report to Congress on the status of scientific research on food allergens and containing recommendations for a scientific-based regulatory process to establish additional major food allergens.

Once the FASTER Act is signed into law, any sesame-containing food introduced or delivered for introduction into interstate commerce on or after January 1, 2023 must be labeled as the FDCA requires.

If you have any questions concerning the updates discussed in this client alert, please contact the members of our Food, Drug, and Device practice.

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