Open Sesame: Congress Adds Sesame to the List of Major Food Allergens

By: Samantha Hong and Jacqueline Chan

UPDATE: President Biden signed the FASTER Act into law on April 23, 2021.

On April 14, 2021, Congress passed the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), which amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to add sesame as the ninth major food allergen.  Under the FASTER Act, sesame would be subject to FFDCA requirements applicable to major food allergens, including disclosure on food labels and current good manufacturing practice (cGMP) requirements related to allergen control.[1]  The FASTER Act was signed into law by President Biden on April 23, 2021, and applies to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023

Prior to the FASTER Act, under FDA’s general laws related to food ingredient declaration, foods containing sesame must declare “sesame” on the label if whole sesame seeds are used as an ingredient. However, where sesame is part of a spice or flavoring, or where the common or usual name of the ingredient does not specify sesame (e.g., tahini), “sesame” is not required to be declared in the ingredient list on the label.  As we previously discussed, FDA issued a draft guidance in November 2020 strongly encouraging food manufacturers to voluntarily declare “sesame” in the ingredient lists of food labels in such circumstances to address these concerns, acknowledging that sesame allergies may be an increasing problem in the U.S.[2] 

The passage of the FASTER Act expeditiously addresses FDA’s public health concerns by adding sesame as a major food allergen, triggering the labeling requirements encouraged by FDA’s guidance.   Specifically, as with the other eight major food allergens, the FASTER Act will require sesame to be declared on food labels in one of two ways:

  • (1) Inclusion of the name of the food source in parentheses following the common or usual name of the major food allergen in the list of ingredients (e.g., “Ingredients: Tahini (sesame), whey (milk), eggs, lecithin (soy)”), or
  • (2) Declaration of the word “Contains” followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients (e.g., “Contains Wheat, Milk, Sesame.”).[3] 

The FASTER Act will cause the requirements pertaining to food allergens under FDA’s rules governing food manufacturing and importation to apply to sesame.  Thus, if food manufacturers do not already include sesame as a food allergen in their Food Safety Plan, Supply-Chain Program, Foreign Supplier Verification Program, and Sanitary Transportation procedures,[4] they will need to do so.  In addition, if cleaning and other GMP procedures do not already prevent sesame cross-contact, they should be revised to do so.

Interestingly, the FASTER Act additionally requires that the Department of Health and Human Services (HHS) submit a report to Congress within 18 months of enactment, including recommendations and strategies “for the development and implementation of a regulatory process and framework that would allow for timely, transparent, and evidence-based modification of the definition of ‘major food allergen’ included in [the FFDCA].”[5]  These new reporting requirements similarly reflect FDA’s increasing attention to potential, emerging food allergens.  What remains to be seen is whether this reporting will result in a more streamlined approach for addressing other potential major food allergens in the future. 

We will continue to monitor FDA’s implementation efforts as the January 1, 2023, compliance date approaches, as well as any agency activities related to other potential food allergens.

[1] Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act of 2021), S. 578, 117th Cong. (2021).  Under the FFDCA (as amended by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)), the current major food allergens are milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.  21 U.S.C. § 321(qq)(1); see also 21 U.S.C. § 343(w) (deeming certain foods that lack the required disclosure of major food allergens as misbranded). 

[2] The comment period for this draft guidance closed on February 25, 2021, and it has not been finalized. 

[3] See 21 U.S.C. § 343(w).  

[4] 21 C.F.R. Part 1, subparts L and O, and Part 117, subparts C and G.

[5] FASTER Act at § 3(a)(2)(C).