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Open Sesame! FDA Draft Guidance and Proposed FASTER Act Open Door to Regulation of Sesame as a Major Food Allergen 

by Elisha Yang

Published: December, 2020

Submission: January, 2021

 



Summary


Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices. Although non-binding, these actions foreshadow the regulation of sesame as a major food allergen in the future.



Two recent legislative actions and an FDA publication address emerging concerns about sesame as an allergen. The U.S. House of Representatives and Senate have approved differing versions of the proposed Food and Safety, Treatment, Education, and Research Act of 2020 (the FASTER Act), which define sesame as a major food allergen under the Food Drug and Cosmetic Act (FD&C Act). The FDA issued a draft guidance (Draft Guidance)1, recommending that food manufacturers voluntarily declare sesame when used as an ingredient in flavors and spices. Although the Draft Guidance is non-binding and the FASTER Act may not be enacted into law before the end of the current Congressional session, future regulation of sesame as a major allergen appears likely.


Draft Guidance


The Draft Guidance recommends that manufacturers declare sesame as an ingredient when it is used in foods as a "flavor" or "spice" and suggests declaration of sesame in a parenthetical following the spice or flavor, such as "spices (including sesame)," or "flavors (including sesame)." Under current regulations, sesame must be declared when whole sesame seeds are used as an ingredient, but not when used in a non-seed form (e.g., when it is ground and used in a spice blend).2


FASTER Act


The House and the Senate both agree that sesame should be regulated as a major food allergen under the FD&C Act and have each proposed a legislative bill referred to as the FASTER Act to implement this change. H.R. 2117, approved by the House on Nov. 17, 2020, amends the FD&C Act to include sesame in the list of major food allergens and establishes an effective date of the FASTER Act of Jan. 1, 2022.3 S. 3451, proposed by the Senate about a month later and approved on Dec. 9, 2020, also amends the FD&C Act to include sesame on the list of major food allergens but pushes the effective date of the FASTER Act a year out to Jan. 1, 2023.4 It is unlikely that the FASTER Act will be enacted into law before the end of the current Congressional session because of differences between the two versions. The below table highlights the key differences.


 


H.R. 2117 (House)


Passed by the House on Nov. 17, 2020


S. 3451 (Senate)


Passed by the Senate on Dec. 9, 2020


  • To be effective on Jan. 1, 2022.
  • Requires the Secretary of Health and Human Services, together with the director of the Centers for Disease Control and Prevention, to conduct national surveys to collect information on the prevalence of food allergies and encourage research to improve the accuracy of existing data.
  • Requires the Secretary to include any food allergy research information in its annual or periodic reporting to Congress.
  • Allows the Secretary to determine any other food as a "major food allergen" under the FD&C Act.
  • To be effective on Jan. 1, 2023.
  • No later than 18 months after the effective date of the FASTER Act, the Secretary must submit a comprehensive report that includes (a) a description of all ongoing research and data collection activities related to food allergy prevalence, diagnostics, and treatment, and (b) recommendations to improve research and data collection activities.
  • Requires the Secretary to post the report on the website of the Department of Health and Human Services.


Conclusion


The FDA, House, and Senate seem inclined to characterize sesame as a major food allergen at some point in the future. The emerging best practice for food manufacturers would be to declare sesame as an ingredient both when used in its whole form and when included in a spice or flavor.


Background


The FD&C Act requires that a food (other than a raw agricultural commodity) that bears or contains a "major food allergen" declare the allergen using its "common or usual name." A food is misbranded if it contains a major food allergen and fails to declare that major food allergen on its label using the major food allergen's common or usual name.5 Under the FD&C Act, there are currently eight "major food allergens," which consist of the following:


  • Milk
  • Eggs
  • Fish (e.g., bass, flounder, or cod)
  • Crustacean shellfish (e.g., crab, lobster, or shrimp)
  • Tree nuts (e.g., almonds, pecans, or walnuts)
  • Wheat
  • Peanuts
  • Soybeans 6


1 https://www.fda.gov/media/143521/download


2 See Section 403(i) of the FD&C Act (21 U.S.C 343(i)); 21 CFR 101.4


3 https://www.congress.gov/bill/116th-congress/house-bill/2117/text


4 https://www.congress.gov/bill/116th-congress/senate-bill/3451/text


5 See Section 403(w) of the FD&C Act.


6 See Section 201(qq)(1) of the FD&C Act; (21 U.S.C. 321(qq)(1).


 



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