Biden Signs FASTER Act; Sesame Becomes 9th Major Food Allergen Requiring Mandatory Food Labeling Disclosures

Hanson Bridgett LLP

Hanson Bridgett LLP

President Biden has signed into law the FASTER Act, which adds sesame as a "major food allergen" under the Food Drug and Cosmetic Act (FD&C Act). Under the FD&C Act, food labels of products containing sesame, whether in whole seed form or as an ingredient in a spice or flavor, must disclose its presence using its plain English name. The law will become effective on January 1, 2023.

Although no regulations now exist to govern the application of the FASTER Act, recent draft guidance on the subject issued by the Food and Drug Administration (FDA) should be useful to food manufacturers who use sesame as an ingredient in their products. The draft guidance recommends that manufacturers declare sesame as an ingredient when it is used in foods as a "flavor" or "spice" and suggests declaration of sesame in a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 Pre FASTER Act 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).1

The FASTER Act also requires the Department of Health and Human Services (DHHS) to prioritize research and reporting of information related to food allergies. The Secretary of the DHHS is required by the FASTER Act to prepare and deliver 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. The FASTER Act requires the issuance of this report no later than 18 months from its effective date or by June 30, 2024.

As a result of the FASTER Act, sesame becomes the 9th major food allergen governed by the FD&C Act, which 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.2Below is a list of the original 8 "major food allergens":

  • 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, and
  • Soybeans.3

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

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

3See Section 201(qq)(1) of the FD&C Act; (21 U.S.C. 321(qq)(1).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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