The FASTER Act - Sesame as Major Food Allergen
Neal Fortin summarizes FDA's recommendation that manufacturers voluntarily declare “sesame” in relevant ingredient lists, even though formal requirement does not go into effect until 2023.
The Food Allergy Safety, Treatment, Education and Research (FASTER) Act passed in 2021 designates sesame as the ninth major food allergen. The first eight major allergens/allergen categories are peanuts, tree nuts, fish, crustacean shellfish, soy, milk, eggs, and wheat as designated by the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004. Because the FASTER Act amends section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it means that sesame will be subject to FD&C Act requirements for major food allergens, including labeling disclosure, cGMPs, and preventive controls requirements for allergen control.
The FASTER Act has an effective date of January 1, 2023. However, FDA recommends voluntary disclosure of sesame. In FDA’s draft guidance, Voluntary Disclosure of Sesame as an Allergen, FDA recommends that manufacturers, as a voluntary matter, declare “sesame” in the ingredient list when it is used in foods as a “flavor” or “spice” in a parenthetical following the spice or flavor, such as, “spice (sesame),” “spices (including sesame),” “flavor (sesame)” or “flavors (including sesame).” If a term is used for a food that is or contains sesame, such as tahini, FDA recommends that sesame be included in a parenthesis, e.g. “tahini (sesame)” in the ingredient list.
This voluntary declaration of all sources of sesame in the ingredient list is prudent in light of the evidence that the reported prevalence of sesame allergies in the U.S. appears to have increased, and when reactions to sesame occur, they can be relatively severe.