The FDA issued a draft guidance for the Voluntary Disclosure of Sesame as an Allergen to provide food manufacturers with the Agency’s current view on sesame as an allergen and to provide recommendations to voluntarily disclose sesame in certain circumstances. The purpose of the draft guidance is to help consumers who are allergic or sensitive to sesame avoid these products.

Sesame is a food allergen that can cause reactions such as hives, vomiting, wheezing, and anaphylaxis. However, sesame is not one of the eight major food allergens required to be included in allergen labeling by the 2004 Food Allergen Labeling and Consumer Protection Act (FALCPA). Under 21 U.S.C. 343(i), if whole sesame seeds are used as an ingredient, they must be declared on the label, but in some circumstances, sesame can be declared in an ingredient list as “spice” or “flavor” without specifying the presence of sesame.

As our readers know, on October 30, 2018, the FDA published a notice inviting additional data on the prevalence and severity of sesame allergies in the US and the prevalence of sesame-containing foods sold in the US that are not required to disclose sesame as an ingredient. FDA received over 4,800 comments regarding the prevalence of sesame. Based on the information received, the FDA noted that sesame allergies may be an increasing problem in the US, and therefore the Agency intends to continue to evaluate emerging evidence and develop factors to inform future regulatory actions related to sesame and other emerging food allergens, including possible labeling requirements.

However, in the interim, the FDA recommends that manufacturers take the steps outlined in the draft guidance to help consumers who are allergic to sesame. In short, the Agency recommends that manufacturers voluntarily 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, the FDA recommends that sesame be included in a parenthesis, e.g. “tahini (sesame)” in the ingredient list.