USFDA Issues a Draft Guidance for Industry on Voluntary Disclosure of Sesame in Food Labels

On November 10, 2020, the U.S. Food and Drug Administration announced the publication of a draft guidance “Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for Industry.”

The aim is to encourage manufacturers to clearly declare sesame in the ingredient list, when it is used as a “flavouring” or “spice” or when the common or usual name (such as tahini) does not specify sesame. This voluntary labelling guidance to industry aims to help consumers who are allergic or sensitive to sesame to avoid these products.

The scope of the draft guidance document to include following focal areas for consideration-

• Recommendation of usage of a food that is or contains sesame, such as tahini, should be voluntarily included in parentheses following the ingredient.
• 2018 FDA notice indicated that the reported prevalence of sesame allergies in the U.S. population appears to have increased, that sesame causes a relatively high frequency of severe allergic adverse events, and that allergic reactions to sesame may occur from products with undeclared sesame ingredients.
• The Agency does not have the authority to amend the eight major food allergens established by Food Allergen Labelling Consumer Protection Act (FALCPA); however, it has the authority to require labelling for other food allergens not covered by the requirements in FALCPA under the Federal Food, Drug, and Cosmetic Act.
• Performing continuous assessment on allergens of public health importance, including potential science-based options to empower consumers with information about these allergens.
• Helping individuals who are allergic to sesame, by identifying those foods that may contain sesame as an ingredient.

The draft voluntary sesame labelling guidance is open for public comments within 60 days after publication in the Federal Register.

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