FDA issues recommendation on sesame labelling

The US FDA has published “Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry” with recommendations to the food industry about sesame labelling.  Whilst the described labelling is currently voluntary, the FDA say that they “…continue to evaluate the emerging evidence and are working to develop factors to inform future regulatory actions related to sesame and other emerging food allergens, including possible labeling requirements”. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities but industry should be aware of the current recommendations and possible future legal requirements.

The following is from the FDA’s recommendation dated November 2020:

Allergenic reactions to sesame

The information available to the US FDA indicates that the reported prevalence of sesame allergies in the U.S. population appears to have increased. Furthermore, when reactions to sesame occur, they can be relatively severe and adverse event reports submitted in response to the notice reported reactions associated with products containing undeclared sesame.

What is FDA recommending about sesame labelling?

Sesame can be included in “flavors” and “spices” and therefore sometimes not listed specifically as an individual ingredient on labels.  Thus, we recommend that manufacturers, as a voluntary matter, clearly 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, we recommend 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 will help consumers, especially those allergic to sesame, avoid foods that could cause an allergic reaction.

What is the FDA doing about food allergens?

The FDA is currently working to develop our own set of factors for evaluating which food allergens, beyond the eight major food allergens specified in the FD&C Act, should be designated as requiring additional controls, including allergen labeling. While FDA considers these factors and regulatory options regarding declaration of sesame, because of increasing concern about sesame allergies in the United States, we are providing these voluntary recommendations to manufacturers regarding what we currently believe are best practices for sesame labeling.

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