FDA Asks For Comments on Voluntary Sesame Allergy Labeling

Nov. 12, 2020
While sesame is not yet declared a major allergen, the agency is gathering data and suggesting an interim warning on labels.

The FDA moved a step closer to labeling sesame a major allergen on Nov. 10 in issuing a draft guidance for voluntary sesame labeling.

It's still a draft and it's voluntary, but "The FDA is recommending that manufacturers voluntarily declare sesame following the spice or flavor, such as, “spice (sesame)” or “flavor (sesame)." And "This voluntary labeling guidance to industry aims to help consumers who are allergic or sensitive to sesame to avoid these products."

While it's not included in the 2004 "Big Eight" allergens list (eggs, tree nuts, peanuts, cow's milk, fish, shellfish, soy and wheat), sesame has been known to cause reactions such as hives, vomiting, wheezing, and anaphylaxis in sensitive people.

While in most cases it's required in the ingredient statement, an exception is when sesame is part of a flavoring or spice. "In those cases, it may be declared as simply 'spice' or 'flavor' on the label without requiring 'sesame' to be included, so its presence may not be obvious to consumers," the agency said.

FDA is also recommending if a term is used for a food that is or contains sesame, such as tahini, sesame should be voluntarily included in parentheses following the ingredient.

Back in October 2018, FDA issued a notice requesting data and information on the prevalence and severity of sesame allergies and the prevalence of sesame-containing food in the U.S. "Data and information received in response to the 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."

Comments on the draft voluntary sesame labeling guidance should be submitted by about Jan. 10 to www.regulations.gov. Written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD 20852.

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