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New FDA Draft Guidance On Sesame Labeling

In November 2020 the FDA issued a draft guidance regarding the voluntary disclosure of sesame as an allergen following its evaluation of public information; including scientific and clinical data, a 2014 citizen petition requesting the disclosure of sesame by the common or usual name in ingredients, and over 4,800 responses from a notice published in the Federal Register October 30, 2018 (83 FR 54594), as well as U.S. national prevalence data on sesame and other food allergens and adverse event reports.

While the FDA is continuing to evaluate evidence that sesame allergy may be a serious rising problem in the U.S. population, and works towards developing future regulatory actions relating to this, and other food allergens, they note: “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 […]”.

 

They are recommending that manufacturers take the following voluntary steps:

 

Disclose the presence of sesame in all foods where disclosure is not currently required; including in spices, flavorings, and foods that contain sesame but are known by a different term [such as tahini]. They recommend this labeling be done using parenthetical citations “[e.g. “spice (sesame)”; “spices (including sesame)”; “flavor (sesame)”; “flavors (including sesame)”; “tahini (sesame)”; etc.].”

As of now, sesame is not recognized as one of the major food allergens required to be disclosed on food labels by the 2004 Food Allergen Labeling and Consumer Protection Act (FALCPA). Under current regulations sesame seeds are only required to be declared on the labels of foods that use whole sesame seeds as an ingredient [FD&C Act (21 U.S.C 343(i)); 21 CFR 101.4], and may sometimes be declared in an ingredient statement as “spice” or “flavor” (such as when ground and blended with other spices).

 

Do you have any questions, or would you like to receive further information and consultation? Then please reach out to our experts!

 

Contact:

Meg Darnell
Regulatory Affairs Specialist Tentamus North America
meghan.darnell@tentamus.com
+1 540 684 9211

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