FDA Issues Draft Guidance on Sesame Labeling

FDA has issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels, due to the number of people with sesame allergies.

“Many Americans are allergic or sensitive to sesame, and they need the ability to quickly identify products that might contain sesame,” said Susan Mayne, PhD, director of FDA’s Center for Food Safety and Applied Nutrition, in a prepared statement.

“While most products containing sesame declare it as an ingredient, there are times when sesame is not required to be declared by name on the label, such as when it is used as a ‘flavor’ or ‘spice.’ Other ingredients, like ‘tahini,’ are made by grinding sesame into a paste, but not all consumers are aware that tahini is made from sesame. In these instances, sesame may not be declared by name in the ingredient list on a product’s label. We are encouraging food manufacturers to voluntarily list sesame as an ingredient whenever a product has been made with sesame.”

In 2018, FDA issued a notice inviting data and information on the occurrence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing foods in the U.S. that are not required to disclose sesame as an ingredient. While the exact frequency of sesame allergies in the U.S. is unknown, it is estimated in some recent studies to be more than 0.1%, which is similar to allergies to soy and fish. The responses that FDA received indicated that some allergic reactions, such as hives, vomiting, wheezing and anaphylaxis, may be occurring from products with undeclared sesame or products that contain ingredients such as tahini.

Federal law requires that foods containing one of the eight major food allergens—milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans—declare the food source of the allergen using its common or usual name on the label. The Food Allergen Labeling and Consumer Protection Act (FALCPA) imposes strict requirements that foods containing one of these eight major allergens be clearly marked for the presence of these allergens.

While sesame is not one of the eight major allergens, FDA, through this draft guidance, is encouraging food manufacturers to voluntarily label their products if they contain sesame, even when not required to do so.