For Immediate Release:

The U.S. Food and Drug Administration today issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels.

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

On Oct. 30, 2018, the 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 the 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 like 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. The FDA works closely with manufacturers to quickly recall such products from the market if they are mislabeled. While sesame is not one of the eight major allergens, the FDA, through this draft guidance, is encouraging food manufacturers to voluntarily label their products if they contain sesame, even when not required to do so.

Additionally, the FDA continues to assess allergens of public health importance, including potential science-based options to empower consumers with information about these allergens.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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