Is Sesame Going to be a New Major Food Allergen?

Apr 5, 2021 | FDA, Food, Law & Regulatory

Update 04/27/2021

On April 23, President Biden signed the FASTER Act into law, requiring that all packaged food labels disclose sesame ingredients beginning January 1, 2023.

Orignal Post 04/05/2021

Sesame is a common ingredient in many of the foods in the U.S., however, it currently does not have to be declared as one of the eight major food allergens established by the Food and Drug Administration (FDA). According to the American Academy of Allergy, Asthma & Immunology (AAAAI), sesame is the 9th most common allergy affecting .2% of children and adults.

“It is important for consumers to be aware of sesame allergies,” said Ruchi S. Gupta, MD, MPH. “With evidence mounting that sesame allergy is on the rise and can result in severe reactions, we are hopeful that the FDA will take this data into account as they determine whether or not to add sesame to their list of major food allergens.”

On November 10, 2020, the FDA issued a press release encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels. It stated, “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 While sesame is not one of the eight major allergens, the FDA, through this draft guidance, is encouraging food manufacturers to voluntarily label their products if they contain sesame, even when not required to do so.”

The food industry has not, for the most part, taken heed of the FDA’s suggestion to list sesame as a major food allergy on food labels. On March 2, 2021, the Senate unanimously passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which would require that sesame be labeled as an allergen on packaged foods. Sesame would become the ninth food allergen for which the FDA requires plain-language labeling. Sesame is often used when a label reads “natural flavors” or “natural spices,” adding another layer of difficulty when consumers review product labels at their local grocery store.

The bill would also require the Secretary of Health and Human Services (HHS) to issue a report on scientific opportunities in food allergy research that examines prevention, treatment, and new cures. In addition, the legislation establishes a risk-based scientific process and framework for establishing additional allergens covered by the Federal Food, Drug, and Cosmetic Act (FD&C).

The Senate’s version of the FASTER Act is now in the House, receiving much support from advocacy groups, and is expected to pass, as the House had previously passed its own version in December of 2020.

It is not certain when the new requirement to declare sesame as a major food allergen will take effect, but it is certain that it is on its way.

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