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Sesame Declared As the 9th Major Food Allergen

On April 23, 2021, President Joe Biden signed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act into law in the United States. This legislation declares sesame as the 9th major food allergen, following the eight foods identified as major food allergens in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

Soon, this bill will require all FDA-regulated packaged food products containing sesame to clearly label the ingredient as an allergen in the United States. Although some manufacturers have already started to enforce the forthcoming changes, it will not be required until the legislation takes full effect on January 1, 2023. Once in effect, all packaged foods, including dietary supplements, that are introduced or delivered for introduction into interstate commerce must disclose the correct labeling, while also following Section 403(w)(1) of the FD&C Act.

In terms of sesame oil, Section 403(w) of the FD&C Act exempts highly refined oils from the allergen labeling act, but they still must meet 21 Code of Federal Regulations (CFR) 101.4(b)(14), which requires the source of the oil to be declared on the label. If the sesame oil is not highly refined, it must then comply with the conditions of Section 403(w).

According to the FDA, the ingredient should already appear in the ingredient statement due to their general labeling requirements, unless the sesame is part of a natural flavoring or spice. To mitigate this technicality, the FDA issued draft guidance in November 2020 to protect consumers who may be allergic to sesame. Therefore, the FDA urges manufacturers to voluntarily display sesame in their ingredient list or a separate “Contains” statement, even if they fall under current exceptions. As of now, the FDA’s draft guidance is not legally enforced or required but recommended for the food manufacturers to act in accordance with their suggestions.

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