On Friday, April 23, 2021, President Biden signed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 into law. The law contains two main components. First, sesame is added as a major food allergen, marking the first official change to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) since its passage. Second, the FASTER act requires reports on selected food allergy topics to be delivered to Congress, including those on how to establish and implement criteria for future updates to the list of major food allergens.
Sesame seeds (Sesamum indicum) are an oilseed crop, with yellow, white, red, brown, and black varieties grown for various food ingredients. Sesame seeds are approximately 50% fat, 23% carbohydrate, 18% protein, 4% ash, and 5% water. In 2019, the estimated global production of sesame was 6.5 million metric tons; the top producing countries were Sudan, Myanmar, India, Tanzania, Nigeria, and China. Sesame-derived food ingredients can include whole seeds, oils, flours, and pastes (commonly referred to as tahini).
Sesame is also known to cause food allergies and can be responsible for serious and life-threatening allergic reactions in sensitive individuals. The prevalence of sesame allergy varies around the world, with relatively higher prevalence observed in the Middle East, Israel, and Australia and lower prevalence observed in North America and Europe. Recent estimates in the U.S. indicate a convincing self-reported sesame allergy prevalence of approximately 0.2% in both adults and children. In comparison with the prevalence of other food allergies reported in the same studies, allergy to sesame is less prevalent than reported allergies to current major allergens (peanuts, tree nuts, wheat, soy, milk, crustacean shellfish, egg, fish) and molluscan shellfish. The allergenic potency of sesame is broadly similar to other seeds and nuts. The VITAL 3.0 reference dose (the ED01, or the dose expected to elicit reactions in the 1% most sensitive sesame-allergic individuals) is 0.1 mg total sesame protein. For comparative purposes, the sesame ED01 is the same as hazelnut, but higher than cashew and walnut and lower than peanut. The proteins in sesame seeds that have been identified as allergenic are predominantly seed storage proteins, as is also the case with tree nuts and peanuts.
In several regulatory jurisdictions around the world, including Canada, the EU, and Australia and New Zealand, sesame has been a priority food allergen for many years, with corresponding labeling requirements. In the U.S., sesame was not originally considered a major allergen in the context of FALCPA, but labeling of sesame or sesame ingredients was still required for many products in which such ingredients were used. For example, whole sesame seeds used as an ingredient were required to be labeled as such. However, sesame paste might have been declared as tahini, thus requiring sesame-allergic consumers to know that tahini was made from sesame. Additionally, when other forms of sesame (i.e., not whole seeds) were used, there were selected instances where those ingredients could be labeled as “spice” or “flavor.” The FASTER Act sought to remedy some of the potential confusion and improve labeling clarity by requiring sesame-derived ingredients to be subject to the same labeling regulations as other major food allergens.
The Amendment and Implications for FSMA
The FASTER Act amends Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (qq)) to read:
(qq) The term “major food allergen” means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.
The amendment to include sesame as a major food allergen is effective as of January 1, 2023. With this change, sesame and sesame-derived ingredients will need to follow all FALCPA labeling requirements. Specifically, all sesame and sesame-derived ingredients must be declared as sesame either in the ingredients list or in a “Contains” statement. If a “Contains” statement is used, all major allergen ingredients must be included. As noted above, one common sesame-derived ingredient used in foods is sesame oil. While FALCPA does exempt highly refined oils derived from allergenic foods from labeling, much of the sesame oil used in food production is not highly refined and is therefore not exempt from labeling. FALCPA does not provide a specific definition of highly refined oils, but industry best practice would indicate that processing should include refining, bleaching, and deodorizing. Sesame-derived ingredients must also be declared by their common or usual name; tahini may still be used on the ingredient list, but sesame must appear either parenthetically or in a “Contains” statement.