I. Legal Background and Regulatory Framework of Sesame Allergen Labeling

In the current draft of the “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry,” which was announced in the same Federal Register notice (87 FR 73561), we also state that allergen advisory statements cannot be used in lieu of good manufacturing practices and preventi. [...] 555.250 Major Food Allergen Labeling and Cross-contact.” In this draft CPG, we address the use of “Contains” statements directly and state, “The use of both the ingredient list and the “Contains” statement for declaration of the presence of major food allergens is limited to major food allergen ingredients in a food” and “Major food allergens unintentionally incorporated into a food are not to be. [...] Our laws and regulations do not permit the addition of “sesame,” or any other major food allergen, on the label in the ingredient list or the “Contains” statement if that major food allergen is not an ingredient used to make the food. [...] We intend to continue looking for additional opportunities to clarify that a major food allergen unintentionally present in a food due to cross-contact are not to be declared by naming the allergen in in the ingredient list or in a “Contains” statement. [...] Conclusion For the reasons set forth above and in accordance with 21 CFR 10.30(e)(3), we: (1) deny the request to issue a notice to manufacturers declaring that companies cannot meet their obligation to control allergen cross-contact risks by adding major food allergens intentionally to foods; (2) deny the request to finalize the “Draft Guidance for Industry: Questions and Answers Regarding Food A.