Office of Food Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, College Park, MD, USA.
Office of Compliance, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, College Park, MD, USA.
J Food Prot. 2023 Apr;86(4):100069. doi: 10.1016/j.jfp.2023.100069. Epub 2023 Mar 2.
Allergens are one of the leading causes of food recalls in the US. The Food and Drug Administration (FDA) enforces requirements relating to major food allergens (MFAs) and gluten-free labeling to ensure food safety for allergic and celiac patients, respectively. Violative foods are subject to recalls. In this study, recall data for FDA-regulated foods were analyzed for fiscal years (FYs) 2013-2019 to identify trends and root causes associated with 1471 food allergen and gluten recalls. Of the 1471 recalls, 1415 recalls were due to MFAs, 34 recalls were due to gluten-free labeling violation and 23 recalls involved other allergens. Recalls due to MFAs overall increased during the study period with a peak incidence in FY 2017. MFA recall health hazard classifications were assessed as Class I (51.2%), Class II (45.5%), and Class III (3.3%). A majority of MFA recalls involved one allergen (78.8%). Milk was the most common MFA involved in MFA recalls (37.5%), followed by soy (22.5%) and tree nuts (21.6%). Almond, anchovy, and shrimp were the most common allergens recalled within the MFA groups of tree nuts, fish, and Crustacean shellfish, respectively. About 97% of MFA recalls involved one product category and among them, the category of 'bakery products, dough, bakery mixes and icings' ranked first (367 recalls), followed by the category of 'chocolate and cocoa products' (120 recalls). Labeling-associated errors accounted for 71.1% of MFA recalls with known root causes (914 out of 1286). It is important for the industry to develop and implement appropriate allergen controls to reduce the number of MFA recalls.
过敏原是美国食品召回的主要原因之一。美国食品和药物管理局（FDA）执行与主要食物过敏原（MFAs）和无麸质标签相关的要求，以分别确保过敏和乳糜泻患者的食品安全。违规食品将被召回。在这项研究中，分析了 2013 年至 2019 财年（FY）FDA 监管食品的召回数据，以确定与 1471 起食物过敏原和 gluten 召回相关的趋势和根本原因。在 1471 起召回中，由于 MFAs 引起的召回有 1415 起，由于无麸质标签违规引起的召回有 34 起，涉及其他过敏原的召回有 23 起。在研究期间，由于 MFAs 引起的召回总体上有所增加，2017 财年达到峰值。MFAs 召回健康危害分类评估为 I 类（51.2%）、II 类（45.5%）和 III 类（3.3%）。大多数 MFA 召回涉及一种过敏原（78.8%）。牛奶是最常见的 MFA，涉及 MFA 召回（37.5%），其次是大豆（22.5%）和坚果（21.6%）。杏仁、凤尾鱼和虾分别是坚果、鱼类和甲壳类海鲜 MFA 组中最常见的过敏原。约 97%的 MFA 召回涉及一种产品类别，其中“面包产品、面团、面包混合物和糖霜”类别排名第一（367 起召回），其次是“巧克力和可可产品”类别（120 起召回）。已知根本原因（1286 起中的 914 起）的 MFA 召回中，标签相关错误占 71.1%。对于行业来说，制定和实施适当的过敏原控制措施以减少 MFA 召回的数量非常重要。
