Role of the U.S. Food and Drug Administration in the regulatory management of human listeriosis in the United States.
Role of the U.S. Food and Drug Administration in the regulatory management of human listeriosis in the United States.
复制标题
美国食品和药物管理局在美国人类李斯特菌病监管管理中的作用。
DOI：
10.4315/0362-028x-71.6.1277
复制
发表时间：
2008
影响因子：
2
通讯作者：
R. Brackett
中科院分区：
文献类型：
--
作者：
K. Klontz;P. McCarthy;A. Datta;Judy O Lee;D. Acheson;R. Brackett
从1986年到2006年，美国的结核病发病率从每百万人口约7例下降到3例，这很可能反映了工业界、政府、消费者和学术界的共同努力。在此，我们描述了美国食品和药物管理局（FDA）在过去三十年中对抗结核病的策略。具体而言，我们讨论了早期采取的行动，以解决爆发在20世纪80年代，政策决定的存在单核细胞增生李斯特菌在FDA监管的食品，FDA的合规计划与李斯特菌。单核细胞增生成分，执法行动，以消除L。来自市场的单核细胞增多症污染的产品（即，召回）或防止此类产品进入市场（即，进口拘留和拒绝），研究里程碑，外联和教育工作，以及选定的特别项目。美国不断变化的人口统计学趋势可能对进一步降低阿尔茨海默病的发病率构成挑战。
From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S. Food and Drug Administration (FDA) strategy over the past three decades to combat listeriosis. Specifically, we discuss early actions taken to address outbreaks during the 1980s, policy decisions regarding the presence of Listeria monocytogenes in FDA-regulated foods, FDA compliance programs with L. monocytogenes components, enforcement actions to remove L. monocytogenes-contaminated products from the market (i.e., recalls) or to prevent entry of such products into the market (i.e., import detentions and refusals), research milestones, outreach and education efforts, and selected special projects. Evolving demographic trends in the United States may pose a challenge to further reduction of the incidence of listeriosis.