title: Role of the U.S. Food and Drug Administration in the regulatory management of human listeriosis in the United States.
abstract: 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.
authors.affiliation: Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, College Park, Maryland 20740, USA. karl.klontz@fda.hhs.gov
authors.forename: Karl C
authors.initials: KC
authors.lastname: Klontz
authors.forename: Patrick V
authors.initials: PV
authors.lastname: McCarthy
authors.forename: Atin R
authors.initials: AR
authors.lastname: Datta
authors.forename: Judy O
authors.initials: JO
authors.lastname: Lee
authors.forename: David W K
authors.initials: DW
authors.lastname: Acheson
authors.forename: Robert E
authors.initials: RE
authors.lastname: Brackett
mesh_terms: D003257:Consumer Product Safety; D004196:Disease Outbreaks / Q000517:prevention & control; D005506:Food Contamination / Q000517:prevention & control*; D005516:Food Microbiology; D006801:Humans; D007881:Legislation, Food; D008089:Listeria monocytogenes / Q000254:growth & development*; D008088:Listeriosis / Q000453:epidemiology / Q000517:prevention & control*; D015995:Prevalence; D011634:Public Health; D018570:Risk Assessment; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration