In the news

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210 Cyclosporiasis Illnesses in the United States, June 2023

The CDC reported that 210 people with cyclosporiasis were acquired in the U.S. since April 1, 2023, and 30 people were hospitalized. Twenty-two states reported cases, with states with 3 – 40 cases in Arizona, Georgia, Texas, and New York. States with 21-30 cases are Alabama, South Carolina, and Colorado. And more states with fewer cases. The cases in Georgia and Alabama were linked to raw broccoli that included 20 illnesses. People reported eating broccoli in the 14 days before they got sick. The FDA, state, and local partners conducted traceback investigations and determined that broccoli was imported. However, FDA investigators could not confirm the specific type or producer of the imported broccoli as the outbreak’s source. This outbreak appears to be over, and there is no indication that broccoli continues to be a source of illness for other cyclosporiasis reported in the United States. @ https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/2023/index.html

 

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FDA provided an update on the proposal for the Unified Human Foods Program, including a new model for the Office of Regulatory Affairs

The FDA updated its proposal to create a unified Human Foods Program (HFP), including a new Office of Regulatory Affairs (ORA) model. FDA Commissioner Robert M. Califf, M.D. proposes additional changes to HFP. The changes include (i) The new Deputy Commissioner for Human Foods will have oversight of all budget and resource allocations for the entire HFP, including ORA resources.  ORA’s core mission will be to conduct investigations, inspections, and imports for all FDA-regulated products. (ii) Merging compliance functions currently managed within ORA into the HFP and the product Centers’ existing compliance functions to streamline operations and expedite decision-making. (iii) Realigning the eight Human and Animal Food laboratories ORA into the HFP. (iV) Consolidate certain functions under ORA. (v) Proposing realignment of resources and personnel.  Empower the Deputy Commissioner for Human Foods to have full authority over all foods-related resources and set the strategic direction. The FDA is in the final stages of the Deputy Commissioner for Human Foods recruitment process and will be providing an update soon.  @ https://www.fda.gov/news-events/press-announcements/fda-provides-update-proposal-unified-human-foods-program-including-new-model-office-regulatory?utm_medium=email&utm_source=govdelivery

 

The FDA is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). These additions to the FDA Commissioner’s proposal announced earlier this year will further enhance coordination, prevention and respon

Core update as of June 28, 2023

CORE update as of June 28, 2023, the CORE list of outbreaks and adverse events includes five active cases. The outbreak of Salmonella Paratyphi B var. L(+) tartrate+ (ref #1157) in a not yet identified product, the FDA initiated an on-site inspection and sample collection and analysis. The case count has increased from 33 to 34 cases. For the outbreak of Cyclospora cayetanensis (ref #1159), the case count has increased from 34 to 36 cases. @ https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks?utm_medium=email&utm_source=govdelivery

 

The following is a list of outbreak and adverse event investigations primarily being managed by FDA’s CORE Response Teams.

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FMA International recalled SAS Fromagerie Ottavi Tome Corse Sheep milk cheese imported from France due to Listeria monocytogenes

The FDA reported that FMA International (Brooklyn, NY) recalled one lot of SAS Fromagerie Ottavi Tome Corse Sheep Milk Cheese because it could be contaminated with Listeria monocytogenes. Ottavi Tome Corse cheese was distributed in Oregon to a specialty food distributor. The one case from the recalled lot has since been accounted for and destroyed. It was never sold to any retailers or restaurants. This cheese is associated with an ongoing outbreak of Listeria monocytogenes infections in Europe.@ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fma-international-recalls-sas-fromagerie-ottavi-tome-corse-sheep-milk-cheese-imported-france-because?utm_medium=email&utm_source=govdelivery

 

FMA International of Brooklyn, NY is recalling one lot of SAS Fromagerie Ottavi Tome Corse Sheep Milk Cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, an