Food Safety News

The FDA is reporting that the number of reports of illnesses linked to a dry cereal have almost doubled in the past week, reaching 446.

In a weekly update the Food and Drug Administration indicated that the number had increased from the 231 cases of “adverse events” reported on April 20. Although the update does not name the cereal involved, the FDA has previously confirmed to Food Safety News that it is investigating an outbreak of illnesses linked to Lucky Charms cereal.

The FDA has also confirmed that it sent an alert earlier this week to state and local health departments noting the outbreak and asking for help investigating it. The Ohio Department of Health reported that symptoms related to the cereal include nausea, vomiting and diarrhea. 

Hundreds of similar reports to the crowd sourcing website iwaspoisoned.com have come in in recent weeks. The website operator Patrick Quade works with state and local health departments to help identify foodborne illness outbreaks.

In other outbreak news, the FDA has closed its investigation into a Salmonella Saintpaul outbreak without having identified a source of the pathogen. As of the most recent report the outbreak had affected 60 people. The agency has not reported any information about the patients and has not reported where they live. The FDA did initiate traceback efforts but was not able to collect enough information for on-site inspections or sample collections.

FDA

On August 20, 2021 through September 3, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Agroson’s LLC, located at 735 Drake Street, Bronx, NY 10474-6115. We also conducted inspections on August 12, 2019 and January 29, 2021 through February 16, 2021. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: papayas and limes imported from (b)(4); papayas imported from (b)(4); and limes imported from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. We note that you stated during the inspection that your firm is (b)(4), though you may (b)(4) at some point in the future.

At the conclusion of the FSVP inspection conducted August 20, 2021, through September 3, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. To date, we have not received your response to the Form FDA 483a issued during the follow-up inspection.

The papayas you are importing are “covered produce” as defined in 21 CFR 112.3. As such, you are not required to determine whether there are any biological hazards requiring a control in such food because FDA has determined that the biological hazards in covered produce require a control and compliance with the requirements in part 112 to significantly minimize or prevent the biological hazards. Your “Foreign Supplier Verification Form” for papayas from (b)(4) contains a section that states, “Hazard(s) associated with the ingredient or product: Salmonella, E. Coli, & fecal coliforms,” which is not a requirement. However, the correct biological hazards associated with papayas are Salmonella, E. coli, and Listeria.

Hi All,

I am back from holiday now and after a lovely trip to the USA I will be wading through the issues of the last couple of weeks and posting as much as I can.

Keith

Gulf News

CDC

Use NORS Dashboard to search and access data from reports of foodborne and waterborne disease outbreaks and enteric (intestinal) disease outbreaks spread by contact with environmental sources, infected people or animals, and other means.

RASFF

Possible Presence of Listeria monocytogenes in Shredded Cabbage Products from Ireland in Northern Ireland