FDA investigates grain-linked outbreak; continues with further work on outbreaks

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The FDA is investigating more than 200 “adverse events” linked to an unnamed dry cereal. In recent days, reports from across the country of illnesses linked to Lucky Charms cereal have been filed with government agencies and the iwaspoisoned.com website.

Reports include vomiting, diarrhea, and other gastrointestinal symptoms. The Food and Drug Administration reported separately in recent days that it was investigating complaints about Lucky Charms but did not release further details of the investigation. General Mills, the maker of Lucky Charms, reported that it was not aware of any confirmed illnesses associated with the cereal.

Since April 20, the FDA has launched an on-site inspection regarding grain complaints.

The agency did not report any information on people who complained of adverse effects from the cereal and did not say where they lived.

In a statement released regarding the outbreak of “adverse events” related to “dry cereals”, the FDA states: “For investigations of adverse event reports, the FDA will indicate a product category and will not name publicize a specific product until there is sufficient evidence to implicate that product as a cause of disease or adverse events.

“For the new Adverse Event Investigation – reference #1064 – the FDA is tracking a series of unconfirmed adverse event reports (231 complaints) that may be associated with dry cereal. Although the FDA has not determined that this cereal is linked to these adverse event reports, the FDA is conducting an investigation to determine the potential causation of these complaints.The total number of reported adverse events includes the number of adverse events that were self-reported by consumers to FDA Consumer Complaint Coordinators and the CFSAN Adverse Event Reporting System (CAERS), which may include duplicate reports.

For more information on how to file a non-emergency food concern with the FDA, please click here.

In another investigation into different “adverse event” reports, the FDA revised the number of complaints to six, from 38 reported a week ago. The agency says the total number of complaints has been reduced to reflect only events reported by consumers to FDA complaint coordinators. The outbreak update did not say where the other 32 complaints were filed.

The agency identified the offending product as a “meal replacement drink,” but did not report a brand or distribution network. The FDA has begun traceability efforts on the product in question and has begun collecting and testing product samples.

Other current epidemics

Federal authorities are investigating an outbreak of Listeria infections and testing product samples in connection with another outbreak caused by Listeria monocytogenes.

The new Listeria outbreak has sickened at least 15 people, but the Food and Drug Administration has yet to identify a food source for the pathogen. In accordance with its usual process, the FDA has not released any patient information, such as age, or where they live.

As of April 20, the FDA had begun tracing but had not undertaken any on-site inspections or sample testing in relation to the outbreak.

In another outbreak, also caused by Listeria, the FDA reports that a food source has not been identified, but it has begun an on-site inspection of an unnamed company. The agency has started collecting samples and testing, but it has not reported what is being tested. The number of patients in the outbreak remains at 17.

The agency also has ongoing investigations into an outbreak of norovirus infections attributed to raw oysters from British Columbia, Canada, and an outbreak of Salmonella Saintpaul infections from an unknown source. The norovirus outbreak attributed to oysters has sickened more than 100 people in the United States and more than 300 in Canada.

The FDA is also continuing to investigate an outbreak of Cronobacter infections linked to infant formula made by Abbott Nutrition that sickened four babies and two deaths are under investigation. All production at the involved production facility in Sturgis, MI has been halted.

The table below provides information on outbreak investigations managed by FDA CORE Response Teams. The investigations are at different stages. Some outbreaks have limited information with active investigations underway, others may be nearing completion. The table below has been abbreviated to show only active surveys.

A public health notice will be issued for investigations that result in specific, actionable steps consumers should take to protect themselves, according to the FDA. Please direct your attention to these pages for the most up-to-date information on the investigation and for consumer protection information.

Investigations of outbreaks and adverse events that do not result in specific, actionable actions for consumers may or may not conclusively identify a source or reveal contributing factors. Adverse event surveys rely on self-reported data. Although these reports may name a particular product, the FDA will only list a product category in the table and will not publicly name a specific product until there is enough evidence to implicate that product as the cause. illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, the FDA agrees to provide a summary of those findings.

To view the FDA page with links to specific information on individual outbreaks, please click here.

Click on the table to enlarge. Use the link above to access the FDA page with links to specific outbreak information.

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