The FDA is responding to apparent shortages of powdered infant formula after the issues of Cronobacter contamination at Abbott Nutrition's facility that made Similac and other brands. The update states that before these products were voluntarily recalled because of reports of infant illnesses, there were supply chain issues associated with the COVID-19 pandemic. While Cronobacter was found in environmental samples at the Abbott facility, those samples did not match the isolates from two of the infant patients. And the patient isolates did not match each other. FDA Commissioner Robert M. Califf, M.D. said in a statement, "We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their … [Read more...]
FDA CORE Investigation Table Updated; More Cereal Illnesses Reported
The FDA CORE Outbreak Investigation Table has been updated with more information. The two changes are more cereal illnesses, and the addition of one more case to one Listeria monocytogenes outbreak. There is not much more information posted about any of the six active investigations. In the dry cereal outbreak, there are now 529 adverse events reported. That is an increase of 83 more cereal illnesses since the last update was posted on April 27, 2022. Many news sites, including the website I Was Poisoned, are speculating that Lucky Charms cereal may be the focus of this investigation. In addition, sample collection has taken place, and analysis of those samples has begun. No recall has been issued. In outbreak number 1057, the Listeria monocytogenes outbreak with no identified … [Read more...]
FDA Updates Abbott Nutrition Powdered Infant Formula Cronobacter Issue
The FDA has updated its investigation into the Abbott Nutrition powdered infant formula Cronobacter issues. The investigation into the contamination continues, along with the investigation of consumer complaints and reports of human illness allegedly related to products from the company's Sturgis, Michigan facility. Abbott has "has committed to completing enhanced testing of stored product batches prior to making release determinations." The FDA recognizes that Abbott has conducted "standard product testing," but there were a limited number of samples tested. The FDA also stated that finished product testing does not eliminate the risk of contamination. The enhanced testing "will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level … [Read more...]
Whistleblower Report Alleges Abbott Lax on Contaminated Infant Formula
A new whistleblower report alleges that Abbott Nutrition was lax on concerns about contaminated infant formula, according to information released by Representative Rosa DeLauro (D-CT). DeLauro is the House Appropriations Committee Chair. She submitted the report for the record on April 28, 2022. The whistleblower allegedly worked at the Abbott facility that produces infant formula that was recalled for possible Cronobacter contamination in February 2022. In September 2021 the FDA learned of a potential link between Cronobacter and Similac powdered infant formula. The 34-page report from the whistleblower has allegations of wrongdoing at the facility. They include: Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to … [Read more...]
FDA CORE Table Updates: More Cereal Illnesses, Listeria Cases Grow
The FDA CORE Outbreak Investigation Table has been updated again, with more cereal illnesses. Two unidentified Listeria monocytogenes outbreaks have grown. The outbreak that does not have a pathogen identified, but may be associated with dry cereal, has now had 446 adverse event reports, up from 231 reports in the last update a week ago. This outbreak may be associated with Lucky Charms cereal. Reports on iwaspoisoned.com match up to the dates of this investigation. An on-site investigation has begun, as noted in the last update. The two unidentified Listeria monocytogenes outbreak case counts have increased. One has increased to 17 cases from 15, and the other increased from 17 to 19. In the latter outbreak, traceback has stared, onsite inspection has been initiated, and … [Read more...]
FDA Investigating 231 Dry Cereal Adverse Events: May Be Lucky Charms?
The FDA is investigating 231 dry cereal adverse event reports, according to their CORE Outbreak Investigation Table. This matches up with the reports of gastrointestinal illness claims from people who say they have eaten Lucky Charms cereal in the past few weeks, according to iwaspoisoned.com. In an email about the update, the FDA states: For adverse event report investigations, FDA will indicate a product category and not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. For the new adverse events investigation (reference #1064), FDA is following up on a series of unconfirmed adverse event reports that may be associated with dry cereal. Although FDA has not determined that this cereal is … [Read more...]
New Listeria Monocytogenes Outbreak on FDA CORE Table
A new Listeria monocytogenes outbreak has been announced by the FDA on their CORE Outbreak Investigation Table, with at least 15 people sick. No recall has been initiated, no traceback has started, no on-site inspections are scheduled, and no sample collection or analysis has begun. The food responsible for this outbreak has not yet been identified. There are five other active investigations on the table. Three of those outbreaks have not had a food named that is associated with the illnesses. The Listeria monocytogenes outbreak first announced on February 9, 2022 is still unsolved. There are 17 people sick in that outbreak. Traceback has been initiated, on-site inspections have been conducted, and samples have been collected and analyzed. The investigation into Cronobacter … [Read more...]
Senator Murray Wants Answers on Alleged Food Safety Failures
Senator Patty Murray (D-WA) wants answers on alleged FDA food safety failures after a report in Politico listed problems with that agency. Senator Murray is Chair of the Senate Health, Education, Labor, and Pensions Committee. A letter was sent to FDA Commissioner Robert M Califf, asking for answers and immediate action. The Politico report was based on more than 50 interviews with experts and former officials and found that the FDA is more focused on regulating and overseeing drugs and other medical products than food. For instance, FDA commissioners rarely have experience with food issues, but are usually medical doctors. The report lists deadly food poisoning outbreaks and the recalls associated with the contaminated foods, starkly outlining how long it can take to issue a recall … [Read more...]
Five Active Outbreaks on FDA CORE Table; Three Not Identified
There are currently five active outbreaks on the FDA CORE Outbreak Investigation Table. Three of those outbreaks have not had a food identified, including an outbreak that doesn't have a pathogen attached to it, the Salmonella Saintpaul outbreak, and a Listeria monocytogenes outbreak. Those three outbreaks have sickened at least 1o8 people. The two identified outbreaks are the norovirus outbreak linked to raw oysters imported from British Columbia, Canada, which has sickened at least 91 people in 13 states. No recall has been issued, but restaurants and retailers have been told to not sell or serve oysters with specific landfile numbers from the Baynes Sound area in that province. The Cronobacter illnesses and the Similac investigation is also active. Four infants were sickened … [Read more...]
FDA Update on Similac Cronobacter Investigation Reveals No Match
The FDA has updated the Similac Cronobacter investigation and reports that there is no match between the environmental samples of Cronobacter found at Abbott Nutrition's Sturgis, Michigan plant and the two patient samples the CDC received and tested. In all, four infants were sickened with Cronobacter infections after allegedly consuming powdered infant formula produced by Abbott Nutrition. Two infants who lived in Ohio died, although the FDA has not determined if Cronobacter had a role in those deaths. The FDA states, "Five environmental subsamples collected from the Sturgis, Michigan facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the … [Read more...]
