April 18, 2024

USDA Offers Tips to Keep Infants Safe While Formula Shortages Exist

The USDA offers tips to keep infants safe while powdered infant formula shortages are ongoing. The shortage is caused by pandemic supply chain issues and the closure of Abbott Nutrition's Sturgis, Michigan plant for environmental Cronobacter contamination. The contamination was discovered during an FDA inspection after reports of infant illnesses. Many parents depend on formula in the first year of a baby's life. Some mothers cannot breastfeed, and some infants require supplemental nutrition or specialty formulas because of medical issues. To keep infants safe, the USDA says parents should not make homemade infant formula. There are serious safety and health concerns related to homemade formula because they can be deficient in nutrients that babies need for health and growth. … [Read more...]

USDA Addresses Powdered Infant Formula Shortage

The USDA has announced that it is addressing the powdered infant formula shortage and is asking states to take advantage of flexibility in the WIC (Women Infants and Children) program. The shortage was caused by pandemic-related supply chain issues and by the closure of Abbott Nutrition's Sturgis, Michigan plant, where Cronobacter was found in environmental samples after complains of infant illnesses. Agriculture Secretary Tom Vilsack said in a statement, "We’re acutely aware that the ongoing recall has left many parents and caregivers concerned about access to formula and how they will feed their babies. Our team is committed to the health and safety of all Americans and is calling on states to act immediately to offer maximum flexibility, information, and support to WIC … [Read more...]

Minnesota Offers Powdered Infant Formula Substitution Choices

The Minnesota Department of Health is offering powdered infant formula substitutions for WIC parents since the recall of Abbott Nutrition's products has limited choices. Those Abbott Nutrition products, which include various types of Similac, EleCare, and Alimentum formulas, were recalled in February 2022 after the FDA received reports of infants being sickened with Cronobacter infections. WIC, or Women, Infants and Children, is a special supplemental nutrition program that provides federal grants to states to help low-income pregnant, breastfeeding, and non-breastfeeding postpartum women and infants and children up to the age of five. WIC is located in hospitals, county health departments, clinics, and schools. Since the massive recall, parents have reported having difficulty … [Read more...]

FDA CORE Outbreak Investigation Table Updated Again

The FDA CORE Outbreak Investigation Table has been updated again with more information about the incidents the agency is investigating. Three of the investigations have changed. The reports of adverse reactions possibly related to dry cereal have increased to 555 from 529 in the last update issued on May 4, 2022. On the website iwaspoisoned, there are more than 7,000 reports of illness since late 2021. An on-site inspection has been initiated, and samples have been collected and analysis on a product has begun. One of the two active Listeria monocytogenes outbreaks has also been updated; the number of illnesses has increased to 20 cases from 19. That investigation was launched on February 9, 2022; no source has been identified. For the investigation of "Cronobacter illnesses … [Read more...]

FDA Responds to Apparent Shortages of Powdered Infant Formula

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...]

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