May 20, 2022

FDA Updates Activities on Infant Formula Supply Challenges

The FDA has updated its activities on infant formula supply challenges. The agency is trying to increase the supply and availability of infant formula since the Abbott Nutrition plant in Sturgis, Michigan closed because the FDA found Cronobacter contamination in the environment. The agency warned parents not to use certain powdered infant formula products from that facility on February 17, 2022. A recall was issued by Abbott the same day. Cronobacter is a bacteria that can cause serious illness and death in infants, particularly premature babies and those with other medical conditions. A consent decree of permanent injunction was filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. Abbott has agreed to take corrective actions following the FDA … [Read more...]

Abbott Enters Consent Decree With FDA To Reopen Infant Formula Plant

Abbott enters consent decree with the FDA to reopen their Sturgis, Michigan powdered infant formula plant that was closed after Cronobacter was discovered in the environment. The FDA inspection was prompted by reports of infant illnesses and deaths. The United States filed the decree on behalf of the FDA. It would require Abbott Nutrition to take "specific measures designed to increase safety and ensure compliance wi the Federal Food, Drug and Cosmetic Act" and the FDAs Good Manufacturing Practice requirements. Attorney General Merrick B. Garland said in a statement, "The actions we are announcing today will help to safely increase the supply of baby formula for families. The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential … [Read more...]

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...]

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 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...]

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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