May 24, 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...]

FDA Closes Listeria and Norovirus Outbreak Investigations

The FDA closes Listeria and norovirus outbreak investigations on its CORE Outbreak Investigation Table, while the alleged cereal outbreak case count increased. There are now only three active food poisoning outbreak investigations being conducted by the FDA. The Listeria monocytogenes outbreak that closed has sickened at least 20 people. A vehicle was not identified, even though traceback was initiated, an on-site inspection was initiated, and samples were collected and analyzed. The outbreak status is still listed as "ongoing" because the most recent illness onset date was April 20, 2022. It can take up to 70 days for the symptoms of listeriosis to manifest. The CDC will continue to monitor for more illnesses. This investigation will be reopened if more new illnesses are reported … [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...]

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...]

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