October 6, 2022

FDA Investigating Another Infant Cronobacter Illness and Death

The FDA is investigating another infant Cronobacter illness and death, according to a news update about the issue of Abbott Nutrition's Cronobacter contamination problem. The news is contained at the end of the news release. The statement says that the FDA has reviewed and investigated a total of 129 complaints associated with Abbott Nutrition powdered infant formula products. Of these, 119 complaints were reported after the voluntary recall of Similac, Electra, and Aliments products on February 17, 2022. Nine of those complaints were of infant deaths. Only two were associated with the Abbott Nutrition Sturgis, Michigan plant investigation. The FDA states, "despite extensive investigation the evidence does not rule in or rule out a definitive link between these infant deaths and … [Read more...]

Similac Infant Formula Recalled in Canada For Possible Cronobacter

Similac Infant Formula is being recalled in Canada for possible Cronobacter and Salmonella contamination. This recall was triggered by a consumer complaint, although no illnesses have been reported in Canada in connection with this problem. Shoppers Drug Mart is issuing the recall, since these products were recalled on February 17, 2022 and some units were sold online in error. The recalling firm is Abbott Nutrition. The recalled products are all powdered infant formula. They include Similac Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder sold in 964 gram packages. The UPC number is 0 55325 00163 8 and the codes are L28174SH0 and L36099SH0. Also recalled is Similac Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder, also sold in 964 … [Read more...]

Senator Patty Murray Demands Accountability in Infant Formula Crisis

Senator Patty Murray (D-WA) is demanding accountability in the powdered infant formula crisis. After four infants were sickened with Cronobacter infections starting in September 2021, the FDA conducted an inspection at the Abbott Nutrition Sturgis, Michigan plant and found environmental contamination with that pathogen. The patient isolates did not match the environmental samples, but the plant was closed for weeks for cleaning and an investigation, triggering a shortage. Senator Murray is part of the HELP Committee, which is working on a bipartisan deal to respond to this crisis, as part of th FDA Safety and Landmark Advancements Act. Senator Murray said in a statement, "Families need accountability from FDA and formula manufacturers, and they desperately need formula—and I am … [Read more...]

New E. coli O157:H7 Outbreak Added to FDA CORE Investigation Table

A new E. coli O157:H7 outbreak has been added to the FDA's CORE Outbreak Investigation Table. At least 10 people are sick. We do not know the states where the ill persons live, their age range, illness onset dates, or if anyone has been hospitalized. Traceback has been initiated, but no recall has been issued, there has been no on-site inspection or sample collection, and no analysis of any product has started. This new E. coli O157:H7 outbreak is probably associated with an FDA-regulated food. This outbreak joins four other active outbreak investigations, and the investigation into the Cronobacter illnesses and Abbott Nutrition's powdered infant formula plant closure has been transferred to an IMG investigative unit. The hepatitis A outbreak linked to imported FreshKampo and HEB … [Read more...]

DeLauro Concerned About Abbott Nutrition Facility Reopening

Congresswoman Rose DeLauro (D-CT) is concerned about the Abbott Nutrition facility reopening after Cronobacter contamination was found in the plant. In a press release, she states, "Following credible reports that Abbott Nutrition had falsified records, cut corners, and instituted substandard safety practices, the Sturgis, Michigan, facility reopened to begin manufacturing infant formula once again. Given that there is no transparency on the reopening process to the public, irresponsible is the only word that comes to mind." In testimony to Congress in late May 2022, FDA Commissioner Robert Califf said that inspectors had found "shocking" conditions in the plant and that it had "egregiously unsanitary" conditions. Califf added that an investigation could not conclude that those … [Read more...]

Raw Milk Is Not a Substitute for Powdered Infant Formula

Raw milk is not a substitute for powdered infant formula, according to experts at Cornell University. With many parents desperate for the formula to feed infants and children with special dietary needs after Abbott Nutrition's plant in Sturgis, Michigan was shut down for Cronobacter contamination, there is a lot of bad advice popping up online. Parents are urged not to make homemade formula, which does not have the nutrition infants need. And never feed infants raw milk. Raw milk can be, and has been, contaminated with pathogens that include E. coli O157:H7, Listeria monocytogenes, Campylobacter, Brucella, and Salmonella. In fact, while only 1% of consumers drink raw milk, raw milk causes 70% of milk outbreaks. Raw milk is especially risky when given to any person at high risk for … [Read more...]

FDA Importing Specialized Medical Infant Formula to Increase Supply

The FDA is importing specialized medical infant formula to increase thee U.S. supply after the Abbott Nutrition plant in Sturgis, Michigan was closed when Cronobacter contamination was found. Cronobacter can cause serious and fatal infections in infants, especially those that are premature. The FDA says that millions of bottles of these formulas will be imported. FDA Commissioner Robert M. Califf, M.D. said in a statement, "We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. as quickly as possible. We continue to work closely with our U.S. government partners and domestic and international manufacturers to identify additional formula product that will be … [Read more...]

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...]

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