May 21, 2024

FDA Issues Updated Compliance For Infant Formula

The FDA has issued updated compliance for infant formula after the disastrous shutdown of Abbott Nutrition for cronobacter contamination in 2022 that caused severe shortages. The press release states that, "This effort is part of the FDA's ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry." The FDA released its internal evaluation of the response in 2022. It recommended that the agency review and update its compliance program to make sure it reflected the latest science on Cronobacter, and offered consistency and clarify for manufacturers on inspection and compliance activities. The FDA has published its updated compliance program, which it says builds on the lessons learned over the last several years. Salmonella and … [Read more...]

Infants Fed Powdered Infant Formula Get More GI Infections

A study conducted in the United Kingdom found that infants fed powered infant formula contract more gastrointestinal infections than breastfed infants. Part of the problem is contaminated infant feeding equipment. Almost 3/4 of infants in the UK get infant formula in the first 6 weeks. This number rises to 88% by 6 months of age. At least 3000 hospitalizations every year in the UK may be attributed to formula feeding. Breastfed infants have significantly fewer GI infections. The World Health Organization recommends that water used to reconstitute powdered infant formula (PIF) be at least 70°C (158°F) to kill pathogens. Powdered infant formula manufacturers state that they cannot produce a sterile product and that it can contain pathogens such as Cronobacter and Salmonella. For … [Read more...]

Gerber Good Start SoothePro Formula Recalled For Cronobacter

Gerber Good Start SoothePro powdered infant formula is being recalled for possible Cronobacter contamination. No illnesses have been reported to the company to date in connection with the consumption of this product. The recalling firm is Perrigo Company of Dublin, Ireland. No distributed product has tested positive for Cronobacter. And no other products manufactured at the facility or any other Perrigo facilities are included in this recall. Cronobacter sakazakii is a bacteria that can sicken infants, especially premature infants, and can cause serious illness. Symptoms of a cronobacter infection include poor feeding, excessive crying, low energy, and fever. If the infection progresses to meningitis or sepsis, symptoms include grunting breaths, unusual cry, pale skin, rapid … [Read more...]

FDA Calls For Enhanced Safety Steps in Powdered Infant Formula

The FDA is calling for enhanced safety steps in powdered infant formula in the wake of the cronobacter crisis in that industry in 2022. Back then, Abbott Nutrition had to close their plant in Sturgis, Michigan that manufactured that formula after cronobacter contamination was found. The whole issue started when four infants were sickened and two died in 2021 and 2022. Those infants were fed powdered infant formula made by Abbott Nutrition. Although cronobacter was found in the Abbott facility, the FDA did not find a connection between the illnesses and the facility. In addition, the FDA found insanitary conditions at that facility. The Abbott facility closed for months after the contamination was found, causing a severe shortage in the infant formula products they made. The FDA … [Read more...]

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...]

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