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...]
Cronobacter Added to Notifiable Pathogens Reported to CDC
The Council of State and Territorial Epidemiologists (CSTE) is recommending that cronobacter be added to the list of notifiable pathogens reported to the Centers for Disease Control and Prevention (CDC). This is notable, since this pathogen, which can be deadly to infants, has not been tracked and is not reportable except in two states: Minnesota and Michigan. Because it is not tracked, we do not know how many infants are sickened by this pathogen. It's unfortunate that states will not be required to notify the CDC about these infections, but will only be asked to, although states usually do comply with this type of request. The position statement establishes standardized criteria for case definition and case counting that will be used for public health surveillance purposes. This … [Read more...]
FDA Strategy to Increase Resilience of Infant Formula Market
The FDA has released a national strategy to increase the resilience of the infant formula market in the United States. Last year, cronobacter illnesses among some infants led to the inspection of Abbott Nutrition's Sturgis, Michigan plant where problems were found, including multiple swabs indicating cronobacter contamination. Many recalls were issued and the plant was closed, which threw the infant formula supply in the United States into chaos. While there was not a match between the contamination in the Abbott plant and the sick infants, the situation highlighted how brittle the supply of powdered infant formula is in this country. In 2022, the Food and Drug Omnibus Reform Act directed the FDA to develop this strategy to help keep the market for this product stable. FDA … [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...]
DOJ Starts Criminal Investigation into Abbott Over Formula
According to news reports, the Department of Justice has started a criminal investigation into Abbott Laboratories in relation to the cronobacter contamination at the Abbott plant that caused a shutdown last year and the resulting baby food supply crisis that triggered a severe shortage of powdered baby formula. Cronobacter can cause serious illness in infants and can be deadly. In September 2021, an infant in Minnesota developed a cronobacter infection. Minnesota is the only state in the country that requires reporting this illness. Minnesota officials reported the issue to the Centers for Disease Control and Prevention (CDC). Babies in Ohio and Texas also got sick; the infant in Ohio died. In all, four infants were sickened and two babies died. With more infants sick, FDA … [Read more...]
Abbott Nutrition Recalls Ready to Feed Liquid Infant Formula
Abbott Nutrition is recalling certain bottles of ready to feed liquid infant formula because a small percentage of those products, which are less than 1% of the recalled amount, have bottle caps that may not have sealed properly. That could result in spoilage and could cause symptoms such as diarrhea and vomiting. The recalled product brands include Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. The products included in the recall were manufactured at the company's facility in Columbia, Ohio. The recall notice does not state whether or not any illnesses have been reported. The recall does not include ny other … [Read more...]
Similac Alimentum Infant Formula Recalled For Packaging Defect
Similac Alimentum Infant Formula is being recalled for a possible packaging defect. This recall notice was posted on the FDA's Enforcement Report web page on September 7, 2022, and is not on the usual FDA recall page, so we do not know if any adverse events have been reported to the company to date. The recalling firm is Abbott Nutrition of Columbus, Ohio. The recalled product is Similac Alimentum Infant Formula that is packaged in 32 ounce re-closable plastic bottles. There are eight bottles in each case, and about 720 bottles are included in this recall. The Batch/Lot Number that is stamped on each bottle is 41740RH00. The product number that is printed on the label is 57512 And the Best By date is 06/01/23 (June 1, 2023). This infant formula was distributed in Michigan and … [Read more...]
FDA Developing New Framework For Expanded Access to Infant Formula
The FDA is developing a new framework for expanded access to infant formula options for parents and caregiver in the wake of the Abbott Nutrition plant shutdown after Cronobacter contamination was found this spring. In May 2022, the FDA issued guidance that the agency was going to temporarily exercise enforcement discretion on a case-by-case basis for some requirements to address this shortage. The FDA has prioritized review of requests from firms that can document the safety and nutritional adequacy of their products, can make the largest volume of product available, and can get their products onto shelves in this country quickly. The infant formula supply has dramatically increased in the weeks since that guidance was issued. Many infants and other people rely on infant formula … [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...]
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...]
