Rep Krishnamoorthi launches inquiry into the FDA Similac powdered infant formula response after four infants were sickened and two died. Rep. Krishnamoorthi is the Chairman of the Subcommittee on Economic and Consumer Policy in the U.S. House of Representatives. A letter was sent requesting information about the FDA's alleged "delayed response" in addressing contaminated infant formula. The Chairman wrote, "FDA is tasked with protecting all Americans from life-threatening foodborne illness outbreaks, but fell short in protecting vulnerable infants from contaminated formula. FDA must do more to ensure no lives are lost, or babies sickened, due to delayed inspections and late consumer warnings." The Minnesota Department of health alerted the FDA in September 2021 that an infant's … [Read more...]
FDA: Abbott Didn’t Test Similac Samples in Internal Probe of Infant Death
Analysis Contrary to its own operating procedures, Abbott Nutrition completed an internal probe of a fatal Cronobacter case without testing samples of the associated lot of Similac Pro Total Comfort, according to the FDA's 2022 inspection report of Abbott's facility in Sturgis, MI. Federal health officials have been investigating four Cronobacter illnesses, two of them fatal, reported between September 2021 and January 2022 among infants who consumed Similac products made at Abbott's Sturgis plant. Yesterday, the U.S. Food and Drug Administration (FDA) released the reports from its three most recent inspections of the Sturgis facility. The reports show that Abbott failed to maintain sanitary conditions at the plant where it makes a variety of infant formulas including some for babies … [Read more...]
Timeline: Chronobacter Illnesses Linked to Infant Formula
The CDC, FDA, and state health departments are investigating Cronobacter illnesses among infants who consumed powdered baby formula. Between September 2021 and January 2022, four illnesses were reported -one from Minnesota, two from Ohio, and one from Texas. The two babies in Ohio died. Cronobacter is not a “reportable disease” nationwide. So, doctors and labs aren’t required to report these infections to their state health departments who then report them to the Centers for Disease Control and Prevention (CDC). Minnesota is the only state in the country that requires reporting. The CDC does receive reports of Cronobacter, an average of three a year. It's just not required. So unlike illnesses from E. coli, Salmonella, or Listeria, the genetic fingerprint of the Cronobacter that made … [Read more...]
FDA Updates the Recalled Cronobacter Infant Formula Product List
The FDA has updated the recalled Cronobacter infant formula list with a full list of recalled products. In addition, they say that metabolic and other medical specialty infant formulas were produced at the same plant which made the recalled Similac PM 60/40, but those products were not recalled "because the FDA has determined that the risk of not having these specialty products available could significantly worsen underlying medical conditions. For many of these patients, the risk of life-threatening adverse events from restricted access to these critically needed products is likely greater than the risk from consuming products that have been produced at the facility." So far, at least four infants, who lived in Minnesota, Texas, and Ohio, have been diagnosed with Cronobacter … [Read more...]
FDA Removed a Salmonella Illness From Powdered Infant Formula Count
The FDA removed a Salmonella illness from the powdered infant formula case count, accord to an update issued for that agency's CORE Outbreak Investigation Table. The Table itself does not contain this information; it was sent in an email. Salmonella has been removed from the Pathogen column in that outbreak investigation. There are still four infants in the case count linked to Similac, EleCare, and Alimentum powdered infant formulas. Those infants are from Minnesota, Ohio, and Texas. The two infants who lived in Ohio died, although the FDA is investigating to see if Cronobacter sakazakii contributed to those deaths. Two recalls have been issued for those infant formula products. The first, on February 17, 2022, was for Similac, EleCare, and Alimentum powdered infant formula with … [Read more...]
Similac Recall Includes Formula Made November 2020 to February 2022
Abbott Nutrition's recall of powdered infant formula includes Similac products made at the company's facility in Sturgis, MI over the 15-month period from November 1, 2020, to February 17, 2022, according to recall information the company provided to retailers. Because these dates are not mentioned in the company's public recall announcement, consumers may not be aware that formula they purchased for their infants more than a year ago is part of this recall. The length of the production window associated with the recall also raises questions about the results of the FDA's inspection of the plant. Abbott issued a recall for Similac, Alimentum, EleCare, and EleCare Jr on February 17, 2022, after the U.S. Food and Drug Administration (FDA) announced an investigation of … [Read more...]
DeLauro Wants an Investigation into FDA Handling of Infant Formula Recall
Rep. DeLauro wants an investigation into the FDA handling of infant formula monitoring and recalls, more specifically the Abbott Nutrition powdered infant formula recall associated with at least four Cronobacter illnesses. Rosa Delauro (D-CT) is the chair of the House Appropriations Committee. A letter was sent to the Inspector General of the Department of Health and Human Services, asking for her assistance in this investigation. DeLauro states, "Based on reports, I am concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death. The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula … [Read more...]
Expanded Similac Recall For Cronobacter Complaints Posted
The expanded Similac recall for Cronobacter complaints has been posted on the FDA recall page. At least four infants have been diagnosed with Cronobacter infections after consuming Similac, EleCare, or Alimentum powdered infant formula with specific lot numbers and expiration dates that were produced at Abbott Nutrition's Sturgis, Michigan plant. Two of those infants who lived in Ohio died, although the FDA is investigating to see if Cronobacter contributed to those deaths. The expanded Similac recall for Cronobacter complaints is for Similac PM 60/40 with lot number 27032K80 for the can and 27032K800 for the case. This recall is in addition to the lots of Similac, Alimentum, and EleCare powdered formula that were voluntarily recalled on February 17, 2022. This new recall was … [Read more...]
CDC Cronobacter Investigation Widens, 2 Ohio Infants Dead
In a typical year, between two to four cases of Cronobacter are reported to the Centers for Disease Control and Prevention (CDC). But a current federal investigation that already includes two deaths in Ohio and two illnesses in Texas and Minnesota among infants who consumed Similac powdered infant formula has widened, according to the CDC. After the U.S. Food and Drug Administration (FDA) announced its collaborative investigation with the CDC and state partners of Cronobacter illnesses, and one Salmonella illness, in Ohio, Minnesota, and Texas, the CDC received additional reports of possible Cronobacter illnesses and another Salmonella illness. The agency is using whole genome sequencing tests to sort things out, Brian Katzowitz, a CDC spokesman, told Food Poisoning Bulletin this … [Read more...]
FDA Advice For Parents About Infant Formula Cronobacter Illnesses
This FDA advice for parents about infant formula and the Cronobacter illnesses linked to some types of powdered formula is offered to help parens navigate this difficult time. At least four infants, from Minnesota, Ohio, and Texas, are sick with Cronobacter sakazakii infections after consuming recalled Similac, EleCare, or Alimentum formula produced at Abbott Nutrition's Sturgis, Michigan plant. Because infant formula is the sole source of nutrition for many newborns and infants, the FDA is offering help. The FDA is stating that one infant allegedly contracted a Salmonella infection after being fed this formula, but the CDC is not including this illness in the case count until they complete their investigation. The key to the recall is the lot codes and expiration date on the … [Read more...]
