The Food and Drug Administration (FDA) is investigating after another child died after allegedly consuming infant formula produced by Abbott Laboratories.
An Abbott spokesperson told DailyMail.com the company received ‘limited product and clinical information’ to evaluate the case and, at this time, there are ‘no conclusions’ and ‘no evidence to suggest a causal relationship’ between Abbott products and the reported infant death.
The probe comes less than a month after the FDA gave Abbott the green-light to reopen its factory in Sturgis, Michigan. The plant is the largest baby formula factory in the U.S.
The facility was shuttered in February following a bacteria contamination in four infants, including two who died. Investigation revealed Abbott products were not likely the source of the infections in the prior cases.
The Sturgis plant shuttered again more than a week ago after severe thunderstorms and heavy rains swept caused damage to the facility. The company said it needs time to assess damage and re-sanitize the factory before reopening again.
Meantime, the U.S. continues to battle a nationwide formula shortage. The Biden administration announced Wednesday officials are providing logistical support to import about 16 million 8-ounce baby formula bottles from Mexico starting this weekend.
The move is part of President Joe Biden’s Operation Fly Formula initiative aimed at easing supply shortages disruptions heightened by the closure of the Abbott plant.
The Food and Drug Administration (FDA) is investigating after another child died after allegedly consuming infant formula produced by Abbott Laboratories
The latest infant death occurred in January, according to a consumer complaint sent to the FDA on June 10.
The agency didn’t specify which Abbott product the child allegedly consumed or where the baby formula was produced, but noted its investigation is still in the preliminary stage.
An Abbott spokesperson told DailyMail.com Wednesday the company was informed about the infant death case last week.
However, the formula manufacturer alleges there was ‘limited product and clinical information provided to evaluate the case.’
‘At this time, there are no conclusions that can be drawn and no evidence to suggest a causal relationship between Abbott’s formulas and this reported case,’ the spokesperson said. ‘If additional information is available, we will investigate further per our complaint handling process.’
Abbott shuttered its Michigan plant in February following a bacteria contamination in four infants, including two who died. Investigation revealed Abbott products were not likely the source of the infections in the prior cases. Empty formula shelves are seen at a Walmart in New Jersey on May 26
An American shopper shows how the baby formula aisle at their local grocer is partitioned off amid the national shortage. The photo was shared online on June 13
Abbott issued a formula recall in February 2022 after receiving multiple reports of infant deaths.
The FDA investigated nine reports of infant deaths, including seven that had not been made public prior to earlier this month, between December 2021 and March 2022 that had allegedly been linked to baby formula. The most recent case would mark the 10th alleged death.
The infant death reports were included in a list of consumer complaints issued to the FDA. The complaints were made public by eFoodAlert on June 8.
Two of the deaths listed in the complaints were numbered among the four confirmed cases of Cronobacter sakazakii identified by the Centers for Disease Control and Prevention (CDC).
The FDA reportedly discovered Cronobacter bacteria at the Sturgis plant.
An Abbott spokesperson told DailyMail.com in May that ‘thorough investigation’ by the FDA and Abbott revealed ‘infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was not an outbreak caused by products from the facility’.
The other seven deaths were reported to the FDA its consumer complaint system and two mentioned Salmonella in the complaint description.
The FDA has said that ‘despite extensive investigation’ it could not find enough evidence to ‘not rule in or rule out a definitive link’ between the seven infant deaths and Abbott’s product.
To date, the FDA has reviewed and investigated 129 complaints associated with Abbott formula products, the federal agency confirmed to DailyMail.com.
The majority of complaints, a total of 119, were reported after Abbott voluntarily recalled its products on February 17.
The FDA has previously reported its review of complaints related to nine infant deaths. Only two were associated with the Abbott Nutrition Sturgis plant investigation, and despite extensive investigation the evidence does not rule in or rule out a definitive link between these infant deaths and the product produced at Abbott Nutrition’s Sturgis plant.
A sign notifies customers of purchase limits for baby and toddler formula at a Walgreens store in Las Vegas, Nevada on May 29
An airplane full of baby formula arrived in Louisville, Kentucky on June 16 to help American families impacted by the current shortage
Meanwhile, national leaders are trying to ease the nationwide baby formula shortage that worsened after the Abbott factory shut down due in February.
Abbott recalled several leading brands of formula then, including Similac. That squeezed supplies that had already been strained by supply chain disruptions and stockpiling during COVID-19 shutdowns.
The ongoing formula shortage has been most dire for children with allergies, digestive problems and metabolic disorders who rely on specialty formulas.
The Biden administration announced Wednesday that will be importing formula from Mexico starting this weekend.
The Department of Health and Human Services (HHS) is expediting the travel of trucks that will drive about 1 million pounds of Gerber Good Start Gentle infant formula from a Nestlé plant to U.S. retailers, nearly doubling the amount imported to the U.S. to date.
Cargo flights from Europe and Australia already have brought baby formula into the U.S., including two new rounds of air shipments that begin this weekend.
National leaders are trying to ease the nationwide baby formula shortage that worsened after the Abbott factory shut down due in February
This chart shows how quickly the nationwide crisis escalated
Last month, the Food and Drug Administration moved to ease federal import regulations to allow baby formula to be shipped to the U.S.
Biden also authorized the use of the Defense Production Act to provide federal support to move formula from overseas into the U.S.
‘The FDA is working night and day to ensure that parents and caregivers can readily find safe and nutritious formula products for any child who needs it,’ FDA Commissioner Robert M. Califf said in a statement Wednesday.
‘I have personally spoken with infant formula manufacturers over the past several weeks and all have significantly increased their production efforts, which is resulting in more supply that will be available on stores shelves moving forward.’
In the past month, the FDA has began importing an estimated 17 million cans, or about 365 million full-size, 8-ounce bottles, of formula into the country, Califf reported.
The agency alleged the products have ‘already started to hit the U.S. market’ and more formula will arrive on store shelves in the coming weeks and months.
‘Consumers should have confidence that the infant formula that is being imported to the U.S. through this process involved a thorough review of the information provided by the companies, including details about the product’s nutritional adequacy and safety, microbiological testing results, labeling information, and importantly, details about the manufacturing facility’s food safety production practices and inspection history,’ the FDA said in a statement.
Vice President Kamala Harris is seen greeting a new shipment of baby formula brought from overseas on June 17
The FDA said formula products have ‘already started to hit the U.S. market’ and more will arrive on store shelves in the coming weeks and months. A shopper posted a photo to Twitter on Wednesday showing a stockpile of formula at an American Costco store
The agency also addressed concerns surrounding Abbott’s plant and the recent weather-related shutdown.
It said Abbott has been ‘working quickly’ to assess the damage and is reporting its progress to the FDA.
Officials will return to the facility in the days ahead to ‘work closely’ with Abbott so the plant can resume production of ‘safe and quality formula products as quickly as possible.’
‘Making sure that parents and caregivers have access to both safe and available infant formula remains a top priority for the FDA, and our teams are working night and day to help make that happen,’ the agency said.
The FDA also said it would be releasing establishment inspection reports for several prior evaluations that took place at the Abbott plant, citing ‘overwhelming public interest’ in the reports.
The agency collected and tested samples of finished products from the Sturgis plant during its 2019 and 2021 inspections, officials allege.
The samples tested negative for pathogens, however it was determined during those inspections that the firm had found batches of Cronobacter contaminated finished product at the facility.
Abbott had reportedly had taken the appropriate action to destroy three batches, two in 2019 and one in 2020, before distribution, the FDA stated.
The agency also noted its most recent inspection, which took place in January 2022, was for cause inspection due to consumer complaints of infant illnesses following consumption of infant formula produced at the facility.
Abbott has said its plant is safe and was not responsible for the bacteria infection that killed two kids.
The manufacturer was given the go ahead to resume infant formula production at its facility in Sturgis on June 4 after having met FDA requirements agreed to last month.
