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.
TIMELINE SHOWS HOW AMERICA’S LARGEST BABY FORMULA PLANT CEASED PRODUCTION
Abbott Laboratories, the biggest baby formula supplier in the U.S., ceased production at its Michigan plant in February 2022 amid reports of fatal bacterial infections.
A timeline of events shows reveals the shut down was the plant had previously been under scrutiny by the U.S. Food and Drug Administration (FDA).
September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan.
The inspection report revealed the plant ‘did not maintain’ clean and sanitary conditions in at least one building that manufactured, processed, packaged or held baby formula.
FDA officials also observed poor hand washing among Abbott plant staff who ‘worked directly with infant formula.’
The FDA also noted an instance of improper equipment maintenance and temperature control.
October 2021: A whistleblower sends the FDA a 34-page document outlining potential concerns with the Sturgis plant.
The document, which was made public by Congresswoman Rosa DeLauro in April 2022, was written by a former plant employee.
The employee accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues.
January – March 2022: The FDA conducted multiple inspections at the Sturgis plant over the course of three months in 2022. A ten-page inspection report revealed multiple violations at the facility.
The agency alleged the plant failed to ensure that all surfaces that contact infant formula were maintained to prevent cross-contamination.
The report states the facility ‘did not establish a system of process controls’ to ensure the baby formula ‘does not become adulterated due to the presence of microorganisms in the formula or the processing environment.’
Officials also alleged the plant failed to disclose in an investigation report whether a health hazard existed at the facility.
Additionally, the report stated plant workers were did not wear the ‘necessary protective material’ when working directly with infant formula.
February 17: U.S. health officials urgently warn parents against using three popular baby formulas manufactured at the Abbott plant in Michigan. Investigators claim the products were recently linked to bacterial contamination after an infant died and three others fell ill.
Abbott voluntarily recalled several major brands and shut down its Sturgis plant.
The FDA also said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died.
February 28: Abbott Laboratories expanded its recall of Similac baby formulas after a second infant who was exposed to the powdered baby formula died.
April 15: Abbott releases a statement alleging it is working closely with the FDA to restart operations at the Sturgis plant.
Week of April 24: The nationwide share of out-of-stock baby formula hit 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.
May 10: Abbott releases a statement to DailyMail.com claiming ‘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’.
Abbott claims they are ‘working closely with the FDA to restart operations’ at the plant, with the spokesperson noting: ‘We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall’.
The FDA told DailyMail.com it was holding discussions with ‘Abbott and other manufacturers to increase production of different specialty and metabolic products’ but refused to say when the Sturgis plant could reopen.
Sen. Mitt Romney issued a letter to the FDA and U.S. Department of Agriculture (USDA) urging leaders to address the formula shortage and work to prevent future threats to infant health.
May 11: Lawmakers on Capitol Hill announce plans to hold a hearing in two weeks on infant formula shortages.
Abbott announced it would take up to ten weeks for the company to get baby formula to retailers once the Sturgis plant reopens.
Abbott also said: ‘After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.’
May 12: White House Press Secretary Jen Psaki defends the government’s closure of the Abbott plant.
President Joe Biden met with executives from infant formula manufactures and retailers to address the shortage.
May 13: Biden addresses the formula crisis during a press briefing, saying: ‘We’re going to be, in a matter of weeks or less, getting significantly more formula on shelves.’
The FDA announced it was working to streamline a process that will get more products to consumers – while also meeting safety, quality and labeling standards
May 16: Abbott and the FDA reach agreement to reopen baby formula facility in Michigan.
However, the FDA has yet to disclose a timeframe for allowing the plant to resume production.
The FDA also implemented new measures, in effect for 180 days, to increase imports of baby formula produced overseas.
May 18: Biden invoked the Defense Production Act to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress.
June 1: In response to questions from reporters, Biden admits he wasn’t told about the formula shortage until April.
June 3: White House press secretary Karine Jean-Pierre is grilled by reporters about who told the president about the shortage, when he was told and the process used to determine when information gets to the presidential level.
She dodged multiple questions on the topic and wouldn’t give any specifics.
‘There’s no specific person that I can call out to you. But it’s the regular way that we move forward through the regular channels. I don’t have a specific person. But that’s kind of how it goes on any issue, not just this one. It goes through regular channels, and senior White House staff usually brief him on different issues,’ she said.
June 4: Abbott restarts production at its Michigan plant.
The plant is first prioritizing production of specialty and metabolic formulas, with consumers expected to see these products on store shelves around June 20.
Abbott will then resume production of all other formulas, with the plant having previously said it will take six to eight weeks before stocks are replenished at stores.
June 12: Abbott halts production at its plant in Sturgis, Michigan for a second time since February.
The plant was shut down due to severe thunderstorms and heavy rains that swept through southwestern Michigan, causing parts of the building to flood.
Abbott said in a statement that it needs to assess damage and re-sanitize the factory, but did not indicate how much damage the factory sustained.
Production for its EleCare specialty formula has been suspended, but the company insisted there is enough supply to meet demand until production is restarted.
The company offered no time frame in its statement for when production will resume.