The Food and Drug Administration (FDA) is investigating the death of another child after allegedly consuming infant formula produced by Abbott Laboratories.
An Abbott spokesperson told DailyMail.com that the company had received “limited product and clinical information” to assess 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 investigation comes less than a month after the FDA gave Abbott the green light to reopen its Sturgis, Michigan. The factory is the largest infant formula factory in the United States
The facility was closed in February following bacterial contamination in four infants, two of whom died. The investigation revealed that Abbott products were probably not the source of the infections in the previous cases.
The Sturgis plant closed again more than a week ago after severe thunderstorms and heavy rain caused damage to the facility. The company said it needed time to assess the damage and re-disinfect the plant before reopening.
In the meantime, the United States continues to struggle with a nationwide formula shortage. The Biden administration announced Wednesday that officials will provide logistical support to import about 16 million 8-ounce baby bottles from Mexico starting this weekend.
The move is part of President Joe Biden’s Operation Fly Formula initiative to ease supply shortages accentuated by the closure of the Abbott plant.
The Food and Drug Administration (FDA) is investigating the death of another child after allegedly consuming formula milk produced by Abbott Laboratories
The last infant death occurred in January, according to a consumer complaint sent to the FDA on June 10.
The agency did not say which Abbott product the child allegedly consumed or where the formula was produced, but noted that its investigation was still in the preliminary stages.
An Abbott spokesperson told DailyMail.com on Wednesday that the company became aware of the infant death case last week.
However, the formula’s maker alleges that there was “limited product and clinical information provided to assess the case.”
“At this time, no conclusions can be drawn and there is no evidence to suggest a causal relationship between Abbott’s formulas and this reported case,” the spokesperson said. “If additional information becomes available, we will investigate further in accordance with our complaints handling process.”
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 were not made public until earlier this month, between December 2021 and March 2022, that were allegedly linked to formula. The most recent case would mark the 10th presumed death.
Infant death reports were included in a list of 128 consumer complaints filed with the FDA. The complaints were made public by eFoodAlert on June 8.
Two of the deaths listed in the complaints were counted among the four confirmed cases of Cronobacter sakazakii identified by the CDC. The bacteria was reportedly discovered at the Sturgis plant.
An Abbott spokesperson told DailyMail.com in May that a “thorough investigation” by the FDA and Abbott found that “infant formula produced at our Sturgis plant is not the likely source of ‘infection in reported cases and that there has been no outbreak caused by facility products’.
The other seven deaths were reported to the FDA, its consumer complaints system, and two mentioned Salmonella in the complaint description.
The FDA said it could not find enough evidence linking these seven circumstances directly to Abbott’s plant.
Meanwhile, national leaders are trying to ease the national formula shortage that worsened after the Abbott factory was scheduled to close in February.
Abbott then recalled several major infant formula brands, including Similac. This reduced supplies that had already been strained by supply chain disruptions and storage during the COVID-19 shutdowns.
The current shortage of infant formula has been most severe for children with allergies, digestive issues and metabolic disorders who rely on specialized formulas.
The Biden administration announced Wednesday that it will import infant formula from Mexico starting this weekend.
The Department of Health and Human Services is accelerating the journey of trucks that will carry approximately 1 million pounds of Gerber Good Start Gentle infant formula from a Nestlé factory to U.S. retailers, nearly doubling the amount imported into the U.S. to date .
Cargo flights from Europe and Australia have already brought formula to the United States, including two new rounds of air shipments beginning this weekend.
Last month, the Food and Drug Administration decided to relax federal import regulations to allow infant formula to be shipped to the United States.
Biden also authorized the use of the Defense Production Act to provide federal support to move the formula from overseas to the United States.
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