- –Abbott Laboratories claims its Michigan plant is not responsible for bacteria that killed at least two infants
- –The baby formula manufacturer alleged an FDA investigation revealed ‘infant formula produced at our Sturgis facility is not the likely source of infection’
- –Abbott claims products from the facility did not cause any bacterial outbreak
- –The plant still remains closed despite the findings after shutting down in February amid a major product recall
- –Abbott says it’s ‘working closely with the FDA to restart operations’ at the plant as parents across the nation are struggling to get formula for their babies
- –Are you a parent struggling to get hold of formula milk? Contact natasha.anderson@mailonline.com
via Daily Mail
The biggest baby formula supplier in the U.S. has denied its Michigan plant is responsible for the deaths of two children despite the FDA closing it down.
The plant was shutdown nearly three months ago after a bacterial infection caused the deaths and other serious illnesses.
In mid-February Abbott Laboratories issued a nationwide baby formula recall and ceased operations at its plant in Sturgis, Michigan amid reports of babies contracting bacterial infections from its products.
An Abbott spokesperson told DailyMail.com Tuesday that ‘thorough investigation’ by the U.S. Food and Drug Administration (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’.
However, despite the findings of the investigation, the plant remains shuttered nearly three months later, fueling the nationwide baby formula shortage.
The FDA – which said it found food safety violations at the plant, as well as five strains of Cronobacter, a bacteria that can cause blood infections and meningitis – has refused to say when the plant can resume operations.
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.
The formula shortage, which has become a national crisis, was triggered by supply chain issues, but spiked with the closure of the Abbott plant.
Abbott alleges that none of the formula distributed to consumers tested positive for Cronobacter or Salmonella.
The manufacturer claims the FDA and Abbott officials both tested retained products for the bacterias and yielded negative results.
Abbott notes no trace of Salmonella was found at the Sturgis plant and the Cronobacter that was found in environmental testing during the investigation was in non-product contact areas of the facility.
The company alleged the traces of Cronobacter at their plant have ‘not been linked to the two available patient samples or any other known infant illness.’
February’s recall, which is isolated to powder formulas, including Similac, Alimentum and EleCare, manufactured only at the Sturgis plant has significantly disrupted the supply chain.
The nationwide share of out-of-stock baby formula hit 40 percent in April. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.
As shelves across the country meant to carry baby formula remain largely barren, retailers including Target, CVS and Walgreens are limiting the amount of formula consumers can purchase.
Concerned parents, especially those whose children have unique medical and dietary needs, have expressed feelings of hopelessness and are calling on the government to take action to ‘ensure critical, life-sustaining supply chains don’t break down.’
However, an Abbott spokesperson alleged the recall ‘does not include any metabolic deficiency nutrition formulas, Abbott’s liquid formulas or other Abbott nutrition powders or brands.’
The company is reportedly ‘doing everything it can to address the infant formula supply shortage across the U.S.’ This includes ‘prioritizing production of infant formula products to help replenish the supply in the market’ and shipping products in from overseas.
Last month, the FDA announced it had ‘no objection’ to Abbott releasing limited quantities of nutrition products ‘to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas’.
The manufacturer, which was permitted to supply consumers with the speciality formulas on a ‘case-by-case basis,’ claims no formula being distributed has tested positive for bacteria.
Abbott phone representatives have also been telling parents the FDA is ‘holding back’ metabolic formula made during the recall period, which is why the current supply hasn’t gone out, Politico reported.
The FDA, disputing the company’s allegations, issued a statement to the newspaper on Saturday reading: ‘The FDA has not delayed the release of any specialty and metabolic infant formula products and the agency strongly disagrees with this characterization of events.
‘The agency has been working with Abbott since the Feb. 17 recall on ways to resume production. These are complex discussions, but from the beginning the agency has been committed to making these infant formula products, including specialty and metabolic products, available again as quickly as possible.
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