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Close up view of the headquarters of US Food and Drug Administration (FDA).
(Photo Credit: grandbrothers/Shutterstock)

FDA baby formula shortage investigation overview: 

  • Who: The U.S. Food and Drug Administration has acknowledged in a report that it could have done a better job of responding to the nationwide baby formula shortage. 
  • Why: One of the main ways the FDA says it erred was in its delayed response to a whistleblower’s complaint about the Abbott Nutrition factory where it later discovered contamination. 
  • Where: The baby formula shortage has affected consumers nationwide. 

The U.S. Food and Drug Administration (FDA) acknowledged that there were shortcomings in the agency’s response to the nationwide baby formula shortage that began earlier this year. 

In a 10-page report, the FDA admitted to a delay in responding to a whistleblower’s complaint and evaluating test samples from Abbott Nutrition’s Sturgis, Michigan, infant formula factory — the nation’s largest, the AP reports

The FDA also found that it has outdated data-sharing systems, inadequate training and staffing of food inspectors and a below-par visibility of baby formula manufacturing procedures and supply chains. 

The nationwide baby formula shortage forced the United States to import millions of pounds of baby formula into the country when Abbott’s Sturgis factory shuttered, the AP reports. 

The FDA required Abbott to shut down its Sturgis facility after Similac brand baby formula produced at the plant was linked to a contamination of cronobacter sakazakii and salmonella newport that sickened several infants and led to two deaths. 

Abbott baby formula recall included certain Similac, EleCare, Alimentum products

Abbott was forced to recall certain Similac, EleCare and Alimentum powdered infant formulas manufactured at the Sturgis plant on account of the contamination, with a resulting lack of formula leading to the nationwide shortage. 

Following its report, which was overseen by a key official, the FDA says that it will be seeking a new authority to compel companies to release information to them that would be key to an investigation, the AP reports. 

A whistleblower from within Abbott had reportedly attempted to warn the FDA about poor conditions at the Sturgis facility in September 2021; however, government inspectors did not begin investigating until after the infants were sickened or killed. 

The FDA would release a preliminary report in March in which the agency determined that Abbott had not kept up sanitary conditions at the Sturgis plant where the contaminated Abbott baby formula was produced. 

An investigation into whether or not there is a link between the illnesses and the formula specifically is still ongoing by the FDA, the AP reports. 

Have you been affected by the nationwide baby formula shortage? Let us know in the comments! 


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2 thoughts onFDA investigation into baby formula shortage concludes ‘shortcomings’ hampered agency response

  1. ANDREW L TINKER says:

    Definitely having trouble finding even a close formula to what my daughter needs

  2. Ann Marie Olson says:

    Still are not able to get baby formula. I believe this is being done on purpose. Where do I get the baby formula I need NOW?

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