The Food and Drug Administration listed more than a dozen contributing factors to the national formula shortage earlier this year, but refrained from assigning blame to any specific person or agency.
An internal review of the agency’s handling of the crisis cited a lack of training and outdated information technology as two of 15 reasons for the critical shortage of infant formula. The report says it couldn’t find a “single action” as to why the formula crisis happened.
The internal review was led by Steven M. Solomon, director of the FDA’s Center for Veterinary Medicine, who said in a statement that he identified five key areas of need in his review: improved information technology to exchange emergency data; updating personnel, training and equipment; updated emergency response systems; an assessment of the infant formula industry; and a better scientific understanding of cronobacter – the bacteria that caused the shortage.
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There were other factors that led to the formula crisis, Solomon said — such as the limited number of formula makers and issues with the ingredient supply chain and product distribution — that need to be addressed. outside of the FDA.
“Put simply, if the FDA is to do more, it needs more,” Solomon said in a statement. “As the agency assesses its workforce needs related to infant formula regulation and oversight, we recommend that it use the appropriations process to help secure authorities and resources required.”
In February, infant formula maker Abbott issued a voluntary recall after consumers reported cases of cronobacter, a bacterial infection particularly dangerous to infants, in products made at a plant in Sturgis, Michigan. stores struggled to keep up with demand.
Abbott said in an August press release that it had restarted production at the Sturgis plant and products should begin shipping in late September or early October.
The FDA also admitted in its findings that it – and other federal agencies – “do not have the authority, expertise, or resources to manage supply chain issues and shortages of critical food products. “. To address this issue, Solomon recommends that the government work with federal agencies to establish roles and responsibilities for managing critical food supply chains.