FDA review says multiple factors contributed to baby formula shortage : NPR
The Food and Drug Administration listed more than a dozen factors contributing to the national baby formula shortage earlier this year, but stopped short of attributing blame to a specific individual or agency.
An internal review of how the agency handled the crisis cited a lack of training and outdated information technology as two of the 15 reasons behind the critical baby formula shortage. The report said it couldn’t find a “single action” to explain why the formula crisis occurred.
The internal review was conducted by Steven M. Solomon, director of the FDA’s Center for Veterinary Medicine, who said in a statement that he identified five major areas of need in his review: upgraded information technology to exchange data during an emergency; updated staffing, 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 manufacturers and issues with the ingredient supply chain and product distribution — that needed to be addressed outside of the FDA.
“Simply put, if the FDA is expected to do more, it needs more,” Solomon said in a statement. “As the agency evaluates its workforce needs related to infant formula regulation and oversight, we recommend that it utilize the appropriations process to help secure the authorities and resources needed.”
Last February, baby formula manufacturer Abbott initiated a voluntary recall after consumers reported cases of cronobacter, a bacterial infection especially dangerous for infants, in products manufactured at a facility in Sturgis, Mich. The shortage forced parents to hunt for formula, as markets and retail stores struggled to keep up with demand.
Abbott said in an August news release that it had restarted production at the Sturgis facility, and that 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.” In order to address this, Solomon recommends the government work with federal agencies to establish roles and responsibilities for managing critical food product supply chains.