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September 21, 2022

US infant-formula crisis: internal review highlights FDA failings

But the report said there is no single action to explain the events that occurred.

By Andy Coyne

The US Food and Drug Administration (FDA) made mistakes in the way it responded to the infant-formula crisis that left supermarket shelves depleted of stock earlier this year, an internal review has concluded.

The report, issued yesterday (20 September), pointed to “systemic vulnerabilities” at the FDA as it investigated reports of Cronobacter bacteria-contaminated product at Abbott Laboratories’ infant-formula plant in Sturgis, Michigan. The closure of the plant in February – which lasted for several months – led to a shortage of supply and forced President Joe Biden to introduce emergency measures to bring in infant formula from abroad.

Report author Steven Solomon, a director at the Center for Veterinary Medicine, stressed he had only looked at “aspects of the response that are within the agency’s purview”. He did not consider other factors said to have contributed to the crisis, including the number of infant-formula manufacturers in the US, needed improvements in the ingredient supply chain and better control of product distribution.

But the report, based on dozens of interviews with 61 FDA employees, found delays, lack of procedures and limits on the FDA’s authority shaped its response.

The regulator has acknowledged its reaction to the crisis was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest infant-formula factory.

A company whistleblower had tried to warn the FDA of problems at the Abbott plant in September 2021 but inspectors did not investigate the complaints until February after four infants became sick, with two dying, the agency previously told Congress.

However, Solomon said one key finding from its interviews is there is no single action to explain the events that occurred.

“Rather the report identifies a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernisation and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area,” he reported.

Solomon added: “This incident demonstrated the need for an integrated, multi-disciplinary approach that included scientific, clinical, nutritional, analytical and inspectional expertise, legal processes, supply chain and policy considerations and resources to support this multi-disciplinary work.

“The report also identifies several areas in which the FDA lacks specific authorities and resources. Simply put, if the FDA is expected to do more, it needs more.”

Responding to the report, FDA commissioner Robert Califf said he agreed with Solomon’s findings and recommendations. However, he added “years of consolidation in the infant-formula industry and concerning food safety processes and general procedures at some of the facilities producing these products have resulted in a fragile supply chain that is susceptible to production disruptions when quality issues are identified”.

Califf said: “The agency has already updated some existing processes and procedures that will allow the agency to respond more quickly during a public health emergency. Immediate changes that we’ve been able to implement include improving our emergency response structure and streamlining the ways in which the public can contact the agency to report concerns with food products. We have also developed a sophisticated data system to track production, distribution and purchase of infant formula. There is more work to do, but this is a start.”

He said the long-term resiliency of the infant-formula supply chain will rely on greater diversification of manufacturers, including new entrants to the US marketplace, and investment in new manufacturing facilities by infant-formula producers.

Food and health watchdog The Center for Science in the Public Interest (CSPI) said that while the report’s conclusion that there is no single action to explain events is “undoubtedly true”, it is “so thin on details that it’s hard to make sense of what actually transpired”.

CSPI president Dr. Peter Lurie said: “Many of these recommendations will take years to implement, but this is a solid start. Primary among these are resources for a dedicated staff at the food agency to monitor the supply chain of infant and specialty formulas, and – although the report treads lightly here – the authority to require manufacturers to notify FDA of circumstances that could lead to a shortage.”

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