FDA report details agency fumbles during infant formula investigation that hampered response

By Brenda Goodman

A perfect storm of “systemic vulnerabilities” at the US Food and Drug Administration unfolded as the agency investigated contaminated baby formula, hampering its response to a worsening baby formula shortage, a new internal review shows.

The FDA’s investigation of bacterial contamination in baby formula in January ultimately resulted in a recall of many popular formula brands and forced the shutdown of a major manufacturing plant. The moves exacerbated shortages caused by supply chain disruptions, which still have not been fully remedied.

FDA Commissioner Dr. Robert Califf announced earlier this year that he had appointed an agency veteran to lead its internal review, which was released on Tuesday. It found delays, lack of procedures and limits on FDA’s authority shaped the response.

Based on dozens of interviews with 61 employees, the 10-page assessment highlights major areas where improvement is needed: FDA needs more modern technology; more staff, training, and equipment; updated emergency response systems that can handle more than one incident at a time; more scientific knowledge about Cronobacter bacteria, which is found in infant formula; and a better understanding of the infant formula industry.

“Simply put, if the FDA is expected to do more, it needs more,” Dr. Steven Solomon, director of FDA’s Center for Veterinary Medicine, who led the review, 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.”

The baby formula shortage has eased, but it is not over. Stock numbers from market research firm IRI show about 21% of powdered infant formula was out-of-stock the first week of September, still roughly double the out-of-stock rate for powdered infant formula in January, prior to the recall.

In a statement, Califf said he agreed with the report’s findings, and although domestic infant formula manufacturers “stepped up” to increased production, long-term, the infant formula supply chain needs greater diversity of manufacturers, new facilities and “a commitment by these companies to consistently and continuously adhere to the FDA’s quality and safety standards.”

“The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to ‘do the right thing’ without intervention,” Califf said in a statement.

“Rest assured that we are committed to implementing the necessary changes to help us avoid future supply shortages and ensure parents and caregivers have access to safe and nutritious infant formula whenever and wherever they need it.”

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This is a developing story and will be updated.