The FDA report details developments in the agency investigating infant formula that hindered the response


A perfect storm of “systemic vulnerabilities” unfolded at the U.S. Food and Drug Administration when the agency investigated tainted infant formula, skewing its response to infant formula shortages, a new internal review shows.

An FDA investigation into bacterial contamination of baby formula in January ultimately led to the recall of many popular brands of formula and forced the closure of a major manufacturing plant. The moves exacerbated shortages caused by supply chain disruptions, which have yet to be fully resolved.

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

Based on dozens of interviews with 61 employees, the 10-page assessment highlights key 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.

“In short, if the FDA is expected to do more, it needs to do more,” said Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine, who led the review. “As the agency assesses staffing needs related to infant formula regulation and oversight, we recommend using the appropriations process to help secure the necessary authorities and resources.”

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

In a statement, Califf said he agreed with the report’s findings, and that while domestic infant formula manufacturers had “made progress” in ramping up production, long-term, the infant formula supply chain requires greater manufacturer diversity, new facilities and “their commitment.” companies to consistently and consistently adhere to the FDA’s quality and safety standards.”

“The situation at the Abbott Sturgis facility has highlighted the FDA’s limited authority 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 changes needed to help prevent future supply shortages and help parents and caregivers have access to safe and nutritious infant formula, when and where they need it.”