It took the U.S. Food and Drug Administration more than 15 months to respond to a whistleblower complaint it received about conditions at the Abbott Nutrition plant that was at the center of a nationwide baby food shortage, a new audit shows.
The Department of Labor received the email and three days later forwarded it to the FDA specifically for such complaints. But one of several employees tasked with managing the FDA’s inbox at the time “inadvertently archived” the email in February 2021, and it was not found until a reporter queried it in June 2022.
The episode is one of several leading the Department of Health and Human Services’ Office of Inspector General. to conclude Thursday’s report said the FDA’s policies and procedures for addressing problems at the Abbott plant were inadequate.
The FDA took some action and conducted follow-up reviews, but “more could have been done before recalling Abbott’s powdered infant formulas,” the auditors wrote. The FDA needs better policies for communicating the status of complaints to senior management and ensuring inspections are carried out quickly, the report said.
“The bottom line is that the FDA must do better going forward, and the American public must expect better,” Assistant Inspector General Carla Lewis said in an interview.
Several babies were hospitalized and two died from a rare bacterial infection after being fed powdered formula produced at Abbott’s Michigan plant, the largest in the country. FDA shut down the site within a few months starting February 2022, and the company recalled several lots popular formulas including Similac, Alimentum and EleCare.
FDA inspectors eventually found numerous violations at the plant, including bacterial contamination, a leaking roof and lax safety protocols, but the agency never found a direct link between the infections and the formula.
The new report also found that the FDA took 102 days to inspect the factory after receiving another complaint from a whistleblower in October 2021. During that time, the agency received two complaints — one of illness and one of death — among infants who consumed formula from the factory, but samples of the formula were negative for cronobacter, the bacterium in question.
In a statement, the FDA said it agrees with the inspector general’s findings. In its 2022 report the agency recognized that its response was slowed by delays in processing whistleblower complaints and factory test samples.
“It should be noted that the OIG assessment represents a snapshot in time, and FDA continues to make progress,” an FDA spokesperson said.
The FDA has created a “critical food investigator specialization that will focus exclusively on the inspection and oversight of the production of infant formula (and other critical foods),” the spokesperson said. The FDA said it has also begun improving ways to track printed mail that may include complaints.
Dr. Steven Abrams, a professor of pediatrics at the University of Texas at Austin, said he agrees with the report’s recommendations, which include that Congress should give the FDA the authority to require manufacturers to report any tests showing contamination of infant formula, even if the product does not contain pollution. I’m not leaving the factory.
“As with everything else, mistakes were made. But the government is working very hard, including the FDA. This closes existing gaps,” Abrams said. “People need to be confident that powdered infant formula is safe.”