The FDA has lost a lawsuit over unsanitary conditions in the baby formula industry for a year, auditors have revealed.
The US Food and Drug Administration took more than 15 months to act on a complaint it received about conditions at an Abbott Nutrition factory that was at the center of infant formula shortages across the country, a new study says.
The Department of Labor received the email and three days later forwarded it to the FDA’s address specifically for such complaints. But one of the few employees charged with managing the FDA’s inbox at the time “archived” the email in February 2021, and it wasn’t found until a reporter requested it in June 2022.
The episode is one of several that led the Health and Human Services Department’s Office of Inspector General to conclude in a report Thursday that the FDA’s policies and procedures for dealing with problems at the Abbott plant were inadequate.
The FDA took some steps and conducted follow-up tests but “more could have been done that led to the recall of Abbott powdered infant formula,” the auditors wrote. The FDA needs better policies for reporting the status of complaints to senior management and making sure that inspections are done quickly, the report concluded.
“The bottom line is, going forward, the FDA must do better, and the American public must expect better,” Inspector General Carla Lewis said in an interview.
Several infants were hospitalized, and two died, from contracting a rare virus after being fed formula made at Abbott’s plant in Michigan, the largest in the country. The FDA shut down the site for several months starting in February 2022, and the company recalled several popular formulas including Similac, Alimentum and EleCare.
FDA inspectors eventually found dozens of violations at the plant, including bacterial contamination, leaking roofs and strict safety regulations, but the agency found no direct link between the illnesses and the formula.
The new report also found that it took 102 days for the FDA to inspect the factory after receiving a separate complaint in October 2021. During that time, the agency received two complaints — one of illness and one of death — among children who ate the food. formula from the plant, but samples of the formula were negative for cronobacter, the bacteria in question.
The FDA said in a statement that it agrees with the inspector general’s conclusions. In its 2022 report, the agency admitted that its response was slowed by delays in processing the inspector’s complaint and factory inspection samples.
“It should be noted that the OIG’s review represents a snapshot in time, and the FDA continues to develop,” an FDA spokesperson said.
The FDA has established a “group of key food investigators, which will focus exclusively on the inspection and management of the infant formula (and other key foods) industry,” a spokesperson said. It also began improving how it tracks hard-copy mail items, which can trigger complaints, the FDA said.
Dr. Steven Abrams, 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 power to require manufacturers to report any tests that show contamination in infant formula, even if the product does not. leave the factory.
“Like anything else, there were mistakes made. But the government is working hard, including the FDA. To fix the gaps that were there,” said Abrams. “People should be comfortable with the safety of powdered infant formula.”
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