Months before contaminated baby formula led to the death of two infants, a whistleblower contacted the U.S. Food and Drug Administration (FDA) with concerns about safety violations at the formula’s manufacturing plant, according to reporting by Politico. The FDA’s slow response to the whistleblower’s allegations has drawn a rebuke from members of Congress.
The whistleblower, a former employee at an Abbott Nutrition infant formula plant in Michigan, sent a 34-page document to FDA officials in October 2021 outlining “allegations of lax cleaning practices, purposely falsified records and efforts by plant officials to keep FDA from learning about serious issues related to the plant’s own system for checking for bacteria in formula,” Politico reports.
According to Politico, the whistleblower, who claims they were fired for raising safety concerns internally, “described a plant where current and former employees are ‘fearful of retaliation.’” Allegations made by the whistleblower in the document sent to the FDA include “that plant officials ‘knowingly’ falsified records on a number of occasions,” “that the Sturgis plant had ‘ongoing problems’ with ensuring that its powdered formula cans were fully sealed,” and that “[i]nstead of addressing the problem head on, there were instances in which employees altered the plant’s testing process so that empty cans were tested instead of sealed cans containing the product,” Politico reports.
House Appropriations Committee Chair Rosa DeLauro (D-CT) spoke about the whistleblower’s report on April 28 at the Agriculture Appropriations Subcommittee hearing on the fiscal year 2023 budget request for the United States Department of Agriculture. According to DeLauro, the FDA did not interview the whistleblower until late December 2021, two months after receiving the report, and the agency did not inspect the plant until January 31, 2022.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility,” DeLauro said. “I am equally concerned that the FDA reacted far too slowly to this report.”
“In light of everything we know, it’s outrageous that the FDA failed to quickly take action to protect babies from contaminated formula,” said Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, in a statement. “I’ve been demanding answers from Abbott and calling on the FDA to address its longstanding food safety failures—because families across the country deserve to know they can feed their children without fear that their formula or food might seriously sicken them. These latest revelations make this push all the more urgent—and I won’t rest until we get to the bottom of this.”
“We know there have been questions about the timeline related to the Abbott Nutrition infant formula recall,” a FDA spokesperson told Politico. “However, this remains an open investigation with many moving parts. Our top priority is ensuring that any recalled product produced at the Sturgis, Mich. facility has been removed from the market. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.”