House Oversight requests interviews with 8 FDA officials regarding baby formula shortage.

The House Oversight Subcommittee Investigates Infant Formula Shortage

The House Oversight Subcommittee on Health Care and Financial Services is demanding transcribed interviews from eight top Food and Drug Administration (FDA) officials regarding the recent infant formula shortage.

“The more the Oversight Committee uncovers in our investigation into internal failures at the FDA which led our nation into an infant formula crisis, the more questions we have for the FDA,” Subcommittee Chairwoman Lisa McClain (R-MI) said.

A whistleblower filed an FDA complaint in October 2021, raising concerns about hazardous bacteria at the Abbott Laboratories plant in Michigan, which produced the majority of powdered baby formula in the U.S. Surprisingly, the FDA regulators did not respond to the complaint until December 2021, and the plant continued operating until February 2022.

In May, the subcommittee heard testimony from Susan Mayne, the director of the Center for Food Safety and Applied Nutrition at the FDA, regarding the significant delay in taking action. Mayne revealed that although the FDA had received the whistleblower’s report, it was not promptly escalated to senior leadership for appropriate measures.

During her testimony, Mayne emphasized the need for streamlining the reporting and decision-making process, as well as implementing organizational changes to enhance efficiency and effectiveness.

“We believe where there is smoke, there is fire,” McClain stated in Wednesday’s announcement. “We need to hear from more officials directly involved at the FDA about the lack of structures in place to prevent a crisis like this, and about actions that have or have not been taken to prevent a similar crisis from happening again.”

The subcommittee has reached out to several officials for interviews, including Lionel Carter, the director of the Office of Security and Emergency Management, Justin Green, the assistant commissioner for criminal investigations in the Office of Regulatory Affairs, and Andrea Lotze, the medical director for the infant formula and medical foods division.

McClain expressed frustration with the FDA’s consistent delays in providing information about the infant formula shortage to Congress. She also highlighted the need for the FDA to conduct its own independent review of the crisis.

“We are going to ensure agencies are held accountable and find solutions to better protect American families in the future,” McClain affirmed.

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