The Food and Drug Administration (FDA) had a whistleblower report about a major baby formula plant in Michigan for months before the national shortage reached its peak, but top officials at the agency didn’t get access to it, according to The Washington Post.
Before the FDA instigated a voluntary recall of formula and shutdown of Abbott’s Sturgis, Michigan, plant Feb. 17, a whistleblower sent a 34-page report to the agency in October alleging that the facility was riddled with health and safety concerns that could compromise the health of babies. The top food safety official at the FDA, Frank Yiannas, told the Post he didn’t learn about the complaint for four months.
This is likely the tip of the iceberg and deserves more inquiry and frank regulatory reform.
Whistleblower report on baby formula didn’t reach top FDA food safety official https://t.co/fq08oSpvHW
— Kavita Patel M.D. (@kavitapmd) May 25, 2022
“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Yiannas told the Post. “There were early signals and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”
One infant died and two others were hospitalized before Yiannas, formerly the head of Walmart’s food safety program, saw the whistleblower report, according to the Post. The two food safety divisions at the FDA don’t report directly to Yiannas, the agency’s deputy commissioner for food policy and response. They report to the commissioner of the entire agency, who until Feb. 17 was acting commissioner Janet Woodcock. Dr. Robert Califf now holds the position. (RELATED: REPORT: FDA Seizes Baby Formula From Europe As Biden Claims Victory Over Imports)
Yiannas apparently hung up on a Washington Post reporter and claimed he did not know he was talking to a journalist, even after the reporter gave him their name, title and the nature of the story they were working on, and Yiannas referred to them by name multiple times, according to the Post. An FDA spokesman said the agency will conduct a thorough review of its protocols once the immediate public safety issue is resolved.
Abbott continues to insist there is no confirmed connection between its product and the sickness of children who drank its formula. The company and the FDA recently reached an agreement to re-start formula production at the Sturgis facility.