A top official at the Food and Drug Administration (FDA) said in an interview published Wednesday that he did not see a whistleblower’s complaint regarding Abbott baby formula until four months after it had been sent.
“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Frank Yiannas, the deputy commissioner for food policy and response at the FDA, said to The Washington 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.”
The report was made by a former quality assurance worker who sent out their report in October and alleged that Abbott had removed some baby formula from its distribution after learning that microorganisms had been positively tested for in a batch of baby formula, according to the Post.
However, other batches of baby formula that did not undergo additional testing had been released for distribution, according to the whistleblower. Management at Abbott were reportedly nervous that an FDA inspection at a facility of theirs in Sturgis, Mich., in 2019 would raise concerns about the issue.
“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas told the newspaper. “Those are going to be some of the tough questions that will have to be answered.”
Yiannas later ended the conversation with the newspaper after claiming he did not know he was speaking with a reporter, though the Post noted that a voicemail had been left that included the nature of their story, the reporter’s name and position.
The Post also noted that the FDA had conducted an inspection of the Michigan facility in 2019, in which inspectors found that formula produced there had not undergone adequate pathogen testing and that cronobacter, a deadly pathogen, had been found in the finished products.
The newspaper noted that the agency did not return to the plant until 2021, and that the Abbott plant had not been issued any restrictions following the 2019 inspection.
In February, Abbott said several of its baby formulas were being recalled following the hospitalization of four babies who had used Abbott’s products.
An FDA spokeswoman told the Post the agency’s response to the baby formula shortage would be discussed by FDA Commissioner Robert Califf and declined to comment on Yiannas’s assertion that he had not received the whistleblower report until months later.
The FDA also said in a statement that “mission-critical inspections when possible were made on a case-by-case basis. … We can confirm that during the pandemic, the agency conducted a number of inspections of powdered infant formula manufacturers.”
Abbott told the Post in a statement that there was “no conclusive evidence” that its Michigan plant was tied to the contamination. The company also claimed that the whistleblower was a former employee of their who had been dismissed.
“This former employee was dismissed due to serious violations of Abbott’s food safety policies. After dismissal, the former employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities,” Vicky Assardo, a spokesperson for Abbott, said in a statement to the Post. “Abbott is reviewing this new document and will thoroughly investigate any new allegations.”
The Hill has reached out to the FDA and Abbott for comment.
