Whistleblower report on baby formula didn’t reach top FDA food safety official

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When a whistleblower sent a 34-page report to the Food and Drug Administration in October alleging a host of unsanitary conditions at an Abbott infant formula factory, the top official in charge of food safety didn’t see it.

In fact, Frank Yiannas, the FDA’s deputy commissioner for food policy and response, didn’t learn about the complaint until four months later, according to Yiannas and others knowledgeable about the case.

By that time, one infant had already died and two others were hospitalized after consuming formula from the plant — all while other top FDA officials less-versed in food safety had elected not to send new inspectors to the plant in Sturgis, Mich. As another infant death was linked to Abbott-produced formula, the plant closed down and a recall was issued, sparking a critical national shortage of baby formula.

FDA commissioner testifies to Congress on baby formula crisis: Follow the hearing here

“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Yiannas, who previously ran the food safety program for Walmart, the nation’s largest grocer, told 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 national fallout over the Abbott case has exposed a fractured structure at an agency that has long prioritized drugs and medicine over food safety, experts say — a problem exemplified by its handling of the whistleblower complaint and other warning signs of problems at the plant.

On May 22, experts explained how a special military operation is helping to relieve the U.S. baby formula shortage. (Video: Blair Guild/The Washington Post)

Neither of FDA’s food policy divisions have to report to Yiannas and neither do the agency’s food safety inspectors. Instead, they report directly to FDA Commissioner Robert M. Califf, a physician who was appointed to the top post on Feb. 17, the day Abbott recalled many of its powdered products. Before Califf was appointed, food safety problems were reported directly to Principal Deputy Commissioner Janet Woodcock, another physician who was acting commissioner when the whistleblower complaint arrived.

“The essential thing is that you’ve got three major operating components that are reporting only to the [FDA] commissioner, who, by tradition and current reality is a physician who is focused on medical products and doesn’t have the bandwidth or the inclination to spend time providing the leadership that’s needed for the food program to be successful,” said Michael R. Taylor, who was deputy commissioner for foods and veterinary medicine during the Obama administration.

On Wednesday, two House committees will hold separate hearings to investigate the agency’s actions in the Abbott case as well as whether there are deeper structural problems in the agency.

“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas said. “Those are going to be some of the tough questions that will have to be answered.”

Yiannas spoke to The Post after calling back a reporter who stated their name, title and the nature of the story in a voice mail; after repeatedly addressing the reporter by name, Yiannas later terminated the conversation and claimed he did not realize he was speaking to a journalist.

In a statement on Tuesday, an FDA spokeswoman declined to comment on Yiannas’s claim about a lag of months in learning of the whistleblower’s report. She said that Califf will testify in the hearings about the agency’s response to the formula crisis.

“Once the immediate public health risk is minimized, the FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses and recalls,” the spokeswoman wrote.

Abbott said there is not clear evidence that the contamination affecting babies originated at its plant. “After a review of all available data, there is no conclusive evidence to link Abbott’s formulas to these infant illnesses,” the company said in a statement.

Organizations representing consumers, the food industry and state food regulators are pushing to restructure the FDA. In April, the groups sent a letter to Califf, calling on him to unify the entire FDA food program under Yiannas and to maintain that structure with his successors.

Meanwhile, Yiannas said he continues to be cut out of the FDA’s oversight of the Abbott facility. He began work on a corrective action plan for Abbott in February, but said he was told to “stand down” by Woodcock.

The FDA disputed that Woodcock gave such an order, and also Yiannas’s claim that he hasn’t been given oversight of the facility’s reopening process. The agency said he is managing an agencywide group working to address the formula crisis.

Lawmakers have expressed concern at Woodcock’s role in the FDA as it works with Abbott to address the safety issues to reopen its plant. Rep. Rosa L. DeLauro (D-Conn.) in a hearing called Woodcock — who received the whistleblower complaint and was heading the agency as officials failed to act on it for months — a “fox in the hen house” and said it appeared she was playing a leading position in the Abbott plant review. (The FDA also disputes that Woodcock is overseeing efforts to reopen the plant.)

Tom Neltner, chemicals policy director for the Environmental Defense Fund, who has been working with the agency to eliminate heavy metals from baby foods, said the national formula shortage has been exacerbated because the agency has given authority to officials without training and firsthand experience in the food industry.

“The FDA’s delays on inspection and acting on the whistleblower complaint made the recall so much worse,” he said of the shortage. “They didn’t understand that the Sturgis facility was such a dominant source and that they would need to backfill formula from other sources.”

The Sturgis plant has experienced food safety problems in the past. In September 2010, the company issued a recall of some of its Similac powered infant formula after beetles and beetle larvae were found in the finished formula, which was produced at the plant.

The following month, FDA went into the plant to investigate and cited the company for several food safety violations and a “failure to manufacture foods under conditions and controls necessary to minimize contamination,” public records from the agency show.

After that, the Abbott facility passed annual inspections for nearly a decade without any serious food safety findings, agency records show.

That changed in 2019. During a routine inspection that year, FDA inspectors learned that Abbott had found the potentially deadly pathogen cronobacter in its finished products. They also discovered plant workers were doing inadequate pathogen testing of formula produced at the plant.

“You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards,” the report read.

Inspectors also found the company had received at least 10 complaints from nurses and parents who believed Abbott’s products were making infants sick. One complaint came from a pediatric nurse who said five babies had consumed Similac Sensitive Infant Formula and that “all babies were projectile vomiting,” records show.

In another instance, involving three different Abbott formulas, records show an infant had a seizure and was diagnosed with a bacterial infection from a strain of the cronobacter pathogen.

The children recovered and, in each case, the company said it investigated and determined their products were not responsible, records show.

Despite these findings, FDA did not issue any restrictions on the plant and closed out the investigation. Inspectors did not return to the plant for two years, records show, and the agency cited the pandemic and the risk of spreading the coronavirus as one of the reasons.

In a statement, the FDA noted 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.”

But not at Abbott’s Sturgis facility.

“When you look at the inspection reports, you see FDA not being there during covid, even though they had found serious problems before. That seems crazy, especially for infant formula.” said Bill Marler, a food poisoning attorney who is well known for helping shape federal food safety laws and policies.

Although the FDA is understaffed in its inspection ranks, during the height of the pandemic, the absence of inspectors in food plants was a matter of…

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