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Four infant formula questions for FDA Commissioner Califf

By Scott Faber and Brian Ronholm

Several factors have contributed to the infant formula crisis we are witnessing now and, though the operations at Abbott Nutrition warrant scrutiny, we must look at  how failures at the Food and Drug Administration have also contributed to the crisis.

The FDA waited months to inspect the Abbott facility after learning its formula could be contaminated. And after its inspectors confirmed the contamination, the FDA waited for weeks before alerting the public.

So, when legislators hear from FDA Commissioner Robert Califf today, here are four questions we hope they will ask:

What happened to the whistleblower complaint to FDA?

A whistleblower warned the FDA in October 2021 that Abbott had falsified records, released untested formula, employed lax cleaning practices, misled auditors, failed to take corrective measures and lacked good systems for tracing potentially contaminated products. Also, while the whistleblower report was sent to some food safety leaders within the FDA, it was not shared with the deputy commissioner supposedly responsible for food policy and response.
– Who saw the complaint?
– Why did the FDA wait two months to interview the whistleblower?
– Why didn’t the FDA respond more quickly to the complaints in the whistleblower’s report? 

Why didn’t the FDA respond to other “signals” about this plant?

Abbott received 17 consumer complaints between 2019 and 2021, including 15 complaints of infants testing positive for another pathogen, and one complaint related to Cronobacter. The company also found Cronobacter in two batches of formula, the first just one day after an FDA inspection in 2019, and found Cronobacter in five other environmental samples between 2019 and 2021. Why didn’t these “signals” trigger more scrutiny from FDA inspectors?

Did the FDA’s fragmented food safety leadership contribute to delays in the FDA investigation of Abbott’s formula plant? 

In 2010, then-FDA Commissioner Margaret Hamburg created a new position, deputy commissioner for food, to oversee food programs at the agency. This position was restructured in 2017 by then-FDA Commissioner Scott Gottlieb in 2017, and oversight of FDA food programs returned to being part of a fragmented structure. But so far,  Commissioner Robert Califf has refused to make changes at the top of the agency, despite calls to do so from state and local regulators, industry representatives, consumer advocates and others. Considering that no one bothered to share the whistleblower report with the deputy commissioner, did the FDA’s fragmented food safety leadership contribute to the failure to investigate this facility? 

Why have food safety inspections gone down since the Food Safety Modernization Act  was enacted?

Despite the inspection mandate included in the Food Safety Modernization Act, or FSMA, the percentage of food facilities inspected after enactment of the reforms, in 2011, actually went down, according to the Department of Health and Human Services’ inspector general and FDA data.
– Why isn’t the FDA doing more inspections?
– Why isn’t the FDA contracting with state officials to conduct more inspections?
– Is the FSMA’s inspection mandate a ceiling or a floor?
– If Congress provided more funds, would the FDA inspect more facilities?

Scott Faber is the Senior Vice President for Government Affairs for the Environmental Working Group. 

Brian Ronholm is Director of Food Policy for Consumer Reports