Consumer Reports says HHS audit highlights the importance of FDA’s efforts to reorganize its food safety program
WASHINGTON, D.C. – A new report issued today by the Inspector General of Health and Human Services found that the Food and Drug Administration lacked the necessary policies and procedures to respond effectively to whistleblower complaints about contaminated infant formula that triggered a national shortage in 2022. The FDA’s slow response to the infant formula crisis exposed longstanding problems with the agency and highlighted the urgent need for it to implement its plan to revamp its food safety program, according to Consumer Reports.
“The Inspector General’s report confirms what we’ve known for years about how the FDA’s structure has interfered with its ability to ensure our food is safe,” said Brian Ronholm, director of food policy at Consumer Reports. “The problems highlighted by the infant formula crisis have plagued the FDA for years and have hampered its ability to protect the public on a whole host of food safety issues.
Ronholm continued, “Fortunately, the FDA has begun making the kinds of changes that can help avoid a recurrence of the infant formula debacle, although significant work remains to be done. We look forward to continuing to work with the FDA to ensure its plan to reorganize its human foods program is implemented effectively so that it can carry out its critical mission to protect the public from food safety risks.”
Last week, the FDA’s plan to reorganize its human foods program secured final approval and implementation is set to begin on October 1.
The Inspector General’s report notes that the FDA did not have policies and procedures in place to identify infant formula risks and respond to complaints. As a result, it took more than 15 months to address a whistleblower complaint submitted by a worker at an Abbott infant formula facility in February 2021. FDA staff did not refer a subsequent October 2021 whistleblower complaint to senior leadership until four months after it was received.
The report found that the FDA did not have established timeframes for initiating “mission critical inspections.” As a result, one inspection was started 102 days after a whistleblower complaint was received. Making matters worse, FDA did not have sufficient policies and procedures in place to initiate an infant formula recall.