House Oversight Committee Probes FDA’s Response to Baby Formula Shortage

Baby formula is offered for sale at a big box store in Chicago, Ill., on Jan. 13, 2022. (Scott Olson/Getty Images)

Republicans on the House Oversight and Accountability Committee are pressing the U.S. Food and Drug Administration (FDA) for information about the agency’s response to the nationwide infant formula shortage.

In a March 21 letter (pdf) to FDA Commissioner Robert Califf, Committee Chairman James Comer (R-Ky.) and Rep. Lisa McClain (R-Mich.), chair of the Subcommittee on Health Care and Financial Services, expressed concern that the agency had been “superficial” in its efforts to “bring accountability and make meaningful changes” in the wake of the shortage.

“Formula shortages began in the summer of 2021 as global supply chains were disrupted by the COVID-19 pandemic,” the lawmakers wrote. “As the administration scrambled to contain the issue, families across the nation were presented with the question of how they would feed the infants in their families and communities.

“Now, instead of removing or reassigning the individuals at fault for the poor response to this crisis, the announced restructuring of the [FDA’s] food and nutrition division simply requires certain offices and personnel to report to the newly created position of Deputy Commissioner for Human Foods.”

In January, the FDA proposed a restructuring of its Human Foods Program, citing an outside evaluation performed by the Reagan-Udall Foundation for the FDA as evidence of a need for a “more robust regulatory program.”

Specifically, the December report (pdf) found that a “lack of communication and engagement” across the agency had led to “missteps” in the agency’s response to the formula shortage.

“While it appears that staff at all levels sought to follow the rules and procedures within their division, there was little motivation, and apparently no requirement, to share information and interact across the agency to facilitate critical thinking and proactive decision-making,” the report states. “This is especially problematic in a crisis, where decisions should be made quickly and be vetted properly.”

Yet despite those findings, Comer and McClain noted on Tuesday that the FDA had confirmed there would be no staff reassignments or firings over the administration’s response to the shortage.

Requesting all FDA, Department of Human Health Services (HHS), and White House communications relating to the formula shortage and all documents regarding the agency’s internal response, the Republicans set a deadline of April 4 for the materials to be produced.

FDA Responds

Reacting to the letter on Tuesday, the FDA defended its restructuring plan and overall response to the formula shortage.

“The FDA remains committed to taking steps to implement its vision for a new FDA Human Foods Program and Office of Regulatory Affairs to support the organization as a whole with clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply,” an FDA spokesperson told The Epoch Times in an email. “This will deliver a new Human Foods Program and field force that more quickly adapts to an ever-changing and evolving food system.

Noting that the agency’s proposed approach was developed with the feedback of the external reviewers, stakeholders, and employees in mind, the spokesperson asserted that the new deputy commissioner role “unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way.”

As for the safety of infant formula, the FDA will soon release its “Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market,” which will include the details of the immediate actions that were taken to address the shortage and other areas for improvement outside of the agency.

“In addition, the FDA has developed a prevention strategy outline to address Cronobacter in powdered infant formula and has sent a call to action to industry to improve food safety practices,” the spokesperson added. “The FDA’s regulatory mission for infant formula regulation is to ensure infant formulas are safe and nutritious, and we are maximizing how we can use these tools to encourage redundancy in the market. Industry, stakeholders, and federal partners also have important roles to play when it comes to infant formula supply chains and resiliency in the market.”

A Subcommittee on Health Care and Financial Services hearing on the FDA’s formula shortage response has been scheduled for March 28, during which committee members will question witness Frank Yiannas, former FDA deputy commissioner of Food Policy and Response.

“Now, more than a year after this crisis began, the Biden administration continues to fail parents and caretakers across the country as they are still struggling to find infant formula to feed their babies, with no end in sight,” McClain said in a statement.

“American families deserve answers as to why the Food and Drug Administration and the Biden administration ignored watchdog warnings for months, ultimately making the crisis worse. We are going to conduct oversight of the FDA and be sure we take steps to prevent another avoidable crisis like this from happening again.”