A Federal Watchdog Will Probe the FDA’s Actions Leading Up to the Infant Formula Crisis

A federal watchdog will investigate the Food and Drug Administration's actions leading up to the nationwide baby formula shortage that has left parents scrambling.

There were already formula shortages due to the pandemic-related disruptions to the supply chain, but then that escalated greatly after a plant from one of the largest formula manufacturers in the country (Abbott) was closed in February and several brands of its formula were recalled. The lead up and response to this crisis by industry and federal officials has come under intense scrutiny. 

“As part of its oversight activities, FDA conducts inspections at infant formula manufacturers and can require infant formula manufacturers to recall adulterated infant formula that presents a risk to human health,” said a new posting on the Health and Human Services Department inspector general website. “We will determine whether [the] FDA followed the inspections and recall process for infant formula in accordance with federal requirements.” 

The watchdog will specifically look at “FDA's actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott's initiation of the infant formula recall,” said the post. The report is expected to be released in fiscal 2023, which starts on Oct. 1. 

In March, Rep. Rosa DeLauro, D-Conn., chairwoman of the House Appropriations Committee, requested an investigation into the FDA’s handling of the formula recall and she applauded the IG’s announcement.  

“Let me be clear – we will get to the bottom of what went wrong and we will not allow anyone to skirt accountability,” DeLauro said in a statement. “I hope the [Office of Inspector General] moves speedily to uncover answers so that we can prevent this crisis from potentially happening again.”

Yvonne Gamble, HHS IG office spokesperson, told Government Executive, “There was broad congressional interest in the recall and FDA's response” and the IG office is “conducting this review as part of our oversight of HHS programs to ensure their compliance with federal regulations.” 

A FDA spokesperson said that the agency will "fully cooperate" with the review.  "If [the HHS inspector general] identifies any actionable items and provides the agency with any recommendations, the FDA will review [them] expeditiously to determine the best course of action," said the spokesperson. "In the interim, the FDA has initiated its own review of the actions around the investigation into Abbott’s Sturgis, Michigan [plant], as well as the associated response so that we can make improvements to our programs, processes and decision making."

The spokesperson added that the FDA takes its responsibility on food safety, including formula, "very seriously" and "companies are expected to meet our rigorous standards, which include ensuring the consistent quality and safety of the products they produce."

Abbott did not immediately respond for comment.

FDA Commissioner Dr. Robert Califf testified before Congress twice last week about the shortage. He laid out a timeline for the FDA’s actions and admitted that some of them, such as interviewing the whistleblower who raised concerns in October 2021 alleging a range of sanitary issues at the Abbott plant, were “too slow and some decisions in retrospect could have been more optimal.” He blamed mailroom issues for FDA leadership not receiving the report sooner. 

Also, Califf and Abbott gave “conflicting” accounts of when the Michigan facility will reopen, as Politico reported. 

Nevertheless, the White House and federal agencies have been taking action to mitigate the effects of the shortage, such as by invoking the Defense Production Act, the FDA increasing its flexibilities to import formula, launching Operation Fly Formula to bring formula into the United States from abroad and HHS launching a new webpage for parents and caregivers to find formula options. 

Additionally, President Biden enacted a bill last month to ensure that families can continue using their Special Supplemental Nutrition Program for Women, Infants, and Children or “WIC” benefits amid a public health crisis or supply chain issues to purchase baby formula, among other measures. The House also passed a bill to provide the FDA with $28 million in emergency appropriations to address the shortage and prevent future ones, but the Senate has yet to take that up. 

Biden said on Wednesday he didn’t become aware how serious this issue was until April, which was well after the formula manufacturers knew. “We did everything in our power from that point on,” said the president. “And we’re going to continue to do it until we get the job done.”

This article has been updated with comment from the FDA.