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Lawmakers: FDA delaying investigation, accountability over baby formula shortage

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U.S. House oversight lawmakers reviewing the FDA’s role in the baby formula shortage say the federal agency is dodging oversight and delaying providing answers.

Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain, R-Mich., sent a letter to the U.S. Food and Drug Administration this week asking for interviews with FDA officials to get to the bottom of the baby formula crisis that rocked the U.S. last year.

McClain argues the FDA has delayed the investigation significantly.

“The more the Oversight Committee uncovers in our investigation into internal failures at the FDA which led our nation into an infant formula crisis, the more questions we have for the FDA,” the letter said.

McClain’s Subcommittee on Health Care and Financial Services laid out several FDA failings, saying the “the FDA’s dysfunction and delay worsened the formula crisis” and that the agency “has failed to conduct an independent, objective review of the crisis.”

“Affiliated parties at the FDA have still not been held accountable,” the committee added. “Instead of removing or reassigning the individuals at fault for the poor response to this crisis, the FDA simply announced restructuring of the food and nutrition division.”

McClain pointed to previous testimony from FDA officials, saying the formula crisis “was exacerbated by dysfunction and slow responsiveness by the FDA.”

“We believe where there is smoke, there is fire,” the letter said.

The baby formula shortage sparked fear for parents beginning in 2021 and continuing into 2022 as shelves were emptied in some areas and concerns grew that the U.S. supply of formula would run out.

Stores like Walgreens and CVS Health limited how much formula consumers could purchase at one time. One estimate released in April of last year said 40% of the most popular baby formula brands were out of stock. Now, the crisis has ended but left many wondering how this happened, and who is to blame.

Many lawmakers blasted the FDA for its role in the crisis. In May of last year, U.S. Sen. Tom Cotton, R-Ark., called it a “national crisis hitting poor moms and kids the hardest.” The FDA took fire for its long list of baby formula regulations and how it forced a recall of European formula over labeling issues.

“The FDA needs to immediately step up, be transparent, explain how it will get production restarted, and give parents a timeline,” he added.

The federal government pointed to formula recalls and supply chain issues related to COVID-19.

The criticism of the FDA has been bipartisan. In a hearing in May, both Republicans and Democrats blasted the agency, saying they still do not have the answers they are seeking.

“It’s clear with today’s witness selection Republicans want to blame the FDA, and I’ll level with you: I think some of that blame is well placed,” Rep. Katie Porter, D-Calif., said at the hearing. “We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”

McClain argues the committee needs answers to make sure a crisis like this does not happen again.

“We are going to ensure agencies are held accountable and find solutions to better protect American families in the future,” McClain said.

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