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Press Release Published: Mar 28, 2023

McClain: FDA’s Internal Failures Led Our Nation into an Infant Formula Crisis

WASHINGTON—House Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) delivered opening remarks at today’s subcommittee hearing titled “FDA Oversight Part 1: The Infant Formula Shortage” to conduct oversight of the FDA’s response to the nationwide infant formula shortage.

Subcommittee Chairwoman McClain’s remarks as prepared for delivery are below.

Welcome to the Subcommittee on Health Care and Financial Services.

To the witnesses, thank you very much for your attendance and participation in today’s oversight hearing of the FDA’s response to the infant formula shortage.

Today we will hear from food safety experts to better understand how this crisis happened, how it could have been handled better, and determine whether the FDA is able to prevent a future crisis from occurring.

I have been outspoken in my frustration with the FDA’s response to the infant formula shortage.

The infant formula crisis underscores major problems within the FDA.

The FDA is responsible for the safety of 78 percent of the U.S. food supply.

But the FDA is not prioritizing food safety.

Instead of owning its failure, the FDA has used COVID-19 as an excuse to neglect inspections and justify poor performance.

While states like Michigan were shut down, preventing Michiganders from making a living, the federal government was paying too many of its employees to stay home and not do their jobs adequately.

How did this critical shortage happen?

Let’s go back to the beginning.

In Summer 2021, the FDA was aware of significant supply chain disruptions resulting in potential shortages of several types of infant formula.

By September 2021, the Abbott Nutrition infant formula plant in Sturgis, Michigan had not been inspected in two years.

This plant produces 20 percent of the nation’s supply of baby formula.

In October, an Abbott whistleblower submitted a 34-page complaint to the FDA outlining concerns at the Sturgis facility.

Despite this whistleblower and several reports of babies becoming sick, it took until January 31, 2022 for the FDA to begin inspecting the Sturgis plant.

A couple of weeks later, Abbott voluntarily recalled its product and voluntarily shut down its Sturgis plant.

Had the FDA or the Biden administration done anything to prepare for the closure or ensure the availability of infant formula across the country?

No, they had not.

The health of vulnerable infants—that rely on formula as a single food source—was not a priority.

Today we have more information that we didn’t have before.

We know that the FDA ignored an Abbott employee’s 34-page disclosure detailing concerns at the Sturgis plant.

We know that the FDA’s telework policies and lax approach to oversight left it unprepared to address the shortages when the Sturgis facility was shut down.

Americans are tired of the excuses like blaming COVID-19 or claiming there isn’t enough money in the budget while inspectors telework.

FDA regulators were paid to do a job but chose not to use its remote inspection authority which was specifically intended by Congress to ensure FDA could prevent this type of crisis.

They did not do their job and collected a paycheck on the backs of hard-working Americans.

Americans want accountability.

Today we are going to conduct long overdue oversight of the FDA’s response to the infant formula shortage.

We are going to determine the extent of internal failures within the FDA that led to the crisis.

We are going to discuss ways that the FDA can improve its internal controls to prevent a supply chain crisis of this magnitude from happening again.

We are also going to examine whether the FDA’s proposed restructuring will improve its ability to keep our food safe.

We owe it to parents, caregivers, and infants, to get to the bottom of what happened and prevent it from happening again.

We owe it to the families of the babies that died as a result of contaminated formula.

Thank you to our witnesses and we look forward to your testimony. 

Now I yield to Ranking Member Porter for her opening statement.