Heinrich, Brown, and Casey Call on the FDA to Take Action to Prevent Another Infant Formula Shortage
WASHINGTON - U.S. Senators Martin Heinrich (D-N.M.), Chair of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Sherrod Brown (D-Ohio), and Bob Casey (D-Pa.) called on the Food and Drug Administration (FDA) to take action to prevent another infant formula shortage. In a letter to FDA Commissioner Dr. Robert Califf, Heinrich and colleagues urged the agency to ensure that production levels for domestic infant formula remains constant, and that store shelves continue to be stocked.
As the FDA continues to respond to the formula shortage of 2022, many questions remain on how the FDA is continuing to address this issue.
“It is imperative that we continue to address the nation’s infant formula crisis by meaningfully improving the quality and safety of the U.S. infant formula factory network in order to ensure the health and safety of American infants,” the senators wrote.
In May 2022, following multiple reports of illness and two tragic deaths linked to recalled infant formula manufactured by Abbott Nutrition, Heinrich joined 30 of his colleagues in sending a letter to President Joe Biden urging him to immediately assign a coordinator within the White House to address the infant formula shortage. The senators additionally called for the President to implement a national strategy to increase the resiliency of the infant formula supply chain and protect against future contamination and shortages.
Heinrich also helped to pass into law the Access to Baby Formula Act to ensure that families who rely on the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) were provided the baby formula they needed.
As the Food and Drug Administration (FDA) works with U.S. infant formula manufacturers to make much-needed improvements to aging factories, we write to you today to call on the FDA to ensure that production levels for domestic infant formula remains constant, and that store shelves continue to be stocked.
It is imperative that we continue to address the nation’s infant formula crisis by meaningfully improving the quality and safety of the U.S. infant formula factory network in order to ensure the health and safety of American infants. As a response to the shortage in 2022, Congress passed several laws directing the FDA to enhance its oversight of the domestic infant formula market. We applaud the agency’s work to implement these laws, including increasing inspections and directing companies to make much-needed improvements to factory conditions that resulted in the shortage.
Infant formula is the sole source of nutrition for many infants, and it is critical that the FDA incorporate lessons learned from the 2022 shortage to implement further improvements and ensure stable domestic production levels of infant formula.
As we head toward the end of Fiscal Year 2023, we write to request the following information:
What strategies has the FDA put in place—or will be putting in place— to ensure that infant formula production numbers remain stable as factory improvements are made?
Has the FDA been alerted to potential shortfalls in production by any domestic infant formula manufacturers due to manufacturing enhancements required by the new regulations?
What processes has the FDA put in place to ensure that the agency is made aware of production slowdowns due to product shortages?
How is the FDA engaging with infant formula manufacturers about ways to increase production to compensate for shortfalls?
What actions will FDA take to ensure expeditious review of any new or increased domestic manufacturing options, while ensuring the additional safeguards are being met?
If there is a government shutdown, can you ensure there will be no delay or stand-still of any FDA approvals that will impact the availability of infant formula?
Are there any domestic infant formula factories in operation that meet the new guidelines?
We request a briefing for our staffs to discuss these important questions no later than October 6, 2023. Please contact Kimberly Lattimore and Sara Maskornick to arrange the briefing.