Washington, D.C. – Today, U.S. Senators Bob Casey (D-PA), Sherrod Brown (D-OH), and Martin Heinrich (D-NM) sent a letter to the Food and Drug Administration (FDA) Commissioner Dr. Robert Califf urging the FDA to take action to prevent future infant formula shortages and ensure production levels for domestic infant formula remain constant and store shelves remain stocked as manufacturers begin to upgrade their production infrastructure.
“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.
Senator Casey has led the charge in the Senate to resolve the infant formula shortage and prevent future shortages. In February 2022, Casey pressed the Chairman and CEO of Abbott Laboratories, Robert B. Ford, in a letter demanding answers as to why the company took months to warn the public after an initial complaint of dangerous bacterial contamination of their powder infant formula products that led to multiple hospitalizations and one death. In April 2022, Senators Casey and Brown sent a letter to Commissioner Califf seeking information on the FDA’s actions and plans to investigate these reports and to prevent other infants from falling ill. Casey then raised alarms on a whistleblower report from inside Abbott months before the first infant deaths.
In May 2022, as it became increasingly difficult for families to access infant formula following a massive recall of contaminated infant formula from major supplier, Abbott Nutrition, Senator Casey led 30 of his colleagues in a letter to the Infant Nutrition Council of America, calling on infant formula manufacturers to make every effort possible to get parents and families the formula they need to feed their kids. Shortly after, Casey introduced the Protect Infants from Formula Shortages Act to protect families and patients who rely on infant formula by requiring manufactures to notify the FDA of potential supply disruptions and give the FDA additional tools to work with manufacturers to help prevent potential shortages. The bill advanced out of the Senate Health, Education, Labor and Pensions (HELP) Committee as a part of the bipartisan Food and Drug Administration Safety and Landmark Advancements Act (FDASLA), setting up the legislation to pass via the Fiscal Year 2023 spending bill in December.
Further, in June 2022, Casey, as Chairman of the Senate HELP Subcommittee on Children and Families, urged the Federal Trade Commission (FTC) to investigate how major retail chains may have engaged in price gouging and raised prices for specialized infant formula amid the nationwide infant formula shortage as detailed reported became public that some major retail chains and online marketplaces have, during the infant formula shortage, significantly increased prices for specialized formula products that parents and caretakers of children with special dietary needs depend on.
After Casey’s repeated urging throughout 2022, the FDA took steps to evaluate and remediate the crisis—releasing a report and a commitment to making changes, including the announcement that they had already started making changes to their processes. The agency enlisted an independent entity to recommend how they can do better in the future and further, developed a strategy to prevent foodborne illnesses from contaminated formula. Casey will keep pushing the FDA and working on policy changes to ensure that a similar shortage does not happen again. Families rely on formula, and they deserve better than what happened last year.
Full text of Senator Casey’s latest letter is below and the signed PDF is HERE.
The Honorable Robert Califf, M.D.
Commissioner
Food and Drug Administration
U.S. Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Califf:
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.
Sincerely,
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