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Legislation to give small infant formula manufacturers a boost in heavily consolidated market

New push comes after Reckitt/Mead Johnson, producer of specialty formula for infants with allergies, recalled over 675,000 cans of infant formula

Casey led the charge on accountability for formula producers during massive recall of 2022

Casey: “…we need to make sure this never happens again—there is no greater fear than not being able to feed your child.”

Washington, D.C. – Today, U.S. Senator Bob Casey (D-PA) and U.S. Representative Rosa DeLauro (D-CT-03) introduced the Infant Formula Made in America Act to create a new tax credit program to support new or expanding small U.S. infant formula producers. More than two years after a massive infant formula recall impacted families across the Nation, Casey and DeLauro are taking action to increase domestic formula production so that parents are able to feed their children without fear of contaminated formula.

“The infant formula shortage was a terrifying burden on families. Too many parents and caregivers were left tired and scared, and we need to make sure this never happens again—there is no greater fear than not being able to feed your child,” said Senator Casey. “The Infant Formula Made in America Act is a vital step in expanding the supply chain, investing in American manufacturers, and keeping infant formula on the shelves.”

“The 2022 infant formula shortage was generated because of two key issues: food safety and supply,”
said Congresswoman DeLauro. “It left families and parents scrambling to find infant formula on scarce shelves, and facing the fear that the formula they had purchased may not be safe for their baby’s consumption if they even found it. No parent should face this, and it is why I am committed to enacting policies that prevent a future shortage. While I have introduced several bills to improve food safety, we must also unravel the heavily consolidated market that greatly contributed to the 2022 shortage. The Infant Formula Made in America Act would give smaller manufacturers a boost to compete with giants in the industry and improve market diversity.”

For more than two years, Senator Casey has led the charge in the Senate to resolve the infant formula shortage and prevent future shortages. In February 2022, Casey sent a letter to Abbott 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 sent a letter to FDA 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, 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. In September 2023, Casey followed up to press the FDA to ensure production levels for domestic infant formula remain constant and store shelves remain stocked as manufacturers begin to upgrade their production infrastructure.

In January 2024, Senator Casey sent a letter to formula producer Reckitt/Mead Johnson demanding answers regarding the recent recall of Nutramigen Powder, a specialty infant formula for infants with allergies. He has since met with the company to discuss their response. 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 in 2022.

This bill creates a new tax credit program to support new or expanding small infant formula producers in the United States. This will create a secure, diversified domestic industry capable of meeting children’s and families formula needs. Small infant formula producers—those with less than $750 million in revenue—will be eligible for support to help them grow to compete in this concentrated market.

The Infant Formula Made in America Act is cosponsored by U.S. Senator Martin Heinrich (D-NM).

The legislation is endorsed by National Milk Producers Federation, CROPP Cooperative | Organic Valley, North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, Bobbie, and ByHeart.

Read more about the Infant Formula Made in America Act here.