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
Washington, D.C. – Today, U.S. Senator Bob Casey (D-PA) 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. Less than two years since a massive infant formula recall impacted families across the Nation, Casey is once again holding formula companies accountable so that parents are able to feed their children without fear of contaminated formula.
“Over the past few years, I’ve heard from so many Pennsylvania families who just want peace of mind knowing that what they’re feeding their kids is safe,” said Senator Casey. “Parents of infants with allergies have enough on their plate without the extra burden of having to constantly check to see if their formula has been recalled, or worse, having to find another formula for their kids when a recall does happen. I’m pushing for answers from Reckitt because we need accountability from formula makers that they’re doing everything in their power to make sure this never happens again.”
Over the past 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. 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 letter to Reckitt is below and the signed PDF can be found here.
January 5, 2024
Susan Sholtis
President Nutrition
Reckitt
399 Interpace Parkway
Parsippany, NJ 07054
Dear Ms. Sholtis:
I write today to express my concern over the recent recall of six batches of Nutramigen Powder, a specialty infant formula for infants with cow’s milk allergies, by Reckitt/Mead Johnson Nutrition due to potential contamination with Cronobacter sakazakii, which can cause life-threatening infections.
The recall includes six batches of Nutramigen Powder, totaling over 675,000 cans of infant formula, and the facility that produced these cans of formula remains under FDA inspection. While, fortunately, there have been no reports of illness, this news is alarming to parents and caregivers whose infants rely on this formula, and to families still reeling from the shortages and supply problems of the last two years. Further, since Nutramigen is a hypoallergenic formula, caregivers whose infants rely on Nutramigen have fewer alternatives available to them than families who purchase non-specialty formulas.
As we learned in 2022, ongoing communication directed at the families who rely on Nutramigen will be a key component of your response. Thus, I ask that you respond in writing to the following questions by January 19, 2024:
- Has the facility where the formula was produced ceased production of Nutramigen during the FDA’s inspection?
- Are there other infant formulas produced at the same facility as the recalled infant formula, and if so, will their supply be compromised in any way due to the ongoing inspection by the FDA?
- What impact will this recall have on the domestic supply of Nutramigen? Do you expect to see spot shortages, regional shortages, or shortages for WIC families in the states where you are the WIC provider?
- Is Nutramigen Powder, or other forms of Nutramigen such as ready-to-feed bottles, produced at any additional facilities? Are those facilities located in the United States or in foreign countries? If needed, do they have the ability to increase production to meet demand?
- What steps are you taking to mitigate future contamination of powdered infant formula during production and packaging?
If you have any questions about this request, please contact Sara Maskornick on my staff. I look forward to your timely response.
