Murray, Casey Demand Answers Following Abbott Recall of Contaminated Infant Formula

Abbott announced a recall last week after contaminated powder infant formulas led to multiple hospitalizations, one death

Company received complaints related to the contaminated formula products as early as September 2021

Senators: “It is completely unacceptable that manufacturing conditions allowed a contaminated product to reach babies, and that it took months for the company to act to warn parents and caregivers about this danger.”

(Washington, D.C.) – Yesterday, Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Senator Bob Casey (D-PA), Chair of the Subcommittee on Children and Families sent a letter to Robert B. Ford, Chairman and CEO of Abbott, demanding answers about the company’s response to dangerous bacterial contamination of several of its powder infant formula products. The company announced a recall of three infant formulas last week after contaminated products had led to multiple hospitalizations—dating back as early as September 2021—and one death.

“It is completely unacceptable that manufacturing conditions allowed a contaminated product to reach babies, and that it took months for the company to act to warn parents and caregivers about this danger,” wrote the Senators.

“Formula is a critical source of nutrition for newborns and infants. It is particularly disappointing that you would describe the past year as ‘outstanding’ for Abbott when there are such serious outstanding safety concerns,” continued the Senators. “We want to ensure that no corners are being cut when it comes to infant and newborn safety. We demand assurances that your company is taking every effort to work with its state, federal, and global partners to protect any additional children from illness and to ensure parents and caregivers have the information they need—and we remain deeply troubled that this highly vulnerable population was ever placed at risk.”

In the letter, the Senators expressed particular concern that it took the company months after the initial complaint to take public action to protect families from contaminated products. They demanded Abbott provide internal documents that would shed light on its efforts to address the risk posed to families by contaminated infant formula products.

Full text of the letter below, and PDF available HERE:

February 24, 2022

Robert B. Ford
Chairman of the Board and Chief Executive Officer
Abbott
100 Abbott Park Road
Abbott Park, IL 60064

Dear Mr. Ford:

Last week, Abbott made public that contaminated powder infant formulas manufactured at its Sturgis, Michigan plant have led to multiple infant hospitalizations and one death. While the voluntary recall of three types of formula—Similac, Alimentum, and EleCare—is a critical step to ensuring additional children do not become sickened by these products, we are incredibly concerned that the company received complaints as early as September 2021 but only took public action last week. It is completely unacceptable that manufacturing conditions allowed a contaminated product to reach babies, and that it took months for the company to act to warn parents and caregivers about this danger. We demand answers.

According to press reports, the Minnesota Department of Health began investigating a case of an infant infected with Cronobacter sakazakii in September 2021.^[1] The baby was hospitalized for 22 days. The investigation revealed the infant had been fed with formula produced at Abbott’s Sturgis facility. The Minnesota Department of Health shared this information with the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) at the time. Abbott also confirmed it received a complaint the same month.

Abbott and FDA received additional complaints of infant illness in the subsequent months. FDA has now confirmed four complaints from Minnesota, Ohio, and Texas of Cronobacter sakazakii and one report of Salmonella Newport infection from products manufactured at the facility.^[2] All four infants were hospitalized, and one infant with Cronobacter died.

FDA began a facility inspection on January 31, 2022 and found Cronobacter sakazakii in several samples taken at the plant.^[3] The inspectors also identified records showing additional evidence of bacteria at the plant and previous destruction of contaminated product. On February 17, 2022, Abbott initiated a voluntary recall of powder formulas manufactured under the Similac, Alimentum, and EleCare labels at the Sturgis plant.^[4] The company has not yet identified how many units are being recalled or where they might have been shipped, but FDA identified 36 countries and territories where the recalled products were distributed.^[5]

Formula is a critical source of nutrition for newborns and infants. It is particularly disappointing that you would describe the past year as “outstanding” for Abbott when there are such serious outstanding safety concerns. ^[6] We want to ensure that no corners are being cut when it comes to infant and newborn safety. We demand assurances that your company is taking every effort to work with its state, federal, and global partners to protect any additional children from illness and to ensure parents and caregivers have the information they need—and we remain deeply troubled that this highly vulnerable population was ever placed at risk.

Please provide the following information and documents by no later than March 10, 2022:

1. All internal documents and communications, including emails, related to consumer complaints of contamination in powder infant formula manufactured at the Sturgis, Michigan plant from 2017 to present. This should include documents and communications surrounding the September 2021 report of Cronobacter sakazakii infection in Minnesota.
    
2. All internal documents and communications, including emails, related to monitoring of environmental contamination with Cronobacter sakazakii, Salmonella Newport, or any other bacteria harmful to human health at the Sturgis, Michigan plant from 2017 to present.
    
3. All internal documents and communications, including emails, related to the destruction of product due to the presence of Cronobacter sakazakii, Salmonella Newport, or any other bacteria harmful to human health at the Sturgis, Michigan plant from 2017 to present.
    
4. All documentation from audits, investigations, and reviews conducted by Abbott or outside consultants or entities related to manufacturing practices and conditions at the Sturgis, Michigan plant from 2017 to present.

Thank you in advance for your attention to this matter. If you have any questions or would like to discuss compliance with this request, please contact Elizabeth Letter with Senator Murray’s staff at Elizabeth_Letter@help.senate.gov or Sara Maskornick with Senator Casey’s staff at Sara_Maskornick@help.senate.gov.

Sincerely,

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