Sen. Romney Calls for Action on Shortage and Contamination of Baby Formula
U.S. Sen. Mitt Romney, R-Utah, sent a letter to the U.S. Food and Drug Administration Commissioner Robert Califf and U.S. Department of Agriculture Secretary Tom Vilsack on Tuesday, requesting better protections for infant health and to address the nationwide shortage of infant formula.
According to Romney, there were four adverse events and two deaths associated with Abbott Nutrition powdered infant formulas manufactured at a facility in Sturgis, Michigan.
A bacteria known as Cronobacter, which can be deadly for infants, was discovered at the facility during inspections that occurred from January 2022 to March 2022, and is said to have contributed to the deaths.
The FDA documented instances of the contamination in September 2021, and failed to provide adequate sample testing to prove that the formula products met microbiological quality standards in 2019.
“This documentation suggests FDA’s routine inspection authority is insufficient to meet consumer safety demands, yet its hammer of near-shutdowns of facilities causes a ripple effect throughout the country,” writes Romney in the letter.
The ripple effect, according to Romney, is that there are concerns about baby formula shortages due to the shutdown of the Sturgis facility.
According to Romney, several chain retailers are limiting the number of products per purchase to manage inventory and desperate families are facing skyrocketing costs through third-party sellers.
Adding to the complications, infants can also develop allergies or sensitivities from changing formulas and some infants require specific formulas based on health conditions.
Romney urges the FDA and the USDA to develop a cost-benefit analysis to compare protecting consumers from potentially contaminated products to the dangers of a lack of supply.
He recommends a comprehensive update on the progress of the investigation and a detailed analysis of how the FDA analyzes consumer complaints.
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