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FMI: ‘Parents Should Be Confident in Feeding Infant Formula to Their Children’

Calls on FDA to affirm Abbott Nutrition facility’s compliance with Food Safety Regulations
baby and bottle
Photograph: Shutterstock

FMI–The Food Industry Association  describes itself as the “champion for feeding families and enriching lives with nutritious, safe and affordable food at retail.” So it comes as no surprise that, following the news that the Biden administration is vowing to cut red tape to help get more baby formula on shelves, FMI said the U.S. Food and Drug Administration should be doing more to assure parents that these products meet safety regulations, including the Food Safety Modernization Act.

Chicago-based Abbott Labs—which produces Similac, Alimentum and EleCare formula products and was forced to shut down its Sturgis, Mich., manufacturing plant earlier this year after reports of serious bacterial infections in four infants—said in a May 16 statement that it has agreed to enter into a consent decree with the FDA related to the Michigan plant. The decree is an agreement between FDA and Abbott on the steps necessary to resume production and maintain the facility. The company said in a statement that the decree is subject to court approval.

Attorney General Merrick Garland in a May 16 Justice Department statement said safety is a top priority. “The actions we are announcing today will help to safely increase the supply of baby formula for families,” Garland said.

“Federal laws regarding the safe manufacture of food, particularly food for infants, must be rigorously enforced,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division, in a statement. “The proposed consent decree underscores the department’s commitment to protecting our most vulnerable citizens while also ensuring access to an essential product.”

U.S. Attorney Mark Totten for the Western District of Michigan—the location where the closed Abbott facility is located—said in a May 16 statement, “Parents who feed their babies formula must have confidence these products are safe.” Totten added, “This proposed consent decree aims to protect one of our most vulnerable populations. My office is fully committed to supporting FDA and working with its partners at the Consumer Protection Branch to ensure manufacturers in our district comply with FDA’s safety regulations.”

FMI President and CEO Leslie G. Sarasin said the FDA needs to take a step further and provide assurance to American families.

“FMI is pleased that after nearly three months of investigating the Sturgis facility, FDA and Abbott Nutrition have reached an agreement to reopen the facility for production of much-needed infant formulas,” Sarasin said in a May 17 statement. “However, we urge the agency to clearly reassure consumers that Abbott has taken appropriate steps to come into compliance with food safety regulations and resume safe production so that consumer confidence in the safety of its products can be rebuilt.”

According to Datasembly out-of-stock rates for baby formula spiked to 43% nationwide for the week ending May 8 wreaking havoc on supply chain challenges causing significant impacts.

“As parents around the country can attest, and recent data from research firm IRI confirms, the plant closure and recall have significantly impacted the infant formula supply across the nation, with certain regions facing serious supply challenges,” Sarasin said.

Sarasin said powdered formula sales last month in the South Central United States are down 12.6% from a year ago, down 11.1% in the Mid-South, and down 9.8% in the Plains region. “These numbers drive home the struggles many families across the country have faced in ensuring their children remain healthy and fed,” Sarasin said.

Looking to the FDA, Sarasin said FMI strongly encourages the FDA to issue another public statement making clear that the Abbott Nutrition facility in Sturgis is in compliance with federal food safety standards and regulations, and that "parents should be confident in feeding infant formula to their children."

“Doing so will give consumers greater confidence and help alleviate parents’ confusion regarding the safety of these products once production resumes,” Sarasin said. “We look forward to continuing to work with FDA, the U.S. Department of Agriculture and our industry partners to ensure these products are safe and back on the shelves as quickly as possible. FMI members also need clear direction from FDA and Abbott via identifying marks or codes on the safe, newly produced infant formula containers.”  

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