December 5, 2022

FDA Importing Specialized Medical Infant Formula to Increase Supply

The FDA is importing specialized medical infant formula to increase thee U.S. supply after the Abbott Nutrition plant in Sturgis, Michigan was closed when Cronobacter contamination was found. Cronobacter can cause serious and fatal infections in infants, especially those that are premature. The FDA says that millions of bottles of these formulas will be imported.

FDA Importing Specialized Medical Infant Formula to Increase Supply

FDA Commissioner Robert M. Califf, M.D. said in a statement, “We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. as quickly as possible. We continue to work closely with our U.S. government partners and domestic and international manufacturers to identify additional formula product that will be available to parents and caregivers in the weeks and months ahead. It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”

About 500,000 additional cans of specialized medical infant formula manufactured by Danone’s Nutricia business are coming. These cans will equal more than 5,000,000 full-size 8-ounce bottles. The formula will be distributed through direct orders, hospitals, healthcare professionals, pharmacies, healthcare product distributors, and Social Supplemental Nutrition Program for Woman, Infant, and Children (WIC) local access points.

The FDA has been working with Danone for several months to boost U.S. production of these products at its facilities. More infant formula suppliers are being identified.

The FDA has informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of some infant formula made under the Kendamil brand. About 2,000,000 cans of infant formula products, which translate to 50,000,000 full size 8-ounce bottles, will start appearing in U.S. store shelves in June 2022. Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch.

And the FDA is not objecting to the release of about 300,000 cans of EleCare amino acid-based infant formula that was produced at Abbott Nutrition’s Michigan facility to individuals needing urgent, life-sustaining supplies on a case-by-case basis. Those products will undergo “enhanced microbiological testing” before they are released. Other manufacturers have increased production of comparable product lines.

The FDA has created a web site to collect all of this information in one place for parents to use. It is important that all parents consult wit their pediatricians about the formulas they feed their children.

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