The U.S. Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. This type of specialized medical infant formula is currently in short supply in the U.S.
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“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,” said FDA Commissioner Robert M. Califf, M.D. “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 formula manufactured by Danone’s Nutricia business will be headed to the U.S. These Neocate amino acid-based formula products — some of which are already manufactured for the U.S. market and are made at facilities in Europe — amounts to more than 5 million full-size, 8-ounce bottles.
The U.S. Department of Health and Human Services and Danone continue to partner to evaluate options for getting the products to the U.S. as quickly as possible. The specialized medical formula is expected to be distributed through direct ordering, hospitals, health care professionals, pharmacies, healthcare product distributors and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) local access points to ensure they get to the infants who rely on these products.
The FDA has been working with Danone’s Nutricia business over the past several months to boost production of these products at its facilities and to identify additional supply of other infant formula products moving forward.
The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it.