The U.S. Food and Drug Administration announced the intended availability of base powder to make around 6 million bottles of specialty formula from Mexico as part of its efforts to meet the nationwide supply shortage caused by Abbott Nutrition recall.
Under the FDA’s enforcement discretion to source more infant formula to the U.S., Reckitt Nutrition/Mead Johnson Nutrition will send an initial shipment of 331 thousand pounds of base powder for PurAmino Hypoallergenic Infant Formula, i.e., amino acid-based infant formula with iron.
The initial shipment of base powder could be used to produce about 469,000 cans or about 6 million full-size, 8-ounce bottles of baby formula.
PurAmino is a hypoallergenic, iron fortified, amino acid-based infant formula used for infants and toddlers with severe cow’s milk protein allergy and other food allergies.
The PurAmino base will be produced in August, and blended and packaged in the U.S. The product is expected to be distributed immediately following this primarily through hospitals and other healthcare settings and select retail stores.
Under the FDA’s increased flexibilities, the select infant formula products are being imported to the U.S. following review of information regarding its nutritional adequacy and safety, including microbiological testing, and labeling, among others.
Last week, the U.S. Government announced the planned import of 4.3 million bottles of infant formula from New Zealand under Operation Fly Formula. The Biden Administration is sourcing two flights to transport Danone’s Aptamil Gold Plus Stage 1 infant formula in 8-ounce bottles from New Zealand to Chicago on August 8 and 11.
Biden launched Operation Fly Formula in May to speed up the import of infant formula that meets U.S. health and safety standards and stock enough product in stores as soon as possible.
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