The U.S. FDA is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities.
Company: Reckitt Nutrition/Mead Johnson Nutrition (Mexico)
- Product(s): Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron)
- Type of Formula: Base powder for Specialty Formula (amino acid-based formula)
- Estimated Quantity: an initial shipment of 331K pounds of base powder which will be used to produce (about 469,000 cans or about 6 million full-size, 8-ounce bottles)
- Availability: The PurAmino base will be produced in August, to then be blended and packaged in the U.S. and is expected to be distributed immediately following.
More Information and Where to Find the Products: 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 product will be distributed primarily through hospitals and other healthcare settings and select retail stores.
The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history.
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.
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