Today, the U.S. Food and Drug Administration 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 (Product Origin): Mead Johnson Nutrition/Reckitt (Singapore)
Product(s): Base powder to manufacture Enfamil Stage 1
Type of Formula: Finished product will be general infant formula
Estimated Quantity: 4.5 million pounds of base powder that will be used to produce about 5.7 million cans (more than 66 million full-size, 8-ounce bottles).
Availability: Base powder will begin shipping in June to a Minnesota facility for conversion to final product that will be made available in the coming weeks. Monthly follow-on shipments will continue through November. The U.S. Department of Health and Human Services is evaluating options for getting the product to the U.S. as quickly as possible.
More Information and Where to Find the Products: The finished product would be used to meet contractual obligations under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program.
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.
The FDA issued guidance on May 16 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to increase further the quantity of domestically produced product for the U.S. market. The agency has posted a webpage that will be updated with information about additional products headed to the U.S.
https://www.live5news.com/prnewswire/2022/06/15/fda-infant-formula-update-june-15-2022/
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