FDA has given Mead Johnson the green light to import infant formula powder from its facility in Tuas, Singapore.
Mead Johnson has the go-ahead to import 4.5 million pounds of base powder under an FDA policy of enforcement discretion announced in May to help mitigate the shortage of baby formula in the U.S.
The powder will be used to manufacture around 5.7 million cans, or more than 66 million full-size, 8-ounce bottles, FDA said in a June 15 news release. Base powder will begin shipping this month to a facility in Minnesota for conversion to final product that will be made available in the coming weeks, according to the release. FDA said more monthly shipments will continue through November.
The additional supply of infant formula reflects the largest contribution to date from a manufacturer in solving the U.S. shortage, according to Mead Johnson, which is owned by Reckitt Benckiser Group plc (Reckitt). Pat Sly, president of Reckitt’s nutrition business, praised FDA for a decision that will enable Reckitt to feed, on average, more than 130,000 additional babies per month.
FDA last month issued guidance that outlined a process by which it would not object to the importation of certain infant formula products.
“We appreciate the action taken by the administration and the commitment to ensuring the high safety and quality standards of infant formula in the United States,” Sly said in a news release. “We are thankful for the support from the government, our supply chain partners and employees globally, who have stepped up to enable us to take every measure we can to end this shortage as quickly as possible.”
Additional infant formula is being imported under FDA’s flexible policies. For instance, FDA said this month Nestlé would be importing formula from Germany, amounting to around 745,000 full-size, 8-ounce bottles expected to be sold online at Gerber.com. Nestlé also is importing formula from Mexico, equivalent to nearly 33 million full-size, 8-ounce bottles expected to be sold on Gerber.com and via key retailers.