Reckitt Mead Johnson receives FDA approval to import 66 million formula servings

In the midst of the United States’ ongoing infant formula shortage, yesterday, Reckitt Mead Johnson received confirmation of import approval from the US Food and Drug Administration (FDA) via an enforcement discretion letter. The company intends to import the equivalent of 66 million 8 ounce servings of base infant formula powder from its Reckitt’s Tuas, Singapore, facility between now and November 2022, or 15.5 million 8 ounce servings per month.¹

Reckitt confirmed its will be working closely with the administration and Operation Fly Formula—a partnership between the US Department of Health and Human Services, the US Department of Agriculture, the General Services Administration, and the US Department of Defense tasked with picking up overseas infant formula that meets US health and safety standards and getting it more quickly to US stores.²

This supply, according to the press release announcing the agreement, would represent the biggest contribution yet from any manufacturer to help solve the continued infant formula shortage in the United States and feed more than 130,000 additional infants per month, on average.¹

The company noted that that they will prioritize channels available to parents who qualify for the Special Supplemental Nutrition Program for Women, Infant, and Children.

"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,” said Pat Sly, president of Reckitt’s nutrition business, in the 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. The FDA's import approval, along with the Defense Production Act, assists us in drastically increasing our supply to help more formula reach store shelves and the parents who need it."

References:

1. Reckitt's Mead Johnson receives FDA approval to import 66 million servings of infant formula focusing on vulnerable consumers. Cision PR Newswire. Press release. Published June 15, 2022. Accessed June 16, 2022. https://www.prnewswire.com/news-releases/reckitts-mead-johnson-receives-fda-approval-to-import-66-million-servings-of-infant-formula-focusing-on-vulnerable-consumers-301569076.html
2. U.S. Transportation command kicks off operation fly formula. US Department of Defense. Published May 23, 2022. Accessed June 16, 2022. https://www.defense.gov/News/News-Stories/Article/Article/3040224/us-transportation-command-kicks-off-operation-fly-formula/