Reckitt Benckiser Group plc

08/11/2022 | Press release | Distributed by Public on 08/11/2022 00:06

FDA Approves Importing of PurAmino Formula to US

11 Aug 20222min read 12Views

RECKITT'S MEAD JOHNSON RECEIVES FDA APPROVAL TO IMPORT 6 MILLION SERVINGS OF SPECIALTY INFANT FORMULA TO U.S.

Shipment of PurAmino formula from Reckitt's nutrition facility in Mexico will feed some of America's most vulnerable babies

11 August, 2022 (Slough, UK) - We have received approval from the United States Food and Drug Administration (FDA) to import 150 metric tons (approx. 331,000 pounds) of infant formula base powder from Reckitt's nutrition facility in Delicias, Mexico. Once it is blended and packaged, in the United States, it will yield the equivalent of 6 million 8-oz servings of PurAmino, Mead Johnson's amino acid-based formula. This initial shipment of PurAmino will be produced in August, and is expected to be distributed immediately following the completion of Reckitt's stringent quality and safety checks in the U.S.

PurAmino specialty formula feeds infants and toddlers who cannot digest other types of formula because of a cow's milk protein allergy, multiple food allergies, or a number of gastrointestinal conditions. This PurAmino formula will be distributed primarily through hospitals and other healthcare settings to ensure access to this medically critical product for the babies who need it.

Reckitt's state-of-the-art facility in Delicias, Mexico, which has been manufacturing infant formula since 1970, is our Latin American hub, already exporting products to 15 countries. Reckitt will deliver the PurAmino by ground transport to its facility in Zeeland, Michigan where it will be packaged and distributed via Mead Johnson's existing distribution network. Pat Sly, President of Reckitt's nutrition business, commented:

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"We appreciate the continued support from the government, our supply chain partners and employees globally, who have worked together to help end this shortage as quickly as possible, with the highest standards of safety and quality. Every step we can take to increase supply and get more formula to parents is vital, and the FDA's latest import approval will help us do just that."

Pat SlyPresident of Global Nutrition at Reckitt

To date, our ongoing efforts to increase access to infant formula include:

  • Currently feeding approximately 50% of all infants in the United States
  • Securing FDA approval to import base powder from our facility in Singapore
  • Scaling up and funding air freight for August and September base powder deliveries to the United States from Singapore
  • Operating our plants 24/7
  • Streamlining our product portfolio to maximize production capacity
  • Working with the U.S. government to resolve supply chain constraints
  • Partnering with retailers to expedite orders and prioritize formula at their distribution centers to fill shelves more quickly.