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

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Aug 11, 2022, 08:00 ET

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

PARSIPPANY, N.J., Aug. 11, 2022 /PRNewswire/ -- 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:

"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."

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.

NOTES TO EDITORS:

See full FDA announcement: https://www.fda.gov/news-events/press-announcements/fda-infant-formula-update-august-10-2022
PurAmino is a brand from Mead Johnson, owned by Reckitt, the makers of Enfamil. Enfamil is the #1 trusted brand by pediatricians and consumers.
In H1, Reckitt's United States IFCN (Infant Formula and Child Nutrition) business saw a 40% increase in like-for-like net revenue.
Significant market share growth was driven by strong execution in response to increased demand in light of temporary competitor supply issues.
Total number of babies born per year in the USA is approx. 4 million
About three-quarters of babies in the United States consume infant formula, either exclusively or as a supplement
All of our products are tested for quality and safety before leaving our manufacturing sites, and all of our U.S. sites undergo ongoing FDA audits to ensure quality and safety meets or exceeds the highest regulatory standards. The FDA has never interrupted a Reckitt/Mead Johnson facility over a food safety or quality concern.

About Reckitt:

Reckitt* exists to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We believe that access to the highest-quality hygiene, wellness and nourishment is a right, not a privilege.

Reckitt is the company behind some of the world's most recognisable and trusted consumer brands in hygiene, health and nutrition, including Air Wick, Calgon, Cillit Bang, Clearasil, Dettol, Durex, Enfamil, Finish, Gaviscon, Harpic, Lysol, Mortein, Mucinex, Nurofen, Nutramigen, Strepsils, Vanish, Veet, Woolite and more.

Every day, more than 20 million Reckitt products are bought globally. We always put consumers and people first, seek out new opportunities, strive for excellence in all that we do and build shared success with all our partners. We aim to do the right thing, always.

We are a diverse global team of c. 40,000 colleagues. We draw on our collective energy to meet our ambitions of purpose-led brands, a healthier planet and a fairer society. Find out more, or get in touch with us at www.reckitt.com

* Reckitt is the trading name of the Reckitt Benckiser group of companies

About Mead Johnson Nutrition:

Mead Johnson Nutrition was acquired by Reckitt in 2017, merging the two company's commitments to innovation and science to continue fueling advancements in pediatric nutrition. Today, the nutrition business continues to drive innovation from its Evansville, Indiana site and is trusted by parents and healthcare professionals all over the world to support developing minds and bodies. We're committed to ensuring that every baby has a healthy start.

About PurAmino

PurAmino is a hypoallergenic, iron fortified, amino acid-based infant formula for the dietary management of infants with severe cow's milk protein allergy and other food allergies. It may also be suitable for conditions such as protein maldigestion, malabsorption/chronic diarrhea, short bowel syndrome and eosinophilic esophagitis.

* Reckitt is the trading name of the Reckitt Benckiser group of companies

SOURCE Reckitt