Enough Nestlé baby formula to make 6.5 million bottles headed to the U.S., FDA says

Enough baby formula to make 6.5 million, 8-ounce bottles are headed to the U.S. from Nestlé in Germany, the U.S. Food and Drug Administration said today.

The 249,500 cans of Nestlé NAN Supreme Pro 1 and Nestlé NAN Supreme Pro 2 are expected to arrive in the U.S. in June and July the FDA said.

“The U.S. Department of Health and Human Services is evaluating options for getting the products to the U.S. as quickly as possible.”

The FDA said the baby formula will be offered for sale on Gerber.com and through other online retailers.

The FDA has been exercising “enforcement discretion” to import baby formula in order to address the critical shortage in the United States.

“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.”

President Joe Biden was expected to meet yesterday with baby formula manufacturers including ByHeart, Bubs Australia, Reckitt, Perrigo and Gerber, according to the Associated Press.

“The meeting is expected to provide an update on what the administration has dubbed Operation Fly Formula to import formula from overseas into the U.S. and deploy the Korean War-era production law to require suppliers of the formula manufacturers to prioritize their orders in a bid to ease any production bottlenecks,” the Associated Press reported.

The FDA maintains a list of companies that have received enforcement discretion with respect to baby formula.

On May 27, the FDA said Bubs Australia would be providing at least 1.25 million cans of formula to the United States.

The day before that, the agency reported that Danone’s Nutricia in the U.K. would be sending about 500,000 additional cans of specialized medical formula … “These Neocate amino acid-based formula products — some of which are already manufactured for the U.S. market and are made at facilities in Europe — amounts to more than 5 million full-size, 8-ounce bottles.”

The FDA also has been working with Abbott Nutrition to reopen its Sturgis, Michigan, plant, after it was shuttered in February.

The FDA was investigating bacterial infection in babies who had consumed powdered formula made at the Sturgis plant. Two infants died. Abbott initiated a massive recall of baby formula in February.

Some samples taken from Abbott were positive for a dangerous bacteria but it was not found in parts of the plant where the formula was made. The FDA had said cronobacter bacteria “can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants.”

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Enough Nestlé baby formula to make 6.5 million bottles headed to the U.S., FDA says

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