Enough baby formula to make 19 million bottles headed to U.S. from Ireland - pennlive.com

2022-06-25 04:26:35 By : Ms. Daisy Dai

Danone in Ireland will send enough baby formula to make 19 million bottles to the United States, the U.S. Food and Drug Administration has announced. The formula is expected to arrive here in July and then be sold at major retailers.

Danone in Ireland will send enough baby formula to make 19 million bottles to the United States, the U.S. Food and Drug Administration has announced.

It is the latest shipment of baby formula from overseas that is the result of the FDA’s increased flexibilities to alleviate the critical shortage of formula in the United States.

The FDA said Danone will provide 750,000 cans of Aptamil First Infant Milk Stage 1, which is enough to make 19 million, 8-ounce bottles.

This formula, the FDA cautioned, “is appropriate for most infants and meets U.S. nutrient requirements, but it may not be suitable for infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness.”

The Aptamil is expected to arrive in the U.S. in July. The FDA said it is expected to be sold at major retailers.

The agreement is the latest in the FDA’s attempt to increase the amount of baby formula in the United States by utilizing flexibilities in the importation of some baby formula products.

According to the FDA, under normal circumstances, 98% of the infant formula consumed in the United States is produced in the United States “with the primary source of imports coming from trading partners in Mexico, Ireland and the Netherlands.

However, given the production and distribution issues that have led to reduced supplies of infant formula in some parts of the country, the FDA has outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries.”

Last week, the FDA said Mead Johnson Nutrition/Reckitt in Singapore will provide 4.5 million pounds of the base power used to make Enfamil Stage 1 baby formula will be shipped to the United States from Singapore to provide for families in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program.

The FDA has previously announced the shipment of Similac from Spain, Kendamil and Neocate from the United Kingdom, Bubs from Australia and Gerber Good Start Gentle from Mexico.

“The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D.

The shortage was in part sparked by a national recall of baby formula produced at Abbott Nutrition’s facility in Sturgis, Michigan, which then was shut down for three months.

Abbott closed the factory “in February after the Food and Drug Administration began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died. The company continues to state that its products have not been directly linked to the infections, which involved different bacterial strains,” according to the Associated Press.

Abbott, one of the largest manufacturers of formula in the United States recalled Similac, Alimentum and EleCare powdered infant formulas.

That recall resulted in empty store shelves and retailers putting limits on how much a person could buy. The supply had already been tight because of supply chain issues during the COVID-19 pandemic.

The Abbott plant restarted on June 4 but then was shut down again on June 13 after powerful storms ripped through that area of Michigan causing flooding and damage at the plant. The plant was closed for cleaning, sterilization and repairs.

The FDA maintains a list of manufacturers that have been given “enforcement discretion” in order to increase the supply of baby formula in the United States, which has been experiencing a critical shortage. The database lists the type of formula and when it is expected to be available.

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