FDA says it will take two months for U.S. infant formula shipments to return to normal! Abbott to resume production soon

It is learned that on May 26, Dr. Robert Califf, director of the U.S. Food and Drug Administration (FDA), said that it will take until July for infant formula in stores across the United States to return to normal, and replenishing the shelves with milk powder is a gradual improvement process that will take about two months.

Abbott plans to resume production at its Sturgis, Michigan, plant on June 4 and will begin restocking stores with its specially formulated EleCare formula on June 20. The company previously said it would take six to eight weeks for its formula to be available.

It is reported that Abbott closed the factory and recalled several infant formula products in February after FDA inspectors found Cronobacter in the Abbott factory. The factory closure and recall led to a rapid shortage of infant formula in the United States, causing American parents to fall into a milk powder shortage.

At the same time, the FDA has relaxed import restrictions on milk powder, allowing foreign manufacturers to ship formula to the United States, and the Department of Defense is airlifting 1.5 million bottles of formula from Europe.

US Infant Formula Market

Four manufacturers, Abbott, Mead Johnson, Nestlé USA and Perigord, control 90% of the domestic infant formula market in the United States, with Abbott accounting for 40% of the U.S. infant formula market.

The 2021 outbreak has repeatedly disrupted the global supply chain, causing a large number of families to stockpile formula milk, so the inventory of infant formula milk powder in the United States has been in a tight state since last year. This tension has evolved into a serious nationwide milk powder panic last month.

FDA inspectors found appalling sanitary conditions at the Abbott plant, including multiple areas of bacterial growth, stagnant water, a leaky roof, and other serious sanitary conditions.

Four infants who consumed the plant-based formula were infected with Cronobacter, and two died. But the FDA and the Centers for Disease Control and Prevention said they had found no link between the two deaths and the bacteria found in the plant. Still, the plant cannot reopen until Abbott takes hundreds of steps to meet the requirements of a federal consent decree to comply with U.S. food safety standards.

The senators criticized the FDA for taking too long to conduct a physical inspection of the factory after receiving the report of factory contamination, which increased the possibility of infection for a large number of infants who consumed Abbott's formula. The U.S. Food and Drug Administration first received a report in September 2021 that an infant was infected with Cronobacter after consuming Abbott's formula.

It is learned that a whistleblower filed a complaint with the FDA in October, claiming that the hygiene awareness of the Abbott factory was lax and violated regulations. However, the FDA did not inspect the factory until the end of January 2022. Califf admitted that the FDA responded too slowly to the whistleblower's complaint and took too long to conduct the inspection. Although the FDA received the whistleblower's complaint in October, it did not escalate the chain of command to the agency leadership until February.

Editor ✎Estella/

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