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FDA and Abbott agree plan to resume infant formula production at Michigan plant

The three-month shutdown has contributed to a nationwide shortage.

The Food and Drug Administration and Abbott Nutrition have agreed to a plan to resume operations at its infant formula plant in Sturgis, Michigan, the two announced Monday.

While the news is welcomed by frustrated parents struggling to find formula on shelves, it could still be several weeks before they see relief.

According to Abbott, the agreement with the FDA defines “the steps necessary to resume production and maintain the facility” but remains subject to court approval. Abbott said once the FDA gives it the official green light, it could restart operations at the site within two weeks and then it would take six to eight weeks before the product is back on the shelves. shelves.

“Our number one priority is to provide infants and families with the high-quality formulas they need, and this is a major step towards reopening our Sturgis facility so that we can alleviate the shortage of formulas at the nationwide. We look forward to working with the FDA to quickly and safely reopen the facility,” said Robert B. Ford, president and CEO of Abbott.

It is estimated that Abbott Nutrition is one of only four companies that controls 90% of the market. The industry was already struggling with supply chain issues when federal inspectors found evidence of deadly bacteria at the Sturgis plant and shut it down.

Abbott says there is still no conclusive evidence linking his formula to four childhood illnesses, including two deaths.

FDA Commissioner Bob Califf told ABC’s “Good Morning America” ​​that the administration wants to dig deeper into the cause of the national infant formula shortage beyond the Sturgis plant.

“There’s a formula. It’s just not in the right place at the right time,” he said.

Ahead of the call to reporters on Monday night, the FDA also announced it was easing import restrictions on infant formula made overseas.

The agency said global manufacturers interested in selling its formula in the United States must submit information about their products to regulators.

The FDA, in turn, “will quickly assess whether the product is safe to use and provides adequate nutrition.”

The FDA said it was already in talks with “certain manufacturers and suppliers” regarding additional supply. It does not say which manufacturers.

The United States normally produces 98% of the infant formula it consumes, according to the FDA.

ABC News

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