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

In a move to ease a nationwide infant formula shortage, the Food and Drug Administration (FDA) said Monday it has agreed with Abbott Nutrition on a plan to reopen the company’s manufacturing plant in Sturgis, Michigan, after it was closed following the discovery of deadly bacteria inside.

The FDA also announced Monday that it would make it easier for global manufacturers to sell their products within the US, as long as they meet certain criteria.

Officials warned that it could still be weeks before many parents see more infant formula on shelves, either from Sturgis facilities or foreign suppliers. But both events were hopeful signs that the crisis would be resolved.

“With these additional flexibilities in place, we anticipate that additional products may quickly reach U.S. stores,” FDA Commissioner Bob Califf told reporters on a press call, adding that he hopes the supply “continues to improve in the coming months”.

Companies that make infant formula were already dealing with supply chain issues last fall when the FDA began investigating reports that four infants in three states contracted bacterial infections. After inspectors found a bacteria called Cronobacter sakazakii inside Abbott’s Sturgis factory last February, Abbott closed its plant and agreed to a voluntary recall.

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

“Infants consumed four different types of our prepared formula over the course of nearly a year and illnesses occurred over several months in three different states,” Abbott tweeted last week. “The formula from this plant did not cause these childhood illnesses.”

However, FDA officials warned Monday against any conclusion in the cases and said the investigation remains ongoing. They noted in particular that genetic sequencing of bacteria was only provided in two of the four cases and that more work is needed to rule out causes.

The closure of the Sturgis facility appeared to be the turning point for the supply shortage due to Abbott’s strong influence in the US market, where 90% of the country’s supply comes from just four companies.

Also problematic was that the Sturgis facility was one of the leading producers of special formula required by babies with specific medical needs.

According to Abbott, the latest agreement with the FDA sets out “the steps necessary to resume production and maintain the facility,” but remains subject to court approval.

Abbott said it could restart operations at the site within two weeks pending an official FDA green light and that it would take six to eight weeks after that before the product is back on shelves.

“Our number one priority is providing babies and families with the high-quality formula they need, and this is an important step toward reopening our Sturgis facility so we can alleviate formula shortages across the country,” he said. Robert B. Ford, Chairman and Chief Executive Officer of Abbott.

The FDA also announced Monday that it is easing import restrictions on infant formulas manufactured abroad. The FDA said it is already in discussions with “some manufacturers and suppliers” regarding the additional supply. It doesn’t say which manufacturers, but said it is casting a wide net.

The United Kingdom, Australia and New Zealand have similar health and safety inspections to the United States, and new imports could potentially come from those places, according to a senior Biden administration official.

The FDA said global manufacturers interested in selling formula within the US must submit information about their products to regulators.

The FDA, in turn, will “promptly assess whether the product can be used safely and provides adequate nutrition,” the agency said in a statement.

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

Officials couldn’t predict exactly how soon parents would see the imported product on shelves, other than to say that supply would gradually improve over the next two months.

“I think we’re waiting weeks to get the imported product to market,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition.

ABC News’ Ben Gittleson contributed to this report.

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