FDA working to allow overseas formula makers to stay in US market

Similac Alimentum Hypoallergenic Infant Formula, imported from Puerto Rico, is for sale at a Stew Leonard’s grocery store in Yonkers, New York, on Friday, June 10, 2022. (AP Photo/Ted Shaffrey)

The Biden administration is working on a plan that will allow foreign manufacturers of infant formula to keep their products on the market in the U.S. long term, the Food and Drug Administration (FDA) announced Wednesday.

The move would diversify the supply chain and is aimed at preventing another situation like the current shortage, which occurred after the country’s largest manufacturing plant was shut down for months over safety concerns.

The FDA since May has allowed overseas manufacturers to temporarily ship their products to the U.S. as a way to ease the shortage.

“For some companies, the agency’s flexibility has resulted in their ability to use a greater breadth of their existing, global manufacturing footprint, creating more resiliency in the U.S. infant formula supply chain and reducing the risk of reliance on too few production facilities supporting the United States,” FDA Commissioner Robert Califf and Susan Mayne, the director of the agency’s Center for Food Safety and Applied Nutrition, said in a statement. 

The agency said it will develop a new framework that will be more streamlined and allow companies to meet U.S. requirements and keep their products on the market past November, when the current enforcement flexibility ends.

The FDA said it will issue further guidance in September to show companies that have already received temporary enforcement discretion how they can meet FDA requirements to continue to supply infant formula to the U.S. 

In the meantime, the FDA said it will provide a single point of contact for any company aiming to enter the U.S. infant formula market and will host meetings with companies that import, sell or distribute formula under the FDA’s temporary policy to help determine what additional steps should be taken to ensure uninterrupted marketing of products.

“The FDA expects that our continued efforts will help infant formula manufacturers who are new entrants to the U.S. market better understand their options to continue producing and supplying formula to the U.S. in the weeks, months and years ahead,” Califf and Mayne said. 

Just four companies are responsible for about 90 percent of the U.S. formula market. When a manufacturing plant in Michigan operated by Abbott Nutrition was shut down by regulators in February, the effects cascaded down a supply chain already strained because of the pandemic. 

The FDA has come under fire for failing to realize the severity of the problem until it was too late. 

Administration officials have been working to boost existing supply by easing federal import regulations, as well as by reopening Abbott’s plant. The plant reopened June 4 after the company committed to additional sanitizing and safety protocols but closed again less than two weeks later after severe weather caused damage and flooding to the plant.

The company has not said when the facility will resume production and did not respond when asked on Wednesday.

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