Overseas baby formula could sell in US permanently to avoid shortages, FDA says

·4 min read

The Food and Drug Administration announced plans Wednesday to help allow foreign baby formula manufacturers to stay on the U.S. market with long-term authorization as the Biden administration attempts to diversify the industry in hopes of preventing future shortages.

The FDA aims to provide a path for overseas producers that have already sent supplies to the U.S., under temporary emergency approval, to stay on the market by meeting existing requirements. The plans also will make it easier for new importers to navigate the FDA’s regulatory review process.

“The need to diversify and strengthen the U.S. infant formula supply is more important than ever,” FDA Commissioner Dr. Robert Califf and Susan Mayne, director of the agency’s Center for Food Safety and Applied Nutrition, said in a statement. “The recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become.”

The U.S. has tried to boost its formula supply after regulators shut down a Michigan plant run by Abbott, the largest manufacturer of baby formula in the U.S., over safety concerns in February. Families nationwide struggled with empty shelves in the following months.

The plant reopened June 4 after the company committed to additional sanitizing and safety protocols, but it closed again in mid-June after severe weather damaged the plant.

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Wednesday's move comes after the FDA eased federal import regulations in May to allow some international manufacturers to send as much safe and nutritionally adequate formula as possible to the U.S., under emergency approval to address the nationwide shortage. President Joe Biden authorized the use of the Defense Production Act, providing federal support to get the supplies from overseas.

Temporary distribution of foreign formula products from the May guidance remains in effect through November. As of Wednesday, an estimated total of more than 400 million 8-ounce bottles of formula from nine countries have been imported to the U.S, according to the FDA.

Wednesday's plans could help international companies continue to import, sell and distribute formula into the U.S. past November. The FDA is set to announce more details in September.

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"Many of the companies providing these formula products have expressed interest in continuing to serve the American market permanently," Califf and Mayne said in the statement Wednesday. "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."

Bubs Australia is one of the companies interested in supplying its products to the U.S. permanently. According to the manufacturer, since the FDA issued its May guidance, Bubs has worked to supply 1.25 million cans of six of its formula products to the United States. Bubs founder and CEO Kristy Carr said in a statement that the company plans to work with the FDA to continue to distribute and market its products in the U.S. "without interruption beyond November and over the longer term."

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The Biden administration launched Operation Fly Formula in May to speed up the imports from overseas formula producers. On Wednesday, the White House announced that Bubs, which says it has already delivered 10 million 8-ounce bottle equivalents of infant formula over four flights in the program, plans to deliver an additional 4.7 million 8-ounce bottles in two flights later this month.

In total, Operation Fly Formula will have transported more than 43 million 8-ounce bottle equivalents to the U.S. from international manufacturers by this coming Sunday, the White House said.

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The Biden administration also says it will renew the FDA's import regulation guidance set to expire in November if it's necessary to ensure domestic supply.

“(Wednesday's) announcement by the FDA will help ensure the infant formula supply market is less vulnerable to future supply shocks and will provide families with the confidence of steady access to a variety of safe infant formulas,” White House spokesman Kevin Munoz said.

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Contributing: The Associated Press

This article originally appeared on USA TODAY: Foreign baby formula could get long-term authorization in US, FDA says