US FDA Eases Infant Formula Import Regulations to Expand Supply

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[Asia Economy Reporter Kim Hyunjung] The U.S. Food and Drug Administration (FDA) has eased import regulations on infant formula to address the formula shortage, the Wall Street Journal (WSJ) reported on the 16th (local time).

The FDA has relaxed rules that previously blocked shipments from overseas manufacturers and allowed retailers to stock more imported formula on their shelves. As a result, more companies are expected to enter the formula market, which had been dominated by four companies?Abbott, Reckitt Benckiser, Nestl? SA, and Gerber?with a market share of about 89%.

White House spokesperson Karine Jean-Pierre said, "The FDA will prioritize reviewing companies that are most likely to succeed and can provide the most products on shelves as quickly as possible."

Before entering the U.S. market, overseas companies must request FDA approval for their products in advance and then undergo review procedures to ensure quality control and safety assurance.

In February this year, Abbott, which closed its factory after its formula product "Similac" caused bacterial infections in infants and young children, agreed with the FDA to restart its Sturgis, Michigan plant. The current formula crisis worsened due to supply chain issues caused by COVID-19 compounded by the "Similac" recall incident.

Robert Ford, CEO of Abbott, said, "Reopening the Sturgis plant facilities can help alleviate the nationwide infant formula shortage we are experiencing," adding, "We look forward to working with the FDA to reopen the facility quickly and safely."

Abbott expects to resume formula production at the Sturgis plant within two weeks after the FDA approves the plant's reopening. However, it anticipates that it will take 6 to 8 weeks for the related products to appear on retail shelves.