FDA Allows Importing of 2M Baby Formula Cans From UK

The U.S. Food and Drug Administration is easing regulations to allow infant formula imports from Britain, a move it said on Tuesday would bring around 2 million cans onto empty shelves by June to ease a nationwide shortage.

The FDA said it was "exercising enforcement discretion" to allow Britain-based Kendal Nutricare to import certain infant formula products under the Kendamil brand that it has no safety or nutrition concerns over following an evaluation.

"Under the agency's recent increased flexibilities regarding importation of certain infant formula products, the company initially estimates that about 2 million cans of infant formula are expected to land on U.S. store shelves beginning in June," it said in a statement.

Kendal has 40,000 cans in stock for immediate dispatch that the Department of Health and Human Services is working on bringing into the United States as soon as possible, the FDA said.

"We continue to do everything in our power as part of the all-of-government efforts to ensure there's adequate infant formula available wherever and whenever parents and caregivers need it," said FDA Commissioner Robert Califf.

The United States is experiencing one of the biggest infant formula shortages in recent history after Abbott Laboratories in February recalled some products including Similac and closed its manufacturing plant in Sturgis, Michigan.

Abbott, the biggest U.S. supplier of powder baby formula, shut its facility after reports of bacterial infections among four infants. It exacerbated a shortage among multiple manufacturers that began with supply-chain issues tied to the coronavirus pandemic.

The FDA said it would allow the release of about 300,000 cans of Abbott's EleCare amino acid-based formula for children who urgently need it to survive, on a case-by-case basis.

EleCare was previously produced at the Sturgis facility but were not part of the recall, the FDA said.

Abbott plans to restart production at the facility on June 4, it said in a statement, adding it would prioritize making EleCare and supplying it on or about June 20. Abbott said it would provide the formula to children in need for free.

U.S. President Joe Biden's administration has sought to relieve the shortage by importing emergency supplies from Europe, the first of which arrived earlier this week. Biden invoked the Cold War-era Defense Production Act to help boost supplies.

The FDA said on Tuesday it was in discussion with other manufacturers over additional supplies and that it would prioritize products that demonstrate safety, nutritional adequacy, and are available in large quantities.