FDA working to let foreign formula manufacturers sell products in U.S.

The FDA said in May that it would make it easier to import some baby formulas to ease the nationwide shortage, and the equivalent to more than 400 million 8-ounce bottles has been shipped into the United States from nine countries, the agency said.

The agency’s current enforcement discretion guidance, which allows flexibilities in importing formula products, is in effect until November 14.

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

The FDA said it will work with the manufacturers to create a streamlined process to enter the formula market in the US. This includes hosting meetings with the manufacturers to establish next steps as well as helping them continue to import, sell and distribute formula past November.