Baby formula makers raced for FDA approval. They may be waiting a while

NEW YORK, June 15 (Reuters) - To ease the U.S. shortage of baby formula, Nature's One and Holle are poised to ship hundreds of thousands of pounds, if not millions of pounds, of additional formula into stores, company executives told Reuters.

They may be waiting a while.

Despite the Biden administration's pledge to end formula shortages, slow responses and requests for more information from the U.S. Food and Drug Administration (FDA) have led to weeks-long delays for baby formula makers seeking U.S. approval, the two companies told Reuters.

Highman said that last he heard from the FDA the regulator told him it was "reviewing" his applications.

An FDA spokesperson said in a statement that it "continues to work to address current supply challenges by reviewing a number of requests for enforcement discretion as quickly as possible, including many that would involve the import of infant formula from outside of the U.S."

The FDA requested funding for four more infant formula staff in June 2021, and received approval this March, according to an FDA timeline of its response to the shortage. The regulator has permitted 15 different products totalling more than 6 million cans in less than a month, it said.

The FDA has to use extreme caution with formula standards as impurities or substandard nutrition could cause permanent disability or death in babies.

The FDA has approved formula from Bubs Australia Ltd (BUB.AX), UK-based Kendamil, Nestle SA (NESN.S) and Danone SA (DANO.PA) under the program, but Holle and Nature’s One are among many still waiting, Reuters reporting has found.

Tim Morck, a consultant who helps companies including baby formula makers navigate FDA regulations, described the regulator's infant formula team as "way understaffed." FDA Commissioner Robert Califf said in a hearing in late May there are nine people reviewing applications, which totaled 26 at that time.

Baby formula makers raced for FDA approval. They may be waiting a while | Reuters