× Startups Business News Education Health Finance Technology Opinion Wealth Rankings Politics Leadership Sport Travels Careers Design Environment Energy Luxury Retail Lifestyle Automotives Photography International Press Release Article Entertainment

June 15, 2022

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.

In May, both Holle, a Swiss brand sold throughout Europe, and Ohio-based Nature's One sought FDA approval after the agency said it would allow formula sold in other countries into the United States under a temporary program with relaxed standards. The U.S. government has also flown in formula from overseas plants.

"This should be easy," said Jay Highman, CEO of Nature's One, which is sold in China. "We're ready to go to feed babies." Highman has also been seeking permanent FDA approval since 2020.

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 totaling more than 6 million cans in less than a month, it said.