Baby Formula Makers Still Have to Wait Longer to Get FDA Approval Despite Nationwide Formula Shortage

To ease the shortage of baby formula in the United States, company executives of Nature's One and Holle told Reuters that they are poised to ship hundreds of thousands of pounds, if not millions of pounds of additional formula, into American stores.

Their plans to enter the U.S. market are still up in the air, though, with slow responses and requests for more information from the U.S. Food and Drug Administration (FDA) leading to weeks-long delays for baby formula makers seeking approval to sell their products in the United States. That is despite the pledge of the Biden administration to end formula shortages in the country.

The FDA issued a statement saying it is working as quickly as possible to address the current supply challenges. The federal agency said it is reviewing several applications under a program that relaxes the standards for formulas not approved in the U.S.

Bubs Australia, Kendamil, Nestle, and Danone already approved by the FDA

The FDA said it is working carefully to ensure the products' safety and prioritizing the largest formula providers in the country. The agency has already approved formulas from Bubs Australia Ltd, UK-based Kendamil, Nestle SA, and Danone SA under the new program. Holle and Nature's One are among the many companies still waiting for approval.

Both Ohio-based Nature's One and Holle, a Swiss brand sold throughout Europe, sought FDA approval in May after the agency said it would allow formula sold in other countries into the U.S. under the temporary program.

Jay Highman, CEO of Nature's One, which is sold in China, said that this should be easy, and they are ready to feed babies. He has also been seeking permanent approval from the FDA since 2020.

Highman said the last time he heard from the agency was when he was told that his application was still being reviewed. According to an FDA timeline of its response to the shortage, it had requested funding for four more infant formula staff in June 2021 and only received approval in March. The regulator had permitted 15 different products totaling more than 6 million cans in less than a month.

Read Also: Many Baby Formula Plants Not Inspected in the US Because of COVID Pandemic

FDA's infant formula team understaffed

The FDA must use extreme caution with the standards for formula as impurities, or substandard nutrition could cause permanent disability or death in infants and babies. Tim Morck, a consultant who helps companies, including baby formula makers, navigate regulations of the FDA, described the regulator's infant formula team as "way understaffed."

FDA Commissioner Robert Califf said in a hearing in late May that only nine people were reviewing applications, totaling 26 at that time. China's fourth-biggest infant formula supplier, Health and Happiness International Holdings Ltd, and three Antipodean formula companies have applied to sell their products in the U.S.

Israeli manufacturer MyOr has also applied to sell its AlphaCare formula, made in Mexico, in the United States.

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