Baby formula makers rushed to get FDA approval. They can wait a while


NEW YORK, June 15 (Reuters) – To alleviate the baby formula shortage in the United States, Nature’s One and Holle are set to ship hundreds of thousands, if not millions, of additional formula to stores, company executives told Reuters.

They can wait a bit.

Despite the Biden administration’s commitment to end formula shortages, slow responses and requests for additional information from the U.S. Food and Drug Administration (FDA) have resulted in weeks-long delays for manufacturers of infant formula seeking U.S. approval, the two companies told Reuters.

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In May, Holle, a Swiss brand sold across Europe, and Ohio-based Nature’s One, sought FDA approval after the agency said it would license formulas sold in other countries. other countries to the United States under a temporary program with relaxed standards. The US government has also flown in preparations from foreign factories.

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

Highman said the last time he heard from the FDA, the regulator told him it was “reviewing” its submissions.

An FDA spokesperson said in a statement that it “continues to work to resolve current supply issues by reviewing a number of enforcement discretion requests as quickly as possible, many of which would involve the ‘importing infant formula from outside the United States’.

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

The FDA must exercise extreme caution with formula standards because impurities or substandard nutrition can lead to permanent disability or death of babies.

The FDA has approved the 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 others still waiting, Reuters reports found.

Tim Morck, a consultant who helps companies, including infant formula manufacturers, navigate FDA regulations, described the regulator’s infant formula team as “understaffed.” FDA Commissioner Robert Califf told a hearing in late May that nine people were reviewing the applications, which had risen to 26 at the time.

Health and Happiness International Holdings Ltd (1112.HK), China’s fourth-largest infant formula supplier, and three Antipodean infant formula companies have applied, Reuters reported. Read more

Israeli company MyOr has also applied to sell its AlphaCare formula, made in Mexico, in the United States, co-founder Michael Brandwein said in an interview.


A formula shortage due to pandemic supply chain issues turned into a crisis after Abbott Laboratories (ABT.N), the maker of Similac and specialty hypoallergenic formulas, closed its Michigan plant in February after reports of bacterial infection in children who consumed its products. The factory reopened on June 4, but Abbott said it needed six to eight weeks to restock its products.

About 78% of the formula in the United States was in stock at the start of June, about the same as at the end of May, according to data from IRI, an independent research company.

Thorben Nilewski, managing director of Organic-Family GmbH, a subsidiary of Holle, said in an email that the FDA earlier this month requested clarification regarding statements on the formula’s label regarding the ” biodynamic milk” and the Demeter standard, which both describe European organic food criteria.

Nilewski said he has an exclusive agreement with a distributor who will deliver Holle to Inc’s (AMZN.O) Whole Foods Market and natural grocers.

Nature’s One, which already makes infant formula for the U.S. market, plans to distribute its infant formula to Walmart Inc (WMT.N), Target Corp (TGT.N), Meijer, Publix and others, the company said. company in an email. Nature’s One plans to submit a new application to the FDA this week for a specialty formula for lactose-sensitive babies, Highman said.

Highman said he completed an infant growth study that showed babies eating exclusively Nature’s One grew the same amount as infants consuming competing formulas or breastfeeding, as required for permanent approval.

The FDA requested an additional 60 days to evaluate Highman’s formula in January 2021, citing a “high number” of new submissions, according to a copy of a letter reviewed by Reuters.

The FDA then asked Nature’s One about its growth study in July 2021, Highman said. He resubmitted in April, just as the formula shortage escalated into a crisis.

At that time, the FDA told him it would take up to six months to respond due to the “continuingly high number” of infant formula submissions, “many of which are extremely complex,” according to a copy of the letter seen by Reuters.

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Reporting by Jessica DiNapoli in New York; Editing by Caroline Humer, Vanessa O’Connell and Lisa Shumaker

Our standards: The Thomson Reuters Trust Principles.


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