FDA Eases Baby-Formula Import Rules to Boost Supplies

Government officials said the moves will allow more formula products to enter the U.S. baby market, which is dominated by

Abbott Laboratories,

ABT -0.15%

Reckitt Benckiser Group

RBGLY 0.25%

PLC and

Nestlé SA’s

NSRGY 0.41%

Gerber business, which had met the FDA’s requirements.

It could be some time however, before the products come to store shelves in the U.S. Manufacturers overseas will first have to apply with the FDA to be able to ship their products to the U.S., and then the agency will have to conduct a review to assure quality control and safety.

“FDA will prioritize review of applications that are most likely to be successful and will get the most formula to U.S. shelves as quickly as possible,” White House press secretary Karine Jeane-Pierre said.

Also on Monday, Abbott said it had reached agreement with the FDA for the reopening of the Sturgis, Mich., plant where the company makes many formula products.

The consent decree between Abbott and the FDA, which must be ratified by a federal court, outlines the steps that the company must take for the agency to allow the reopening of the plant.

The company closed the plant in February, after the FDA found bacterial contamination.

“This is a major step toward reopening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely reopen the facility,” Abbott Chief Executive

Robert Ford

said.

The regulatory tweaks are part of a larger effort by the Biden administration to ease the shortage, a White House official said.

The administration, which has been facing pressure from parents, Democrats and Republicans to increase formula supplies, is encouraging companies to give priority to making ingredients and to speed up distributing products to retailers.

The White House has also been working with Abbott and the three other formula makers to identify transportation, logistical and supplier hurdles to increasing production of formula at their U.S. and FDA-approved facilities, the administration official said.

Easing the import rules could add to formula supplies, according to supporters, by allowing manufacturers overseas that haven’t been able to ship their products to the U.S. access to the market if they can meet the FDA’s adjusted requirements.

The FDA didn’t specify the changes it was making to its formula rules, but said they established a more flexible process for overseas companies to be able to ship their products to the U.S., or for domestic companies to keep supplies in the U.S. that were to be exported overseas.

“We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants,” FDA Commissioner

Robert Califf

said.

The White House has asked embassies, retailers and manufacturers to help find companies that could ship formula to the U.S. under the new FDA importation rules, Ms. Jeane-Pierre said.

Formula shortages have left parents scrambling, in some cases driving hours to find stores stocking the particular brands their infants need because of dietary restrictions.

The products have been in shortage for months partly because of supply-chain issues caused by the pandemic. The situation worsened after Abbott, one of the leading formula makers, recalled some products and shut down its plant in Sturgis, Mich., making Similac and other brands.

The FDA said it found a germ called cronobacter sakazakii, which can be deadly in infants, in the Sturgis plant, but not in products.

Abbott said there isn’t evidence linking its formula products to illnesses resulting in the hospitalizations of four infants, including two deaths. The Centers for Disease Control and Prevention also said the strains of bacteria at the plant didn’t match those involved in the cases.

In a court complaint, federal prosecutors alleged Abbott didn’t comply with conditions and practices designed to ensure the quality and safety of baby formula, including steps to protect against contamination by bacteria such as cronobacter, the Justice Department said.

Under the terms, Abbott must hire an outside expert to help bring the plant into compliance with FDA rules, including developing plans for reducing the risk of bacterial contamination, according to the Justice Department.

Abbott said it could begin formula production again at its Sturgis plant within two weeks of the FDA signing off on the facility’s reopening, and it would take six to eight weeks for products to be available on store shelves.

Meanwhile, Abbott said it is shipping to the U.S. formula made at a company plant in Ireland to ease shortages.

Other formula makers, which have ramped up production recently, said the shortage could take months to resolve.

—Tarini Parti contributed to this article.

Write to Liz Essley Whyte at [email protected]