Michigan baby formula plant to restart production in June, company says

Detroit News staff and wire reports

Baby formula manufacturer Abbott announced Tuesday its plant in Sturgis, Michigan, where a recall has helped fuel a nationwide formula shortage, is expected to reopen next month.

"Abbott plans to restart production at the Sturgis facility on June 4 and will prioritize EleCare production, with initial EleCare product release to consumers beginning on or about June 20," the company said in a statement.

The relaunch announcement came a week after the U.S. Department of Justice confirmed a tentative agreement with Abbott to resolve safety issues at its facility, considered the country's largest manufacturing plant for infant formula.

Abbott Laboratories manufacturing plant in Sturgis, Mich., Sept. 23, 2010.

Abbott's recalled products included powder formula sold under the labels Similac, Alimentum and EleCare labels after four children became ill with bacterial infections and two died. Several Abbott employees are accused of manufacturing the baby formula under conditions that did not meet regulatory standards for quality and safety, according to a federal court filing. 

Last week, the DOJ said it had filed a legal complaint against Abbott over allegations of quality and safety violations, and that the company had already agreed to a proposed consent decree to resolve the issues.

More:Baby formula shortage hits Michigan families, especially the poor

In its statement Tuesday, Abbott said the U.S. District Court for the Western District of Michigan has amended the decree allowing the company to release limited quantities of its EleCare specialty amino acid-based formulas that had been on hold following the Feb. 17 recall.

"The consent decree was amended at the request of Abbott and the U.S. Food and Drug Administration ... to enable the company to get EleCare to children in urgent medical need," Abbott officials said. "These EleCare product batches were on hold pursuant to an agreement with the FDA. All products have been tested and meet all product release requirements."

EleCare formulas are hypoallergenic and used by infants and children who have severe food allergies or gastrointestinal disorders that require amino acid-based formulas, the company said.

Abbott said it received permission from regulators to release 300,000 cans of its EleCare specialty formula. The product was not part of the February recall.

"While Abbott has limited inventory of these products, there should be enough to fulfill current patient needs until new product is available in the coming months," Abbott's release said. 

Abbott said it expects to begin shipping product "within the next several days" to healthcare professionals, hospitals or consumers.

"Releasing this product immediately will help families impacted by the lack of availability of EleCare," said Robert B. Ford, chairman and chief executive officer at Abbott. "When we restart our Sturgis facility the first week in June, we will produce EleCare first and make enough so that several months of supply will be available."

The low supplies of baby formula on the shelves at Crossroads Michigan social services agency in Detroit.

Abbott's February recall of products made at the Sturgis plant has exacerbated a nationwide shortage of baby formula caused by supply chain issues. 

For three months, the Abbott plant in Sturgis has remained "voluntarily" closed, according to the FDA. The company has said it's working to correct findings related to the processes, procedures and conditions cited by FDA inspectors in March that raised concerns that powdered infant formula produced at the facility carried a risk of contamination.

The FDA has announced new guidance outlining increased flexibility for the importation of certain infant formula products to further boost availability.

Michigan has temporarily expanded the types of formula that qualify for assistance under the Women, Infants and Children program and notified individuals that received recalled formulas through the state on recommended next steps.

The White House has said that Abbott agreed to continue paying rebates through August in states like Michigan where the company holds the contract for the federal WIC program.

Last week, the Senate passed a bipartisan bill that would permanently loosen regulations around which baby formulas can be purchased under the federal low-income assistance program.  It gives the U.S. Department of Agriculture more flexibility during a product recall, supply-chain disruption or other crisis so families aren't restricted by what brand or kind of infant formula they may purchase, according to a bill summary. 

The House has also approved $28 million in emergency funding for the FDA to address the formula shortage.

Several congressional committees have set hearings to investigate the shortage.

The Federal Trade Commission announced Tuesday that it has launched an inquiry, seeking information on any deceptive or fraudulent business practices related to it.

Meanwhile, the White House announced Sunday the first two Defense Production Act authorizations for infant formula, both coming from the Department of Health and Human Services.

Abbott Nutrition can now receive priority orders of raw materials like sugar and corn syrup for infant formula, which the White House said will allow the manufacturer to increase production quickly by one-third. Reckitt, owner of Mead-Johnson, can now receive priority orders of consumables like filters and other single-use products necessary to generate certain oils needed to produce infant formula, the White House said, which will allow Reckitt facilities to operate at maximum capacity.

The Biden administration has also started airlifting shipments of formula from Europe. The first, a military plane carrying enough specialty infant formula for more than half a million baby bottles, arrived Sunday in Indianapolis.