Abbott Restarts Baby Formula Production At Michigan Plant

NORTH CHICAGO, IL — Baby formula production resumed Saturday at Abbott Laboratories' facility in Sturgis, Michigan, after the company met the initial requirements of a consent decree with federal regulators, company officials said.

Abbott company officials said the plant would begin with production of EleCare and other specialty and metabolic formulas, with the first EleCare formula to hit the shelves around June 20. In a statement, company representatives said they were working to take the necessary steps to start making Similac and other formulas as soon as possible.

"We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America," the statement said. "We will ramp production as quickly as we can while meeting all requirements."

Powdered formula production at the factory had been on pause since February following a Food and Drug Administration investigation into bacterial infections among infants who had consumed formula made there.

Four babies were hospitalized, and two died. Formula produced at the plant was recalled. Representatives of the North Chicago-based company, and the head of the FDA, have said there is no evidence directly linking the illnesses to the Michigan factory.

The FDA was first notified in September 2021 of a Cronobacter sakazakii infection in an infant who had consumed Abbott formula by health officials in Minnesota, the only U.S. state where they are required.

In October 2021, a former quality assurance worker at the plant sent officials a 34-page complaint alleging the falsification of records, release of untested formula, obstructing an FDA audit, lax cleaning practices, failure to take corrective measures and lack of traceability.

"FDA leadership do not receive direct copies of the complaint due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues," when it arrived in the mail, according to a timeline provided in prepared testimony from FDA officials. Nonetheless, regulators received an electronic copy and began planning for an inspection at the Sturgis plant.

In early December, FDA officials requested an interview with the informant, which took place on Dec. 22. On Dec. 30, regulators attempted to schedule a Jan. 3 inspection of the facility, but Abbott sought and received a delay "due to an ongoing COVID-19 outbreak among its staff."

When inspectors sought to reschedule on Jan. 27, Abbott company officials said there was still a coronavirus outbreak at the plant, but investigators went in anyway, starting on Jan. 31, according to the FDA.

"FDA proceeds with an inspection of Sturgis plant despite the COVID-19 outbreak given the fact pattern indicating a potential issue. FDA finds significant, fundamental sanitation, building, and equipment issues and takes multiple environmental samples," according to the timeline.

Related: FDA Chief Testifies About Abbott Labs Recall, Unsanitary Conditions

About 90 percent of baby formula in the United States is produced by Abbott and three other companies, and its Sturgis factory is the only source for many specialty formulas, according to the Associated Press.

The 2 percent of baby formula in the U.S. that is imported from abroad is subject to tariffs of up to 17.5 percent, with additional tariffs once imports reach a certain level. Plus, provisions demanded by U.S. representatives for inclusion in the 2020 United States-Mexico-Canada Agreement, or USMCA trade deal, made it cost-prohibitive to import formula from Canada.

FDA representatives announced Friday that the agency was "exercising enforcement discretion" to allow about 1.3 million cans of Gerber Good Start Gentle manufactured in Mexico, which is expected to become available beginning in July and continuing through October.

Following a meeting last week with executives from baby formula manufacturers, President Joe Biden said no one had told him of the chance of formula shortages until early April.

"I don't think anyone anticipated the impact of the shutdown of one facility — the Abbott facility, and it was accurately shut down because the formula was questioned, in terms of its purity," Biden said. "And so once we learned of the extent of it and how broad it was we kicked everything into gear."

"Didn't those CEOs just tell you that they knew it would have a very big impact?" a reporter asked.

"They did, but I didn't," Biden said.