Assurances on Resolving Baby Formula Shortage Met With Suspicion in Congress

WASHINGTON — Lawmakers at a congressional hearing Wednesday were skeptical of assurances by government regulators and manufacturers that they can resolve the nation’s shortage of baby formula promptly.

They described the problems they observed as part of a bigger trend that requires long-term solutions.

“This presents a disturbing pattern of negligence,” said Rep. Diana DeGette, D-Colo., who chairs the House Energy and Commerce Subcommittee on Oversight and Investigations.

She was referring to the shutdown of the biggest U.S. manufacturing plant of formula in Sturgis, Michigan, in February after revelations of unsanitary conditions suspected of sickening children. 

The plant operated by Abbott Laboratories produced about 20% of the nation’s formula, leading to a shortage of the food essential to infants’ health.

A whistleblower’s report to the Food and Drug Administration last fall said the roof of the plant leaked, leaving contaminated water on the floor. It also said employees were lax in washing their hands and other sanitary procedures.

The whistleblower accused company officials of falsifying health and safety tests, then hiding records from the FDA that might demonstrate their misconduct.

A subsequent FDA inspection in September found Cronobacter sakazakii — a common environmental bacteria — in some critical areas of the plant. FDA inspectors said the bacteria might have contributed to the deaths of two children.

Abbott recalled thousands of batches of its formula in mid-February, which are sold under the names of Similac, Alimentum and EleCare. The FDA ordered the plant closed until Abbott could prove it resolved the sanitary problems.

As a result, the nation’s supply of formula fell to levels that left many children with no access to the food filled with the nutrients important to their well-being.

“Parents are nervous wrecks trying to get [through] this,” DeGette said.

Some parents were victimized by scammers selling falsified formula online at exorbitant prices. Other parents made their own formula or diluted the small amount they could obtain with water, leading to warnings from pediatricians about malnutrition.

Abbott plans to restart work at the Sturgis plant on June 4. The company said the first batches of the formula would be available to consumers around June 20.

It also operates formula plants in Arizona, Ohio and Virginia. Together, Abbott plants produce about 40% of the nation’s formula.

Lawmakers put part of the blame on the FDA for not foreseeing the shortage before its crackdown and closing of the Abbott plant in Sturgis on Feb. 17, 2022.

“The FDA didn’t even complete its follow-up inspection of the facility until March 15,” said Rep. H. Morgan Griffith, R-Va.

By that time, the formula shortage was approaching a serious stage.

FDA Commissioner Robert M. Califf admitted his agency was slow to complete its inspections and to take action to prevent a shortage.

The process was “too slow and there were decisions that were suboptimal along the way,” Califf said.

He blamed a lack of adequate staffing, caused partly by inspectors trying to prevent the spread of COVID-19. He also said the FDA was trying to develop better inspection strategies.

He added that the sanitary problems at the Sturgis plant were too severe to overlook.

“We simply could not allow a plant that was unsafe to be shipping products,” Califf said.

Lawmakers also criticized Abbott for allowing its facility and quality control by employees to degrade.

“Our solution will undoubtedly include legislation,” said Rep. Frank Pallone, D-N.J., as he pledged to never again allow manufacturers to inflict a formula shortage on America’s children.

Christopher J. Calamari, an Abbott senior vice president who oversees nutrition, apologized repeatedly while promising to make improvements in the company’s formula processing.

“We know we let you down,” Calamari said. “We are going to do everything we can to re-earn your trust.”

The improvements include new roofing, non-porous flooring and retraining of employees.

“It will take more time but I want to assure you we are doing everything we can to get more supply on the shelves for families,” Calamari said.

Tom can be reached at [email protected] and @TomRamstack