Last fall, the U.S. Food and Drug Administration (FDA) began investigating a series of infant illnesses that were linked to bacterial infections. After regulators found bacterial contamination in Abbott Nutrition (NYSE: ABT) baby formula that had been connected to two infant deaths, the company issued an voluntary recall and shut down the factory where the product is made, sparking off a nationwide crisis. Now, that plant is reopening.
According to FDA Commissioner Robert Califf, the Sturgis plant was in a state of disrepair when it was inspected in February, with a leaking roof, standing water on the floor, and cracked and contaminated equipment.
"Frankly, the inspection results were shocking," Calliff told the House Energy and Commerce Subcommittee on Oversight and Investigations on May 25. "We had no confidence in integrity of the quality program at the facility."
Abbott says that it has since met the FDA's "initial requirements" as part of its agreement with the agency to "resume production and maintain the facility". Along with its agreement with Abbott to reopen the plant, the FDA has also loosened certain requirements for global baby formula manufacturers to sell to U.S. consumers.
"With these additional flexibilities in place, we anticipate that additional products can quickly hit U.S. stores," Califf told reporters after the agreement was made.
However, the director for the FDA's Center for Food and Applied Nutrition said it would be "weeks" before the imported baby formula products become available to American parents. The companies and their products will need to receive prior approval from the FDA.
Abbott's production restart won't include all of its products: the company's specialty EleCare formula will soon restart production, but Similac and other cow's milk formulas are still under a recall order. EleCare and other hypoallergenic formulas are first in line due to the risks of switching formulas for medically vulnerable babies.
"We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America," Abbott said in a statement. "We will ramp production as quickly as we can while meeting all requirements."
Abbott expects the plant to return to full capacity again in another six to eight weeks, with the specialty formula returning to shelves "on or about June 20".
"We're committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years," the baby formula maker continued.
Since the contamination was found, Abbott has maintained that there is no "conclusive evidence" that their formula played a role in the two infant deaths. Both infants had eaten Abbott's formula prior to their illnesses.
"The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states," the baby formula company tweeted in early May. "The formula from this plant did not cause these infant illnesses."
Abbott may say it wasn't responsible for the infant illnesses, but it has acknowledged the role its plant closure has had on the national formula shortage.
"The past few months have distressed us as they have you, and so I want to say: We're sorry to every family we've let down since our voluntary recall exacerbated our nation's baby formula shortage," CEO Robert Ford wrote in a Washington Post op-ed. "I have high expectations of this company, and we fell short of them."
Along with his apology, Ford also wrote that the company is creating a $5 million fund "to help these families with medical and living expenses as they weather this storm."
Even prior to the Abbott plant closure, supply chain issues were already causing shortages for baby formula manufacturers across the U.S., stemming from the COVID-19 pandemic. The Abbott closure was one part of a complex issue.
During most years, 98% of the baby formula used in the U.S. is manufactured domestically. Abbott is the largest formula supplier in the country, and the Sturgis plant is also one of Abbott's . The plant is also a top supplier of specialty formula for infants with medical conditions, and the closure has been making these already rare products even more difficult to find, putting already at-risk infants in greater danger.
It's also important to note that the shortage of baby formula does not affect all communities equally: according to the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) Association, between half and 65% of all formula used in the U.S. is purchased using government assistance. Formula use also tends to be higher in minority families, usually due to limited resources and time.