Abbott restarts formula factory linked to contamination
WASHINGTON (AP) — Abbott Nutrition has restarted production at the Michigan infant formula plant that was shut down for months due to contamination, the company announced on Saturday, taking a step toward mitigating of a nationwide supply shortage that is expected to persist through the summer.
The February closure of the nation’s largest formula factory led to supply issues that forced some parents to seek formula from food banks, friends and doctor’s offices.
Abbott said it would initially prioritize production of its specialty EleCare formulas for infants with severe food allergies and digestive issues who have few other options for nutrition. The company said it would take about three weeks before the plant’s new formula starts showing up on store shelves.
“We will ramp up production as quickly as possible while meeting all requirements,” Abbott said in a statement.
The reopening of the plant is one of several federal measures that should improve supply in the coming weeks. President Joe Biden’s administration eased import rules for foreign manufacturers, airlifted the formula from Europe and invoked federal emergency rules to prioritize U.S. production.
Abbott closed the Sturgis, Michigan plant in February after the Food and Drug Administration began investigating four bacterial infections in infants who consumed formula from the plant. Two of the babies died. The company continues to claim that its products have not been directly linked to infections, which involved different bacterial strains.
FDA inspectors eventually uncovered a slew of violations at the plant, including bacterial contamination, a leaky roof, and lax safety protocols. The FDA has come under scrutiny for taking months to close the plant and then negotiate its reopening. Agency executives recently told Congress they needed to reach a legally binding agreement with Abbott to ensure all issues were resolved.
Abbott’s recall in February of several major brands, including Similac, reduced supplies that had already been strained by supply chain disruptions and storage during COVID-19 shutdowns.
The shortage has been more severe for children with allergies, digestive issues and metabolic disorders who rely on specialized formulas. The Abbott factory is the sole source of many of these products, providing nutrition to about 5,000 American babies, according to federal officials.
Abbott is one of only four companies that produce about 90% of the American formula. Recalls and the closure of the business triggered a cascade of effects: retailers restricted customer purchases to conserve supplies and parents were told to switch brands for in-stock formula.
FDA Commissioner Robert Califf recently told lawmakers that it could be about two months before supplies of formula return to normal levels. The agency has waived many of its regulatory requirements to accept more formula from the UK, Australia and other countries.
U.S. manufacturers, including Reckitt and Gerber, have also ramped up production, operating factories 24/7 and sourcing more formula from other facilities.