“We understand the urgent need for formulas, and our top priority is putting high-quality, safe formulas in the hands of families across America,” Abbott said in a statement. “We will ramp up production as quickly as possible while meeting all requirements.”
The factory was shut down five months ago after an FDA inspection allegedly found unsanitary conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulations, so its closure severely curtailed supplies.
The company has previously said it will take two weeks to fully resume production and another six to eight weeks for the product to hit store shelves. The plant will prioritize production of EleCare, a special amino acid-based formula for children with multiple allergies, before ramping up production of its mainstream products. On Saturday, Abbott said it expects to release EleCare to consumers “on or about June 20.”
The FDA said Saturday it “continues to work diligently to ensure the safe resumption of infant formula production” at Abbott Nutrition’s Sturgis facility.
The facility’s temporary closure resulted in a dramatic disappearance of specialty foods, causing panic among many parents who rely on the products to feed their children. The crisis raised questions about the fragility of the supply chain for a critical food source. Four major companies control 90 percent of the infant formula supply in the United States: Abbott, Gerber, Mead Johnson, and Perrigo Nutritionals. Congress and others have severely criticized FDA leadership, Abbott executives, and even the White House for failing to handle the crisis.
Biden says he didn’t hear about the baby food shortage until late
FDA Commissioner Robert M. Califf talked about when the Sturgis facility was likely to start operating, telling lawmakers on May 19 that it could happen as soon as the following week. But in a hearing last week, he said problems his agency had found there were “beyond the pale” and might require a more comprehensive fix.
The February inspection came after two infants became ill and two other infants died after ingesting contaminated formula. Abbott says there’s no clear evidence the contamination came from the factory. Inspectors found Cronobacter sakazakii bacteria on samples taken outside the main formula production area. They found standing water on the floor due to a leaking valve, and moisture and condensation in dry infant formula powder production areas. They found cracks and pits in dryers, as well as duct tape and debris on the floor.
Abbott says it’s made a number of upgrades, including replacing a leaky roof and installing non-porous, easy-to-clean and sanitary floors to eliminate the risk of standing water. In addition, Abbott has updated its education, training and safety procedures for employees and visitors, as well as its cleaning and maintenance procedures at the facility.
The reopening of the facility will not result in fully stocked grocery shelves immediately. Even with Operation Fly Formula bringing in millions of bottles from Australia, the UK and Germany, data research firm IRI reported that stock levels were still slightly worse in recent weeks compared to early May. Parents continue to report difficulty finding the formula they need, as some drive long distances and others pay a premium to buy it online.
One reason the shortages have persisted, despite efforts to increase production, is that domestic manufacturers, including Abbott, have focused on increasing the availability of specialty foods for children with allergies and digestive disorders. Air shipments of baby food from abroad are mostly distributed via pediatric surgeries and hospitals. Califf has said part of the shortage is also due to parents hoarding formulas for fear they will run out.
FDA agrees with baby formula factory to resume production
Abbott said the EleCare product could hit stores in about 16 days, but it could take weeks for the formula made in Sturgis to fully hit shelves because the formula has to be dried and safety checked. The factory makes the type of formula that comes in powder form and needs to be mixed with water before feeding. Batch testing adds days to the production process.
On May 16, Abbott reached an agreement with the FDA to fix safety issues at the factory. As part of the consent decree, Abbott agreed to clean and disinfect its facility and all equipment and engage an independent on-site expert to ensure the facility complies with FDA regulations. It also includes requirements for testing products, halting production, and immediately notifying the FDA if contamination is found.