“We understand the urgent need for infant formula, and our top priority is getting safe, high-quality formulas into the hands of families across America,” Abbott said in a statement. “We will increase production as quickly as possible while meeting all requirements.”
The plant was closed earlier this year after an FDA inspection revealed allegedly unsanitary conditions. The plant produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so its closure drastically reduced supplies.
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The company previously said it would take two weeks for production to fully resume and another six to eight weeks to get the product on store shelves. The plant will prioritize production of EleCare, a specialized amino acid-based formula for children with multiple allergies, before ramping up production of its consumer products. On Saturday, Abbott said it plans to launch EleCare “to consumers starting on or around June 20.”
The FDA said Saturday it “continues to work diligently to ensure the safe resumption of infant formula production” at Abbott Nutrition’s facilities in Sturgis.
The temporary closure of the establishment has led to a dramatic disappearance of specialty formulas, causing panic among many parents who rely on the products to feed their children. The crisis has raised questions about the fragility of the supply chain of an essential food source. Four major companies control 90% of the infant formula supply in the United States: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Congress and others have sharply criticized FDA leadership, Abbott executives, and even the White House for failing to avert the crisis.
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FDA Commissioner Robert M. Califf questioned when the Sturgis facility would likely be operational, telling lawmakers May 19 that could be as soon as the following week. In a hearing last week, however, he said the issues his agency had uncovered were “out of reach” and may require more extensive remediation.
The inspection in February came after two infants fell ill and two others died after consuming contaminated formula, but the source of the contamination is unclear.
Other things could have contaminated the formula before it was consumed and after the product left the manufacturing facility. For example, in one case, bacteria was found on a bottle of distilled water in the infant’s home.
Abbott says there is no clear evidence the contamination came from the factory. Inspectors found Cronobacter sakazakii bacteria on environmental samples they took outside the main infant formula production area. They found standing water on the floor due to leaking valves, as well as dampness and condensation in dry powder infant formula production areas. They found cracks and holes in the dryers as well as tape and debris on the floor.
Abbott says it has made a number of upgrades, including replacing a leaky roof and installing non-porous, easy-to-clean and hygienic 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 on site.
The reopening of the establishment will not immediately lead to fully stocked grocery shelves. Even with Operation Fly Formula bringing in millions of bottles from Australia, the UK and Germany, data research firm IRI reported that store stocks were still slightly worse in recent weeks compared to early May. Parents continue to report difficulty finding the formula they need, with some traveling long distances and others paying a premium to buy it online.
One of the reasons the shortages persist despite efforts to increase production is that domestic producers, including Abbott, have focused on increasing the availability of specialty formulas for children with allergic and digestive disorders. Formula airlifts from overseas are largely distributed through pediatricians’ practices and hospitals. Califf said part of the shortage also stems from parents hoarding formula out of fear of running out.
FDA reaches agreement with infant formula factory to resume production
Abbott said the EleCare product could reach stores in about 16 days, but it could take weeks for the Sturgis-made formula to fully hit shelves due to the time it takes for the formula to be dried and tested for safety. 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 address safety issues at the plant. Under the decree of consent, Abbott has agreed to clean and sanitize its facilities and all equipment, and keep its new independent expert on site to ensure the plant is in compliance with FDA rules. The consent decree also includes requirements to test products, as well as to cease production and immediately notify the FDA if contamination is detected.