Abbott Laboratories has restarted production of EleCare infant formula at its Sturgis, Michigan plant.
Production of all Abbott infant formulas was suspended at the factory in February following consumer complaints related to Cronobacter sakazakii or Salmonella disease from consuming baby powders made at the factory. The shutdown sparked a shortage in the United States, where baby powder manufacturing is concentrated between Abbott, Nestle-owned Gerber and Reckitt Benckiser.
While the site then restarted production of EleCare on June 4 following US Food and Drug Administration (FDA) clearance, the company and facility suffered a setback as flooding prompted another shutdown on June 15. Abbott had planned to start shipping products again around June 20.
Production of EleCare at the Sturgis site restarted on July 1 and Abbott will begin shipments in the “coming weeks”, a spokesperson for the Illinois-based company confirmed. just food.
“We will begin production of metabolic products this month after the first runs of EleCare. We are working to restart production of Similac as soon as possible,” the spokesperson said.
The infant formula maker previously disputed “there is no conclusive evidence to link Abbott’s formulas to these childhood illnesses” following investigations by the FDA and the Centers for Disease Control and Prevention. .
Nonetheless, market shortages sparked an outcry among parents and politicians, with the US administration taking unprecedented steps to address the shortfall as Gerber and Reckitt Benckiser joined the call to arms.
President Joe Biden signed into law the Defense Protection Act in May to prioritize local production and launched Operation Fly Formula to bring in emergency supplies from overseas. The FDA has put in place a so-called discretionary temporary enforcement order to stimulate imports, subject to regulatory and health controls, to which Bubs Australia, along with its local counterpart Bellamy’s Organic, along with Fonterra and A2 Milk Co. of New Zealand, subscribed.
The FDA has since responded with a plan to permanently open the market to foreign and domestic players beyond Nov. 14, when the executive order expires.
FDA Commissioner Robert Califf said last week as the food safety body announced a new framework initiative: “The need to diversify and strengthen the US supply of infant formula is more important than never. The recent closure of a major infant formula factory, compounded by unforeseen natural weather events, showed how vulnerable the supply chain has become.
At an unspecified date this summer, the agency plans to have meetings with companies “that import, sell, and/or distribute formula under the FDA’s Temporary Applicability Discretionary Policy to determine what steps more would be needed to pave the way for long-term, uninterrupted marketing for a safe and nutritious formula”.
Further information should be provided in September.
Read Just Food’s analysis: Why there’s no one formula to fix the US infant formula market