By: Kelsey Sweeney
Image courtesy of nerissa’s ring; CC-BY
U.S. health and safety regulators are supposed to conduct annual inspections of baby formula plants to ensure the facilities are following safe manufacturing procedures and are distributing uncontaminated formula products. However, between 2020 and 2022, regulators did not inspect any of the three largest manufacturers as a result of the pandemic. After a two-year gap in inspections, inspectors finally visited the Michigan Abbott Nutrition Plant, the largest plant in the U.S. They found standing water and lax sanitation procedures within the factory, yet failed to issue any sort of formal warning on account of the plant’s faulty practices (1). As a result, four infants suffered from bacterial infections, including two who died, after consuming powdered formula from the Michigan plant (2). In February 2022, inspectors issued a four-month shutdown and a recall of Abbott Nutrition formula products after discovering bacterial contamination within the factory— leading to a supply shortage crisis that forced the U.S. to airlift baby formula products from overseas (1). The shortage has sent parents scrambling to find formula as big pharmacy chains like CVS and Walgreens have imposed limits on the amount of formula cans customers can purchase at a time. Walgreens limits families to purchasing three 12.4 ounce cans at a time, which is just over a weeks’ worth of supply (2).
The baby formula crisis has elicited scrutiny from Congress and government watchdogs who are currently evaluating the gap in baby formula inspections, as well as the series of missteps that resulted in a number of infant bacterial infections and a nationwide shortage (1). In response to the crisis, the government issued a bill that mandates the FDA to conduct inspections of baby formula plants every six months. Additionally, the government Inspector General for health has launched a comprehensive investigation into the FDA’s handling of Michigan’s Abbott Nutrition facility (1). Abbott was able to resume production earlier this month under a legally binding contract with the FDA in hopes to mitigate the nationwide formula shortage (2). The agreement between the FDA and Abbott outlines extensive safety and training practices for both employees and visitors, as well as protocols regarding water, sanitation, and maintenance procedures at the factory (3). Following confirmation from the FDA that these requirements have been met, Abbott will begin production of EleCare®, Alimentum® and metabolic formulas. These products will not be available in stores until six to eight weeks after the factory resumes production, but in the meantime, Abbott will import formula from an FDA-registered facility in Ireland to domestic suppliers (3).
Since resuming routine inspections in 2022, the FDA has shut down 20 of the nation’s 23 baby formula facilities due to levels of bacterial contamination, unsanitary conditions, and health and safety risks (2). The shortage in baby formula continues to persist and has left many families unable to secure formula products as inventory decreases and prices increase. Parents have turned to the Biden administration who have been hesitant and slow in their response to the crisis. Facing increased pressure, Biden invoked the Defense Production Act on May 18th, 2022 which allows the federal government to direct manufacturing production for national defense and ensures manufacturers have necessary ingredients to make safe and healthy formula (4). Biden also announced a second effort earlier this month called Operation Fly Formula. Under this program, the Department of Defense and the Department of Health and Human Services is issued to send U.S. military aircraft overseas to import FDA certified formula from abroad for distribution on U.S. shelves. Furthermore, the House is scheduled to vote on two bills later this month which would increase access to formula products and allocate funding for the FDA to hire and train more employees under a federal program (4).