Abbott enters consent decree with the FDA to reopen their Sturgis, Michigan powdered infant formula plant that was closed after Cronobacter was discovered in the environment. The FDA inspection was prompted by reports of infant illnesses and deaths. The United States filed the decree on behalf of the FDA. It would require Abbott Nutrition to take “specific measures designed to increase safety and ensure compliance wi the Federal Food, Drug and Cosmetic Act” and the FDAs Good Manufacturing Practice requirements.
Attorney General Merrick B. Garland said in a statement, “The actions we are announcing today will help to safely increase the supply of baby formula for families. The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”
In a complaint that was filed on May 16, 2022, the United States alleges that Abbott and its officials “manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii. The Cronobacter sakazakii bacteria can live in dry foods, such as powdered infant formulas, and can cause deadly sepsis or meningitis in infants. The complaint further alleged that FDA testing of environmental samples taken in February detected Cronobacter sakazakii in the defendants’ manufacturing facility.”
The decree must still be reviewed and entered by a federal court. Abbott must retain outside expert assistance to bring its facility into compliance. The expert will assist Abbott Nutrition, under FDA supervision, in the development of plans designed to reduce and control and risk of bacterial contamination.
FDA Commissioner Robert M. Califf, M.D. said in a statement, “Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan. The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve. We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”
At the same time, the Attorney General is urging state attorneys general to make sure that families are not taken advantage of during this time. The Department of Justice should be contacted with any evidence of collusive price fixing, bid rigging, or market allocation.
