December 7, 2022

FDA Updates Activities on Infant Formula Supply Challenges

The FDA has updated its activities on infant formula supply challenges. The agency is trying to increase the supply and availability of infant formula since the Abbott Nutrition plant in Sturgis, Michigan closed because the FDA found Cronobacter contamination in the environment.

FDA Updates Activities on Infant Formula Supply Challenges

The agency warned parents not to use certain powdered infant formula products from that facility on February 17, 2022. A recall was issued by Abbott the same day. Cronobacter is a bacteria that can cause serious illness and death in infants, particularly premature babies and those with other medical conditions.

A consent decree of permanent injunction was filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. Abbott has agreed to take corrective actions following the FDA inspection of the plant. The decree “obliges Abbott to take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility.”

When production at that plant is restarted, the company must confirm with the provisions of the consent decree and meet FDA food safety standards. The company must notify the FDA if contamination is identified. The source of the problem must be identified, and a root-cause investigation must be conducted before they can resume production.

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.”

The FDA is also looking at manufacturers of infant formulas around the country and the world to see if they can reallocate the distribution of these products to help parents get the formulas they need.

The consent decree alleged that the powdered infant formula manufactured at Abbott Nutrition’s Sturgis facility was adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. Cronobacter sakazkii was found in the facility. The FDA also observed significant operational deficiencies during the inspection.

Abbott must retain an independent expert to review their operations and to ensure compliance with the law. The requirements cover testing products and ceasing production if contamination is detected. Sanitation and environmental monitoring plans must be implemented, and employees must be trained.

Meanwhile, the FDA is in negotiations with all infant formula manufacturers in the U.S. They are all producing at an expanded capacity. Gerber has increased the amount of their formula available to consumers by about 50% in March and April. Reckitt is supplying more than 30% more product year to date.

The most complete data shows nearly 80% in-stock rates for the week ending May 8, 2022. That means if a local supermarket normally carries 50 different infant formula products, 40 of those 50 products are available. But there is still less variety than before the recall.

The availability of specialty formulas continues to be problematic. The FDA has taken steps with Abbott to make product available to patients with life-threatening conditions on a case by case basis. Other manufacturers have increased production of comparable product lines.

Finally, the FDA has requested that Congress let them collect supply data from the broader infant formula industry and is building on work with its 21 Forward supply chain continuity system. That is a data analysis tool created in response to the COVID-19 pandemic, which interrupted supply chains around the world.

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