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The U.S. Food and Drug Administration (FDA) on Friday unveiled a new strategy aimed at boosting the resiliency of the country's infant formula market. The move comes in the wake of a 2022 recall and subsequent formula shortage that affected families nationwide.

Building on a strategy released in early 2023, the FDA's new plan includes measures to ensure the ongoing inspection of infant formula manufacturers, committing to conducting inspections at least annually. Additionally, the agency will continue to train investigators to better evaluate infant formula quality.

"Visibility into the infant formula market is crucial, especially when considering specialty infant formulas," the FDA stated. These formulas are essential for infants with allergies, low birth weight, rare genetic disorders, or other specific medical conditions. The agency emphasized the importance of these formulas being the sole source of nutrition for certain vulnerable infants.

The new strategy also focuses on preventing contamination in infant formula and easing barriers for new companies entering the U.S. market. This initiative is designed to enhance the FDA's ability to monitor supply chain risks and mitigate potential shortages.

The strategy follows a major incident in early 2022 when the FDA and the Centers for Disease Control and Prevention (CDC) launched an investigation into Abbott's powdered infant formula after several infants fell ill due to Cronobacter sakazakii contamination. Two infants died, with all affected having consumed Abbott’s Similac PM 60/40 formula. The pathogen, Cronobacter sakazakii, can lead to severe sepsis and infections, as well as bowel damage.

The FDA faced scrutiny during a May 2022 hearing, where lawmakers expressed concerns about the agency's delayed response to the contamination at Abbott’s Sturgis, Michigan, plant, despite a whistleblower report in October 2021. The incident contributed to the national shortage of infant formula.

To improve supply chain resilience, the FDA outlined its efforts to work closely with manufacturers and leverage data sources to enhance visibility into the infant formula market. This includes identifying vulnerabilities in the supply chain and promoting a diverse production base to reduce risks of future shortages.

In December, the FDA also released draft guidance for manufacturers on how to notify the agency about permanent or temporary interruptions in formula production. The draft aims to help manufacturers comply with the Federal Food, Drug, and Cosmetic Act during times of potential or actual supply disruptions.

By strengthening oversight and enhancing industry collaboration, the FDA aims to ensure a more reliable supply of infant formula for American families moving forward.