FDA unveils strategy to strengthen U.S. infant formula market resilience

USA – The US Food and Drug Administration has introduced a long-term strategy to strengthen the resilience of the infant formula market, aiming to prevent a repeat of the 2022 recall and subsequent shortages. 

Reported by the agency, the strategy focuses on diversification, risk management, and improved supply chain oversight to address vulnerabilities in this highly concentrated market, where the number of major manufacturers has decreased from four to three since 2022.

According to the FDA, a key component of the strategy includes enhanced surveillance and safety inspections, ensuring that all infant formula manufacturers undergo annual sampling and regulatory evaluations. 

The agency has also committed to collecting microbiological and nutritional samples from foreign manufacturers each year and has intensified efforts to combat Cronobacter contamination through industry discussions and scientific data analysis.

A report by the FDA highlights the importance of supply chain visibility to forecast and mitigate potential disruptions. 

However, the agency currently has limited monitoring capabilities and relies on voluntary data from manufacturers and state agencies. 

Since the 2022 crisis, the FDA has conducted inspections of both domestic and foreign facilities, increased surveillance sampling of imported formula, and issued warning letters to manufacturers as part of its Cronobacter sakazakii prevention strategy. 

The agency intends to continue these efforts while developing models to assess market health and resilience.

The strategy also includes measures to support market diversification by expediting reviews of new infant formula products, issuing guidance to manufacturers on safety and nutritional standards, and assisting smaller businesses in entering the industry. 

Meanwhile, the FDA will require specialty formula manufacturers and encourage standard formula producers to develop redundancy risk management plans to address potential over-reliance on single production lines, suppliers, and inventory weaknesses.

According to the agency, strengthening contractual flexibilities under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is also under consideration. 

The FDA is planning to collaborate with the USDA to create a governance framework that can guide crisis responses at the state level and adapt to individual agency needs. 

Producers and retailers will be provided with information on critical control points, production levels, distribution processes, and mandatory reporting requirements.

The FDA acknowledges that additional oversight is needed despite the recent expansion of its regulatory powers by Congress. 

The agency intends to request mandatory authority to remotely access records of all critical food manufacturers, including infant formula producers. 

It will also seek regulatory requirements for manufacturers to provide advance notice before discontinuing essential products. 

Reported by the agency, suspending tariffs to alleviate supply chain pressures is another potential measure under discussion, particularly in the event of significant market disruptions.