FDA Announces Actions to Improve Supply of Infant Formula

On Wednesday, the Food and Drug Administration (FDA) announced in a press release that it will continue to take steps to improve the supply of infant and specialty formula products amid shortages.

The press release provided updates on the FDA’s work following its February 17 warning to consumers to not use certain powdered infant formula products from Abbott Nutrition’s facility in Sturgis, Michigan, Abbott’s voluntary recall and subsequent lawsuits.

The FDA notes that many consumers have been unable to access infant formula and critical medical food and states that it is “doing everything in our power to ensure there is adequate product available.” Further, the press release states that ensuring the availability of sale nutrition products like infant formula is of “the utmost importance to the FDA.”

To support the supply of infant formula products, the FDA states that it will meet regularly with major U.S. manufacturers to better understand their capacity to increase production, expedite review of manufacturing changes, closely monitor the status of the infant formula supply and compile data of in-stock rates of baby formula at the national and regional levels. Additionally, the FDA states that it will try to improve the import of infant formula by expediting the necessary certificates for imports, offering a streamlined import review process and exercising enforcement discretion of minor labeling issues for both domestic and imported products. 

The press release also announced that the FDA will not be objecting to Abbott Nutrition releasing product that has been on hold at its Sturgis facility to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis. The FDA argues that, due to the current supply chain issues, access to these products along with consultation from their healthcare providers may provide benefits that outweigh the potential risk of bacterial infection. The FDA further states that it will be working with the health care provider associations and stakeholders to understand the risks and benefits of pursuing Abbott Nutritions products. 

The FDA states that it will continue to dedicate all available resources to help ensure that infant formula products remain available for consumers in the U.S. and will continue to update the public on its progress.