FDA Announces National Academies Study of Supply, Market Competition, and Regulation of Infant Formula in the U.S.

Constituent Update

May 19, 2023

Today, the U.S. Food and Drug Administration announced that the National Academies of Sciences, Engineering, and Medicine (NASEM) will conduct an independent study on challenges in supply, market competition, and regulation of infant formula in the United States.

The study will explore the current state of the U.S. infant formula market, including the diversity of manufacturers; the types of formulas they produce (e.g., non-specialty or specialty, powdered or liquid); manufacturing facilities, production, and production capacity; the amounts of infant formula produced domestically and the amounts imported; and other characteristics. The study will also examine how these characteristics compare to those of the market prior to the COVID-19 pandemic, and just prior to the Abbott recall in February 2022. The study will consider a range of conditions and systems that may be influencing competition in the U.S. infant formula market. Additionally, the study will examine the differences in the nutritional content, labeling, and other regulatory requirements between infant formula sold in the United States and formula sold in foreign markets, such as in the European Union. Upon completion of the study, NASEM will submit a report to both Congress and the FDA.

As part of the Food and Drug Omnibus Reform Act of 2022, Congress directed FDA to develop an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which was released in March 2023; to engage with NASEM on a deeper study of challenges in the U.S. supply, market competition, and regulation of infant formula; and then for FDA to use the information gained through the NASEM study to develop a long-term national strategy.

The FDA is committed to working with our government partners to improve the resiliency of the infant formula supply and to ensure that consumers have the utmost confidence that infant formula available in the U.S. is safe and nutritious.

For more Information

• Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
• Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, Constituent Update
• FDA’s Infant Formula Response Activities – Fact Sheet
• Demystifying Cronobacter and Actions FDA is Taking to Keep the Food Supply Safe