An ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) will examine challenges in the supply, market competition, and regulation of infant formula in the U.S. The project is sponsored by FDA.
The study will explore the current state of the country’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 with 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 market. Additionally, the National Academies 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.
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.
NASEM will submit its findings to both Congress and FDA.