New FDA guidance seeks to improve baby formula supply in the U.S.

For much of 2022, parents across the country were struggling with supply shortages of baby formula. To help alleviate these concerns long-term, the U.S. Food and Drug Administration (FDA) has published new guidance on infant formula that will work to diversify the supply, making future shortages less likely. 

“We’ve made important progress toward improving the infant formula supply in the U.S. and paving the way for a more robust and diverse marketplace for the future,” said Dr. Robert M. Califf, FDA commissioner. “However, the FDA can’t do it alone. We’ll need to work with all stakeholders to evaluate what other steps could be taken to encourage a more diverse and resilient infant formula marketplace. Manufacturers from around the world have demonstrated their commitment to helping bolster U.S. supply and, in turn, we are committed to continuing these flexibilities for their products to safely remain on the market while ensuring they meet our standards.” 

What will be different?

The most important thing moving forward is having an adequate supply of infant formula. Under this new guidance, the FDA will temporarily allow for enforcement discretion from certain formula companies that are located overseas or across the country. This guidance will run through October 2025, and will help bolster the supply of formula that consumers have access to in the U.S. 

These companies may not typically comply with the regulations or guidelines that are followed for infant formula. However, many of these products are still nutritious and safe for infants, and the FDA is asking them to submit information to be considered for production under the enforcement discretion policy. 

The FDA has been more flexible with importing formula since May of this year, when the shortage got particularly difficult across the country. The agency has since allowed eight companies from nine countries to produce and import formula for the U.S., which has significantly increased the supply. 

Under this new guidance, the FDA hopes to continue this pattern, while also giving parents and caregivers peace of mind when it comes to feeding their infants. 

“The FDA remains committed to strengthening the U.S. infant formula market, ensuring one of the nation’s most vulnerable populations has access to safe, nutritious products,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. “In addition, we understand that the continued availability of infant formulas brought in through enforcement discretion is important for infants who started on a specific formula during the shortage and now are accustomed to that formula as an essential source of nutrition.”