FDA Asking for Comments To Begin Review of Infant Formula

May 13, 2025

The agency issued a request for information on changes to minimum and maximum levels of certain nutrients and other new scientific data.

Dave Fusaro

The Dept. of Health and Human Services and FDA today (May 13) issued a request for information (RFI) to begin the nutrient review process required by law for infant formula.

Infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998, the agency said.

Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including from international sources. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider and how such changes may improve health outcomes.

The agency called this the next step in Operation Stork Speed -- an initiative launched in March reaffirming the agency’s commitment to infant formula safety and nutritional quality. In addition to today’s RFI, the FDA is increasing testing for heavy metals and other contaminants in infant formula and other food consumed by children.

Coincidentally, on May 2, Virginia Governor Glenn Youngkin signed the Baby Food Protection Act which will require baby food manufacturers to conduct laboratory tests for “toxic heavy metal,” defined as arsenic, cadmium, lead and mercury, and display those test results via a QR code on the label. The Virginia law, which takes effect January 1, 2026, is extremely similar to Maryland’s Rudy’s Law, which took effect at the beginning of this year. (Our thanks to law firm Venable for synopses of those two state laws.)

As part of the FDA initiative, the agency will convene a publicly accessible expert panel in June.

Commenters will have 90 days to submit responses. Further information on how to submit a comment can be found here.

About the Author

Dave Fusaro | Editor in Chief

Dave Fusaro has served as editor in chief of Food Processing magazine since 2003. Dave has 30 years experience in food & beverage industry journalism and has won several national ASBPE writing awards for his Food Processing stories. Dave has been interviewed on CNN, quoted in national newspapers and he authored a 200-page market research report on the milk industry. Formerly an award-winning newspaper reporter who specialized in business writing, he holds a BA in journalism from Marquette University. Prior to joining Food Processing, Dave was Editor-In-Chief of Dairy Foods and was Managing Editor of Prepared Foods.