FDA Seeks Public Feedback on Infant Formula Nutrient Guidelines Rewrite

Product recall text on wooden blocks red background — Product Recall written on a wooden blocks on red. Business concept. Warranty and quality control.

The FDA has opened a historic review of infant formula nutrient standards, prompting curiosity about potential changes on the horizon.

Quick Takes

FDA’s first major review of infant formula in over three decades seeks public input.
The review could lead to updated nutrient requirements and inclusion of new nutrients.
The public comment period is open until September 11.
An expert panel meeting is scheduled for June.

FDA’s Nutrient Review Initiative

The FDA has announced a landmark review of infant formula nutrient standards, the first of its kind in over 30 years. This initiative, known as “Operation Stork Speed,” aims to assess the nutritional quality of infant formulas available in the U.S., ensuring they meet modern scientific standards. The FDA oversees the safety, nutritional adequacy, packaging, and labeling of these products and conducts annual inspections of manufacturing facilities.

The review is being launched in response to the infant formula shortage crisis that occurred due to a product recall three years ago. The FDA plans to review if the current nutrient requirements need to be updated, potentially adding new nutrients to the standards. The agency is actively inviting insights and recommendations from the public to help guide these reforms.

The HHS & FDA have just launched Operation Stork Speed.

This initiative is a resolute commitment to ensuring the safety, nutritional integrity, and availability of infant formula for our nation’s families.

RFK will be undertaking a comprehensive review of infant formula…

— Joey Mannarino 🇺🇸 (@JoeyMannarinoUS) May 13, 2025

Public Engagement and Safety Standards

The FDA has issued a Request for Information (RFI) to review infant formula nutrients, and the public has until September 11 to submit comments through official channels. An expert panel meeting has been scheduled in June as part of the initiative, emphasizing the FDA’s commitment to transparency and thorough evaluation.

Health and Human Services Secretary Robert F. Kennedy, Jr. said, “Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center.”

Ensuring the safety and efficacy of infant formula remains a priority for the FDA, particularly given that these products serve as a primary source of nutrition for infants. Concerns have been raised about potential contaminants like added sugars and harmful levels of arsenic and lead found in some formulas, prompting increased safety measures.

Why the first time in 25 years unless the FDA leaned more to profits for the formula makers than health standards for our most vulnerable sector (our babies). https://t.co/jRvZBCBY5d

— JB and family (@SimmonsBart) May 14, 2025

Industry Collaboration and Commitment

The FDA is collaborating with major formula producers like Abbott Nutrition and Reckitt Benckiser-Mead Johnson to enhance transparency and improve labeling for parents. The agency aims to work closely with industry leaders to ensure comprehensive and effective changes for the health benefit of infants across the nation.

FDA commissioner Dr. Marty Makary said, “Protecting our most vulnerable is not just a moral duty—it is our responsibility. For many children, infant formula is their only source of nutrition. That’s why it’s absolutely crucial to continually assess the nutrition standards and incorporate gold standard science to ensure we are providing the safest, most effective nutrition possible.”

With the Infant Nutrition Council of America (INCA) affirming that its members use safe, high-quality ingredients, there is a strong commitment to continuous improvements and responsiveness to new scientific developments. The FDA’s initiative reflects a proactive approach to safeguarding the health and well-being of America’s youngest citizens.