FDA Launches 'Operation Stork Speed' to Modernize Infant Formula Safety and Nutrition Standards

• The FDA and HHS have initiated 'Operation Stork Speed,' the first comprehensive review of infant formula nutritional standards since 1998, seeking public input through September 2025.
• The program will expand testing protocols for heavy metals and contaminants in infant formula, following a Consumer Reports investigation that found potentially harmful chemicals in nearly half of tested products.
• Federal officials are working with manufacturers like Abbott Laboratories and Reckitt Benckiser to improve transparency, enhance product labeling, and encourage development of new formula options for vulnerable consumers.

In a significant move to strengthen infant nutrition safety standards, the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) have launched "Operation Stork Speed," a comprehensive initiative to review and potentially update the nutritional requirements for infant formula products.

The program marks the first thorough evaluation of infant formula standards since 1998, though individual nutrients have been reviewed periodically. This extensive review comes amid growing concerns about formula safety following the 2022 nationwide shortage and recent findings of contaminants in some products.

Comprehensive Review of Nutritional Standards

The FDA has initiated the program with a Request for Information (RFI) to gather public input on current infant formula nutrient requirements. The agency is seeking scientific evidence to determine whether updates are needed based on the latest research, including international data.

"Protecting our most vulnerable is not just a moral duty -- it is our responsibility," said FDA Commissioner Martin A. Makary, M.D., M.P.H. "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."

The public comment period for the RFI will remain open until September 11, 2025. Additionally, the FDA plans to convene an expert panel in June to gather further information and expertise through a publicly accessible meeting.

Enhanced Safety Testing Protocols

A key component of Operation Stork Speed involves expanded testing for heavy metals and other contaminants in infant formula products. This increased scrutiny follows a March 2025 Consumer Reports investigation that detected potentially harmful chemicals—including acrylamide, arsenic, BPA, lead, and PFAS—in nearly half of the 41 infant formula products tested.

"The FDA is deeply committed to ensuring that moms and other caregivers of infants and young children and other individuals who rely on infant formula for their nutritional needs have confidence that these products are safe, consistently available, and contain the nutrients essential to promote health and wellbeing during critical stages of development and life," stated Acting FDA Commissioner Dr. Sara Brenner.

Industry Collaboration and Consumer Transparency

HHS Secretary Robert F. Kennedy Jr. recently met with executives from major formula manufacturers, including Abbott Laboratories (maker of Similac) and Reckitt Benckiser (producer of Enfamil), to discuss improvements to formula safety and transparency.

"The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them," Kennedy said in a statement.

The initiative aims to encourage formula companies to collaborate with regulatory agencies to enhance product labeling clarity for consumers and develop new formula options that meet the highest safety and nutritional standards.

Addressing Past Concerns

The heightened focus on infant formula safety follows the 2022 crisis when FDA inspections discovered bacteria linked to two infant deaths at Abbott's Sturgis, Michigan plant. The subsequent plant closure triggered a nationwide formula shortage that affected millions of families who depend on formula to feed their babies.

With approximately one in five U.S. newborns starting on formula, ensuring the safety and nutritional adequacy of these products remains a critical public health priority. Consumer advocates have expressed cautious optimism about the new initiative.

"We look forward to seeing the details of how they intend to implement the plan, and we hope the FDA is providing adequate resources and staffing to actually follow through with these promises," said Brian Ronholm, director of food policy at Consumer Reports.

Multi-Faceted Approach

Operation Stork Speed encompasses several key objectives:

1. Reviewing the nutrient content requirements for infant formula
2. Increasing testing for heavy metals and contaminants
3. Encouraging companies to develop new, improved formulas
4. Clarifying product labeling to better inform consumers about ingredients

The comprehensive approach reflects the FDA's recognition that infant formula serves as the sole source of nutrition for many infants during a critical developmental period, making its safety and nutritional adequacy paramount to public health.