The U.S. Food and Drug Administration (FDA) is inviting public comments as part of Operation Stork Speed—a new initiative aimed at strengthening the safety, nutritional quality, and transparency of infant formula in the United States.

Launched in March, Operation Stork Speed was developed in response to the 2021–2022 infant formula crisis, which was triggered by a deadly outbreak of Cronobacter infections linked to contaminated formula produced by Abbott Nutrition. The outbreak led to the recall of popular brands like Similac and Enfamil and caused a nationwide shortage of infant formula.

Now, for the first time since 1998, the FDA is conducting a formal review of infant formula standards through a Request for Information (RFI). This public comment period will help the agency evaluate whether current nutrient requirements need to be updated based on the latest scientific research—including international data.

Key focus areas for public feedback include:

• Whether current nutrient minimums and maximums should be revised.
• Suggestions for additional nutrients to include.
• Scientific evidence supporting improved nutritional outcomes.
• Potential health benefits from proposed changes.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. emphasized that the initiative aligns with his broader health agenda, stating,

“Every child deserves a healthy start. By taking a hard, honest look at the nutrients in infant formula, we’re ensuring that parents have the tools to give their children the best nutrition from the very beginning.”

FDA Commissioner Dr. Martin Makary reinforced the agency’s commitment, calling the initiative a moral imperative:

“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.”

Alongside the RFI, the FDA is ramping up its testing for heavy metals and other contaminants in infant formula and children’s food. The agency is also urging manufacturers to partner with regulators to improve transparency and enhance clarity in labeling.

The FDA encourages all stakeholders—health professionals, researchers, manufacturers, and the public—to share their insights. This collaborative approach is aimed at ensuring that every infant receives the safest and most beneficial start in life.

The public and industry stakeholders will have 90 days to submit their comments. Detailed instructions on how to provide input are available on the FDA website. As part of the initiative, the FDA will also host a public roundtable on June 3. To register for the event, email [email protected].

Source: FSN

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