FDA considers overhaul of infant formula requirements amid growing concerns over nutrition and safety
By willowt // 2025-05-16
Copy
 
  • The FDA has launched its first comprehensive review of infant formula nutrient requirements in 25 years, inviting stakeholders, researchers and the public to provide insights on adjusting nutrient levels and mandating additional nutrients through a Request for Information (RFI). Public comments will be accepted until September 11.
  • The last review occurred in 1998, and since then, scientific understanding of infant nutrition has significantly advanced. The review aims to incorporate the latest scientific research to ensure the safety and efficacy of infant formulas.
  • Recent studies have raised concerns about the presence of added sugars, particularly from corn, and harmful contaminants like arsenic and lead in some infant formulas. These findings have fueled calls for stricter regulatory oversight and more rigorous safety standards.
  • The infant formula industry, led by major manufacturers like Abbott Nutrition and Reckitt Benckiser-Mead Johnson, faces scrutiny over its practices. While industry representatives emphasize adherence to safety and nutritional standards, critics argue for greater transparency and accountability. Public awareness and advocacy efforts have intensified, with parents seeking more information about formula ingredients.
  • The review is part of the FDA's Operation Stork Speed initiative, reflecting a broader shift toward prioritizing public health and safeguarding vulnerable populations. The agency aims to modernize nutrition standards and address concerns about infant formula composition, ultimately working towards a healthier future for America's infants.
The U.S. Food and Drug Administration (FDA) has initiated its first comprehensive review of infant formula nutrient requirements in 25 years, marking a significant step toward potentially improving the safety, nutrition and transparency of infant formulas. Announced on May 13, the review is part of the FDA’s Operation Stork Speed, a broader initiative launched in March 2025 to address concerns about the quality and availability of infant formula in the United States. The agency has issued a Request for Information (RFI), inviting stakeholders, researchers and the public to contribute insights on whether to adjust the minimum and maximum levels of current nutrients, as well as which additional nutrients should be mandated. The review will also consider how these changes could improve infant health outcomes. Public comments will be accepted until September 11. “This is a pivotal moment for safeguarding the health of our youngest citizens,” said FDA Commissioner Dr. Marty Makary. “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 last comprehensive review of infant formula requirements was conducted in 1998, and since then, scientific understanding of infant nutrition has advanced significantly. The Federal Food, Drug and Cosmetic Act mandates that infant formulas contain specific nutrients, including protein, fat, essential fatty acids and certain vitamins and minerals. However, concerns have been raised about the presence of added sugars and harmful contaminants like arsenic and lead in some formulas.

Public health concerns spark demand for change

Recent studies have highlighted troubling trends in the composition of infant formulas sold in the United States. Researchers have found that many formulas contain added sugars, particularly derived from corn, rather than lactose, which is naturally present in cow’s milk. A 2025 analysis published in The Lancet found that most U.S. infant formulas contain primarily added sugars, with some formulas derived from corn products containing as little as 5% lactose compared to human milk, which contains around 70% lactose. Additionally, Consumer Reports revealed in March 2025 that testing of infant formulas in the U.S. revealed potentially harmful levels of arsenic and lead in some brands. These findings have amplified calls for stricter regulatory oversight and more rigorous safety standards. Health Secretary Robert F. Kennedy Jr. emphasized the urgency of the issue, stating, “You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.” The FDA’s review comes at a time when public awareness about the nutritional content and safety of infant formulas has grown significantly. Advocacy groups and parents have expressed concerns about the long-term health impacts of consuming formulas with high levels of added sugars and contaminants.

The role of industry and advocacy

The infant formula industry, dominated by companies like Abbott Nutrition and Reckitt Benckiser-Mead Johnson, which collectively produce nearly 80% of U.S. infant formula, has faced scrutiny over its practices. While these companies did not respond to media inquiries by publication time, Perrigo, another major manufacturer, referred questions to the Infant Nutrition Council of America (INCA). INCA has stated that its members adhere to rigorous safety and nutritional standards, using high-quality ingredients scientifically proven to support healthy infant growth. “INCA members remain committed to working with HHS and the FDA on Operation Stork Speed to ensure domestic infant formula products continue to meet the highest standards for nutrition and safety,” an INCA spokesperson said. Industry representatives have also emphasized that infant formulas undergo extensive research, testing and regulatory approval before reaching the market. However, critics argue that the current system lacks sufficient transparency and oversight.

The larger context: Why this matters now

The FDA’s review of infant formula requirements comes amid growing public and political awareness of the critical role that nutrition plays in early childhood development. Recent years have seen increased attention to the issue of infant formula safety and availability, particularly following the 2022 congressional hearing on the Abbott Nutrition recalls, which highlighted vulnerabilities in the infant formula supply chain. Furthermore, the rise of consumer advocacy groups and the availability of independent research have shed light on the potential risks associated with certain infant formula ingredients. As a result, parents are increasingly seeking more transparency and accountability from regulators and manufacturers. Operation Stork Speed, which includes enhanced testing for heavy metals and contaminants, as well as efforts to improve labeling clarity, reflects a broader shift toward prioritizing public health and safeguarding vulnerable populations.

A path forward for healthier infants

The FDA’s comprehensive review of infant formula requirements represents a critical opportunity to modernize nutrition standards and ensure that the products available to parents meet the highest standards of safety and efficacy. By engaging the public and leveraging the latest scientific research, the agency can take a significant step toward addressing the growing concerns about infant formula composition. As scientists, industry leaders and policymakers weigh in, one thing is clear: the health and well-being of America’s infants depend on getting this right. The FDA’s commitment to transparency and evidence-based decision-making will be key to achieving this goal. With this review, the agency is setting the stage for a healthier future — one bottle at a time. Sources for this article include: TheEpochTimes.com FDA.gov ScienceDirect.com
Copy