The United States Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have announced a comprehensive review of the nutrients in infant formulas. The initiative is part of the "Operation Stork Speed" project, launched in March 2025 to ensure greater safety, transparency, and nutritional quality in products intended for infants.
The FDA has issued a Request for Information (RFI) to collect updated scientific data, both national and international. The goal is to assess whether current minimum and maximum nutrient thresholds should be modified. This is the first full review since 1998.
“Every child deserves a healthy start. We can't talk about public health unless we begin here,” said Health Secretary Robert F. Kennedy Jr. “We want parents to have access to clear, science-based information.”
In addition to the RFI, the agency announced increased testing for contaminants such as heavy metals, both in infant formula and other baby foods. A panel of experts is also expected to convene publicly in June.
“For many infants, formula is the only source of nutrition. It’s essential that our nutrition standards are current and scientifically sound,” explained FDA Commissioner Martin A. Makary.
Measures announced include:
- launch of a full review of nutrients
- intensified testing for heavy metals and contaminants
- extension of the personal importation policy
- active dialogue with manufacturers to improve transparency and labeling
- collaboration with the National Institutes of Health to fill research gaps on the long-term effects of infant formula
“We want every family to trust the products that feed their children,” said Acting FDA Commissioner Sara Brenner. “Whether breastfed or formula-fed, children must be able to rely on safe and adequate foods.”
The public consultation will remain open for 120 days. Participation details are available in the official document published in the Federal Register.
Glossary
- FDA: Food and Drug Administration. U.S. government agency regulating food, drugs, supplements, and medical devices.
- HHS: Department of Health and Human Services. Oversees federal health policies in the United States.
- Infant formula: A food product created to replace breast milk during the first months of life. Provides essential nutrients for newborn growth.
- Operation Stork Speed: Federal program launched in 2025 to improve the safety, access, and nutritional quality of infant formula.
- RFI (Request for Information): Public request for information. The FDA seeks data, studies, and comments from experts, companies, agencies, or individuals.
- Minimum and maximum nutrients: Set values for each nutrient (proteins, fats, vitamins, minerals) in infant products. These include minimum limits (to ensure adequate amounts) and maximum limits (to avoid harmful excess).
- Contaminants: Unwanted substances that may be present in food. These can include heavy metals (lead, arsenic, cadmium), pesticides, bacteria, or microplastics.
- Heavy metals: Toxic elements even in small amounts. Their presence in food is regulated by legal limits.
- NIH (National Institutes of Health): U.S. government body funding medical and scientific research.
- Labeling: Information shown on product packaging. Must clearly list ingredients, nutrients, usage instructions, and other legally required details.
Infant Formula Nutrient Requirements – Request for Information
