The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) has released a report, titled, Infant Formula Roundtable Series Report on Cross-sector Stakeholder Insights, capturing key insights from a series of four moderated roundtable discussions on infant formula safety held in September 2025. The discussions convened a diverse group of stakeholders—including public health experts, manufacturers, researchers, and caregivers—to provide input on the safety, quality, and regulation of infant formula in the U.S.

The roundtables were designed to support FDA’s ongoing efforts under “Operation Stork Speed,” an initiative launched in May 2025 with the U.S. Department of Health and Human Services (HHS) to enhance infant formula safety and resiliency. In 2022, safety concerns regarding powdered infant formula potentially contaminated by Cronobacter sakazakii led to a voluntary recall of specific lots of powdered infant formula products manufactured at Abbott Nutrition's facility in Sturgis, Michigan. This recall, combined with the overall strains on supply chains experienced during the COVID-19 pandemic, led to a powdered infant formula shortage that revealed several vulnerabilities and underscored the importance of strengthening systems to safeguard the safety and availability of this essential product.

Overall, roundtable discussion participants emphasized the importance of maintaining the high safety and nutritional standards already required for U.S.-marketed infant formulas, and urged caution when implementing regulatory changes to avoid unintended impacts on product availability and affordability. They also underlined the need for concerted public communication and education efforts to counter misinformation and build consumer trust, and emphasized the value of ongoing cross-sector collaboration.

The discussions focused on three priority areas: comprehensive nutrient review, contaminants and heavy metals, and labeling and marketing claims.

Modernizing Nutrient Standards

There was broad consensus on the need to update FDA’s nutrient requirements for infant formula, last comprehensively reviewed in 1998. Stakeholders supported incorporating functional health outcomes, such as neurodevelopment and microbiome health, into regulatory evaluations. They also called for the establishment of maximum nutrient levels (e.g., manganese, calcium, phosphorus) and emphasized the importance of considering all sources of nutrient exposure, including water and supplements.

Recommendations included:

• Routine nutrient reviews every four years
• Post-market monitoring of updated standards
• Separate regulatory pathways for novel ingredients
• Increased funding for infant nutrition research.

Addressing Contaminants and Heavy Metals

Stakeholders expressed concern over the lack of enforceable limits for heavy metals in infant formula and urged FDA to expand its Closer to Zero initiative to include infant formula products in its scope. Participants highlighted the need for:

• Clear, evidence-based contaminant limits
• Transparent communication strategies
• Visual tools (e.g., color-coded indicators) to convey safety information
• Education for families using non-standard water sources.

Trusted messengers, such as pediatricians and public health professionals, were identified as critical to effective risk communication about contaminants in infant formula.

Stakeholders suggested that harmonization with international standards, such as those created by Codex Alimentarius, the European Food Safety Authority (EFSA), and the World Health Organization (WHO), could provide a framework for reference and act as a starting point for establishing limits. However, participants expressed caution and stressed the need to align with U.S.-based exposure risks and to distinguish between toxicology-based thresholds and market-driven standards.

Improving Labeling and Claims Oversight

Participants called for stronger oversight of marketing claims such as “gentle,” “closer to breast milk,” and “all natural,” which are often unregulated and potentially misleading. There was strong support for:

• Standardizing efficacy claims with scientific substantiation
• Aligning regulations for toddler drinks with those for infant formulas
• Enhancing label accuracy through third-party audits
• Using plain language and consumer-friendly ingredient names.

A public, FDA-managed database of approved formulas was proposed to improve transparency and help families make informed choices.