‘Operation Stork Speed’ Expert Panel Highlights Infant Formula Safety Vulnerabilities
In June 2025, an expert panel was convened to discuss the nutrition, regulatory and safety oversight, and marketing of infant formula in support of the U.S. Food and Drug Administration’s (FDA’s) “Operation Stork Speed” initiative. A series of manuscripts summarizing the panel’s conclusions and recommendations were recently published in Advances in Nutrition.
Part 2 of the manuscript series focuses on regulatory and safety considerations. It underscores the need for streamlined FDA approval processes for infant formulas, enhanced transparency in ingredient safety through “generally recognized as safe” (GRAS) determinations and food additive petitions, and stronger protections against the presence of environmental contaminants (e.g., heavy metals). Microbiological safety was briefly mentioned, although the panel did not call for any specific actions to improve FDA oversight in this area.
Factors Restricting Number of Formula Products in U.S. Market
The panel underlined that the current registration process for novel infant formulas or major changes to existing formula composition and processing conditions is cumbersome, time-consuming, and expensive for companies—hindering the introduction of new formulas to the market. Additionally, contracting policies with federal programs and hospitals, as well as the significant capital investment needed to secure FDA approval, further restricts market access. Factors such as these limit the number of infant formulas on the U.S. market, posing the risk of nationwide shortages in the event of supply disruptions, as was seen in the infant formula shortages of 2022.
Actions that may make it easier for new formulas to enter the market include revising and clarifying aspects of the required protein quantity and quality studies, growth studies, and clinical tries.
Limits to FDA’s Oversight of Infant Formula Supply
Following the 2022 shortages, the National Academies of Sciences, Engineering, and Medicine (NASEM) evaluated FDA’s shortcomings in infant formula oversight. FDA responded with a strategy to improve resiliency in the formula supply chain. However, aspects of these plans would require legislation, especially those that would mandate companies to report all positive test results, not just those released into the market, and have remote access to all test data. Congress could also provide FDA greater oversight by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of critical foods to give sufficient advanced notice to FDA when they discontinue a critical food.
Interestingly, FDA does not provide a list of registered infant formulas. The agency could consider maintaining a public list of all formulas available on the market.
New Ingredients Entering Formula via GRAS Determinations and Additive Petitions
All ingredients used in infant formulas on the U.S. market must adhere to the safety criteria of food additive petitions or the GRAS process. Although the criteria for assessing ingredient safety and toxicology are identical for food additives and GRAS ingredients, food additive petitions are beholden to lengthy pre-market approvals, whereas GRAS ingredients can be immediately introduced to market without FDA notification, given that it has a complete GRAS evaluation dossier.
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GRAS has come under scrutiny in recent years for being a “loophole” that allows formally unreviewed and potentially unsafe ingredients to enter the market. Most recently, Health Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to tighten GRAS ingredient oversight. A proposed rule has been sent to the White House for review.
New infant formula ingredients, such as oligosaccharides, have entered the market via GRAS determinations, in which these substances were reviewed by GRAS panel members whose training and experience qualified them as experts.
Throughout the several decades since the Infant Formula Act of 1980, many ingredients have been introduced to U.S. infant formulas, such as probiotics, docosahexaenoic acid, lactoferrin, polyunsaturated fatty acids, and oligosaccharides. U.S. regulations have not established minimum or maximum values for these components.
Regulatory Limits for Environmental Contaminants Are Lacking
Exposure to certain contaminants is particularly concerning for infants and young children, including toxic heavy metals (i.e., lead, mercury, arsenic, and cadmium), plasticizers (i.e., phthalates), per- and polyfluoroalkyl substances (PFAS), microplastics and nanoplastics, endocrine disrupting chemicals such as polychlorinated biphenyls (PCBs) and dioxins, some pesticides, flame retardants, some additives and dyes, and mycotoxins.
Despite the vulnerability of infants to contaminants, in the U.S., there are no established maximum allowable levels for any environmental contaminants in infant formula. This is a concern, as the presence of contaminants, especially heavy metals, has been demonstrated. Other jurisdictions around the world (e.g., the EU, Canada, Australia/New Zealand) have set maximum limits for various environmental contaminants, and Codex Alimentarius provides specifications, which FDA could reference.
The panel emphasizes the importance of standardizing industry testing practices for contaminants and establishing a list of which environmental contaminants are most relevant to assess. The panel also urges increased transparency from FDA regarding the frequency of testing and the most recent contaminant levels.
The panel recommends that, regardless of the initial selection of regulated environmental contaminants in infant formula, a systematic review cycle should be conducted at least every five years, allowing for an expanding list as research identifies additional harmful substances.
Additionally, the panel notes that preventing environmental contaminants from entering food requires mitigating environmental contamination, which requires collaboration with the U.S. Environmental Protection Agency (EPA) to safeguard soil, air, and water.
Microbiological Contaminants: More Defined Oversight, But Failures Still Occur
According to the panel, FDA has established "strict microbial limits for infant formula," specifically, for: Salmonella, Cronobacter, coliforms, Shiga toxin-producing Escherichia coli (STEC), Bacillus cereus, Staphylococcus aureus, and Pseudomonas aeruginosa. The report highlights Cronobacter sakazakii as a microbial contaminant of particular concern, as it causes serious infections in infants and can be difficult to eradicate in food production environments due to its proclivity to form biofilms.
FDA has not established maximum levels for yeast and molds and has yet to address viruses that may pose a public health risk. However, thermal processing conditions for producing powder and liquid forms of infant formula can inactivate most viruses and other microbes.
Although FDA’s safety standards for infant formula ingredients and quality control procedures are "designed" to reduce microbiological risks, implementation challenges and industrial variability limit their effectiveness. Failures still occur—demonstrated most recently in an infant botulism outbreak linked to ByHeart formula products that sickened dozens of babies nationwide. FDA inspection documents revealed serious food safety and hygiene violations at ByHeart production facilities.
New Approach Methods to Accelerate Toxicology Assessments
Toxicology testing plays a crucial role in ensuring the safety of regulated products. The modernization of toxicology assessments may be advanced through New Approach Methods (NAMs), which are animal-free, in silico and in vitro techniques that leverage modern technological advancements. Use of these tools aim to accelerate ingredient safety evaluation while reducing reliance on traditional animal studies. NAMs can help predict toxicity pathways, assess bioactivity, and support more efficient regulatory decisions.
