Every tin of baby formula sold in the United States must meet a set of nutrient requirements set by the FDA. These requirements determine the minimum levels of protein, fat, vitamins and minerals that formula must contain, and in some cases the maximum levels permitted. They are the regulatory floor beneath every formula on every shelf in every store in America.
Those requirements were last comprehensively reviewed in 1998. Think about what else was true in 1998. Smoking was still permitted in many restaurants. Trans fats were in everything - crackers, margarine, fast food - before the science caught up and the FDA banned them in 2015. Cooking oils were dominated by partially hydrogenated vegetable oils that we now know cause cardiovascular disease. The food pyramid still put bread and pasta at the base. The idea that the gut microbiome played a significant role in immune development, allergy risk, or neurological health was not yet mainstream science. The link between early nutrition and long-term obesity risk was poorly understood.
In the 27 years since, nutritional science has advanced enormously. The understanding of DHA and brain development has been transformed. The evidence on corn syrup solids and gut microbiome has accumulated. The links between early nutrition and long-term health outcomes - obesity, allergy, immune development - have been established and strengthened. None of this was reflected in what the FDA required or permitted in formula. Until now.
What triggered Operation Stork Speed
The catalyst was not a sudden recognition of the science gap. It was a crisis. In February 2022, the FDA shut down Abbott Nutrition's Sturgis, Michigan plant after a Cronobacter bacterial contamination killed two infants and hospitalised others. Abbott produced roughly 40% of the US formula supply from that single facility. The resulting shortage left parents unable to find formula for weeks. It was a supply chain failure that exposed, simultaneously, how concentrated the US formula market had become and how inadequate the regulatory framework overseeing it was.
In March 2025, Consumer Reports published test results showing potentially harmful levels of at least one contaminant in roughly half of the 41 formula products they tested. The same day those results were shared with the FDA, the agency announced Operation Stork Speed - a multi-pronged initiative to modernise formula regulation for the first time in a generation. Then, in November 2025, the ByHeart recall hospitalised 48 infants and reinforced every concern the review had been set up to address.
Abbott plant closure
Cronobacter contamination at Sturgis facility causes two infant deaths and triggers nationwide formula shortage. 40% of US supply disappears overnight.
Operation Stork Speed announced
FDA and HHS announce the first comprehensive formula review since 1998, triggered in part by Consumer Reports finding contaminants in half of 41 formulas tested.
FDA issues Request for Information
First formal step in the nutrient review. Expert panel convened. Public comment period opens. Focus areas: nutrients, heavy metals, contaminants, labelling transparency.
ByHeart recall
48 infants hospitalised with infant botulism linked to ByHeart formula. Contamination traced to organic whole milk supply chain. Reinforces urgency of Operation Stork Speed.
FDA report expected
The FDA's comprehensive contaminant and nutrient review is expected to be released this month. It will likely include new enforceable limits for heavy metals and revised nutrient requirements.
What the expert panel actually found
In June 2025, the FDA convened an expert panel of paediatricians, nutritional scientists, and dietitians. Their findings, published in Advances in Nutrition in January 2026, were more damning than the FDA's measured public language suggested.
On corn syrup solids: the panel noted that over half of US formulas contain glucose polymers - corn syrup solids - despite lactose being the primary carbohydrate in human milk. They cited observational studies linking corn syrup-based formulas to multiple potential health risks including excess weight gain, and called for reconsideration of non-lactose carbohydrate substitutions in formula for healthy infants.
On DHA: the panel found that current FDA regulations specify only total fat content and minimum linoleic acid - with no requirement for DHA at all. This is despite what the panel called "substantial international consensus" on the critical role of DHA in neurocognitive development and visual acuity. The EU has required minimum DHA levels in infant formula since 2020. The US has not.
On iron: the panel recommended reducing the allowable iron content in routine formulas, consistent with European Food Safety Authority recommendations and emerging safety data on high iron intake in infancy.
On protein: the panel recommended decreasing the upper range of allowable protein intake, citing concerns about excessive protein contributing to later obesity risk - a risk well-established in European research but not yet reflected in US standards.
The second expert panel report, also published in January 2026, addressed safety and regulatory considerations. It found that heavy metals, PFAS and other toxins can be found in formulas, and infants can be at increased risk of effects. The US lacks enforceable limits, unlike EU, Canadian and Australian counterparts. Lead, arsenic, cadmium, and tin are currently unregulated in US formula. The EU sets maximum levels for all of them. The US has set none.
"The nutrition of every bottle-fed infant in America is at stake."
Professor Tom Brenna, University of Texas at Austin - FDA expert panel member, Wall Street Journal, 2026US vs EU: the concrete differences
This is not a theoretical gap. The differences between US and EU formula standards translate directly into what is permitted in tins on US shelves today versus what is permitted in European formulas.
What hasn't changed yet
Operation Stork Speed is a review process, not a law. The FDA issued a Request for Information in May 2025, gathered public comment through September 2025, and is expected to release its report this month - April 2026. But a report is not a regulation. Any new enforceable standards will require a formal rulemaking process that typically takes years.
This means that right now, today, when you buy formula in a US store:
Lead and arsenic are unregulated. Corn syrup solids are permitted. DHA is not required. The hexane extraction of DHA is permitted under USDA organic certification. High iron levels that European regulators have flagged as concerning are standard. And the formula your paediatrician recommends is likely made to standards that were written before most parents now buying formula were in high school.
One of the most significant regulatory gaps the expert panel identified is the GRAS pathway - "Generally Recognised As Safe." Under US law, formula manufacturers can add new ingredients to formula if they determine those ingredients to be "generally recognised as safe" - without requiring FDA review or approval before going to market. The EU requires pre-market authorisation for all new formula ingredients. The US does not. This means parents in the US have been, and continue to be, unknowing participants in post-market ingredient safety surveillance.
What this means for parents today
Operation Stork Speed will, eventually, improve US formula standards. The expert panel recommendations are clear, science-based, and largely aligned with EU standards. If implemented, they would require DHA in all US formula, restrict corn syrup solids, set limits for heavy metals, and improve ingredient transparency. This is genuinely good news.
But "eventually" is doing a lot of work in that sentence. Regulatory change in the US is slow. And while the process unfolds, the formula on the shelf today is still made to 1998 standards. The gap between what the science says and what the FDA requires is still wide. And it is still parents - specifically parents who research formula at 2am - who are bearing the cost of that gap.
The practical implication is the same one that runs through everything on this site: EU-certified organic formula is not a premium lifestyle choice. It is a product made to a regulatory standard that the US FDA's own expert panel is now recommending the US adopt. The EU got there first. By about 27 years.
Operation Stork Speed is the most significant development in US formula regulation in a generation, and it is genuinely welcome. The expert panel's findings validate concerns about corn syrup, DHA, heavy metals, and protein levels that parents researching formula have been raising for years without official acknowledgment.
But the review is still a review. Until new standards are enacted and enforced, the formula landscape has not changed. EU-certified formulas remain the only option subject to a regulatory standard that reflects current nutritional science - not 1998 standards, not post-market GRAS safety surveillance, but a precautionary framework built around what we currently know about infant nutrition.
"Every formula we recommend meets EU standards the FDA is only now working to adopt."
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