An infant formula industry with a catastrophic safety problem has again put babies at risk, and the federal response has still not matched the scale of the danger. A Food Safety News column argues that the system remains too slow, too timid and too deferential to industry to protect infants after years of warnings, recalls and preventable harm.
The evidence is no longer abstract. In 2022, Abbott Nutrition's Sturgis, Michigan, facility had internal records documenting the destruction of product contaminated with Cronobacter sakazakii, while the FDA had not inspected the plant in two years. In that same Abbott-related incident, four infants became ill with Cronobacter, two died and one child was sick with Salmonella. The FDA received the first complaint in September 2021, but the recall did not come until February 2022.
That delay matters because infant formula is not a niche consumer product. It is food for the youngest and most vulnerable babies, including those who cannot be breastfed or who rely on formula for survival. When the safety system fails here, the consequences are measured in hospitalizations and deaths, not in inconvenience or market share.
The same pattern showed up again in the fall of 2025, when a multistate outbreak of infant botulism was linked to ByHeart Whole Nutrition infant formula. By the time the CDC declared the outbreak over in February 2026, 48 infants across 17 states had been hospitalized, and every one of them required treatment with BabyBIG, the only antitoxin for infant botulism. That treatment exists solely because California developed and maintained it, a reminder that the country still depends on a patchwork solution for a national problem.
ByHeart's history makes the second outbreak harder to dismiss as an isolated mistake. FDA inspectors visited its Iowa facility in 2022 and found Cronobacter sakazakii near the milk dryer, along with microcracks in equipment that could harbor bacteria. The company also had a prior Cronobacter recall in 2022. Later testing detected Clostridium botulinum in opened and unopened cans of ByHeart formula and in a powdered milk ingredient, undercutting any argument that the contamination was limited to a single container or a single bad lot.
The clash here is plain. Regulators have repeatedly been shown what can go wrong, yet the response has stayed reactive, slow and narrow. A plant can go two years without inspection. Complaints can sit for months before a recall. Prior contamination can be documented, then followed by another crisis. That is not a system designed to catch failures early. It is a system that waits until infants are already sick.
Marler's argument is blunt: infant formula safety needs fixing now, not after another outbreak. The record from Abbott and ByHeart answers the headline question directly. The FDA infant formula safety results are not reassuring. They show that the current system has failed to keep pace with the risk, and babies are paying for that failure.