Bill Marler Cites 48 Infants in Fda Infant Formula Safety Results
Bill Marler used fda infant formula safety results to argue that the federal response to formula contamination has moved too slowly for families relying on powdered infant food. The food safety lawyer and columnist said he has spent more than three decades suing the food industry and wrote that the infant formula industry has a catastrophic safety problem.
He pointed to two outbreaks: the 2022 Abbott crisis and the ByHeart outbreak tied to infant botulism in fall 2025. By February 2026, 48 infants had been hospitalized across 17 states in the ByHeart outbreak, and all 48 required treatment with BabyBIG.
Abbott Sturgis And The 2022 Recall
Marler said the FDA received the first complaint in September 2021 about the Abbott infant formula issue, but the recall did not come until February 2022. He also said Abbott Nutrition’s Sturgis, Michigan, facility had internal records documenting the destruction of product contaminated with Cronobacter sakazakii.
In the same account, he said the FDA had not inspected Abbott’s Sturgis plant in two years before the 2022 crisis. Four infants became ill with Cronobacter in that outbreak, two died, and one child was sick with Salmonella.
Marler quoted himself saying, “the first Cronobacter case — a pathogen so rare and so strongly associated with powdered infant formula that any good epidemiologist should have treated it as a four-alarm fire — should have been enough for the FDA to move immediately.”
ByHeart Whole Nutrition In 2025
Marler said the fall 2025 outbreak was linked to ByHeart Whole Nutrition infant formula. He said Clostridium botulinum was detected in opened and unopened cans of ByHeart formula and in a powdered milk ingredient.
He also said FDA inspectors had visited ByHeart’s Iowa facility in 2022 and found Cronobacter sakazakii near the milk dryer, along with microcracks in equipment that could harbor bacteria. He added that the company had a prior Cronobacter recall in 2022.
That record left him with a direct conclusion. “We are the wealthiest nation in the history of human civilization,” he wrote, followed by, “We can make infant formula safe.”
Bill Marler On FDA Oversight
Marler’s column tied the two outbreaks to a broader failure in oversight, saying the federal government had been too slow, too timid, and too deferential to industry to fix the problem. He said, “I represent over one half of the infants.”
The practical takeaway for families is narrower than the broad policy argument: the safety record Marler described centers on two plant inspections, two recalls, and outbreaks that reached infants in multiple states. His column does not describe a new federal rule or a fresh recall, so the unresolved issue is whether the FDA will move faster after a second large contamination episode has already produced hospitalized infants across 17 states.
