A few months ago, I was scheduled to meet with the House and Senate Safe Food Caucuses in Washington, D.C., and suffered a heart attack the night before I was scheduled to speak. I’m doing great. After receiving excellent care at Howard University Hospital and making a few lifestyle adjustments, I returned. But as I lay in my hospital bed, I kept thinking about the babies who weren’t so lucky. Babies are hospitalized across this country because the formula their parents believed would keep them alive was contaminated with deadly pathogens that could, and sometimes could, kill them.
I have spent over 30 years litigating cases against the food industry. I sat across the table from parents who watched their children die. E. coli, salmonella or Listeria. I have seen what happens when systems fail the most vulnerable among us. And I am here to speak clearly and without ambiguity. The infant formula industry has critical safety problems, and the federal government has been too slow, too timid and too lenient on the industry to address them.
Let’s be honest about what happened.
In 2022, the United States faces an infant formula crisis that has revealed some very shocking revelations. Abbott Nutrition’s Sturgis, Michigan facility had internal records documenting the disposal of contaminated product. Chronobacter Sakazaki— and the company didn’t tell anyone. The FDA hasn’t inspected the plant in two years. Four infants became ill. Chronobacter. Two people died. a child was sick salmonella. Abbott acknowledged finding evidence that: Chronobacter It has publicly denied that contaminated recipes reached consumers in areas that did not come into contact with the factory’s products. The FDA received its first complaint in September 2021. The recall wasn’t until February 2022. 5 months. Five months while sick babies piled up.
I said it for the first time then. Chronobacter The case – a pathogen so rare and so closely associated with powdered infant formula that any competent epidemiologist would treat it as a four-alarm fire – would have been enough for the FDA to take immediate action. It wasn’t like that.
It seems we have learned nothing.
In the fall of 2025, Vietnam witnessed several provinces experiencing infant botulism outbreaks linked to ByHeart Whole Nutrition infant formula. By February 2026, when the CDC declared the outbreak over, 48 infants were hospitalized in 17 states. All 48 required treatment with BabyBIG, the only antitoxin for infant botulism. This antitoxin exists because California had the foresight to develop and maintain it. No children died. And that fact does more to account for the presence of the antitoxin and the vigilance of California public health officials than anything the FDA or the baby formula industry did to prevent contamination in the first place. I represent more than half of the infants.
Here’s what we know: Clostridium botulinum It was detected in opened and unopened cans of By Heart powdered milk and in powdered milk ingredients. FDA investigators visited ByHeart’s Iowa facility in 2022 and made the discovery. Chronobacter SakazakiNear the milk dryer. They pointed out microcracks in the equipment that could harbor bacteria. The company in advance Chronobacter It was recalled in 2022 and received an FDA warning letter in 2023. However, this formula is still available in the market. The infants continued to be sick with botulism. Cases were followed until December 2023 after the case definition was expanded.
Let me put it bluntly: We are experiencing systemic failure. It is not the failure of one company, but the company bears a great deal of responsibility. This is a failure of the entire regulatory structure that treats, and parents assume, powdered infant formula, the product fed to the most immunologically vulnerable humans on the planet (primarily consumed from day one), as anything other than a sterilized, rigorously tested and constantly scrutinized product.
Powdered infant formula is not a cracker. It’s not cereal. For many babies, this is the only food they consume. Parents who open a can of formula for their newborn and mix it with water are placing absolute trust in the company that made it and the government that allowed it to be sold. That trust has been broken repeatedly by the same pathogens in the same vulnerable populations, in completely predictable and often preventable ways.
In March of this year, Rep. Rosa DeLauro (CT-03) Infant Formula Safety Modernization ActThis is comprehensive, bipartisan legislation to modernize federal oversight of America’s infant formula supply and address long-standing gaps in testing, transparency, and regulatory enforcement.
Building on the work of our House members, here’s what we need to do: It’s not radical. I am rational:
Like liquid infant formula, powdered infant formula must be commercially sterilized. full stop. The technology exists. Other products also require it. The argument that infertility is technically and commercially difficult does not impress me when the alternative is babies on ventilators and feeding tubes. If a company cannot produce sterile products for infants, it should not produce infant formula. Leave it to the industry to figure out how to achieve this (retorting, reconstitution, whatever works). But set standards and enforce them.
Mandatory premarket testing is required. Before a can of powdered infant formula hits store shelves, its ingredients must be tested by an independent, accredited laboratory, not the company itself. C. botulinum, Chronobacter Sakazaki, salmonella, bacillus cereusand other related pathogens. Tests must be statically robust, both in the product and in the environment. Current voluntary and largely self-reporting systems are inadequate. Failed. You will fail again.
FDA inspections must be conducted on a regular, unannounced basis, and food safety must be fully funded. It is unconscionable that there is a two-year gap in testing at the Abbott Sturgis facility while infants are sick. FDA is required to inspect all infant formula manufacturing facilities on a regular, mandatory schedule. When an inspector finds microcracks in a milk dryer. Chronobacter There should be immediate, mandatory follow-up to confirm resolution, not a warning letter or hope that the company will follow through, as was the case with ByHeart in 2022. We also need a dedicated funding stream for food safety and getting DOGE Bros out of public safety.
Real risk assessments and updated regulations are needed. FDA’s existing framework for powdered infant formula is not designed to: C. botulinum As a major threat. Hopefully, the ByHeart outbreak will change that calculation. We need comprehensive and well-funded risk assessments. C. botulinum spore, Chronobacter Sakazaki, salmonellaand bacillus cereus Infant formula and its components – raw milk, pasteurized milk, dairy powder. We need to understand the pathways of contamination, assess whether current detection methods are sensitive enough, and determine where in the supply chain spores enter products.
I have repeatedly heard that more regulation will harm innovation, burden small producers and increase costs for families. I have heard these claims in every industry I have litigated. This is the same claim the beef industry made before the USDA made its declaration. E. coli O157:H7 An impure person. The industry adjusts. Innovate. Once standards are implemented, find ways to meet them. And today we rarely see it. E. coli Outbreaks associated with beef.
In conclusion, 48 infants and young children were hospitalized due to an outbreak of Bayhart. All of them were fed formula that their parents believed was safe because the companies and the government said it was safe. All babies were between 16 and 264 days old. Some were newborns. These were people fighting for their lives in intensive care units after just a few days of birth.
We are the richest nation in the history of human civilization. We spend countless billions of dollars on war, artificial intelligence, ballrooms and arches. You can make safe infant formula. So far we have decided not to undertake the rigorous regulatory work required to ensure this.
I am finally asking us to choose differently.
Babies in hospital beds cannot advocate for themselves. Their parents, exhausted and frightened, can barely stand up for themselves. That’s why the rest of us should, too.
William “Bill” Marler has been a food safety attorney and advocate since Jack-in-the-Box in 1993. E. coli The outbreak was documented in the book “Poisoned” and the recent Emmy-winning Netflix documentary. The billing operation was featured in the New Yorker’s “A Bug in the System.” Seattle Times, “30 years after fatal incident E. coli Outbreak, Seattle Lawyers Still Fighting for Food Safety.” The Washington Post (WP) reported, “He helped make hamburgers safer, and now he’s fighting food poisoning again.” And a few others.
