In the past seven months, there have been two outbreaks of infant botulism in this country, both caused by whole-milk infant formula. The first incident linked to ByHeart sickened 48 babies in 17 states, all of whom were hospitalized. I represent over 25 of those families. A second hospital affiliated with Nara Organics admitted three additional infants ages 2 to 5 months in California, Pennsylvania, and Washington, all treated with BabyBIG. I represent two of those families.
Two outbreaks. One ingredient. And now reports suggest there is likely the same upstream supply flow behind both. The contamination did not just happen to affect two unrelated companies. The system went through a chain that it missed the first time and missed again.
Here’s what’s eating me. None of this was surprising. On March 8, 2023, two years before the first ByHeart baby got sick, the FDA call to action letter The following name was given to the entire powdered milk industry, signed by the chairman and the director of the Food Safety Center. Clostridium botulinum Classify them by genus and species and instruct manufacturers to control them throughout the chain. 2 years later, below stork operation speedThe agency said it would further test the formula and its ingredients against spore-forming bacteria. C. botulinum Among these, we have begun sampling for problematic dairy ingredients. However, there are still no rules requiring whole milk formulas to be tested for botulinum before shipping. The risks were predictable. The regulator named it twice in writing. And our federal regulations still require final powder testing for only two organisms. salmonella and Chronobacter. There are no botulinum standards for powdered milk. Sealed cans of liquid powdered milk have a complete low-acid canned botulism regime. Powder barrels get nothing. That’s the hole these babies fell into.
Over the past few days I have done what I can. I wrote.
i wrote Open letter to Secretary KennedyBecause on June 2, he toured a powdered milk factory and on the same day praised whole milk, which was the vector of both outbreaks. He met CEOs. He never met his parents. I asked him to fix it.
i wrote Letter to Acting Director Kyle DiamantasThat’s because before he put pen to paper at the FDA, he spent years defending infant formula manufacturers against claims of failure to warn. He, of all people, knows what warning is and what predictability means. I asked him to write down the standards of care in the rules. It’s about testing and inspecting the entire chain, not just the last can in the line.
and i wrote Support for HR 7867Added family comments as an appendix to the Infant Formula Safety Modernization Act. Because this bill fills the exact gap that allowed these babies to get hurt, and a second outbreak occurred while the bill was already pending.
I believe that letter. But I’ve been doing this for 33 years and I want to be honest with you about what I’ve learned along the way. The point is that the letter appeals to someone’s discretion and that discretion can be ignored without consequence. Little reform has occurred in this country because a lawyer wrote a persuasive letter. It arrived just as Jack in the Box had put enough sick children in the news that the USDA had to declare it. E. coli O157:H7 An impure person. It was born when doing nothing, with enough people in enough places at the same time, became the more difficult choice.
Now I know why I am writing this to you.
There are about 55,000 of you who read food safety news. And you are not an ordinary crowd. You are former and current regulators, public health researchers, epidemiologists, plaintiffs and advocates, quality industry people who have walked through these factories, journalists, academics, and parents who have lived through the worst of times. Overall, you know more about how to actually work this system than anyone else, including me.
I want to ask you a practical question, not a rhetorical one. What’s your next move?
Here’s where my head is in preparation for the pump. Please let me know what I did wrong and what I am lacking.
• Official Citizen Petition Added per 21 CFR § 10.30 C. botulinum and bacillus cereus § 106.55 requires upstream sampling of dairy ingredients. This document is included in a list of documents to which the agency is legally obligated to respond and where the public can participate.
• Congressional Hearings with Parents on the Witness TableSworn testimony to “meet the family” not only at the discretion of anyone but also the bill.
• Supply Chain Tracking Through lawsuits and public records, the story of shared suppliers is a documented fact, and not just the brands on the can, but the entire chain understands the cost of keeping the gap open.
• an unlikely union We call for the same fix: the American Academy of Pediatrics, the Institute of Public Health, responsible manufacturers who have already voluntarily tested for spore formers, and a state attorney general or two.
• GAO or HHS Investigator General Review There are systemic findings that will outlast any administration, with testing gaps and cuts to prosecutorial resources.
That’s my list. I’m sure it’s incomplete. Perhaps the best idea is one that I haven’t thought of and one that one of you already has. Maybe it’s a statewide testing requirement. Maybe it’s an internal industry phenomenon that can’t be seen from the outside.
Please tell me. Please send me an email. bmarler@marlerclark.com Under the title ‘Next Move’ I will read them all, print the best of what you send on subsequent publisher platforms, credited or anonymously if you wish, and then act upon them.
The risk has been named 2023. We haven’t buried the baby yet. Fortunately, we filled so many hospital beds twice. It was written down by the government years before the danger arrived. I wrote a letter. Now please help me figure out how to get someone to answer the question.
