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Spotlight on America asks the question FDA still hasn’t answered: How did botulism get into infant formula?

By Bill Marler on October 5, 2026
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Lisa Fletcher, Andrea Nejman and Nathan Aaron at Spotlight on America have kept digging on the ByHeart and Nara infant formula botulism outbreaks long after most of the press moved on. Their latest piece asks the question that matters most. Fifty babies were hospitalized and two brands were implicated, so where did the toxin come from?

The answer, three years after the first infection, is that nobody knows. According to the reporting, internal FDA documents show the agency traced the milk back to 22 dairies but never publicly identified them. Spotlight found no evidence that FDA sent investigators to those farms, even though a recent WHO panel identified the farm as the place where botulism risk begins. ByHeart told the reporters it had no visibility into which farms its supplier used, and Nara did not answer questions about its milk sources.

Barbara Kowalcyk, who lost her son Kevin to E. coli in 2001 and now directs GW’s Institute for Food Safety and Nutrition Security, called the traceability system broken. She had a pointed suggestion for manufacturers who can’t trace their own ingredients: “please go sell T-shirts instead.”

I’d add two things.

First, if you never go to the farm, and you never tell the public which farms were involved, you never find the root cause. If you never find the root cause, you get the next outbreak.

Second, testing for C. botulinum in infant formula is still not required. H.R. 7867 would change that. Congress got baby bottles and T-shirts from us last month as a reminder. It’s time to pass it.

Kudos to Spotlight on America for staying on this story.

Photo of Bill Marler Bill Marler

Bill Marler is an accomplished personal injury lawyer and national expert on foodborne illness litigation. He began representing victims of foodborne illness in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the Jack in the Box E. coli O157:H7…

Bill Marler is an accomplished personal injury lawyer and national expert on foodborne illness litigation. He began representing victims of foodborne illness in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the Jack in the Box E. coli O157:H7 outbreak, resulting in her landmark $15.6 million settlement. That case is the subject of the book Poisoned and the Emmy Award-winning Netflix documentary of the same name. Marler founded Food Safety News in 2009, and teaches food safety at the Harvard T.H. Chan School of Public Health.

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  • Posted in:
    Administrative and Regulatory, Food, Drug & Agriculture
  • Blog:
    Marler Blog
  • Organization:
    Marler Clark, Inc., PS
  • Article: View Original Source

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