For months, we've been tracking two devastating infant formula botulism outbreaks that left dozens of babies severely ill, raising critical questions about acco
For months, we've been tracking two devastating infant formula botulism outbreaks that left dozens of babies severely ill, raising critical questions about accountability.
What did the U.S. Food and Drug Administration know, when did they know it, and could these hospitalizations have been prevented?
Our latest investigation exposes a gaping flaw in the agency’s oversight. While federal officials were actively investigating the outbreak, the FDA was simultaneously conducting what it touted as the largest-ever study of infant formula safety.
Yet, the agency completely excluded pathogens — including the very bacteria that causes botulism — from its testing. Despite omitting the toxin, the FDA publicly declared the nation’s baby formula supply safe.
The public reaction was immediate and fierce.
Within days of our report airing, nearly a million views, and we were flooded with thousands of comments expressing outrage, frustration, and deep disappointment.
The timeline of the agency's actions reveals a stark disconnect. While 52 infants were hospitalized, some paralyzed and rushed on stretchers to emergency care, the FDA’s high-profile safety report was quietly excluding the exact threat causing the crisis.
"I expect them to protect babies," said Katie Connolly, whose baby girl recovered from paralysis during the outbreak, joining dozens of impacted families now demanding answers from federal regulators.
The FDA says it is still investigating the root cause of the botulism outbreak that sent babies, like Katie Connolly's 8 month old daughter into intensive care units across the country. Photo: Connolly FamilyAs public pressure mounts, readers and viewers across the country are echoing that call, demanding answers from the nation's top food safety regulator.
Our investigations have been trying to track down answers from the FDA.
The same day our story aired, the agency again rejected our request to quickly release records about the supply chain associated with the outbreak, saying we didn't demonstrate an urgent need for the information to be released. We're continuing to press for it.
Pressure is mounting elsewhere.
On Capitol Hill, Rep. Rosa DeLauro introduced legislation that would not just require formula makers to test for the toxin that causes botulism, but also put strict monitoring requirements in manufacturing plants and inform Congress if a pathogen is found.
Congresswoman Rose DeLauro says she's tired of requests and recommendations and wants a federal law that requires botulism testing for infant formula. Photo: SBGDeLauro told us she's done relying on letters, instead of laws, to protect babies.
I’m tired of recommended guidelines and voluntary procedures," she said. "We have seen such an outbreak, and two in one year. We need to move with mandatory procedures.
Food safety attorney Bill Marler, who represents families of infants afflicted by the botulism outbreak, says he knows the congressional silence all too well.
Marler has sent multiple formal letters to key committee members, urging lawmakers to support new oversight legislation, meet with affected families, and call formal hearings to put both formula manufacturers and the FDA on the record.
Two back-to-back outbreaks of botulism in infant formula sent 52 babies to the hospital, some of whom were in ICU and on breathing tubes. Photo: SBGTo date, he said those letters have gone entirely unanswered.
Days ago, Marler’s team escalated their efforts, walking the halls of Congress to deliver baby bottle-shaped T-shirts directly to the offices of all 77 target representatives as a stark visual reminder that protecting infants from deadly pathogens should transcend partisan politics.
T-shirts shaped like baby bottles were given to all 77 members of Congress who have the ability to move bills forward that would require botulism testing on infant formula.Not every mother can breastfeed, and infant formula has to be an option," said Sydney Marler, who spent several days on the Hill doing outreach. "In order for that to happen, it needs to be tested for botulism after these outbreaks.
Sydney Marler, of the law firm Marler Clark, spent two days on the Hill asking lawmakers to support the bill that would require infant formula companies to test for botulism. Photo: SBGWe contacted every lawmaker on the House and Senate Committees with the power to move this legislation — more than 70 of them — and asked two questions: Will you support the bill requiring infant formula to be tested for pathogens including botulism? And will you push for a Congressional hearing to investigate the outbreaks?
Only one member, Massachusetts Rep. Lori Trahan, out of the 77 with influence over this bill, responded. Trahan supports the bill.
"Those are the sorts of things that government officials in the industry want to ignore because they're hard," Marler said. "But that's the kind of thing that creates change."
We also asked the FDA for an interview, and whether the agency would commit to testify before Congress about its investigation if called.
It did not respond.
.DeLauro said public pressure will move the bill forward.
"The public needs to be on its feet because it is about the safety and the lives of newborns," she said.
To find contact information for your local lawmaker to weigh in on the bill currently in Congress, click here.
The FDA said the root cause of the botulism remains unknown. We continue to examine the supply chain and outbreak investigation.
