WanaLawsuit? WanaBana.

by | Mar 13, 2024 | FDA, FOIA, Law Firms, Non-Profits, Pharmaceuticals

FOIAengine Spotlights a Non-Profit Newsroom and Another Problem for the FDA

The Food and Drug Administration was already under fire from Congress and others after hundreds of toddlers in 44 states were poisoned last year by lead-tainted pouches of apple puree and applesauce.

The FDA, alerted by authorities in North Carolina after toddlers became ill, was playing catch-up from the moment the scandal broke, three days before Halloween.  Lead levels were extraordinarily high in the children who were tested.

The agency sent out an alert about the pouches sold under the brand name WanaBana and various generic store labels.  The next day, WanaBana announced a voluntary recall.  Four children already were ill.  But neither the FDA nor WanaBana knew how widespread the problem was, or where the lead was coming from. 

The news kept getting worse.  By November 13, 22 children in 14 states were reported sickened.  A month later, it was 205 children in 33 states.  A few weeks after that, 287 cases in 37 states.  Then 354 cases in 41 states.  Then 468 cases in 44 states.  The numbers continued to rise.  What in the world was happening?  (The FDA posted a timeline here.)

The FDA official in charge of “human foods” had a theory.  “All of the signals we’re getting lead to an intentional act on the part of someone in the supply chain,” he told Politico in December.  “And we’re trying to sort of figure that out.”   

Sort of. 

Lawsuits were mounting.  Lawmakers on both sides of the aisle in Congress had heard enough.  They were demanding answers, summoning the FDA’s commissioner, Robert Califf, to explain how his agency failed to “prevent and detect illicit food contamination.”   There’s been no public hearing so far, and the FDA did not respond substantively to our questions or provide us with its response to the House members who complained.

This might have been dismissed as a rare outlier in the food safety net were it not for what happened next.  On February 27, the New York Times broke a blockbuster investigation based on “hundreds of pages of documents” showing “that in the weeks and months before the recall, the tainted applesauce sailed through a series of checkpoints in a food-safety system meant to protect American consumers.”  The Times article called it “the most widespread toxic exposure in food marketed to young children in decades.”

Notably, the Times had a reporting partner on its story: The Examination, a newcomer to the non-profit news world.  The co-bylined article explained the source of the lead poisoning:  cinnamon laced with toxic lead chromate.  The adulteration was attributed to a supplier in Ecuador.

“Time and again,” the Times story explained, “the tainted cinnamon went untested and undiscovered, the result of an overstretched FDA and a food-safety law that gives companies, at home and abroad, wide latitude on what toxins to look for, and whether to test.”  (For more background about the FDA’s food-and-drug inspection issues, see our story from last July 20, “Big Safety Questions About India’s Pharma.”)

After the Times story ran, the FDA updated its timeline to confirm the essential elements of the Times’ investigation.  Yes, “this was likely an act of economically motivated adulteration.”  The culprit was in Ecuador.  And, by way of excuse, “FDA has limited authority over foreign ingredient suppliers.” 

A documents-based story like this gets our attention, even more so when one of the players, like The Examination, is new on the scene.  

That’s where we’ll pick up the thread this week.  Although The Examination told us that the Times story was based on documents obtained from its reporting partner in Ecuador, rather than on FOIA documents, FOIAengine shows that the group currently has 13 other FOIA requests pending at the FDA and the Occupational Safety and Health Administration. 

On its website, The Examination calls itself “an independent non-profit newsroom that investigates preventable health threats and empowers people in harm’s way.”  The organization styles itself as the next wave in health journalism.  “In an age of cutbacks and retrenchment, many newsrooms worldwide lack even a single health reporter. The Examination partners with news organizations and engages with communities across the globe to help bridge the knowledge and accountability gap, exposing and explaining health risks and inequities, and pointing the way to possible solutions.”

Ben  Hallman, The Examination’s founder and executive director, told us in response to emailed questions that the start-up got on its feet last September with $3 million in funding from Bloomberg Philanthropies, the Pulitzer Center, and individual donors.  He didn’t provide specific amounts from each, and the public charities mentioned haven’t yet filed their 2023 information returns. 

Since The Examination hasn’t yet received its official 501(c)(3) designation from the Internal Revenue Service, it’s a “sponsored project” of Rockefeller Philanthropy Advisors, a nonprofit incubator that matches start-ups with donors. “This is a common arrangement in the non-profit sector, and among non-profit newsrooms,” Hallman said.

The group’s website lists 18 team members, most of them journalists and all working remotely (there is no main office).  The group is seeking a development director.  Hallman and Will Fitzgibbon, the co-author of the Times investigation, came over from the International Consortium of Investigative Journalists.  

In addition to its work with the Times, investigative stories have been published in collaboration with the Washington Post, the Guardian, and outlets in Africa, South America and Europe.  “Partnerships are core to our model,” Hallman said, “so we are always working on stories with other outlets.” 

According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, The Examination got busy with FOIA requests upon inception.  The group’s earliest FOIA requests were filed on September 8.  One replicated a 2022 FOIA request from London-based Bureau of Investigative Journalism, and sought contacts between the FDA and Dr. Matthew Holman, the chief scientist of Philip Morris International.  The other request sought “emails and other correspondence” to or from current FDA Commissioner Califf mentioning “revolving door” or “conflict of interest.” 

Most recently, and as a predictive signal about the story The Examination co-authored with The Times, the group filed numerous FOIA requests for documents underpinning the FDA’s WanaBana investigation. 

FOIA requests to the federal government can be an important early warning of bad publicity, litigation to come, or uncertainties to be hedged and gamed out.  We’ll be watching to see what comes next. 

To see all the requests mentioned in this story, log in or sign up to become a FOIAengine beta user

Next:  Hedge fund requests to the FDA. 

John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere.  He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis.  His most recent book is The Partisan: The Life of William Rehnquist.  Jenkins founded Law Street Media in 2013.  Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly.  FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller.  Learn more about FOIAengine here.  To review FOIA requests mentioned in this article, subscribe to FOIAengine.    

Write to John A. Jenkins at [email protected].