Thanks to my great clients for being willing to tell their stories. It put what the FDA does – and does not do – in context.
‘If I had heard about the problem even one week earlier … life today would be very different.’
Peter Ebb holds get-well cards he received in 2017 following a food-related illness. Ebb was critically sickened after consuming I.M. Healthy SoyNut Butter, surviving a food illness that sent his kidneys into failure. | M. Scott Mahaskey/POLITICO
People had been getting sick from eating I.M. Healthy Original Creamy SoyNut Butter for more than two months when Peter Ebb, a 59-year-old Boston lawyer and health enthusiast, went for a run and then ate his usual gluten-free English muffin smeared with soy nut butter.
Later that morning — March 6, 2017 — Ebb saw a message from Amazon, which had sold him the nut butter, that the manufacturer had recalled it for contamination by E. coli bacteria. Ebb threw away a protein drink he had made with the soy nut butter, but didn’t worry too much. The Food and Drug Administration warning that was linked to the email was worded very cautiously: Though serious illnesses might result, even potentially leading to death, “most healthy adults can recover completely within a week.”
Six days later, Ebb was hospitalized and developed a deadly type of kidney failure. Within days, doctors told his wife to send for their children in case they needed to bid him a last goodbye. He survived, but remains unable to work full time and has trouble climbing the stairs. Now, he’s joining with 18 other victims to file claims against the companies responsible and call attention to the inadequacy of the nation’s recall system.
“If I had heard about the problem even one week earlier and stopped then, I might have been able to avoid the disease completely, and life today would be very different,” Ebb said.
A POLITICO investigation found that the I.M. Healthy SoyNut Butter case — which officials at the FDA and the Centers for Disease Control and Prevention have hailed as an improvement over past failures — was nonetheless emblematic of persistent weaknesses in the nation’s food-safety system, some of which haven’t been corrected for two years after being flagged by the agency’s inspector general.
Two months elapsed between the first person sickened by eating I.M. Healthy SoyNut Butter on Jan. 4 and the recall orders that began on March 3 and expanded three more times until March 10. The FDA, working through a national network of labs that identifies outbreaks, pinpointed the contamination on Feb. 22. The nine-day lag time in persuading the manufacturer to begin recalling the tainted products was a significant improvement over previous lag times — which were as high as 165 days in one infamous case, according to the inspector general. But victims maintain that the FDA should have ordered a recall on its own authority, given that a few days or even hours can make a difference in a deadly outbreak.
“They have the authority to mandate a recall and, in theory, that would go more quickly than a voluntary recall,” said Sandra Eskin, who directs food safety at the Pew Charitable Trust. The FDA has used its authority to order recalls only three times since 2011. Instead, it usually waits to give companies time to decide whether to pull a product from shelves voluntarily.
There were complications, as well, in alerting customers to the fact of the recall. The FDA did not identify which retailers sold the contaminated batches of products. (The agency has traditionally considered this information to be trade secrets, and left it to manufacturers to alert retailers.) Thus, customers who saw only the FDA’s recall notice had no way of knowing whether the products they bought were among those that were contaminated.
“They just did not effectively execute the recall,” said Eskin. “You really have to monitor where the product is sold and reach out to the sellers online.”
Indeed, the contaminated products remained available for months afterward. Linda Harris, a food-safety microbiologist for the University of California at Davis who researched the case for the victims, said she was able to buy a three-pack of I.M. Healthy Original Creamy SoyNut Butter on Amazon in September, five months after the recall. In addition, some stores either missed or ignored the recall and kept the product on the shelves, Harris discovered.
Part of the problem, critics contend, was a lack of urgency: The cautious language of the FDA’s warning didn’t mention potential illnesses until the third paragraph, and the only instruction offered was to return the product to the place it was bought to receive “a full refund.”
“Amazon didn’t provide the information about the seriousness of the recall and the reason,” contended Sarah Sorscher, deputy director of regulatory affairs for the Center for Science in the Public Interest. “You should not have to click through to a government website while you’re eating breakfast to find out that you have a deadly product in your kitchen.”
The weaknesses in the soy nut butter case were all the more notable because they came 8½ months after the FDA’s inspector general declared that it lacked adequate procedures for handling food outbreaks.
“We found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply,” Inspector General Daniel Levinson wrote on June 8, 2016. “This issue is a significant matter and requires the FDA’s immediate attention.”
Now, more than two years after the IG’s warning, the agency is still updating its procedures. In congressional hearings and blog posts earlier this year, FDA officials have pledged to take specific steps to improve the recall system, including a proposed rule to alert the public to dangers before recalls are announced. Among the other changes promised include revealing which retailers sold the tainted products “in certain cases,” developing a database to help the agency identify contaminated products and requiring companies to issue public warnings more quickly.
Meanwhile, the Trump administration, seeking to improve safety standards, proposed in mid-June consolidating all food-safety functions in a new agency within the U.S. Department of Agriculture as part of a broader reorganization that would require congressional approval. But few observers expect any congressional action in the near term.
In a statement to POLITICO, FDA Commissioner Scott Gottlieb, who took over the agency in May 2017, just after the soy nut butter recall, stressed his commitment to improving the current system.
“When the FDA learns about potentially unsafe foods in the marketplace, we must act quickly to keep people from getting sick or being harmed,” Gottlieb wrote. “The FDA is taking several policy steps this year as part of a broader action plan to further improve our oversight of food safety, and ensure that all food recalls are initiated, overseen, and completed quickly and effectively to best protect consumers. These and other efforts will increase transparency, empower consumers and ultimately lead to fewer potential recall situations with less people getting sick from contaminated food.”
Ten-year-old Mason Stoll began showing digestive symptoms suggestive of a food-borne illness on Jan. 7, 2017. Within four days, the boy was admitted to Johns Hopkins University Hospital, where his father, Bob, works as a project manager in the Applied Physics Laboratory.
Pretty soon, Mason was clinging to life with complications so severe that he coded four times. As he fought for his life, his parents began speaking with Maryland State Department of Health officials, trying to locate the cause of the contamination and passing on information about everything Mason had eaten, including the soy nut butter.
Like many of the families whose relatives were poisoned by contaminated I.M. Healthy Original Creamy SoyNut Butter, the Stolls were familiar with the threats posed by digestive illnesses: Many of the victims were eating soy nut butter because they had food-borne allergies or diseases like Crohn’s that left them unable to eat nuts or dairy products. For his part, Mason was allergic to peanuts, dairy and eggs. The Stolls were comfortable navigating the public-health bureaucracy. Like other families who spoke to POLITICO, they moved quickly on their own initiative to brief local officials and eventually the CDC, sharing receipts and providing detailed information about the foods they consumed.
More than three weeks after Mason began feeling sick, on Jan. 30, an 8-year-old boy named Trevor Simmons entered a hospital in Santa Clara, California, suffering from E. coli poisoning.
Trevor’s mother, Erin Parisi Simmons, said she spoke within two days to the Santa Clara Health Department and discussed possible sources of the illness. When his condition worsened, Trevor was moved to the intensive-care unit of the Stanford Medical Center. Erin Parisi Simmons recalled with chagrin that she unsuspectingly brought I.M. Healthy Original Creamy SoyNut Butter to the hospital on two different occasions to try to entice Trevor to eat, because it was his favorite food. Fortunately, he was too sick even to take a bite.
Mason Stoll, 10, was sickened for 14 months after eating tainted soy spread. He is now on a kidney transplant list. | John Shinkle/POLITICO
Around the same time, a Seattle woman named Nicole Cash purchased soy nut butter for her 11-year-old son, Oliver, and 8-year-old daughter, Hannah: Because of Oliver’s peanut allergy, the soy nut butter was a family staple. By Feb. 21, Hannah was experiencing diarrhea so severe that Nicole had to put her in diapers; when Hannah said she had blood in her stool and began vomiting uncontrollably, Nicole rushed her to the hospital.
Within a few days, Hannah was experiencing kidney failure and had to go on dialysis, and Nicole was talking to the CDC about what products might have made the girl so sick.
On March 2, Nicole had her answer, via an unlikely source: A closed group of people on Facebook who were posting reports about the E. coli outbreak said it was caused by soy nut butter, a day before I.M. Healthy began its first recalls.
At the same time, Maryland state officials told Mason Stoll’s family that his E. coli poisoning was caused by I.M. Healthy Original Creamy SoyNut Butter, which contained fecal matter. And California officials delivered the same news to Erin Parisi Simmons.
On March 3, the SoyNut Butter Company began its series of voluntary recalls. Even then, the recalls applied only to products with best-by dates of Aug. 30 and 31, 2018. More batches of soy nut butter were recalled the following day, March 4, and the recall was expanded again on March 7 and 10.
The FDA launched an inspection of the facility in which the soy nut butter was made by a food services company called Dixie Dew. Inspectors were at the Dixie Dew facility from March 3 through March 15, finding that it had rodent droppings, a sink that had not had hot water running in two years and an infestation of flies.
FDA records show that it wasn’t until March 28 that the agency finally suspended operations at the Dixie Dew facility.
Even though the FDA announced that the recall was completed by May 4, batches of the tainted products remained on sale through the fall. Over Labor Day weekend, Harris, the University of California at Davis food-safety microbiologist helping lawyer Bill Marler, who represents 19 victims, bought a three-pack on Amazon for $40. Once she received it, she notified Amazon and the state of California.
“It was a complicated recall, in part because it was a small company,” said Harris. “It still was a product that should not have been on the market.”
The vendor selling the nut butter contacted Harris to tell her that the specific jars she purchased were not affected. Harris had to explain that they were, indeed, part of the lot that was recalled. Amazon pulled the nut butter from its site by the Tuesday after Labor Day.
“They did not scroll to the bottom of the website and click to the link that said expanded recall,” Harris said. “When there are these complex recalls that happen in stages, you can’t have the notice of the expanded recall at the bottom of the page.”
Then, in October, Harris found another online retailer selling the nut butter and contacted FDA. The agency ensured that it was removed quickly. But it took until Oct. 13 for the FDA to issue a statement that read “FDA Reminds Public that All I.M. Healthy Soy Nut Butter Products are Recalled.” The notice added that “retailers cannot legally offer for sale” the product.
The FDA said it responded promptly once it learned that the recalled products were being offered for sale.
The FDA launched an inspection of the facility in which the soy nut butter was made by a food services company called Dixie Dew. Inspectors were at the facilities from March 3 through March 15, 2017, finding that it had rodent droppings, a sink that had not had hot water running in two years and an infestation of flies. | M. Scott Mahaskey/POLITICO
“The agency worked quickly to locate any remaining products to ensure they were no longer available to consumers and we put out a public notice to remind consumers of the dangers of these recalled products,” an FDA spokesman wrote in an email.
While the recall may be over, most of the victims are still dealing with long-term health effects and the trauma the experience left on their families.
After Peter Ebb left the hospital on March 30, his family had to reconfigure their house because he has trouble taking the stairs. He remains anemic and his kidneys have not returned to normal. “It’s definitely been a life-changing event, one of the worst,” said his wife, Fran Green.
Nicole Cash’s daughter Hannah has largely recovered, but she still has annual checkups to make sure there are no lingering complications. The Cashes, who are Australian, have reconsidered why they are living so far away from family.
Erin Parisi Simmons said her son is still being seen regularly by Stanford University’s nephrology department and is struggling with post-traumatic stress disorder. Her family is trying to stitch itself back together: She said she lost her tech job because her company was taken over while she was caring for her son. Her husband is trying to restore his stature within his company since some colleagues did not understand why he was off for so long. And their older son is still struggling with feelings of abandonment because his parents spent so much time caring for Trevor.
Bob Stoll reports that Mason’s 14 months of illness have depleted the family’s savings. Mason returned to school full time in April. On June 26, he had cervical spine surgery. And they’re preparing for a kidney transplant in their son’s future.
“It has had an emotional impact,” said Bob. “We’re just trying to piece together what normal looks like again.
In the months after the outbreak, Marler, the victims’ attorney, filed four lawsuits in federal court in Chicago, after which both the SoyNut Butter Company and Dixie Dew declared bankruptcy. Now, the 19 victims represented by Marler are applying to bankruptcy court to divide up $12 million in insurance and assets. After that, Marler said, he plans to file suit against the retailers and shippers who provided the products.
Terrence Guolee, the lawyer representing the SoyNut Butter Company, said that his client only handled marketing and that Dixie Dew handled the manufacturing.
“My client’s company shut down within a couple of weeks of being notified by the CDC as to what happened because they couldn’t survive any further,” Guolee explained.
Dixie Dew did not respond to requests for comment through its lawyer.
An Amazon spokesperson said in an email that “Customer safety is our highest priority. Third-party sellers are required to comply with all relevant laws and regulations when listing items for sale on Amazon. When sellers don’t comply with our terms, we work quickly to take action on behalf of customers.”
The spokesperson noted that after FDA sent out its March recall, Amazon immediately stopped selling the soy nut butter. Then, six months later, when a third-party seller evaded Amazon’s systems and offered the item again for sale, Amazon took the item down, took action against the seller and notified customers.
While Marler is targeting the companies involved, he also has choice words for the FDA, particularly over its failure to publicize the retailers who sold the tainted products.
The FDA suspended Dixie Dew’s food facility registration on March 28, 2017, shutting down the company’s food processing plant in Erlanger, Ky., where it manufactured soy nut butter products. An office in the now-closed facility is pictured in April. | M. Scott Mahaskey/POLITICO
“This is, in my view, a classic failure of the FDA’s recall system,” he said. “When you don’t have full transparency, there’s confusion not only from consumers — retailers fall into the same trap. They either ignored the warnings or they simply didn’t understand the recall notice.”
In most cases, the FDA does not publicize the stores, restaurants or online retailers that sold contaminated food, a policy that has raised the ire of some members of Congress. “The primary goal of the FDA is to keep food safe,” declared Rep. Rosa DeLauro (D-Conn.). “FDA’s mission is not to protect the trade secrets of corporations.”
The FDA policy is especially perplexing since the U.S. Department of Agriculture, which is responsible for the safety of meat and poultry, changed its own policy against disclosing retailers nearly a decade ago.
Former USDA Under Secretary for Food Safety Richard Raymond recalls taking on the Grocery Manufacturers Association and other big food lobbies to get the policy changed. “Most of the people at USDA said ‘You won’t get this done. You’re wasting your time,’” said Raymond. “The FDA does not have to replow new ground. It was plowed by me.”
Gottlieb, the FDA commissioner, suggested in a statement that his agency is moving toward providing more information about retailers.
“Following on our commitment earlier this year to improve our oversight of food safety and how we implement our recall authorities, the FDA will soon issue guidance on additional information the FDA will now make available during certain recall notifications,” Gottlieb wrote. “Note that the agency recently released detailed distribution information by state for the outbreak linked to pre-cut melon so consumers could better know how to avoid the hazardous recalled food.”
As to lessons learned from the soy nut butter case, he wrote: “Anytime there’s a serious outbreak and consumers are hurt the answer is that we could always have done better. We won’t be able to prevent every outbreak and prevent every consumer from being at risk of a food-borne illness but our aim is a system that continues to reduce these risks and we strive toward that goal. I believe we’re heading in the right direction and over time we will see the benefits of our efforts.”
The Trump administration’s proposal to combine all the government’s food-safety functions into a new agency under USDA will continue to be debated. The notion of creating a new food-safety agency won the early support of key advocates and the House Agriculture Committee Chairman Mike Conaway (R-Texas), though even he suggested that it was just the start of a longer review process.
Changes cannot come quickly enough for the victims of the I.M. Healthy contamination, who remain convinced that tighter government oversight and earlier warnings might have spared themselves or their children.
“When it was happening, we felt helpless,” said Bob Stoll. “Now I don’t feel helpless. I feel angry.”
2017 soy nut butter outbreak
First documented illness starts in Wisconsin.
Mason Stoll gets sick.
Trevor Simmons comes home sick with first symptoms.
Trevor Simmons is admitted to hospital.
Cash family cannot find nut butter at Safeway. Unaware of any problems, they purchase it at Target.
Hannah Cash starts having diarrhea.
Hannah Cash is admitted to hospital. CDC identifies outbreak on PulseNet and calls FDA.
A multistate conference call takes place with health departments and federal authorities about outbreak. Trevor Simmons is released from hospital.
CDC asks states to do a more-focused questionnaire and ask victims whether they have consumed this nut butter.
Maryland and Arizona report to federal authorities that nut butter caused the illnesses.
Maryland Department of Health and Mental Hygiene picks up four jars from Bob Stoll’s house. FDA and CDC call the owners of the SoyNut Butter Company to advise the firm of the multistate outbreak linked to its SoyNut Butters.
The SoyNut Butter Company voluntarily recalls its I.M. Healthy Original Creamy SoyNut Butter with “best by” dates of Aug. 30 and 31, 2018. FDA has media blast and contacts school lunch programs and early childhood associations. Dixie Dew refuses to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issues a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provides FDA investigators the necessary records.
FDA inspects Dixie Dew facility.
The SoyNut Butter Company expands the recall of its I.M. Healthy Original Creamy SoyNut Butter.
Peter Ebb and Bob Stoll both receive recall notices from Amazon.
Hannah Cash is released from hospital. Recall is expanded.
Peter Ebb gets sick.
Recall is expanded.
Peter Ebb is admitted to the hospital.
Facility inspection report is released.
Pro Sports Club recalls 20/20 Life Styles Yogurt Peanut Crunch bars because they were made with soy nut butter supplied by the SoyNut Butter Company.
FDA suspends company’s registration.
FDA announces company’s suspension in a notice. Peter Ebb leaves the hospital.
Last illness reported.
CDC declares outbreak is over.
Linda Harris visits the contaminated facility for lawyer Bill Marler.
Scott Gottlieb becomes FDA commissioner.
Mason Stoll released from Dupont Hospital.
Labor Day weekend
Linda Harris buys nut butter online.
FDA announces they have learned that it’s still being sold.