Thanks to my great clients for being willing to tell their stories.  It put what the FDA does – and does not do – in context.

Victims blame FDA for food-recall failures

‘If I had heard about the problem even one week earlier … life today would be very different.’

By CHRISTINE HAUGHNEY

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

Jan. 4

First documented illness starts in Wisconsin.

Jan. 7

Mason Stoll gets sick.

Jan. 25

Trevor Simmons comes home sick with first symptoms.

Jan. 30

Trevor Simmons is admitted to hospital.

Early February

Cash family cannot find nut butter at Safeway. Unaware of any problems, they purchase it at Target.

Feb. 19

Hannah Cash starts having diarrhea.

Feb. 22

Hannah Cash is admitted to hospital. CDC identifies outbreak on PulseNet and calls FDA.

Feb. 23

A multistate conference call takes place with health departments and federal authorities about outbreak. Trevor Simmons is released from hospital.

Feb. 28

CDC asks states to do a more-focused questionnaire and ask victims whether they have consumed this nut butter.

March 1

Maryland and Arizona report to federal authorities that nut butter caused the illnesses.

March 2

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.

March 3

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.

March 3-15

FDA inspects Dixie Dew facility.

March 4

The SoyNut Butter Company expands the recall of its I.M. Healthy Original Creamy SoyNut Butter.

March 6

Peter Ebb and Bob Stoll both receive recall notices from Amazon.

March 7

Hannah Cash is released from hospital. Recall is expanded.

March 9

Peter Ebb gets sick.

March 10

Recall is expanded.

March 12

Peter Ebb is admitted to the hospital.

March 15

Facility inspection report is released.

March 24

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.

March 28

FDA suspends company’s registration.

March 30

FDA announces company’s suspension in a notice. Peter Ebb leaves the hospital.

April 18

Last illness reported.

May 4

CDC declares outbreak is over.

May 9

Linda Harris visits the contaminated facility for lawyer Bill Marler.

May 11

Scott Gottlieb becomes FDA commissioner.

July 14

Mason Stoll released from Dupont Hospital.

Labor Day weekend

Linda Harris buys nut butter online.

Oct. 13

FDA announces they have learned that it’s still being sold.

1,053 cases have been reported from 01 January 2017 to 20 June 2018. The number of new cases reported each week has decreased since the implicated products were recalled on 04 March 2018 (Figure 1). Neonates ≤28 days of age are the most affected age group, followed by adults aged 15 – 49 years of age (Figure 2). Most cases have been reported from Gauteng Province (58%, 613/1 053), followed by Western Cape (13%, 132/1 053) and KwaZulu-Natal (8%, 81/1 053) provinces (Table 1).

Prior to 2017, an average of 60 to 80 laboratory-confirmed listeriosis cases per year (approximately 1 per week), were reported in South Africa. In July 2017, an increase in laboratory-confirmed cases of listeriosis was reported to National Institute for Communicable Diseases (NICD) which was followed by investigations into the reported increase. On 05 December 2017, the listeriosis outbreak was declared by the Minister of Health, Dr. Aaron Motsoaledi. The source of the outbreak was identified as ready-to-eat processed meat products manufactured at Enterprise Foods’ Polokwane production facility. A recall of affected products was initiated on 04 March 2018.

The CDC reports today that 210 people in 36 states have become ill with the outbreak strain of E. coli O157:H7. These people reported becoming ill in the time period of March 13, 2018 to June 6, 2018. There have been 96 hospitalizations and five deaths. There are cases in 36 states: Alabama (3) Alaska (8), Arkansas (1), Arizona (9), California (49), Colorado (3), Connecticut (2), Florida (3), Georgia (5), Idaho (12), Illinois (2), Iowa (1), Kentucky (1), Louisiana (1), Massachusetts (4), Michigan (5), Minnesota (12), Mississippi (1), Missouri (1), Montana (9), Nebraska (1), New Jersey (8), New York (11), North Carolina (1), North Dakota (3), Ohio (7), Oklahoma (1), Oregon (1), Pennsylvania (24), South Dakota (1), Tennessee (3), Texas (4), Utah (1), Virginia (1), Washington (8), and Wisconsin (3).

(PHAC) identified eight ill people in several Canadian provinces infected with the same DNA fingerprint of E. coli O157:H7. On June 22, 2018, PHAC reported that the outbreak in Canada appears to be over.

The FDA, along with CDC and state partners, initiated an environmental assessment in the Yuma growing region to further investigate potential sources of contamination linked to this outbreak. To date, CDC analysis of samples taken from canal water in the region has identified the presence of E. coli 0157:H7 with the same genetic fingerprint as the outbreak strain.

Below it the Yuma growing region which straddles the Colorado River and the California and Arizona border and Gila River.

On April 19, 2018, Alaska health partners announced that eight persons with E. coli O157:H7 infections from a correctional facility have been confirmed as part of the outbreak. These individuals ate whole-head romaine lettuce from the Yuma growing region. Following this announcement the FDA advised consumers to avoid all romaine lettuce from the Yuma growing region. In the following weeks FDA continued its traceback investigation, part of which was able to trace the Alaskan correctional facility back to Harrison Farms.

Note above the location of Harrison Farms to the West Main Canal.  Although the FDA did not name the canal where the positive E. coli O157:H7 samples were drawn, the location of the canal to Harrison Farms in more than coincidental.

And, we figured out yet another Point of Service with a cluster of illnesses, Distributor and Processor today – St. Lukes Hospital in Boise, Grasmick and Church Brothers/True Leaf – see above.

And, we figured out yet another Point of Service with a cluster of illnesses, Distributor and Processor today – Costco in Boise and True Leaf – see above.

And, we figured out yet another Point of Service with a cluster of illnesses, Distributor and Processor today – Papa Murphy’s (CA), ProPacific Fresh Inc., C.H. Robinson Company and Greengate Fresh – See above.

More to follow.

By the way, this is what the FDA has given us so far:

Given the size of the outbreak, at least 218 in the US and Canada, and the number of unnamed farms and fields implicated, I am not surprised that the source of the outbreak was broad environmental contamination – like water.  As a study that was performed in the Yuma growing area from 2007-2009 said: “Despite the fact that Arizona leafy greens has never been associated with foodborne outbreaks, this study is contributing with relevant information that can be used for future regulatory guidelines”.  Well, that clearly has changed. Survey of Selected Bacteria in Irrigation Canal Water – Third Year_0

This outbreak appears to be over as of June 28, 2018.

Epidemiologic, laboratory, and traceback evidence indicated that romaine lettuce from the Yuma growing region was the likely source of this outbreak.

The FDA and state and local regulatory officials traced the romaine lettuce to many farms in the Yuma growing region. The FDA, along with CDC and state partners, started an environmental assessment in the Yuma growing region and collected samples of water, soil, and manure. CDC laboratory testing identified the outbreak strain of E. coli O157:H7 in water samples taken from a canal in the Yuma growing region. WGS showed that the E. coli O157:H7 found in the canal water is closely related genetically to the E. coli O157:H7 from ill people. Laboratory testing for other environmental samples is continuing. FDA is continuing to investigate to learn more about how the E. coli bacteria could have entered the water and ways this water could have contaminated romaine lettuce in the region.

As of June 27, 2018, 210 people infected with the outbreak strain of E. coli O157:H7 were reported from 36 states. Illnesses started on dates ranging from March 13, 2018 to June 6, 2018. Ill people ranged in age from 1 to 88 years, with a median age of 28. Sixty-seven percent of ill people were female. Of 201 people with information available, 96 (48%) were hospitalized, including 27 people who developed hemolytic uremic syndrome, a type of kidney failure. Five deaths were reported from Arkansas, California, Minnesota (2), and New York.  (PHAC) identified 8 ill people in several Canadian provinces infected with the same DNA fingerprint of E. coli O157:H7. On June 22, 2018, PHAC reported that the outbreak in Canada appears to be over.

Canada called the imported romaine lettuce E. coli outbreak over after eight people were sickened.  It is expected that the CDC will update the US part of the outbreak in the morning.  The numbers of ill are likely to be far above 200 and the number of deaths may likely rise as well.  Those with long-term complications – (HUS) will still be extraordinary high, as will be the percent of hospitalizations.

Thus far the FDA has been “somewhat silent” on the chain of distribution and will unfortunately remain so.  Here is what they have told the public as of the end of May:

We have been busy doing both a trace forward and trace back.  With over 100 clients, most can identify the specific place that they consumed romaine (point of service) in the 3-5 days before the onset of illness.  Some have multiple purchases and consumptions, which for now, make linking the supply chain a challenge.  But I like a challenge.

I expect that the various retailers (points of service) will continue to provide information on the supply chain (distribution center, processor, grower/harvester) – either willingly or by subpoena.  And, once we have that information (trace back), we can than trace forward to eliminate situations where E. coli culture matched victims had multiple purchases in the incubation period.

Check back for more information.

Retailers above, please give me a call.

The Mexican federal consumer protection agency has issued a warning about the possible presence of salmonella in boxes of Kellogg’s Honey Smacks cereal.

The warning from the Federal Consumer Protection Agency in Mexico (Profeco)

comes almost a week after the first reports of the contaminated cereal, manufactured and packaged in the United States, began to surface.

That US Food and Drug Administration alerted consumers last week after 73 people in 31 states were reported to have become sick after eating salmonella-infected Honey Smacks. The illnesses took place between March and May. Twenty-four people were hospitalized, but there have been no fatalities.

Profeco said the 434, 652 and 866-gram boxes of the cereal are most likely to be contaminated, but authorities in Mexico and the U.S. have advised consumers to avoid the cereal altogether.

The affected products have “best before” dates between June 14, 2018 and June 14, 2019.

On its Mexico website Kellogg’s asked consumers who bought the product not to eat it, dispose of it and contact the company for an exchange with another Kellogg’s product. It said no other product was affected by the salmonella contamination.

There had been limited distribution of the Honey Smacks cereal in Mexico and several other countries, the company said.

Perhaps Mexico will pay for it!

As of June 14, 2018, 73 people infected with the outbreak strain of Salmonella Mbandaka have been reported from 31 states. A list of the states and the number of cases in each can be found on the Case Count Map page.

Illnesses started on dates from March 3, 2018, to May 28, 2018. Ill people range in age from less than one year to 87, with a median age of 58. Sixty-five percent are female. Out of 55 people with information available, 24 (44%) have been hospitalized. No deaths have been reported.

Epidemiologic evidence indicates that Kellogg’s Honey Smacks cereal is a likely source of this multistate outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Thirty (77%) of 39 people interviewed reported eating cold cereal. In interviews, 14 people specifically reported eating Kellogg’s Honey Smacks cereal. Ill people in this outbreak reported this cereal more often than any other cereals or food items.

On June 14, 2018, the Kellogg Company recalled 15.3 oz. and 23 oz. packages of Kellogg’s Honey Smacks cereal.

Recalled Kellogg’s Honey Smacks cereal have a “best if used by” date from June 14, 2018 through June 14, 2019. The “best if used by” date is on the box top.

The recalled 15.3 oz. Kellogg’s Honey Smacks cereal has a UPC code of 38000 39103. The recalled 23.0 oz. Kellogg’s Honey Smacks cereal has a UPC code of 38000 14810. The UPC code is on the bottom of the box.

I have no idea if this is a change of policy – but it should be.  I have been complaining a bit over at www.foodsafetynews.com about the FDA not being as transparent as it should when it comes to recalls.  So, when it does it right, you have to give credit where credit is due.

Thanks to the FDA for making the retail recall notification on the Caito manufactured cut melon recall available.  It helps make consumers aware of the at risk items and helps retailers get the product off shelves. Here is the complete list to date:

https://www.fda.gov/downloads/Food/RecallsOutbreaksEmergencies/Outbreaks/UCM610720.pdf

And here is the latest from the FDA on the outbreak and recall:

  • FDA advises consumers not to eat recalled fresh cut watermelon, honeydew melon, cantaloupe, and fresh-cut fruit medley products containing any of these melons produced at the Caito Foods facility in Indianapolis, Indiana. Products produced at this facility have been distributed in Georgia, Illinois, Indiana, Iowa, Kentucky, Michigan, Missouri, North Carolina, Ohio, Pennsylvania, West Virginia, and Wisconsin. The products were packaged in clear, plastic clamshell containers and distributed to Costco, Jay C, Kroger, Payless, Owen’s, Sprouts, Trader Joe’s, Walgreens, Walmart, and Whole Foods/Amazon. Caito Foods, LLC has voluntarily recalled fruit salad mixes that contain pre-cut melons to prevent further distribution of potentially contaminated products.
  • The CDC reports that 60 people in five Midwestern states have become ill. Among 47 people with information available, thirty-one cases (66%) have been hospitalized.
  • The 60 illnesses occurred within the period of April 30, 2018 to May 28, 2018.
  • The FDA is working with CDC, along with state partners in Illinois, Indiana, Michigan, Missouri, Iowa, and Ohio to trace back the pre-cut melons to identify the source to determine the full distribution of pre-cut melons, and to learn more about the potential route of contamination.
  • As this is an ongoing investigation, the FDA will update this page as more information becomes available, such as product information, epidemiological results, and recalls.
  • Additional distribution information has been added that identifies retail locations that received potentially contaminated product. The FDA is advising consumers to discard any recalled products purchased at the listed locations. The FDA is sharing this information with consumers as soon as possible and additional distribution information may be added as it becomes available. It is possible that some stores may be mentioned more than once because they received more than one shipment or more than one product. Consumers may wish to ask a firm directly if the recalled product was available for sale.
  • Consumers who have symptoms of Salmonella infection should contact their health care provider to report their symptoms and receive care. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. Most infections usually lasts 4 to 7 days and most people recover without treatment, however some people develop diarrhea so severe that they need to be hospitalized.

Time to dust off www.fair-safety.com and www.realrawmilkfacts.com

The Knox County Health Department (KCHD) is investigating a cluster of Escherichia coli (E. coli) O157 cases in children likely associated with consumption of raw milk and contact with farm animals.

Most of the children are known to have consumed raw milk from a local cow-share dairy. Due to possible contamination with E. coli O157 and out of an abundance of caution, KCHD advises the public not to consume raw milk or any other unpasteurized products from French Broad Farm in Mascot, Tenn. at this time. Officials also recommend consumers dispose of all raw milk and unpasteurized products they may have from this farm.

Any further exposure to the farm animals in question has been mitigated as the facility is not currently operating. Therefore, no further directive on that potential source is necessary.

“Bacteria, like E. coli, cannot be seen with the naked eye,” said KCHD Director Dr. Martha Buchanan. “For some perspective, roughly 1,800 can fit on the head of a pen, and it only takes about 10 to make you sick.”

Raw milk and other unpasteurized products can contain harmful bacteria, including E. coli O157. While it is possible to get sick from many other foods, raw milk is one of the riskiest. E. coli can also be found in the feces of cattle, goats, sheep and other ruminant animals. Historically, the major source for human illness is cattle, which can carry E. coli 0157 and show no signs of illness. These bacteria, however, can cause severe diarrhea and even life-threatening complications for humans, especially children, older adults, pregnant women and those with compromised immune systems. Information on preventing E. coli can be found on the CDC’s website.

Symptoms of E. coli infection vary for each person, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. Some may have a low fever (less than 101 ̊F). Some infections are mild, but others can be severe.

As of May 30, 2018, there are 197 cases in 35 states: Alaska (8), Arkansas (1), Arizona (9), California (45), Colorado (3), Connecticut (2), Florida (1), Georgia (5), Idaho (11), Illinois (2), Iowa (1), Kentucky (1), Louisiana (1), Massachusetts (4), Michigan (5), Minnesota (12), Mississippi (1), Missouri (1), Montana (9), Nebraska (1), New Jersey (8), New York (10), North Carolina (1), North Dakota (3), Ohio (7), Oklahoma (1), Oregon (1), Pennsylvania (24), South Dakota (1), Tennessee (3), Texas (3), Utah (1), Virginia (1), Washington (7), and Wisconsin (3).

Illnesses started on dates ranging from March 13, 2018 to May 12, 2018. Ill people range in age from 1 to 88 years, with a median age of 29. Sixty-eight percent of ill people are female. Of 187 people with information available, 89 (48%) have been hospitalized, including 26 people who developed hemolytic uremic syndrome, a type of kidney failure. Five deaths have been reported from Arkansas (1), California (1), Minnesota (2), and New York (1).

As of 1 PM (ET) October 6, 2006, Friday, 199 persons infected with the outbreak strain of E. coli O157:H7 have been reported to CDC from 26 states.

Among the ill persons, 102 (51%) were hospitalized and 31 (16%) developed a type of kidney failure called hemolytic-uremic syndrome (HUS). One hundred forty-one (71%) were female and 22 (11%) were children under 5 years old. The proportion of persons who developed HUS was 29% in children (<18 years old), 8% in persons 18 to 59 years old, and 14% in persons 60 years old or older. Among ill persons who provided the date when their illnesses began, 80% became ill between August 19 and September 5. The peak time when illnesses began was August 30 to September 1- 31% of persons with the outbreak strain became ill on one of those 3 days.

Three deaths in confirmed cases have been associated with the outbreak. One was in an elderly woman from Wisconsin. Yesterday, Idaho confirmed that stool samples from a 2-year-old child with HUS who died on September 20 contained E. coli O157 with a “DNA fingerprint” pattern that matches the outbreak strain. Today, Nebraska reported the death of an elderly woman with an illness compatible with E. coli O157 infection who consumed raw spinach; E. coli O157 with the outbreak strain “DNA fingerprint” was detected in the remaining spinach. Maryland is investigating a suspect case in an elderly woman who died on September 13 and had recently consumed fresh spinach. E. coli O157 was cultured from her stool, but “DNA fingerprinting” has not been possible.