Federal, state, and local officials investigated dozens of foodborne outbreaks during 2023, with some ongoing as the year ended.

One common denominator among the outbreaks is that far more people are likely to have gotten sick than were confirmed ill in each outbreak. Based on its research, the Centers for Disease Control and Prevention reports that for every confirmed case of Salmonella, there are 29 patients. For E. coli, that number is 26 for the Shiga toxin-producing O157 strain and 106 for the Shiga toxin-producing non-O157 strain. For Listeria monocytogenes, two cases generally go undetected for every confirmed patient.

The reasons behind the numbers include many people not seeking medical treatment because they think they have a “stomach bug” and others not being correctly diagnosed by healthcare providers because specific pathogen testing is not ordered.

Deadly cantaloupe outbreak
The most recent outbreak in the headlines is ongoing and has been traced to whole cantaloupe from Mexico. The recalled cantaloupe has been used in a wide variety of fresh-cut products that have also been recalled.

The deadly outbreak spans the border, with patients having been documented in the United States and Canada. As of late December, there were 302 people infected in the United States, with four having died. In Canada, there are 164 sick people, with seven having died. 

Investigators from the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Public Health Agency of Canada, and the Canadian Food Inspection Agency continue identifying patients and other potentially contaminated products.

Another ongoing outbreak involves lead poisoning traced to cinnamon applesauce pouches marketed particularly for children. The number of children affected by the extremely high levels of lead in cinnamon in the applesauce pouches continues to grow, and some adults are now reported in the outbreak. 

The outbreak has been traced to three brands of cinnamon applesauce: Wanabana, Schnucks, and Weis. Astrofoods produced all three in Ecuador and used cinnamon from the supplier Negasmart. The recalled cinnamon applesauce pouches were made with cinnamon containing as much as 2,000 times the recommended amount of lead. 

The cinnamon in the applesauce is a problem for U.S. and Ecuadorian officials. The U.S. Food and Drug Administration is testing other products. As of Dec. 26, the Food and Drug Administration reported receiving 82 reports of affected people. As of Dec.22, the CDC had received reports of 73 confirmed cases, 157 probable cases, and 21 suspected cases for 251 cases from 34 states. The CDC and FDA have separate reporting systems, so there may be some overlap, meaning the total numbers from the agencies should not be added together.

An outbreak of infections from Listeria has been traced to fresh peaches and sparked a recall of whole, fresh peaches, plums, and nectarines. Eleven confirmed patients have been reported across seven states. One patient has died. The peaches, plums, and nectarines were sold in retail stores between May 1 and November 15, 2022, and between May 1 and November 15, 2023. The fruit was sold as individual pieces and in plastic pouches. The outbreak is an example of how investigators use whole genome sequencing of pathogens and a national database to identify patients in a single outbreak spread across time and distance.

As of the end of this year, the FDA is investigating at least two outbreaks of unknown origin. A Listeria outbreak first reported on Dec. 6 has sickened at least three people, and a Salmonella outbreak first reported by the FDA on Nov. 22 has sickened at least 44 people. The agency has not provided any further details on the two outbreaks.

Salmonella outbreak linked to dog food — An ongoing investigation into an outbreak of human Salmonella infections traced to dog food has identified seven patients in seven different states, according to the CDC. One patient has been hospitalized. The age range of known patients is younger than 1 to more than 65 years old. As with all outbreaks, the true number of sick people in this outbreak is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses, according to the CDC. The outbreak has been linked to various varieties of Victor brand dog food.

A Canadian outbreak of particular note was traced to meatloaf and vegan loaf served by a central kitchen serving several daycare centers. The investigation closed in October. As of Sept. 27, 351 children were confirmed sick in the E. Coli O157:H7 outbreak. The outbreak saw 37 hospitalized, with 22 children diagnosed with hemolytic uremic syndrome (HUS), which attacks the kidneys and bloodstream and can lead to multiple organ failure, brain damage, and the need for transplants.

FDA unresolved sources
Eight investigations by the FDA have been closed this year without the source being found—four of those involved E. coli infections, with a total of 74 people sickened. Salmonella caused one outbreak. It sickened 54 people. One outbreak of Cryptosporidium of unknown origin was reported, with 11 confirmed patients. Three outbreaks from unknown sources of cyclospora were investigated. They sickened a total of 271 people.

Other 2023 outbreaks of note — in no particular order
This year, they continued a decades-long string of infections from unpasteurized, raw milk. At one point this fall, four states’ authorities were investigating outbreaks. Most of the time, investigations linked to raw milk outbreaks do not involve federal authorities because selling raw milk across state lines is illegal. Here are details on four known outbreaks reported in September and October:

  • Public health officials in Salt Lake County reported an outbreak of campylobacter infections associated with raw, unpasteurized milk. The Salt Lake County Health Department confirmed at least 14 people with infections. Twelve of the patients reported drinking raw milk before becoming sick, according to a notice from the department. The department reported that the patients ranged from 2 to 73 years old. One of them was hospitalized.
  • The Wyoming Department of Health confirmed that two children were hospitalized after drinking raw milk in September. Five people, one adult and four children, became ill after drinking raw, unpasteurized milk purchased through the Slow Food in the Tetons online market. The patients were infected with campylobacter and E. Coli bacteria.
  • Nine people were sickened, and three were admitted to hospitals after drinking raw milk and becoming infected by Salmonella. Health officials from the County of San Diego linked the nine patients to unpasteurized milk sold by Raw Farm LLC in Fresno. The nine San Diego County residents who became ill reported consuming Raw Farm LLC raw milk or milk products the week before their illness onset. The patients range in age from 1 to 41 years old. All three of the hospitalized patients were children.
  • State health officials in Idaho investigated a cluster of illnesses believed to be associated with the consumption of unpasteurized, raw milk. Central District Health announced reports of illness in five Ada County residents who drank raw milk. Three of the five individuals tested positive for campylobacteriosis, a bacterial infection and reported drinking raw milk produced by Provider Farms in Mountain Home before getting sick.

Cyclospora —  An outbreak of infections from the cyclospora parasite has been declared over by the Centers for Disease Control and Prevention, with more than 2,000 patients logged. The CDC first reported the outbreak on May 25. As of Oct. 24, the agency reported 2,272 laboratory-confirmed patients from 40 states. “These individuals had not traveled outside of the United States during the 14 days before they got sick,” according to the CDC. Sick people ranged in age from 2 to 96 years, with a median age of 51. Of 2,242 people with information available, 186 were hospitalized.

Cantaloupe August-September — First posted on Aug. 17 by the Food and Drug Administration, there was little information on the outbreak, except for the patient count, which was 87 people across 11 states.

Listeria monocytogenes in leafy greens — An outbreak of infections from Listeria monocytogenes in leafy greens sickened 19 people across 16 states, with 18 of the patients requiring hospitalization. Of 14 people with complete information available, 13 reported eating leafy greens before becoming sick. No specific brand of leafy greens was determined. It is particularly difficult to identify sources of Listeria infection because it can take up to 70 days for symptoms to develop.

Salmonella in onions — As of Dec. 4, 2023, the CDC announced that an outbreak from Gills brand diced onions was over. The agency reported a total of 80 illnesses in 23 states. There was a total of 18 hospitalizations and one death associated with the outbreak. The last illness onset was Nov. 11. There is some concern that consumers may have frozen the onions for future use.

 Salmonella in raw cookie dough — The CDC reported that 26 people were confirmed as part of the outbreak, four requiring hospitalization. Papa Murphy’s raw cookie dough was identified as the source of the pathogen. According to the CDC, Illnesses started from Feb. 24 to May 28.

Salmonella in ground beef — The CDC declared an outbreak of Salmonella Saintpaul infections over, with 18 sickened people from four states. According to a notice from the Centers for Disease Control and Prevention, investigators linked the outbreak to ground beef sold at ShopRite stores in the Northeast. Seven of the 18 patients were so sick they had to be hospitalized. Patients were from four states. No one died.

Salmonella in raw flour — In April, the CDC announced 14 patients across 13 states from coast to coast were infected. Three were hospitalized. Gold Medal Flour from the same plant linked to a 2016 E. Coli outbreak that sickened 38 people across 20 states was determined to be the source of the Salmonella.

Hepatitis A virus in frozen strawberries — Ten patients in four states were identified, with four requiring hospitalization. Frozen organic strawberries imported from Baja California, Mexico, were determined to be the source of the virus. Additionally, the strain of hepatitis A virus causing illnesses this year was genetically identical to the strain that caused an outbreak of hepatitis A virus infections in 2022, which was linked to fresh organic strawberries imported from Baja California, Mexico, and sold at various retailers. Investigators found that a single farm was associated with the distribution of strawberries consumed by ill people in both outbreaks.

Campylobacter in oysters — The FDA has warned about certain oysters harvested in Canada and sold in the United States because two people have become infected with Campylobacter jejuni. On Dec. 18, the Utah Shellfish Authority notified the Food and Drug Administration of two cases of Campylobacter connected to consumption of oysters from British Columbia, Canada. The FDA has notified the Canadian Food Inspection Agency (CFIA) of the illnesses, and that agency is investigating. The two patients consumed oysters in Utah and Wisconsin, and the FDA is coordinating with the CFIA and state authorities to determine if any additional distribution occurred.

Listeria and ice cream — The Food and Drug Administration confirmed that “On the Go” ice cream cups were behind foodborne illnesses in two states. The ice cream made by Real Kosher Ice Cream of Brooklyn, NY, was contaminated with the same strain of Listeria monocytogenes as found in samples from two patients. Both patients, one in New York and the other in Pennsylvania were so sick that they required hospitalization.

Outbreaks associated with schools and restaurants

Norovirus and sushi restaurant — As of the second week of December, authorities reported 241 complaints from patrons of Nine Sushi, a restaurant in Raleigh, NC. The complaints began Nov. 28, according to local health department officials. The suspected pathogen was norovirus, with at least three restaurant customers testing positive. The restaurant closed temporarily for cleaning.

Huntley High School and E. coli — An infected food handler has been identified as the most likely source of an E. coli outbreak at an Illinois high school that saw 16 students sickened and two hospitalized. A breakdown in hand-washing protocol was the most likely cause of the illnesses, according to a 152-page report from the McHenry County Department of Health. An infected food handler was identified by laboratory testing of stool samples.

Chicago area restaurant and Salmonella — At least 55 people were infected with Salmonella after eating food from a Chicago taqueria. Ten people were hospitalized. The Chicago Department of Public Health and the Illinois Department of Public Health investigated the outbreak. The agencies reported that Carniceria Guanajuato voluntarily closed the taqueria for cleaning.

University of Arkansas and E. coli — Public health officials closed an investigation into an E. Coli outbreak at the University of Arkansas without finding the source of the pathogen. University officials said the Arkansas Department of Health reported five confirmed and 37 probable patients in the outbreak. On Sept 25, university officials said more than 3,200 people had been surveyed during the investigation. The outbreak was reported on Sept. 1, but no patients were identified after Aug. 25. Four confirmed patients were hospitalized.

Sushi restaurant and mushrooms — At least 30 people were sickened and two people died after eating at a restaurant in Montana. The restaurant was Dave’s Sushi in Bozeman, MT. People who became ill generally had symptom onset between 30 minutes and 4 and a half hours after eating at the restaurant. Health department officials report that the implicated mushrooms were imported. The mushrooms were cultivated in China, shipped to a distributor in California, and subsequently sent to multiple states.

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Federal officials are reporting that the patient count in an outbreak of lead poisoning traced to imported cinnamon applesauce stands at more than 200, with all of those affected being six years old or younger.

The Food and Drug Administration and the Centers for Disease Control and Prevention keep separate lists of those affected by the applesauce, which has been found to have five thousand times the amount recommended for safe consumption.

The implicated applesauce was made in Ecuador and sold in pouches in the United States under the brands Wanabana, Schnucks, and Weis. The Wanabana brand was sold in stores nationwide and online. The Schnucks and Weis brands were sold in those regional grocery store chains. The Schnucks brand pouches were sold individually and in variety packs.

As of Dec. 19, the CDC’s investigation has identified 67 confirmed cases, 122 probable cases, and 16 suspected cases for 205 cases from 33 states.

The FDA’s investigative team has received 69 complaints.

“The CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond. In addition, some people who were affected by the contaminated product might be reflected in both the numbers reported by the FDA and the numbers reported by CDC, so the numbers should not be added together,” according to the Tuesday update.

All implicated cinnamon applesauce, sold in pouches designed for children, has been recalled. 

The FDA’s deputy commissioner for its Human Foods Program, Jim Jones, has said that he believes the cinnamon used in the applesauce was intentionally contaminated with lead. Lead can increase the weight of foods.

The applesauce was made at an Austrofoods facility in Ecuador using cinnamon from Negasmart. Both U.S. authorities and investigators from the Ecuadoran government have said the problem with the applesauce came from contaminated cinnamon.

About lead poisoning
Parents and caretakers should consult a healthcare provider if they suspect a child may have been exposed to lead. 

Short-term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. 

Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss. 

Permanent consequences can lead to developmental delays and brain damage.

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Usually, an elected official charges before the evidence is in, and the bureaucrat provides an open-ended background about the food safety problem.

But with the lead poisoning of applesauce pouches sold for children, those roles seem to have switched. Jim Jones, FDA’s new Deputy Commissioner for Human Foods, has raised the possibility that the applesauce packages are “purposefully contaminated with lead.”

Jones said the FDA’s investigation continues, but “all the signals we’re getting lead to an intentional act on the part of someone in the supply chain.”  That specific supply chain traces back to Ecuador.

Meanwhile, a three-page letter from Sen. Rick Scott, R-FL, to FDA Commissioner Robert Califf raises broader questions about the applesauce contamination, including whether China might be involved.

Higher than normal lead levels — some 500 times greater than acceptable levels for lead — have been found in more than 60 U.S. children younger than age 6.  The spiked lead levels came after the children were fed from applesauce pouches sold under one of three brands — Weis, WanaBana, and Schnucks. All three products have been recalled.

All originate from a facility in Ecuador.

Sen. Scott wants the FDA to look at China because it is a large producer of cinnamon, which may be a source of lead poisoning. The Florida Republican said the supply chain is more global now than before the pandemic.

Scott said the FDA’s safety alert was issued on Oct. 28, 2023, and now requires “swift and decisive” actions. He said there are indications that the Ecuadorian supplier “may have been purchasing cinnamon from Asian countries, such as Communist China.”

Scott wrote: “High lead or heavy metal levels in spices, such as cinnamon, typically come from three potential sources: either high levels in the soil the product was grown in, potential contamination in the supply chain during processing, or economically motivated adulteration such as adding lead chromate to increase the product’s weight.”

The Senator said the high lead levels may be “a  case of potential economic adulteration.”

Officially, the FDA is investigating several theories for how the high lead levels may have occurred.  FDA reportedly has little authority over foreign ingredients not directly shipped to the U.S.

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Officials from the FDA have closed their investigation into the Ecuadoran company that supplied lead-tainted cinnamon applesauce products to the United States after finding that the lead content was thousands of times higher than recommended levels.

The applesauce, sold in pouches packaged for children, has been found to have a lead content of 5110 parts per million (ppm) and 2270 ppm. The international Codex body is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon.

Sold under the brands Wanabana, Schnucks, and Weis, the applesauce was made at an Austrofoods facility in Ecuador using cinnamon from Negasmart.

The FDA’s deputy commissioner for its Human Foods Program, Jim Jones, has said that he believes the cinnamon was intentionally contaminated with lead. Lead can increase the weight of foods.

To date, the FDA has received reports of 65 children across the country with high levels of lead in their blood. All are 6 years or younger, and all have eaten applesauce from one of the three recalled brands. The Wanabana brand was sold nationwide in stores and online. Those regional grocery chains sold the Schnucks and Weis brands.

“At this time, the FDA is still relying on officials in Ecuador to support the investigation into Negasmart. To date, the FDA has confirmed that Negasmart does not ship product directly to the U.S. and that, of Negasmart’s direct customers, only Austrofoods ships product to the U.S.,” according to an update from the Food and Drug Administration.

“The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing before export. Thus, the FDA cannot take direct action with Negasmart. However, we continue to work closely with Ecuadorian officials, as they are conducting their own rapidly evolving investigations into the source of contamination.”

Although the FDA has concluded its inspection of the Ecuadoran companies, it continues to investigate lead levels in other foods.

The FDA has tested multiple products, and based on the current evidence, no further products are being added to the recall. The FDA and state partners tested 136 samples of non-cinnamon-containing products, and all have been negative for elevated lead levels. Of those 136 non-cinnamon-containing samples, 11 are the Smoothie Mango Passionfruit Banana flavor of WanaBana purees. Three of these samples are of the same lot that the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) in Ecuador initially reported as positive for lead. FDA results were negative for elevated lead for all samples. In addition, the FDA collected samples of WanaBana Organic Mango Puree at import, with negative sample results for elevated lead levels.

“While our information at this time indicates that in the U.S., the contaminated cinnamon is limited to only the applesauce products that have already been recalled, the FDA is still investigating whether the cinnamon in the recalled products was used in other products exported to the U.S. Increasing screening for imported cinnamon from certain countries remains in place. The FDA does not indicate that this issue extends beyond these recalled products,” according to the agency’s Dec. 18 update.

Officials in Ecuador report that Negasmart does not ship products outside Ecuador. They also told the FDA that their testing thus far of raw cinnamon from all cinnamon importers in Ecuador does not appear to be contaminated with lead. In contrast, the ground or powdered cinnamon from Negasmart is contaminated. The Ecuadorian processor used by Negasmart is not currently operating.

About lead poisoning

Parents and caretakers should consult a healthcare provider if they suspect a child may have been exposed to lead. 

Short-term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. 

Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss. 

Permanent consequences can lead to developmental delays and brain damage.

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Federal officials have begun an onsite inspection of a company in Ecuador that exported cinnamon applesauce to the United States that was used in three brands of applesauce traced to an outbreak of lead poisoning in children.

The Food and Drug Administration is inspecting the Austrofoods facility located in Ecuador. Cinnamon samples collected from the lots used in recalled products will undergo laboratory analysis. FDA will update the U.S. public to share the sample results once the analysis is complete. 

Federal officials have received a total of 125 reports of cases of lead poisoning from 22 different states through their reporting structure. Three brands of cinnamon applesauce pouches designed for children have been recalled: Wanabana, Schnucks, and Weis. The Wanabana brand is sold at retailers nationwide and online. The FDA has received reports that the recalled applesauce is still on shelves at Dollar Tree stores. The Schnucks and Weis brand applesauce was sold at those regional grocery store chains and removed from stores.  

Anyone with the recalled applesauce on hand is urged not to feed it to children or eat it themselves. Some of the recalled applesauce has been found to have 500 times the recommended amount of lead.

Parents and caretakers should consult a healthcare provider if they suspect a child may have been exposed to lead. Short-term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss. Permanent consequences can lead to developmental delays and brain damage.

To date, the FDA has worked with Ecuadorian authorities to gather information about Negasmart, the supplier of cinnamon to Austrofoods, including whether the cinnamon in the recalled products was used in other products exported to the United States. Working with Ecuadorian authorities, the FDA has confirmed that, of Negasmart’s direct customers, only Austrofoods ships products to the US. In addition, the FDA has confirmed that Negasmart does not directly export products to the US. 

As of Dec. 11, 2023, the FDA has received 65 reports of adverse events potentially linked to recalled products. To date, confirmed complainants, or people for whom an adverse event was submitted, are younger than 6 years of age. 

The U.S. Centers for Disease Control and Prevention’s National Center for Environmental Health is conducting case-finding efforts in collaboration with state and local health departments. The CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within three months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after Nov. 2022. As of Dec. 8, CDC has received reports of 46 confirmed cases, 68 probable cases, and 11 suspected cases for 125 cases from 22 different states through their reporting structure. For more information, please visit the CDC’s page to review their case reporting methodology and findings.

CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond. In addition, some people affected by the contaminated product might be reflected in both the numbers reported by the FDA and the numbers reported by the CDC, so the numbers should not be added together.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.

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The company behind an outbreak of high lead levels in children who ate certain cinnamon applesauce has named the supplier of the cinnamon.

Austrofood, along with Wanabana USA, has named Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador, as the cinnamon supplier.

Based on its investigation, the U.S. Food and Drug Administration had already concluded that the cinnamon in certain applesauce products was the source of the lead. After conducting its investigation, Austrofood has come to the same conclusion. FDA testing has shown the implicated applesauce has 200 times the acceptable lead level.

“The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S.,” according to an update from the FDA.

As of Nov. 30, 57 children aged less than 1 to 5 years old have been confirmed with high levels of lead in their blood after eating cinnamon applesauce. The children are spread across 22 states. Three brands of cinnamon applesauce pouches have been recalled. They are Wanabana, sold in stores nationwide and on the internet, and Schnucks and Weis store brands sold at those regional grocery chains. The Schnucks cinnamon applesauce is sold individually and in a variety of packs.

“At this time, the FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, the FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. As of Nov. 30, 2023, no screening results have tested positive for higher levels of lead,” according to the FDA update. 

“Separately, Austrofood CIA LDA’s apple cinnamon fruit puree pouch products exported to the U.S. were added to Import Alert 99-42, detention without physical examination of foods due to heavy metal (toxic element) contamination.” 

Lead is toxic to humans and can affect people of any age or health status, but children are particularly susceptible to lead toxicity. Lead poisoning can result in several long-term problems, including developmental disorders and brain damage.

“These products have a long shelf life. Consumers should check their homes and discard these products. Most children have no obvious immediate symptoms of lead exposure,” according to the FDA’s alert. “If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.”

Short-term exposure to lead can result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss.

Investigation background
The FDA first became aware of the problem when state public health authorities reported children with elevated lead levels in mid-October.

On Oct. 18, the FDA received information about an investigation by the North Carolina Department of Health and Human Services. 

On Oct. 24, North Carolina officials notified the FDA of additional information that included four children with elevated blood lead levels. 

On Oct. 25, the FDA began receiving analytical worksheets from the North Carolina Health Department for the samples of applesauce with cinnamon pouches with elevated lead levels. 

On Oct. 27, the FDA completed an “accelerated” review of the analytical findings the North Carolina officials provided and notified Wanabana LLC regarding the levels detected in their analysis. 

On Oct. 28, the FDA discussed the analytical findings with Wanabana LLC and issued a safety alert warning consumers not to use WanaBana Apple Cinnamon Fruit Puree products. Wanabana LLC agreed to recall the WanaBana Apple Cinnamon Fruit Puree products the same day.

The FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to the FDA as an initial step in determining if a product is a potential shared source of exposure amongst complainants. 

“While our total reports included in this advisory represent complaints that have been reported to the FDA, we recognize there are other avenues for reporting of elevated lead levels. For example, through case reporting from the state health departments to CDC, which is routinely done for cases of childhood lead exposure,” according to the FDA statement. 

“Because these different avenues for reporting represent two different data collection mechanisms, we are currently not including them in our advisory. However, we are working with our state partners and CDC to gather and evaluate as much data as possible while recognizing different mechanisms are being leveraged.” 

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The FDA has opened two new outbreak investigations, one for Listeria infections and one for E. Coli infections.

In the Listeria monocytogenes outbreak, the Food and Drug Administration reported 11 patients. The agency did not report an age range for the patients or where they live.

The FDA has begun sample collection and testing for the listeria investigation and is reporting that the source of the pathogen remains unknown. The agency did not report what kind of samples are being tested. Although sample collection and testing have begun, the FDA has not begun traceback efforts or on-site inspections.

For the new E. Coli 0103 outbreak, the FDA reports that there are a dozen confirmed patients. The agency did not report patient information, such as where the patients live.

The agency has begun traceback efforts in the E. Coli investigation but did not report what food or foods are being traced.

In other outbreak news, the FDA continues investigating three other outbreaks.

A Salmonella Thompson outbreak traced to Gills brand diced onions has sickened 73 people, with 15 requiring hospitalization. The FDA first reported the outbreak on Oct. 4. The agency last posted an update on the investigation on Oct. 24. The most recent patient became ill on Sept. 25.

An E. Coli O121:H19 outbreak that has sickened 37 remains under investigation, with no source identified. The FDA first posted the outbreak on Nov. 1. The agency has not reported any patient information, including where patients live. The agency has begun traceback efforts but has not reported what food or foods are being traced.

An outbreak of adverse reactions to lead has been traced to applesauce pouches produced by WanaBana. As of Nov. 15, there have been 22 children reported with symptoms. WanaBana has recalled its product. Schnuck’s and Weis grocery chains have also recalled their brands of applesauce in pouches produced by WanaBana.

Consumers are warned not to feed the recalled products to their children or eat them themselves. Lead is toxic to humans and can affect people of any age or health status, but children are particularly susceptible to lead toxicity. Lead poisoning can result in several long-term problems, including developmental disorders, learning disabilities, and brain damage.

“These products have a long shelf life. Consumers should check their homes and discard these products. Most children have no obvious immediate symptoms of lead exposure,” according to the FDA’s most recent alert. “If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.”

Short-term exposure to lead can result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss.

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There are now almost two dozen children with reported adverse effects linked to applesauce pouches that have high levels of lead.

The 22 children impacted live across 14 states, with the state of residence for one of them being unknown. 

There are recalls for four products related to the illnesses:

  • Recalled WanaBana apple cinnamon fruit puree pouches
  • Recalled Schnucks-brand cinnamon-flavored applesauce pouches and variety pack
  • Recalled Weis-brand cinnamon applesauce pouches

The WanaBana product has been distributed nationwide. The Schnucks and Weis brand products were distributed within those regional grocery store chains. The recall also includes markets outside of the United States. Customer information provided by the company shows that the product was also distributed to Cuba and the United Arab Emirates.

The Food and Drug Administration reported the situation on Oct. 28. The WanaBana company announced the recalls on Oct. 31.

“As part of this investigation, FDA and state partners are collecting and analyzing additional product samples of fruit puree and applesauce pouches. At this time, sample analyses have not shown elevated levels of lead in any non-recalled products,” according to the FDA’s updated alert on Nov. 13.

Federal investigators began working on the outbreak of “adverse reactions” after the North Carolina Department of Health and Human Services and the North Carolina Department of Agriculture & Consumer Services reported four children with elevated blood lead levels, indicating potential acute lead toxicity. 

The North Carolina investigators identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure. As part of their work, North Carolina investigators analyzed multiple lots of WanaBana Apple Cinnamon Fruit Puree, detecting high lead concentrations. The FDA has reviewed and supported those analytical findings and determined that levels of lead found in the analyzed pouches could result in acute lead toxicity.

Consumers are warned not to feed the recalled products to their children or eat them themselves. Lead is toxic to humans and can affect people of any age or health status, but children are particularly susceptible to lead toxicity. Lead poisoning can result in several long-term problems, including developmental disorders and brain damage.

“These products have a long shelf life. Consumers should check their homes and discard these products. Most children have no obvious immediate symptoms of lead exposure,” according to the FDA’s expanded alert. “If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.”

Short-term exposure to lead can result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss.

As of the Nov. 13 outbreak update, the FDA reported children with symptoms in Alabama, Arkansas, Louisiana, Maryland, Missouri, North Carolina, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Washington.

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Le Verger à Ti-Paul Inc. of Saint-Elzéar, Quebec, Canada, is recalling their company’s brand of Cider because of lead contamination.

The recalled products have been sold in Quebec, Canada, according to the recall notice posted by the Canadian Food Inspection Agency.

Recalled products:

BrandProductSizeCodesUPC
Le Verger à Ti-Paul“Le clandestin – cidre à l’érable – cidre aromatisé pétillant gazéifié”355 mlF320303227 64283 30096 6
Le Verger à Ti-Paul“L’intraitable – cidre de pomme pétillant”750 mlF271612217 64283 30097 3

Consumers and retailers should not use, sell, serve or distribute the affected products.

About lead contamination
Lead is a toxic substance present in the environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water.

Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and the age of the person exposed.

Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning. 

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BrandStorm Inc. is recalling certain Natierra Organic Freeze-Dried Blueberry pouches because of the presence or potential presence of lead above the FDA’s recommended limits.

The concern was identified during testing. An investigation was conducted by the packing site. The original heavy metal reports received for the crop year showed no presence of lead and/or cause for batch testing. After further investigation, it was found that the products’ country of origin is Lithuania and aggressive monitoring of heavy metals may be deemed necessary.

As an immediate action, the packing site is actively working to enhance food safety system by implementing mandatory batch testing for heavy metal.

The recalled products were distributed in the United States through retail and online stores services.

There is concern that consumers may have the product in their homes because of its long shelf life. Consumers can use the following information to determine whether they have the recalled blueberries in their homes.

Recalled products:

The recall is limited to two batches of Natierra Freeze-Dried Blueberries with the following codes Best By Date 12/2024 & 01/2025.

  • Lot 2021363-1, Best By Date: 12/2024
    • 1 serving, 1.2oz (34g), UPC 812907011160
  • Lot 2022026-1, Best By Date: 01/2025
    • 1 serving, 1.2oz (34g), UPC 812907011160

The impacted product is sold in white and blue pouch with Natierra brand and Logo. The product can be identified by checking the product name, manufacturer details and lot number on the bottom right of the pouch.

As of the posting of this recall, BrandStorm Inc. has not received any reports of adverse events related to use of the product. Should any consumer of this product have experienced any of the symptoms listed above, they should seek medical advice from their physician immediately.

Do not consume the product impacted. Consumers who purchased the recalled product should discard of it. Refunds are available at the location of purchase.

About lead contamination
Lead is a toxic substance present in the environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water.

Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and the age of the person exposed.

Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning. 

A child with lead poisoning may not look or act sick. Lead poisoning in children can cause learning disabilities, developmental delays, and lower IQ scores.

(To sign up for a free subscription to Food Safety News, click here)