Urgent Investigation: FDA Expands Recall Amidst Lead Contamination Concerns in WanaBana Fruit Puree

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In a safety alert issued by the Food and Drug Administration (FDA) on October 28, 2023, a disturbing investigation into potential acute lead toxicity has been initiated in response to reports of four children with elevated blood lead levels. Collaborating with the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS), the FDA is meticulously examining the source of exposure, leading to an alarming discovery centered around WanaBana Apple Cinnamon Fruit Puree pouches.


Product

Recalled cinnamon apple puree and applesauce products. Information on lot codes and UPCs can be found in the firm’s recall announcement.

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

Symptoms of Lead Toxicity 

Lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is particularly important because they are more susceptible to lead toxicity. Most children have no obvious immediate symptoms. Parents and caretakers should consult a healthcare provider if you 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; anemia. Longer term exposure could result in the following additional symptoms: irritability; lethargy; fatigue; muscle aches or muscle prickling/burning; constipation; difficulty concentrating/muscular weakness; tremor; weight loss.

Stores Affected

  • WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Amazon, Dollar Tree, and other online outlets.
  • Schnucks-brand cinnamon-flavored applesauce pouches and variety pack are sold at Schnucks and Eatwell Markets grocery stores.
  • Weis-brand cinnamon applesauce pouches are sold at Weis grocery stores.

Status

Ongoing; updates to this advisory will be provided as they become available.

Recommendation

  • Consumers should not eat, sell, or serve recalled WanaBana, Schnucks, or Weis-brand apple cinnamon pouches and should discard them.  
  • 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. 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. 
  • Contact your healthcare provider if you think you may have symptoms of lead toxicity after eating recalled fruit pouches.

Multiple states have reported potential cases to the U.S. Food and Drug Administration (FDA) of high blood lead levels (BLLs) in children consuming recalled cinnamon-containing applesauce products that have high levels of lead. The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to advise clinicians and health departments to consider the possibility of illness due to lead exposure and report cases to their local health authorities.

Background
FDA, CDC, and state and local partners are investigating a potential link between high BLLs and consuming certain cinnamon-containing apple purée and applesauce products.

State partners tested multiple lots of the reported products, and test results indicated the products contained extremely high levels of lead. WanaBana, Schnucks, and Weis have initiated voluntary recalls of certain lots of the following products:

  • WanaBana brand apple cinnamon fruit purée pouches
  • Schnucks brand cinnamon applesauce pouches
  • Weis brand cinnamon applesauce pouches

More information about the specific recalled products may be found on the FDA’s website: Investigation of Elevated Lead Levels: Applesauce Pouches (November 2023) | FDA

As of November 7, 2023, there are 22 cases, in states including Alabama, Arkansas, Louisiana, Maryland, Missouri, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Washington, ages 1 to 3 years, with BLLs ranging from 4 to 29 micrograms per deciliter (µg/dL). Cases experienced signs and symptoms including headache, nausea, vomiting, diarrhea, change in activity level, and anemia.

No safe level of lead in children’s blood has been identified. CDC does not use the term “elevated blood lead levels” when recommending what actions to take based on a child’s blood lead level (BLL). CDC uses a blood lead reference value (BLRV) of 3.5 µg/dL to identify children with BLLs that are higher than most children’s levels. The BLRV is based on the 97.5th percentile of the BLLs among U.S. children ages 1–5 years. The BLL can be obtained using a capillary or venous blood draw. Capillary lead levels ≥3.5 µg/dL require confirmatory testing with a venous blood level to rule out contamination. Children who have eaten the recalled products or have other suspected sources of lead exposure should be tested.

Lead toxicity primarily targets the central nervous system. Children are more vulnerable to lead poisoning than adults because their nervous systems are still developing. Children also tend to absorb a higher fraction of ingested lead than adults. Although children with lead exposure may have no apparent acute symptoms, even low levels of lead have been associated with learning, behavioral, and cognitive deficits. A child who is exposed to large amounts of lead may develop acute lead poisoning, presenting with gastrointestinal, hematological, and neurological effects, including one or more of the following signs and symptoms: anemia, abdominal pain, weakness, and severe neurological sequelae (e.g., seizures, encephalopathy, and coma), which may result in brain damage. Some effects of lead poisoning in a child may continue into adulthood. Adults who have high BLLs may be at increased risk for high blood pressure, other cardiovascular effects, kidney problems, adverse reproductive outcomes, and gout. More information about adverse effects of lead exposure can be found in the ATSDR Lead Toxicological Profile.

Managing acute lead poisoning includes eliminating the exposure, providing supportive and symptomatic care, and quantifying lead exposure by checking BLLs. Children who are symptomatic with elevated BLLs above 45 µg/dL may require hospital admission for monitoring and chelation therapy using medications such as succimer, dimercaprol, or edetate calcium disodium (EDTA). Healthcare providers can find recommendations on management of childhood lead exposure and other resources on the Pediatric Environmental Health Specialty Units website.

Recommendations for Clinicians

  1. Counsel patients or their caregivers and guardians not to eat specific cinnamon-containing apple purée or applesauce products named in the FDA recall announcements.
  2. Educate patients or their caregivers and guardians about the health effects of lead exposure in children and the importance of seeking medical care. Most children have no obvious symptoms, but appropriate screening can detect lead in blood. Children who have consumed a recalled applesauce pouch product should be tested for lead exposure. Clinicians may refer to CDC’s guidance on testing children for lead exposure. The American Academy of Pediatrics has also published clinical guidance for managing lead exposure in children. More specific recommendations for obtaining BLLs in your jurisdiction may be available from your local health department or regional Pediatric Environmental Health Specialty Unit (PEHSU).
  3. Consider lead exposure in the differential diagnosis of patients presenting with compatible clinical findings associated with lead poisoning, which may include the following:
    1. Constitutional symptoms such as generalized weakness, fatigue, malaise, arthralgias, myalgias, irritability, anorexia, insomnia, and weight loss.
    2. Abdominal pain (“lead colic”), constipation, nausea, and other gastrointestinal symptoms.
    3. Anemia (normochromic or microcytic, possibly with basophilic stippling).
    4. Central nervous system effects, such as headache, impaired visual-motor coordination, tremor, and, in severe cases, seizure, encephalopathy, and coma.
    5. Stunted growth, hearing problems, impaired neurobehavioral development, decreased intelligence, and failure to meet expected developmental milestones.
    6. Impaired kidney function, such as acute tubular dysfunction.
  4. Obtain a detailed exposure history in patients with suspected lead exposure, including those who consumed a recalled product. Also, ask about household members with known lead exposures and possible lead sources in and around the home. Parents and caregivers who work in jobs, hobbies, or other activities that expose them to lead can bring lead-containing dust home with them. Lead-containing dust can be tracked onto carpets, floors, furniture, and other surfaces that a child may touch, and expose other family members without knowing.  Known risk-factors for lead exposure include the following:
    1. Lead paint and dust in homes built before 1978.
    2. Lead in soil, for example due to prior contamination from leaded gasoline, exterior lead paint, or old home renovations.
    3. Nearby active lead and other types of smelters, battery recycling plants, or other industries that release lead into the air,
    4. Certain folk remedies (e.g. Ayurvedic or traditional Chinese herbal medicines, Azarcon, Greta), cosmetics (e.g. kohl, kajal, surma), religious powders (e.g. sindoor), and other cultural products.
    5. Imported powdered spices, such as turmeric, chili, and curry powders.
    6. Certain types of jewelry made with lead-containing metal alloys or paints.
    7. Ceramics made with lead-containing glazes.
    8. Older toys made with lead-based paint, lead-containing metal alloys, or certain types of plastic.
  5. Know that individuals with high BLLs may not be symptomatic and are identified through screening. Be familiar with CDC’s testing recommendations for lead, indications for confirmatory testing, and recommended actions based on BLL. CDC recommends a blood lead reference value (BLRV) of 3.5 µg/dL to identify children with BLLs that are higher than most.
  6. Obtain early consultation with or provide a referral to a medical toxicologist or pediatric specialist with expertise in managing lead exposure for medical workup and managing patients with high BLLs.
  7. Contact your local health authority to report cases of individuals with BLLs above the reference value, including those who have consumed these recalled products.
  8. Contact your local poison center (1-800-222-1222) for advice on diagnosing and managing lead toxicity.

Recommendations for Public Health Professionals

  1. Know that individuals with high BLLs may not be symptomatic. Case finding may be mainly from reporting by clinicians who recognize risks of exposure and perform screening.
  2. Consider conducting case-finding activities that leverage existing data sources such as medical encounter and hospital discharge data, electronic syndromic surveillance systems, your local poison center, and other applicable surveillance systems.

Recommendations for the Public (Parents, Caregivers, Guardians)

  1. Do not buy, eat, sell, or serve recalled cinnamon-containing applesauce pouch products because they may contain lead.
  2. Parents and caregivers of children who may have consumed recalled products should contact the child’s healthcare provider about getting a blood test for lead.

NCDHHS Investigation Unveils Lead Contamination

The NCDHHS investigation, a crucial component of this unfolding crisis, identified WanaBana Apple Cinnamon Fruit Puree pouches as a common denominator in the cases of elevated lead levels. In their rigorous analysis of multiple lots of the product, NCDHHS unearthed shockingly high concentrations of lead, prompting heightened concerns over the potential for acute lead toxicity in affected individuals. The FDA has diligently reviewed and endorsed NCDHHS’s analytical findings, validating the severity of the situation.

Elevated Illness Reports Prompt Wider FDA Action

As of November 13, 2023, the FDA has received a troubling total of 22 reports of illnesses potentially linked to the recalled product. In response to this surge in reported cases, the FDA, in collaboration with state partners, is intensifying efforts to collect and analyze additional product samples of fruit puree and applesauce pouches. Encouragingly, analyses of non-recalled products, at this point, have not revealed elevated levels of lead.

WanaBana LLC’s Voluntary Recall and Expansion

Recognizing the gravity of the situation, WanaBana LLC took swift action by initiating a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches on October 31, 2023. However, the extent of the recall expanded on November 9, 2023, to encompass Schnucks and Weis cinnamon applesauce pouches. This broader recall not only affects markets within the United States but also extends to international distribution, reaching consumers in Cuba and the United Arab Emirates.

Global Ramifications and Collaborative Investigation

The impact of this lead contamination transcends national borders, as evidenced by the distribution of the affected products to Cuba and the United Arab Emirates. In response to the escalating crisis, the FDA has transferred the investigation to its Coordinated Outbreak Response & Evaluation (CORE) Network. Collaborating closely with the Centers for Disease Control and Prevention (CDC) and various state and local partners, the CORE Network is intensifying efforts to trace the origins of the lead contamination and to identify any additional products linked to the reported illnesses.

Expanded Recall Involving Other Brands

In addition to WanaBana, two other brands of products are now subject to recall due to potential lead contamination. Specific Schnucks cinnamon-flavored applesauce pouches and variety packs, as well as certain Weis cinnamon applesauce pouches, are now included in the widening recall.

Ongoing FDA Investigation

The FDA is actively and continuously evaluating incoming reports of illnesses, underscoring the agency’s commitment to identifying the source of lead contamination and determining the full extent of the affected products. As the investigation progresses, the FDA pledges to update the public through advisories, ensuring transparency and providing crucial information to safeguard consumer health.

Conclusion

The unfolding investigation into lead contamination in WanaBana Apple Cinnamon Fruit Puree pouches has evolved into a far-reaching public health concern, prompting swift and comprehensive action from regulatory authorities. With an expanding recall affecting multiple brands and international distribution, the urgency of the situation is underscored. The collaborative efforts of the FDA, CDC, state, and local partners, combined with ongoing investigations, are vital in safeguarding public health and preventing further instances of lead toxicity. As the situation develops, consumers are advised to stay informed through FDA updates and exercise caution with the consumption of affected products.


reference link : https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023

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