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Roughly 2 weeks ago the FDA issued a consumer alert regarding the discovery of elevated lead levels in several skews of applesauce products, warning:
The FDA is advising parents and caregivers not to buy or feed WanaBana apple cinnamon fruit puree pouches to children because the product may contain elevated levels of lead. Parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test.
Last Thursday, the manufacturer issued a nationwide recall of these affected products. These products were distributed under a variety of names, including several batches of Schnucks Apple Sauce 90g pouches with cinnamon and Weis Cinnamon Apple Sauce 90g.
Due to the potential health impact, yesterday afternoon the CDC released a HAN Health Advisory to alert clinicians, and the public, and the FDA updated their warning (excerpts follow):
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.
A link, and excerpts from yesterday's HAN advisory follow. While of greatest interest to clinicians, there are also recommendations for the public. Click the link to read it in its entirety.
High Blood Lead Levels in Children Consuming Recalled Cinnamon Applesauce Pouches
Distributed via the CDC Health Alert Network
November 13, 2023, 2:00 PM ET
CDCHAN-00500
Summary
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: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
- WanaBana brand apple cinnamon fruit purée pouches
- Schnucks brand cinnamon applesauce pouches
- Weis brand cinnamon applesauce pouches
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.
