The Food and Drug Administration (FDA) is reporting at least 69 complaints of adverse events that are potentially linked to recalled cinnamon applesauce pouches shown to contain elevated levels of lead. All reported cases involve children under 6 years of age.
Additionally, testing during an inspection of a facility in Ecuador showed lead levels in cinnamon as high as 2,000 times one recommended maximum limit, FDA officials said this week.
As of Dec. 15, the Centers for Disease Control and Prevention (CDC) has received reports of 67 confirmed cases, 122 probable cases and 16 suspected cases of lead toxicity from 33 different states. CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond.
FDA Deputy Commissioner for Human Foods Jim Jones told Politico the lead contamination may have been an “intentional act,” and added the agency’s investigation into the contamination continues.
In November, the FDA announced recalls of several cinnamon applesauce fruit pouches that were manufactured in Ecuador and sold under WanaBana, Weis and Schnucks brands. The agency is recommending consumers discard the pouches immediately.
Lead exposure has been associated with health, learning and behavior problems, and there is no known safe level.
Earlier this month, the FDA conducted an onsite inspection of the Austrofoods facility in Ecuador, where investigators collected samples of cinnamon Negasmart supplied to Austrofoods. The samples show extremely high levels of lead contamination of 5110 parts per million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission (Codex) is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024.
Protecting children from exposure to lead is particularly important because they are more susceptible to lead toxicity. Most children have no obvious immediate symptoms. Short-term exposure to lead could result in headache, abdominal pain/colic, vomiting and/or amenia. Longer term exposure could result in irritability, lethargy, fatigue, muscle aches or muscle-prickling/burning, constipation, difficulty concentrating/muscular weakness, tremor or weight loss.
If you suspect a child may have been exposed to lead, contact your health care provider immediately.
The CDC recommends clinicians do the following:
- Counsel patients and families not to eat the recalled cinnamon-containing apple purée or applesauce products.
- Educate patients and families 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.
- Test children who have consumed a recalled applesauce pouch for lead exposure. Refer to CDC guidance on testing children for lead exposure and AAP clinical guidance for managing lead exposure in children. Recommendations for obtaining BLLs may be available from your local health department or regional Pediatric Environmental Health Specialty Unit.
- Consider lead exposure in the differential diagnosis of patients presenting with clinical findings associated with lead poisoning.
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