Part of a federal investigation into lead in certain cinnamon applesauce products has been shifted to a followup status.

The new approach by the Food and Drug Administration is designed to provide post-incident response action. The agency will continue surveillance activities as well as prevention and compliance activities, according to an update posted by the FDA on April 16.

The Centers for Disease Control and Prevention is continuing to monitor the outbreak of lead poisoning and most recently reported 519 children impacted in the outbreak. The outbreak stretches across 44 states. The FDA has collected 90 “adverse incident” reports in the outbreak. The two agencies use different reporting methods, so their numbers may overlap somewhat and should not be added together. The CDC continues to add patients to its count.

Also, there can be significant lagtime between consumption of the lead contaminated cinnamon applesauce and the detection of elevated blood levels of the heavy metal.

Three brands of cinnamon applesauces sold in pouches and marketed for children have been recalled. They are Wanabana, Schnucks and Weis. Only cinnamon applesauce products have been implicated.

The FDA was first notified about the lead in the applesauce in mid-September of 2023 by public health officials in North Carolina. On Oct. 28 the FDA discussed analytical findings of lead in cinnamon applesauce produced by Astrofoods in Ecuador with the producer. Also on Oct. 28 the FDA issued a warning to U.S. consumers.

It was eventually determined that the lead was from contaminated cinnamon purchased from a third-party supplier. The FDA has reported that the lead was likely added to the cinnamon to increase its weight and therefore its commercial value.

Other key dates in the investigation include:

  • On Oct. 29, 2023, Wanabana LLC notified their customers about recall of the WanaBana Apple Cinnamon Fruit Puree products.
  • On Oct.30, 2023, and through continued cooperation with the FDA, Wanabana LLC issued a press release regarding their voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches.
  • On Nov. 2, 2023, after reviewing records provided by the firm as part of their initial recall, the FDA learned that other products (i.e., certain Schnucks and Weis cinnamon applesauce pouches) were implicated in the recall and required additional public notice.
  • On Nov. 3, 2023, the FDA updated its safety alert to, among other things, include certain Schnucks and Weis cinnamon applesauce pouches.
  • On Nov.5, 2023, the FDA held a call with the firm, Wanabana LLC. During the call, FDA staff discussed the investigation, requested additional information from the firm, and asked the firm to update their press release regarding their voluntary recall and to provide additional clarification regarding the scope of the recall of all apple cinnamon fruit puree products, which the firm verbally agreed to provide.
  • On Nov. 6, 2023, Apple Cinnamon Fruit Puree products from Austrofoods were added to Import Alert 99-42.
  • On Nov. 9, 2023, Wanabana LLC issued their expanded recall announcement to include information on recalled Schnucks and Weis cinnamon applesauce pouches, which also impacts markets outside of the United States. Customer information provided by Wanabana LLC shows that product was also distributed to Cuba and the United Arab Emirates.

About lead poisoning
Parents and caretakers should consult a healthcare provider and ask for blood tests if they suspect a child may have been exposed to the recalled cinnamon applesauce products. 

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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