Lead Poisoning in children linked to Cinnamon in Apple Sauce

The FDA has reported that the lead was likely added to the cinnamon to increase its weight and therefore its commercial value.

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.

Cases are reported to the CDC through state health departments. State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. In order to be considered in CDC’s case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit purée product after November 2022.  Based on the amount of information available, CDC asks states to further classify cases as “suspect”, “probable”, and “confirmed”. As the investigation progresses, cases might be assigned to different case categories.

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.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.