FDA continues probing lead in applesauce

Published 10:25 am Thursday, December 28, 2023

The U.S. Food and Drug Administration (FDA) is providing additional context about the amount of lead in testing results from cinnamon used as an ingredient in the recalled applesauce pouches and in testing results of the recalled pouches.

The recalled products include:

  • WanaBana brand apple cinnamon fruit puree pouches.
  • Schnucks brand cinnamon applesauce pouches.
  • Weis-brand cinnamon applesauce pouches.

FDA tested samples of the cinnamon collected from the Austrofoods manufacturing facility in Ecuador which was used in the recalled applesauce pouches.  The highest result was 5,110 parts per million (ppm), which was more than 2,000 times the level of 2.5 ppm being considered for bark spices (including cinnamon) by the international standard-setting body, Codex Alimentarius Commission (Codex).

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In addition, the testing results previously reported for the sample of recalled WanaBana cinnamon apple puree pouch collected from Dollar Tree had a lead concentration of 2.18 ppm which, for context, is more than 200 times greater than the action level of 0.01 ppm that the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

Although there are proposed action levels for lead used for comparison, the FDA notes they do not need an action level or guidance to act when food contains a harmful substance, such as lead, that may render the food injurious to health.

As of Dec. 26, the FDA has received 82 confirmed complaints/reports of adverse events potentially linked to recalled product, including three in Kentucky.  To date, confirmed complainants, or people for whom a complaint or adverse event was submitted and met FDA’s complainant definition, range from infants to 53 years of age.

The FDA has tested multiple products, and based on the current evidence, there are no further products being added to the recall at this time.

To properly discard the recalled product, the FDA says consumers and retailers should carefully open the pouch and empty the content into a trash can before discarding the packaging, to prevent others from getting any of the product from the trash.  Clean up any spills after disposing of the product, then wash your hands thoroughly.