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FDA Inspection Reveals Failure to Test for Heavy Metals in Contaminated Applesauce Pouches

385 Illness Cases Linked to Products, with Elevated Levels of Chromium and Lead Discovered in Recent Tests

  • Lead-contaminated cinnamon applesauce pouches that may have sickened hundreds of children in the U.S. were not tested for heavy metals during their manufacture at an Austrofood facility in Ecuador, according to an FDA inspection report.
  • 385 reported cases of illness – of which 97 are confirmed, 253 probable and 35 suspected – have been linked to the fruit puree products across 42 states, according to the US Centers for Disease Control and Prevention.
  • The FDA inspection document noted that in September, the Austrofood facility conducted a hazard analysis for all raw materials and ingredients, including ground cinnamon. However, cinnamon was not considered a significant hazard requiring a preventive control for heavy metals including lead.
  • This month, the FDA announced that while testing recalled products and cinnamon collected from the Austrofood facility, it found elevated levels of chromium as well as lead.
  • An FDA official told Politico in December that the lead contamination in cinnamon applesauce pouches may have been an “intentional act.”
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