FDA Issues Warning for Lead Contamination in Fruit Puree

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FDA Issues Warning Letter to Manufacturer of Lead-Contaminated Apple Cinnamon Products

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, August 28, 2024

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On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall last year.
The letter follows up on inspections that were conducted in December of last year and which “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation” in 21 CFR Part 117.
The specific violations of these rules that were referenced include:
- The failure to conduct an appropriate hazard analysis to identify and evaluate lead as a known or reasonably foreseeable hazard requiring a preventive control. FDA noted that lead is often found in spices and that children (the intended consumers) are particularly sensitive to it. Although lead was identified as a hazard, the plan concluded that no preventive control was required based on vague and faulty rationales like “supplier without historical precedents [of lead contamination].”Although the plan concluded that no lead control was required, it nevertheless required that cinnamon be purchased from an approved supplier with certificates of analysis (COA). However, the supplier approval plan was not properly implemented and no on-site audits were conducted. FDA recommended that COAs from labs using scientifically valid methods and procedures document that supplied ingredients (e.g., cinnamon) meet food-grade production standards for every major analytical parameter (e.g., heavy metals).
- The plan for heavy metal monitoring in the finished product that was provided to FDA did not include critical information like what constituted a representative sample, what method would be used by the test lab, and how the company would assure that the method was properly followed.
The warning letter is part of FDA’s continued efforts to reduce the incidence of lead and other heavy metal contamination.