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Recalled cinnamon applesauce pouches.

FDA: Recalled cinnamon applesauce pouches containing lead test positive for chromium

January 5, 2024

The Food and Drug Administration (FDA) announced Friday that tests of recalled cinnamon applesauce pouches that contain excessive levels of lead show the products also contain chromium. They agency, however, does not know if the chromium poses a health risk.

The Centers for Disease Control and Prevention (CDC) outlined recommendations for clinicians for possible lead and chromium exposure.

In November, the FDA announced recalls of several cinnamon applesauce fruit pouches manufactured in Ecuador and sold under WanaBana, Weis and Schnucks brands. The recalled products should be discarded immediately. Anyone who ate the recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their health care provider to monitor their health and seek supportive care, if needed.

As of Dec. 29, 2023, the CDC has received 287 reports of possible lead exposure related to the products from state and local health departments in 37 states. The numbers include 80 confirmed cases, 187 probable cases and 20 suspected cases.

During its investigation, the FDA inspected the Austrofoods facility in Ecuador, where investigators collected samples of cinnamon supplied by Negasmart to Austrofoods. The samples had extremely high lead levels of 5,110 and 2,270 parts per million (ppm). For context, the international standard-setting body Codex Alimentarius Commission (Codex) is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, this year.

As its investigation continued, the FDA said analysis of recalled cinnamon apple products and the cinnamon collected in Ecuador showed the cinnamon and recalled products also contained a high level of chromium. Two cinnamon samples yielded 1,201 and 531 ppm. Because of the limited amount of cinnamon used in the finished product, the level of chromium detected in the reanalysis of FDA samples of the recalled WanaBana Cinnamon Apple Puree product yielded 0.590 and 0.566 ppm.

Chromium is a naturally occurring element with trace levels normally found in the diet. The most common forms of chromium found in chromium compounds are trivalent chromium (chromium(III)) and hexavalent chromium (chromium(VI)). Chromium(III) is considered an essential nutrient and can be found in dietary supplements.

Chromium(VI), however, is a known carcinogen. Currently, FDA testing cannot identify whether the chromium in the cinnamon and recalled apple cinnamon puree pouches is chromium(III) or chromium(VI).

Chronic, prolonged inhalation and skin exposure to chromium (VI) has been associated with chronic lung disease and ulceration of skin and mucous membranes. While harm resulting from ingesting lead-contaminated food is relatively well-researched, the effects of eating food contaminated with chromium(VI) as a constituent of lead chromate are not well-understood.

The FDA also conducted testing for arsenic and cadmium, but those elements were not detected above trace levels in the cinnamon collected from the Austrofoods facility in Ecuador or in the recalled products. Some state partners also conducted testing for toxic elements and only detected levels of lead and chromium.

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