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Thursday, January 11, 2024

FDA and CDC Provide Update on Lead-in-Apple Sauce Contamination - Additional Reported Cases and the Finding of Chromium in Product

In a January 5, 2024 update to the lead contamination issue linked to cinnamon apple sauce product produced in Ec . and sold under the WanaBana Brand as well as by retailers Schnucks and Weis in the US, CDC is reporting that there are 321 reported cases. FDA states that as of Jan, 8, 2024, 87 of these cases have been confirmed. These cases range from zero and 53 years of age and the median age is one year old. (CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022. As of January 5, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases for a total of 321 cases from 38 different states through their reporting structure.)

FDA is also reporting that in their testing of the recalled products and the cinnamon collected from the Austrofoods facility, the agency has found chromium. People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium.

From the FDA report, "Chromium is a naturally occurring element. It is an essential trace nutrient important to the diet that exists predominantly in two forms, chromium (III) and chromium (VI). Chromium (VI) is more toxic than chromium (III). Due to limitations in available testing methods, FDA was not able to definitively determine the form of chromium in the cinnamon apple puree sample (i.e., whether the chromium present is chromium (III) or chromium (VI)). The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4) (which contains chromium (VI)), but this is not a definitive indicator that lead chromate or chromium (VI) (the more toxic form of chromium) was present. Information on the health effects of eating food contaminated with chromium (VI) are limited. The chromium in lead chromate may also be converted to chromium (III) (the less toxic form of chromium) due to the acidity of the applesauce and the stomach."

This was first reported in October of 2023 and FDA/CDC have provided updates over time.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-chromium-levels-cinnamon-applesauce-pouches-november-2023
Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches (November 2023)
Current Update

January 9, 2024

As of January 8, 2024, FDA has received 87 confirmed complaints/reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people for whom a complaint or adverse event was submitted and met FDA’s complainant definition, are between zero and 53 years of age and the median age is one year old.
CDC’s National Center for Environmental Health is conducting case finding efforts in collaboration with state and local health departments. CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022. As of January 5, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases for a total of 321 cases from 38 different states through their reporting structure. For more information, please visit CDC’s page to review their case reporting methodology and findings.

CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond. In addition, some people who were affected by the contaminated product might be reflected in both the numbers reported by the FDA and the numbers reported by CDC, so the numbers should not be added together.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. Previous updates not captured by the initial timeline are below in the Previous Updates section. FDA will update the advisory as information becomes available.

https://www.cdc.gov/nceh/lead/news/lead-poisoning-outbreak-linked-to-cinnamon-applesauce-pouches.html
Lead and Chromium Poisoning Outbreak Linked to Cinnamon Applesauce Pouches
Apple Cinnamon Fruit Puree Pouches & Cinnamon Apple Sauce


The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and state and local partners are investigating a link between blood lead levels (BLLs) ≥3.5 µg/dL in children consuming certain cinnamon-containing apple purée and applesauce products.

Data updated on January 5, 2024.

CDC has received the following reports from state and local health departments:

Total Cases: 321
Confirmed Cases: 86
Probable Cases: 209
Suspect Cases: 26
States: (38 total) AL, AR, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, WI, WV

Recall: Yes

Investigation status: Active

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.

Update

FDA product testing has also identified high levels of chromium, in addition to lead, in cinnamon samples and recalled applesauce pouch products. (Go here for a list of affected products.)

Potential Health Effects
Consumers should be aware of these elevated levels of chromium and lead found in the cinnamon applesauce pouches and the potential for adverse health effects.

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 a normal diet and in some dietary supplements. Chronic, prolonged exposure to chromium (VI) in occupational settings through inhalation and skin exposure has also been associated with chronic lung disease and ulceration of skin and mucous membranes. Chromium (VI) is a known carcinogen. The exact form of chromium in the recalled applesauce products is unclear. However, lead chromate has previously been reported as a contaminant in spices and foods.

There is limited information about health effects from consuming food contaminated with chromium compounds such as lead chromate. The main health problems seen in laboratory animals following ingestion of chromium (VI) compounds are irritation and ulcers (in the stomach and small intestine) and anemia.

However, the health effects of eating food contaminated with chromium (VI), in the form of lead chromate, are not well understood. Chromium (VI) compounds may be converted to chromium (III) in acidic environments. It is difficult to predict the amount of chromium (VI) and chromium (III) absorbed from ingestion of contaminated food.

While the health effects of chromium are difficult to predict in this scenario, we know that there is no safe level of lead. CDC recommends discarding all affected products and not eating any of them. Anyone who may have eaten the affected products should talk with their healthcare provider.

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