FDA and CDC provided an update on lead contamination issue in cinnamon apple sauce imported from Ecuador. As you know, they have identified the cinnamon as the source of the lead (and then later cadmium was identified as well), and the cinnamon was sourced from Sri Lanka. Beyond that, there is no information on how the contamination got into the cinnamon.
At this point, CDC states that there are 413 reported cases with 100 cases confirmed.
This shows how it is so important it is to work with your foreign supplier when they are controlling their suppliers. As lawsuits arise from this, to what degree will those foreign suppliers shoulder the financial burden.
https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-chromium-levels-cinnamon-applesauce-pouches-november-2023?utm_medium=email&utm_source=govdelivery
Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.
Current Update
February 6, 2024
Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, the processor of the ground cinnamon supplied by Negasmart to Austrofoods and later used in recalled apple cinnamon products, is the likely source of contamination and is not in operation at this time. Additionally, according to ARCSA, the unprocessed cinnamon sticks used in recalled products were sourced from Sri Lanka and were sampled by ARCSA and found to have no lead contamination. ARCSA’s investigation and legal proceedings to determine ultimate responsibility for the contamination are still ongoing.
The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera.
FDA has no indication that this issue extends beyond these recalled products and does not have any confirmed reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.
As of February 5, 2024, FDA has not received any additional 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 February 2, CDC has received reports of 100 confirmed cases, 277 probable cases, and 36 suspected cases for a total of 413 cases from 43 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 below are in the Previous Updates section. FDA will update the advisory as information becomes available.
FDA Complaint/Adverse Event Report Overview
Total Complaint/Adverse Event Report: 90*
Report Date Ranges: October 17, 2023 – January 16, 2024
States with Complaint/Report: AL (1), AR (1), AZ (1), CA (1), CT (1), FL (1), GA (2), IA (1), IL (5), IN (1), KY (3), LA (4), MA (3), MD (7), MI (8), MO (3), NC (6), NE (2), NH (1), NJ (1), NM (1), NY (8), OH (3), OK (1), PA (2), SC (2), TN (3), TX (3), VA (2), WA (4), WI (2), WV (3), Unknown (3)
Product Distribution: Nationwide
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.
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.
What can I do?
Do not eat cinnamon-containing apple purée or applesauce products included in the FDA recall announcements. Anyone who may have eaten the affected products should talk with their healthcare provider. Medical treatment for chromium exposure focuses on treating symptoms. There is no specific antidote to treat chromium exposure and there is no evidence to support the use of chelation therapy.
Additionally, if you suspect that you or your child may have been exposed to lead, you should talk to your healthcare provider about getting a blood lead test. Healthcare providers and most local health departments can test for lead in the blood. Many private insurance policies cover the cost of testing for lead in the blood. The cost of blood lead testing for children enrolled in Medicaid is covered by the Centers for Medicare & Medicaid Services.
More Information
Information about FDA’s investigation, with current updates, can be found on the FDA website, Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023) | FDA.
For more information on chromium, ToxFAQsTM for Chromium
Information for Clinicians can be found on the COCA Now webpage, Update on High Blood Lead Levels in Children Consuming Recalled Cinnamon Applesauce Pouches and Potential Chromium Exposure
Fast Facts
Data updated on February 2, 2024.
CDC has received the following reports from state and local health departments:
Total Cases: 413
Confirmed Cases: 100
Probable Cases: 277
Suspect Cases: 36
States: (43 total) AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, 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.
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