"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 January 29, 2024, FDA has not received any additional confirmed complaints/reports of adverse events potentially linked to recalled product."
FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses
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)
Current Update
January 30, 2024
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 January 29, 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 January 26, CDC has received reports of 98 confirmed cases, 269 probable cases, and 37 suspected cases for a total of 404 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
*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.
Recalled Product
In response to this investigation, Wanabana has voluntarily recalled all WanaBana Apple Cinnamon Fruit Puree Pouches regardless of expiration date and lot code. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.
International Distribution for Recalled Products
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 26, CDC has received reports of 98 confirmed cases, 269 probable cases, and 37 suspected cases for a total of 404 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
*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.
Recalled Product
In response to this investigation, Wanabana has voluntarily recalled all WanaBana Apple Cinnamon Fruit Puree Pouches regardless of expiration date and lot code. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.
International Distribution for Recalled Products
The recall impacts markets outside of the United States. Customer information provided by the firm shows that product was also distributed to Cuba and the United Arab Emirates.
About Chromium:
Chromium is a naturally occurring element. It is an essential trace nutrient important to the diet. Chromium exists predominantly in two forms, chromium (III) and chromium (VI). Chromium (III) is a nutritional form but can be toxic at elevated levels. Both forms of chromium are used in many industrial applications and may be a by-product of manufacturing processes. Chromium (VI), a more toxic form, may be used in these processes or produced as a by-product.
The FDA does recognize some accepted uses of various types of chromium as an ingredient in foods, including dietary supplements and for animal feed; however, chromium (VI) falls outside of these accepted types and exposure to elevated levels of this type of chromium in food is not well understood.
About Chromium:
Chromium is a naturally occurring element. It is an essential trace nutrient important to the diet. Chromium exists predominantly in two forms, chromium (III) and chromium (VI). Chromium (III) is a nutritional form but can be toxic at elevated levels. Both forms of chromium are used in many industrial applications and may be a by-product of manufacturing processes. Chromium (VI), a more toxic form, may be used in these processes or produced as a by-product.
The FDA does recognize some accepted uses of various types of chromium as an ingredient in foods, including dietary supplements and for animal feed; however, chromium (VI) falls outside of these accepted types and exposure to elevated levels of this type of chromium in food is not well understood.
CDC
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 26, 2024.
CDC has received the following reports from state and local health departments:
Total Cases: 404
Confirmed Cases: 98
Probable Cases: 269
Suspect Cases: 37
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.
No comments:
Post a Comment