Thursday, March 7, 2024

FDA Issues Health Alert on Cinnamon Product Due to Elevated Lead Content, Recalls Issued

"Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium."

Companies producing product with elevated lead as determined by FDA testing issued recalls.
  • El Chilar Rodriguez LLC of Apopka, FL is recalling 127 cases (12 bags/case) of El Chilar Ground Cinnamon “Canela Molida” (1.25 oz bag).
  • Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER"
  • Colonna Brothers of North Bergen, NJ is recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon 
  • Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER"
  • La Fiesta Food Products, La Mirada California is recalling Cinnamon Ground .87oz 
First, this is a great reminder of why it is important to pay attention to recalls and health alerts.  If you are an importer of a product or ingredient, that that ingredient was involved in major outbreak, it is just a matter of time before regulatory authorities are taking a broader look at other issues.  It does not have to be from the same supplier or originate from the same country.

The levels were not anywhere as high in these implicated products compared to the levels in the cinnamon apple sauce involved in the lead poisoning outbreak.

"Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm) (see table above for a full list of lead levels in these products). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon."

What level is unsafe?

FDA.gov - "Although no safe level for lead exposure has been identified, the FDA has calculated an IRL for lead based on the Centers for Disease Control and Prevention’s (CDC) blood reference level of 3.5 micrograms of lead per deciliter of whole blood (µg /dL). The blood reference level is the level at which the CDC recommends clinical monitoring of lead exposure in children."

"The IRL for lead includes a 10x safety factor. This means that it is nearly ten times lower than the amount of lead intake from food that would be required to reach the CDC’s blood reference level. The calculated IRLs are 2.2 micrograms (µg) per day for children and 8.8 µg per day for females of childbearing age. The IRL for females of childbearing age is to protect against possible fetal exposure in women who are unaware that they are pregnant and to protect against infant exposure during nursing:.

https://www.fda.gov/food/alerts-advisories-safety-information/fda-alert-concerning-certain-cinnamon-products-due-presence-elevated-levels-lead
FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead

March 6, 2024

What is the problem?

Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe.

The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share our findings and request that the company initiate a recall. The FDA will update this notice with the communications from firms that voluntarily agree to recall as we receive them.


Purpose

The FDA is advising consumers to throw away and not to buy the ground cinnamon products listed above because samples of these products were found to contain elevated levels of lead. Based on FDA’s assessment, prolonged exposure to these products may be unsafe and could contribute to elevated levels of lead in the blood. Long-term exposure (months to years) to elevated levels of lead in the diet could contribute to adverse health effects, particularly for the portion of the population that may already have elevated blood lead levels from other exposures to lead. No illnesses or adverse events have been reported to date in association with these products.

While the ground cinnamon products in this alert may not be a food targeted to young children, cinnamon is used in many foods young children consume. Consistent with the agency’s Closer to Zero initiative, which focuses on reducing childhood exposure to lead, the agency is recommending voluntary recall of the products listed above because prolonged exposure to the products may be unsafe. Removing the ground cinnamon products in this alert from the market will prevent them from contributing elevated amounts of lead to the diets of children.

Summary and Scope of the Problem

Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium.

Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm) (see table above for a full list of lead levels in these products). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon.

In addition to the FDA’s sampling and analysis, some states also analyzed samples of cinnamon through the Laboratory Flexible Funding Model. This is a cooperative agreement with states to help investigate, monitor and remove adulterated foods from commerce and aid regulatory programs. The Maryland and Missouri Departments of Health collected cinnamon samples included in this safety alert.

FDA Actions

The FDA will continue to work with manufacturers, distributors, and retailers to remove unsafe products from the market, and to further investigate the sources of the lead contamination as appropriate.

The FDA is also continuing its Toxic Elements monitoring program, which includes testing of a variety of foods including colored spices offered for sale in the U.S. Our sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of our surveillance activities, these monitoring programs only evaluate a subset of the commodity being imported. FDA will follow-up on these findings as well as continue our activities at import to prevent unsafe cinnamon from reaching consumers in the U.S., including by adding firms and products to import alert where appropriate. Ultimately, it is the responsibility of the manufacturers and the importers to ensure the safety of the products that enter into the U.S. market.

The FDA also sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.

Potential Health Effects

Based on FDA’s assessment, consuming these products could contribute to elevated levels of lead in the blood. Long-term exposure (months to years) to elevated levels of lead in the diet could contribute to adverse health effects, particularly for the portion of the population that may already have elevated blood lead levels from other exposures to lead. If you are concerned that you or anyone in your family may have symptoms of lead toxicity, the FDA recommends you contact your healthcare provider.  

The potential for adverse health effects from consuming food contaminated with lead vary depending on the level of lead in the food; age of the consumer; length, amount, and frequency of exposure to lead in the food; and other exposures to different sources of lead. For example, the very young are particularly vulnerable to the potential harmful effects from lead exposure because of their smaller body sizes and rapid metabolism and growth. High levels of exposure to lead in utero, infancy, and early childhood can lead to neurological effects such as learning disabilities, behavior difficulties, and lowered IQ.

FDA’s Advice to Help Protect Against the Effects of Lead

Good nutrition – like meeting the recommendations in the Dietary Guidelines for Americans – can help protect against the health effects from exposure to lead. Eating a variety of healthy foods can make it less likely for an individual to be exposed to the same contaminant from the same food many times and helps to provide the range of nutrients needed for health and, for children, healthy development. Having adequate nutrients stored in the body also can help to prevent lead from having harmful effects. To get adequate food variety, FDA recommends that consumers eat many different foods from the five food groups – vegetables, fruits, grains, dairy, and protein foods – and to alternate how often you provide the same food.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/el-chilar-rodriguez-llc-issues-voluntary-recall-el-chilar-ground-cinnamon-canela-molida-due-elevated
El Chilar Rodriguez LLC. Issues Voluntary Recall of El Chilar Ground Cinnamon “Canela Molida” Due to Elevated Lead Levels
Summary
Company Announcement Date:  March 06, 2024
FDA Publish Date:  March 06, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Metal Contaminant - Lead
Company Name:  El Chilar Rodriguez LLC
 Brand Name:El Chilar
Product Description:  Ground Cinnamon “Canela Molida”

Company Announcement

El Chilar Rodriguez LLC of Apopka, FL is recalling 127 cases (12 bags/case) of El Chilar Ground Cinnamon “Canela Molida” (1.25 oz bag), because it may contain traces of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects. Lead can cause serious health problems if too much is ingested, such as damage to the brain and kidneys and can interfere with the production of red blood cells that carry oxygen to all parts of your body.

The product was distributed by La Raza LLC, 8795 D'Arcy Rd, Forestville, MD 20747, which distributes to brick-and-mortar retail stores within the state of Maryland.

The product can be identified by the lot codes D300 EX1024 and F272 EX1026, which is stamped on the front side of the packaging (see attached example).

No illnesses have been reported to date.

The recall was initiated after the Maryland Department of Health collected product samples and analysis came back with elevated concentrations of lead. Subsequent investigation indicates the problem might be caused by potentially adulterated raw material from the supplier.

Consumers who have purchased El Chilar Ground Cinnamon “Canela Molida” with lot code D300 EX1024 and F272 EX1026 are urged to stop using the product immediately and to return it to the place of purchase for a full refund. Parents and caregivers of toddlers and young children who may have been exposed to lead should contact their health care provider to report their symptoms and receive care. Consumers with questions may contact EL CHILAR RODRIGUEZ LLC at 407-880-6007, on regular business hours (Mon - Fri 8:00AM – 4:30PM).

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/colonna-brothers-inc-issues-voluntary-recall-15oz-marcum-ground-cinnamon-225oz-supreme-tradition
Colonna Brothers, Inc. Issues a Voluntary Recall for “1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon” Because of Possible Health Risk Due to Elevated Lead Levels
Summary
Company Announcement Date:  March 06, 2024
FDA Publish Date:  March 06, 2024
Product Type:  Food & Beverages  Spices, Flavors & Salts
Reason for Announcement:  Elevated Lead Levels
Company Name:  Colonna Brothers, Inc.
Brand Name:  Colonna
Product Description:  Marcum Ground Cinnamon & Supreme Tradition Ground Cinnamon

Company Announcement

FOR IMMEDIATE RELEASE – March 6, 2024 - Colonna Brothers of North Bergen, NJ is recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon because of a possible health risk due to elevated lead levels. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. The effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

The Cinnamon was distributed nationwide through retail stores and mail order. The products come in a clear plastic jar labeled with either “Marcum Cinnamon Ground 1.5oz” or “Supreme Tradition Ground Cinnamon 2.25oz”. Only the following lot codes (found on the jar above the label - below the cap) were affected:

1.5oz Marcum Ground Cinnamon Best By:10/16/25 10DB
1.5oz Marcum Ground Cinnamon Best By: 04/06/25 0400B1
2.25oz Supreme Tradition Ground Cinnamon 09/29/25 09E8
2.25oz Supreme Tradition Ground Cinnamon 04/17/25 04E11
2.25oz Supreme Tradition Ground Cinnamon 12/19/25 12C2
2.25oz Supreme Tradition Ground Cinnamon 04/12/25 04ECB12
2.25oz Supreme Tradition Ground Cinnamon 08/24/25 08A
2.25oz Supreme Tradition Ground Cinnamon 04/21/25 04E5
2.25oz Supreme Tradition Ground Cinnamon 09/22/2025 09E20

No illnesses have been reported to date in connection with these products.

The recall was the result of a targeted sampling program of discount brands by the FDA, following heightened sensitivity around Cinnamon. Colonna Brothers is participating in this recall voluntarily as requested by the FDA. Colonna Brother’s has not violated any Federal guidelines/legislation/laws regarding levels of lead in Cinnamon/Spice nor any protocols requiring testing for heavy metals. The FDA is stating that the lot codes above contain elevated levels of lead that the FDA deems a potential health risk.

Colonna Brothers has voluntarily ceased the production and distribution of all Cinnamon.

Consumers who have purchased the Supreme Tradition Ground Cinnamon or Marcum Ground Cinnamon, with the lot codes listed above, can discard it or return it to the store for a full refund. Anyone concerned they may have been exposed to lead, should contact their healthcare provider to report their symptoms. Consumers with questions may contact us at 201-864-1115 between the hours of 9-5 EST.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raja-foods-skokie-il-recalling-swad-brand-cinnamon-powder-35oz-retail-packs-possible-lead
Raja Foods Skokie, IL Is Recalling “Swad Brand Cinnamon Powder 3.5OZ Retail Packs” for Possible Lead Contamination
Summary
Company Announcement Date:  March 06, 2024
FDA Publish Date:  March 07, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Metal Contaminant - Lead
Company Name:  Raja Foods LLC
Brand Name: SWAD
Product Description:  Cinnamon Powder
Company Announcement  
Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER" because it has the potential to be contaminated with lead. Short term exposure to very low levels of lead may not elicit any symptoms. It is possible that increased blood levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposures to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/body weight. If a child is exposed to lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

The products included in this recall are, SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, from either of the following two batches and Best Before Dates: Batch KX21223 Best Before July 2026 and Batch KX08123 Best Before March 2026.

Product was distributed thru retail grocery stores in the Midwest, Northeast, and Southeast regions of the United States. There have been no illnesses reported to date. The recall was the result of a routine sampling program by the FDA.

Consumers who have purchased “SWAD CINNAMON POWDER 3.5OZ” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 847.972.2865, Monday to Friday 9am to 4pm CST.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raja-foods-skokie-il-recalling-swad-brand-cinnamon-powder-35oz-retail-packs-possible-lead
Raja Foods Skokie, IL Is Recalling “Swad Brand Cinnamon Powder 3.5OZ Retail Packs” for Possible Lead Contamination
Summary
Company Announcement Date:  March 06, 2024
FDA Publish Date:March 07, 2024
Product Type:Food & Beverages
Reason for Announcement: Potential Metal Contaminant - Lead
Company Name: Raja Foods LLC
Brand Name: SWAD
Product Description: Cinnamon Powder
Company Announcement
Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER" because it has the potential to be contaminated with lead. Short term exposure to very low levels of lead may not elicit any symptoms. It is possible that increased blood levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposures to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/body weight. If a child is exposed to lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

The products included in this recall are, SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, from either of the following two batches and Best Before Dates: Batch KX21223 Best Before July 2026 and Batch KX08123 Best Before March 2026.

Product was distributed thru retail grocery stores in the Midwest, Northeast, and Southeast regions of the United States. There have been no illnesses reported to date. The recall was the result of a routine sampling program by the FDA.

Consumers who have purchased “SWAD CINNAMON POWDER 3.5OZ” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 847.972.2865, Monday to Friday 9am to 4pm CST.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/la-fiesta-food-products-recalls-cinnamon-ground-because-possible-health-risk
La Fiesta Food Products Recalls Cinnamon Ground Because of Possible Health Risk
Summary
Company Announcement Date: March 06, 2024
FDA Publish Date: March 08, 2024
Product Type: Food & Beverages
Reason for Announcement: Potential Metal Contaminant - Lead
Company Name: La Fiesta Food Products
Brand Name: La Fiesta
Product Description: Ground Cinnamon
Company Announcement
03/06/2024, La Fiesta Food Products, La Mirada California is recalling Cinnamon Ground .87oz because it has the potential to be contaminated with lead.

Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.

The affected product was distributed in California as well as Arizona, Washington, and Texas through distributors to retail stores from April 20, 2023 through May 3, 2023.

The impacted Cinnamon Ground products are identified below:
La Fiesta Brand Cinnamon Ground .87oz UPC#032327000449

La Fiesta Food Products became aware of the issue after the FDA collected samples of the product and lab analysis revealed elevated concentrations of lead. There have been no reports of illnesses to date. There have been no reports of illnesses to date.

Consumers who have purchased this product are advised to dispose of it or return to place of purchase for refund. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers with questions can contact 408-326-0487 or qualityassurance@lffp.com, Monday-Friday, 9am-4pm PST.

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