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  5. A Conversation with FDA on Steps the Agency is Taking to Address Unsafe Levels of Lead Found in Cinnamon
  1. Conversations with Experts on Food Topics

A Conversation with FDA on Steps the Agency is Taking to Address Unsafe Levels of Lead Found in Cinnamon

Conrad Choiniere, Ph.D., Acting Deputy Center Director for Regulatory Affairs within FDA’s Center for Food Safety and Applied Nutrition (CFSAN)

On March 6, 2024, the FDA issued a safety alert advising consumers not to buy or eat certain ground cinnamon products because samples of these products were found to contain elevated levels of lead.  The alert followed FDA’s targeted lead analysis survey of  ground cinnamon products from discount retail stores, and additional testing by states under the Laboratory Flexible Funding Model Cooperative Agreement (LFFM). The FDA initiated this testing to evaluate the presence of lead in cinnamon following the October 2023 voluntary recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products which contributed to lead poisoning in children.

The FDA collected and tested 75 samples from retail locations, and the Maryland Department of Health and the Missouri Department of Health performed additional analysis under the LFFM. Based on those findings, the FDA issued a safety alert and recommended voluntary recalls of product representing six brands of cinnamon containing elevated lead levels (for details about the levels of lead in the products and related recalls see the Safety Alert). It is important to note that no illnesses or adverse events have been reported related to these products, and the lead levels detected are significantly lower than what was detected in the cinnamon used in the apple sauces pouches associated with the October 2023 recall; however, we understand that consumers might be concerned about the news they are hearing.  

In the conversation piece below, Conrad Choiniere, Ph.D., Acting Deputy Center Director for Regulatory Affairs within FDA’s Center for Food Safety and Applied Nutrition (CFSAN), answers questions that might be on the minds of consumers and explains what else the FDA is doing to enhance the safety of cinnamon and other spices in the U.S. market.

Should consumers be concerned about the cinnamon in their pantries?  

We initiated this testing because we wanted to know the same thing, and what we found resulted in our advisory about certain products that are listed in the safety alert, which we recommend people do not buy or use. As for other cinnamon people may have at home, we don’t have evidence at this time that there are safety concerns related to other products. If we find new information that changes our thinking, we will update our recommendations and communicate them publicly. 

Will consumers who have been using these cinnamon products experience lead poisoning symptoms?

Lead exposure can impact individuals differently, depending on a variety of factors such as size, weight, age, nutrients in the diet that can prevent absorption of the lead, amount of lead consumed, etc. We use a public health protective approach to consider those who may be most vulnerable, for example young children, including development during pregnancy, and people who already have elevated blood lead levels. Based on FDA’s assessment, prolonged, ongoing exposure to these specific cinnamon products that were found to have elevated levels of lead could contribute to adverse health effects. If you or someone in your family consumed any of the cinnamon listed in the safety alert or you have other reasons to be concerned about potential exposure to elevated levels of lead, we recommend you contact your health care provider.

Is there anything consumers can do to reduce absorption of lead in their bodies?

A diverse, nutritious diet– like that recommended in the Dietary Guidelines for Americans – can help protect against negative health effects from exposure to lead. It’s important that people get essential nutrients like iron, zinc, and calcium from the foods they eat – among many other important benefits, they decrease the amount of lead the body can absorb, and having enough 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 eat the same foods.

How did these products become contaminated?

The FDA does not know how these products became contaminated with lead.  Lead can enter the food supply from the environment where foods are grown, raised, or processed. Levels of lead in the environment can vary depending on differences in geography and proximity to current or past uses of products made with lead. However, lead can also enter food through processing and manufacturing, such as through the use of non-food grade equipment containing lead. The FDA will be working with the firms to further investigate how these products became contaminated.

How does this alert and recall relate to the recall of cinnamon apple puree and applesauce products this past fall?

The FDA initiated this sampling of cinnamon at the retail level following the recall of the cinnamon apple puree and apple sauce products and the related investigation this past fall. What we found is that the levels of lead in the ground cinnamon listed in the safety alert and associated with the current recalls is approximately 2,000 ppm to nearly 5,000 ppm lower than the levels of lead associated with the cinnamon in recalled apple puree and apple sauce products.  The lead levels in the ground cinnamon that we sampled at retail were between 2 and 3.4 ppm compared to between 2,270 ppm to 5,110 ppm for the cinnamon in the recalled apple puree and apple sauce products. So, although we have concern about these products in the safety alert, they do not present the same level of risk to human health as the cinnamon in the apple puree and apple sauce products.

How does this recall relate to the FDA’s Closer to Zero initiative?

Our Closer to Zero initiative aims to reduce dietary exposure to contaminants like lead to as low as possible, particularly from foods commonly consumed by babies and young children. While the ground cinnamon listed in the Safety Alert may not be a food directly intended for young children, we understand that many parents may be preparing foods for their young children with cinnamon. As children are generally more vulnerable to the effects of lead exposure, FDA seeks to work with industry to take steps to prevent lead exposure from contamination. 

What are FDA’s next steps?

We’re continuing to work with manufacturers, distributors, and retailers to remove unsafe products from the market, and to further investigate the sources of the contamination. We also just 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 is  continuing its Toxic Elements monitoring program, which includes testing of a variety of foods including spices  that are offered for sale in the U.S. Our previous and ongoing sampling at import have prevented cinnamon with elevated lead levels from entering U.S. commerce; however, like all of our surveillance activities, these monitoring programs only evaluate a small subset of the commodity being imported. Ultimately, it is the responsibility of the manufacturers and the importers to ensure the safety of the products entering the U.S. market.

The FDA is also looking to work with the spice industry to provide awareness about these findings so that the spice industry can make informed decisions that help ensure the safety of their products. FDA will follow-up on these findings as well as continue our surveillance activities concerning imported spices to prevent unsafe cinnamon from reaching consumers in the U.S., including adding firms and products to import alert where appropriate.

The FDA is considering additional inspections of facilities that use cinnamon in their finished products to ensure compliance with the FDA’s Preventive Controls for Human Food rule. The FDA is also considering additional focus on chemical contaminants, including lead, when conducting inspections of importers subject to the FDA’s Foreign Supplier Verification Program for Food Importers (FSVP) regulation. The FSVP regulation requires the importer to develop, maintain, and follow an FSVP that provides adequate assurances that the food is produced in compliance with applicable FDA food safety regulations.  

Would an action level for lead have prevented this?

Action levels give industry clarity about the levels of contaminants in a food the FDA may consider to render the food adulterated, but the FDA does not need action levels or guidance to take action when the level of a contaminant, such as lead, is unsafe. It is industry’s responsibility to take the necessary steps to ensure that the food they produce is safe.

So I don’t think the elevated levels of lead detected in these products could have been entirely prevented through action levels. However, what could have been helpful in preventing these products from entering the market is end-product testing. Currently, federal law does not explicitly require industry to test ingredients or final products for contaminants. As part of the President’s FY2024 Budget proposal, we’ve asked that Congress amend the FD&C Act to add a requirement that industry conduct testing of final products (including those marketed for consumption by infants and young children) for contaminants, maintain testing results for FDA inspection, and provide the FDA remote access to test results. These new authorities would help the FDA understand levels of contaminants in foods, allow the FDA to monitor industry progress in reducing levels over time, and identify where the FDA should devote more time and resources. 

What responsibility does industry have in these situations?

While it is not possible to completely prevent lead from entering the food supply, for foods that contain lead, it may be possible to reduce the levels through changes to agricultural or manufacturing practices. By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed.

Additionally, importers have an important responsibility for ensuring the safety of the products they import into the U.S. Under FSMA, our FSVP program introduced a new responsibility on importers to verify that the manufacturers they import products from are following applicable food safety requirements.

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