By Donna Campisano, specialist, Communications, APHL

Applesauce is a pantry staple and a favorite snack among toddlers.

But lately applesauce, specifically cinnamon applesauce packaged in squeeze pouches, has been making headlines—and for alarming reasons.

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

Consumers should be aware of these elevated levels and the potential for adverse health effects.

What’s been recalled?

Ecuadorian food manufacturer Austrofoods has voluntarily recalled its 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.

These products were sold through multiple retailers, including Dollar Tree and Amazon.

Consumers should not eat, and retailers should not sell nor serve, the recalled brands of apple cinnamon fruit pouches.

What started the recall?

This recall started with a joint investigation by the North Carolina Department of Health and Human Services, local health departments and the North Carolina Department of Agriculture & Consumer Services after the NC State Laboratory of Public Health identified three children with high blood lead levels in the western portion of the state.

An in-home investigator made the applesauce/lead connection after observing identical products in the pantries of two children reported to have elevated blood lead levels. The NCDHHS then identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure and reported their finding to the FDA. As part of the investigation, NCDHHS analyzed multiple lots of the product, detecting extremely high concentrations of lead. The FDA has reviewed and supports the NCDHHS’ findings.

Early in the FDA’s investigation, it leveraged the capability and capacity of the Laboratory Flexible Funding Model (LFFM) laboratories. The LLFM is a cooperative agreement between the FDA and state human and animal food testing laboratories. The intent of the agreement is to increase the ability of states to generate actionable data and ensure the safety of the US food supply.

An email and next-day emergency call resulted in 12 LFFM laboratories pivoting their sampling efforts. In four business days, 97 samples were collected for testing. Laboratories were instructed to collect both cinnamon-containing and non-cinnamon-containing products; some laboratories were also asked to perform XRF testing (an X-ray technique that can show what elements a compound contains) on the purée packaging to help isolate the contamination source.

How big is the problem?

State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. When a case definition is met, the state health department then reports the case to the CDC.

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 three months after consuming a recalled WanaBana, Schnucks or Weis brand fruit purée product after November 2022.

As of Feb. 24, 2024, the CDC has received 111 confirmed cases of elevated blood lead levels in people consuming these products as well as 320 probable cases and 37 suspected cases for a total of 468 cases from 44 different states. As of Jan. 30, 2024, the FDA has received 90 confirmed complaints/reports of adverse events potentially linked to recalled product.

The median age of those affected is one year.

It’s important to note that the 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.

How did the applesauce get contaminated?

The FDA completed an onsite inspection of the Austrofoods facility located in Ecuador, testing samples of the cinnamon used in the recalled applesauce pouches. The highest result was 5,110 parts per million (ppm), which was more than 2,000 times the level of 2.5 ppm being considered for bark spices (including cinnamon) by the international standard-setting body, Codex Alimentarius Commission (Codex).

The FDA has identified lead chromate found in the cinnamon of these products to be the source of contamination. Lead chromate is a lead-and-chromium-containing compound with yellow, red or orange pigments, depending on the type. The FDA hypothesizes that the lead chromate was illegally and deliberately added to the cinnamon by the supplier to increase the cinnamon’s weight and enhance its color.

While the CDC reports that the health effects of chromium consumption are difficult to predict in this scenario, there is no safe level of lead.

The FDA does not need an action level or guidance to act when food contains a harmful substance, such as lead, that may render the food injurious to health. However, the agency has limited authority over foreign ingredient suppliers who do not directly ship their products to the U.S. Thus, the FDA has reduced ability to take direct action against Negasmart (the supplier of cinnamon to Austrofoods)  or Carlos Aguilera (the processor of the cinnamon sticks).

Carlos Aguilera is currently not in operation.

What’s next?

Anyone who may have eaten the affected products should talk with their healthcare provider.

Lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is particularly important because they are more susceptible to lead toxicity. Most children have no obvious immediate signs of lead toxicity, but when symptoms do develop, they can include:

• problems with learning, behavior, hearing and/or speech
• slowed growth
• lower IQ
• physical symptoms, such as abdominal pain, weakness, anemia, seizures and even coma

Ask your healthcare provider about having your child tested for lead. If your child has elevated lead levels, your healthcare provider will recommend next steps.

If this investigation has you wondering about the safety of other cinnamon, you aren’t alone. FDA and state LFFM laboratories have expanded cinnamon testing beyond the recalled products. FDA has determined that certain ground cinnamon products do contain elevated levels of lead. While the levels detected in other products are only slightly elevated, prolonged exposure to these products may be unsafe.

This investigation is discussed in detail in the APHL/CSTE webinar, “Collaborative Insights: Detecting Lead and Chromium in Cinnamon Fruit Pureés,” which you can access in the APHL Learning Center.

APHL has guidance available to public health laboratories implementing a lower reference value for blood lead.

The post Applesauce Tainted with Lead Chromate: What We Know and Next Steps appeared first on APHL Blog.