Following additional reports of illnesses potentially linked to lead in recalled fruit and applesauce pouches, the U.S. Food and Drug Administration (FDA) announced that it is screening shipments of cinnamon from multiple countries for possible lead contamination. So far, cinnamon rolls and other cinnamon-containing products can be still by joyfully had this Thanksgiving and holiday season as there have been no reported illnesses or elevated blood lead levels beyond fruit and applesauce pouches.
As background, FDA and the Center for Disease Control (CDC), together with state and local partners, are investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches, manufactured in Ecuador and sold under WanaBana, Weis, and Schucks brands. The pouches were sold at retailers including Amazon, Dollar Tree, Sam’s Club, and Schnucks and Weis stores. FDA continues to evaluate incoming adverse reports of illnesses in response to the more than 34 reports of illness potentially linked to recalled product submitted to the Agency.
Through an FDA product collection and analysis, the FDA detected elevated lead levels in one finished product sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree. The level detected in the FDA sample was more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for young children and babies.
While there is no safe level of lead exposure, the CDC uses a marker of 3.5 micrograms per deciliter to identify children with higher lead levels; in the case of the consumption of the pouches, the affected children’s blood lead levels ranged from 4 to 29 micrograms per deciliter. Lead is also subject to California’s Proposition 65, a consumer protection statute requiring disclosure of chemicals that are known to the state to cause cancer or reproductive toxicity. The law requires businesses to provide a warning for any product causing exposures of more than 0.5 micrograms of lead per day.
Here, FDA’s principal hypothesis is that cinnamon used in these recalled pouches is the likely source of the contamination for these products. While FDA has no indication that this issue extends beyond these recalled products, to protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. FDA has yet to issue any widespread Import Alert on cinnamon imports.
In the wake of the recall and ongoing investigation, FDA reminded industry that companies who distribute food products sold in the U.S. have a legal responsibility to comply with application FDA regulations. Legally, food manufacturers are responsible for significantly minimizing or preventing chemical hazards as needed. This includes implementing appropriate preventive controls to reduce or eliminate the presence of lead in their products. FDA reminded industry that most food manufacturers and processors are covered by the preventive control requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The Preventive Controls rule requires industry to implement controls to significantly minimize or prevent any identified chemical hazards, such as lead, requiring a control. Additionally, some manufacturers may conduct verification activities like finished product testing based on company operations. Ultimately however, the manufacturer and processor are required to develop GMP procedures based on specific company products and operations.
For the sake of pumpkin pie and cinnamon twists this holiday season, we hope cinnamon doesn’t continue to be flaky!
For more information on FDA regulation and enforcement, please contact us at info@garg-law.com.
