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FDA winds down part of lead-contaminated applesauce probe


The Food and Drug Administration said Tuesday it’s winding down some of its U.S. response to lead-contaminated cinnamon applesauce pouches, which have sickened hundreds of children across the country. 

The FDA will continue to actively investigate how WanaBana’s apple cinnamon fruit puree pouches, which were recalled in late October because of high lead levels, became contaminated. However, much of the work the agency has done to ensure no one else buys the applesauce pouches has ended.

The agency has pulled the product from stores and prevented any more of it from being imported into the United States. Two other products made by WanaBana — Schnucks applesauce pouches with cinnamon and Weis cinnamon applesauce — were also recalled and removed from stores.

The WanaBana pouches had been sold at discount retail stores, including Dollar Tree. For several months after the recall, there were reports of it still being on store shelves.

“It would be comforting to see data about how many stores had the products listed as contaminated and to see how they’ve ensured the removal of those products from store shelves,” said Laurie Beyranevand, director of the Center for Agriculture and Food Systems at Vermont Law and Graduate School. “These concerns are especially important given the prevalence of those stores being located in communities with lower incomes.”

The FDA did not immediately respond to a request for additional comment.

The issue will be transferred from the agency’s outbreak response team to its post-investigations unit, where officials will continue to determine exactly how the applesauce pouches became contaminated with lead.

The leading hypothesis is that the cinnamon in the applesauce was contaminated with lead. In February, according to the FDA, Ecuadorian officials identified a cinnamon processor as “the likely source of contamination.”

The processor sourced his cinnamon from Sri Lanka. The Ecuadorian officials said that the cinnamon sticks were lead-free before they were processed, and contaminated after processing.

That cinnamon was then sent to a supplier in Ecuador called Negasmart and, in turn, to a facility, Austrofoods, where the applesauce pouches were produced before being exported to the U.S.

The FDA will continue to review reports of lead poisoning that are voluntarily submitted to it; however, it says there may not be enough information for follow-up.

The FDA’s new focus will largely transition to surveillance and prevention. In March, the agency said it identified more cinnamon products sold at discount retail stores that had elevated lead levels.

The FDA, along with the Centers for Disease Control and Prevention, had been working with state health officials to track cases of lead poisoning in the U.S. linked to the pouches.

Because the applesauce pouches have a long shelf life, agency officials were concerned that they may still have been in people’s homes after the recall.

As of March, the CDC said that it had received 519 reports of confirmed, suspected and probable cases of lead poisoning linked to the pouches from 44 states. Many young children were among the people sickened. 

The announcement comes less than a week after FDA Commissioner Dr. Robert Califf testified before a congressional committee in part on the agency’s applesauce response.

He called on Congress to pass legislation that would require food manufacturers to test for lead in imported foods. Although many food manufacturers do test for harmful chemicals in their products, there is no federal requirement for them to do so.


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