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The Food and Drug Administration (FDA) is investigating the possibility that recalled applesauce products may have been intentionally contaminated with high levels of lead.
“The FDA can confirm that one of the theories the agency is investigating regarding the high levels of lead in the recalled cinnamon applesauce bags is that the cinnamon contamination may have resulted from commercially motivated adulteration,” a spokesperson said FDA told FOX Business in a statement.
However, because the investigation is ongoing, the agency reiterated that this is only a theory it is investigating and that “additional research must be conducted before the FDA reaches any conclusions.”
New York health officials confirm primary case related to applesauce recall
WanaBana, Schnucks or Weis brand apple cinnamon pouches – made by Ecuador-based Austrofood – were recalled in November due to elevated lead levels as cases of lead poisoning rose across the country.
FDA expands investigation into applesauce contaminated with lead. (FDA/Fox News)
The FDA and the Centers for Disease Control and Prevention (CDC), as well as state and local partners, are currently investigating reports of elevated blood lead levels in people who consumed apple cinnamon fruit puree pouches.
AT LEAST 22 TODDLERS HAVE BEEN MADE SICK BY FRUIT Pouches, WHICH HAVE LEAD CONCERNS, FDA AND CDC SAY
As of December 11, the FDA has received 65 reports of adverse events that may be related to the recalled product. The confirmed complainants or people for whom an adverse event was reported were all under 6 years of age, the FDA said.
Separately, the CDC reported that it had received over 200 reports of cases from state and local health departments nationwide.
The FDA said cinnamon samples supplied by Negasmart to Austrofoods had “extremely high levels of lead contamination at approximately 5110 parts per million (ppm) and 2270 ppm.”
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By comparison, the FDA said the Codex Alimentarius Commission – an international food standards body co-founded by the Food and Agriculture Organization and the World Health Organization – is considering a maximum level of 2.5 parts per million for lead in bark seasonings in 2024 , including cinnamon.
The FDA said it was “relying on officials in Ecuador to assist with the investigation into Negasmart.”
However, the agency has confirmed that the company does not ship products directly to the United States. Only Austrofoods, one of Negasmart's direct customers, ships products to the USA
The FDA told FOX Business that it will continue to keep the public updated as the investigation progresses.