Bipartisian lawmakers from the House Energy and Commerce Committee are requesting a briefing from the Food and Drug Administration (FDA) regarding their suspicion that the recalled applesauce products were intentionally contaminated.
The agency has until Feb. 2 to detail why it believes the lead contamination in the recalled applesauce pouches could have been intentional and the steps it has taken to investigate the matter as well as prevent future illicit food contamination in the supply chain.
"It is crucial to understand the FDA’s strategies for detecting and addressing intentional contamination in the food supply chain given the limited authority your agency has over contaminated cinnamon from abroad, which was identified as the potential source of this issue," lawmakers said in a letter to FDA Commissioner Robert Califf.
As illnesses started to rack up nationwide, the FDA said it was exploring the possibility that the high lead levels in the WanaBana, Schnucks, or Weis-brand apple cinnamon pouches — manufactured by Ecuador-based Austrofood — was the "result of economically motivated adulteration."
Officials believe the cinnamon – supplied from Negasmart to Austrofoods – could be the source of the contamination.
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The FDA has been clear that this is only one possibility that it is exploring, and additional investigation needs to occur before it can come to any conclusion.
However, the committee said its concerns about intentional product adulteration along the global supply chain are "particularly urgent" given that children are more susceptible to lead toxicity.
Lawmakers cited reports suggesting that more than 60 children under the age of 6 in the United States have already tested positive for lead poisoning.
As of Jan. 22, the FDA has received a total of 90 confirmed complaints or reports of adverse events potentially linked to the pouches, which were initially recalled in November after four children were found to have elevated blood lead levels.
In its most recent update, the FDA said the people infected range in age between newborns and 53 years old. The median age of the illnesses is 1 year old, according to the FDA.
The Centers for Disease Control and Prevention, which is also investigating the outbreak, received 385 reports of lead poisoning, 97 of which have been confirmed.
Now, the FDA has just over a week to submit responses to nearly a dozen questions regarding the investigation and its safety protocols.
For one, the FDA is being asked to submit a timeline of events leading to the discovery of lead contamination in the aforementioned applesauce brands.
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It must also describe how it determined that the adulteration of raw cinnamon may have been intentional and how it is collaborating with domestic and international partners, particularly Ecuadorian authorities, to investigate this issue thoroughly.
It must also describe what steps it has taken to determine if other foods have been contaminated as a result of this supply chain vulnerability and how, if at all, the FDA's process for detecting lead contamination in food products differs for foods produced domestically from food produced abroad.
