In light of the recent string of lead poisoning cases in children across the U.S. linked to fruit puree pouches contaminated with lead and chromium, members of the House Committee on Energy and Commerce have written a letter to the U.S. Food and Drug Administration (FDA) to express concerns and request an immediate briefing. FDA’s investigation of the food safety incident is ongoing.
In late October 2023, The North Carolina Department of Health and Human Services (NCDHHS) notified FDA about reports of elevated blood lead levels (BLLs) in children, which was connected to the consumption of WanaBana Apple Cinnamon Fruit Puree pouches containing high levels of lead. FDA testing found lead levels in the WanaBana puree samples to be 2.18 parts per million (ppm), more than 200 times higher than the agency’s proposed action level for lead in fruit purees. Similar adulteration was detected in fruit puree pouches under the Weis and Schnucks brands, prompting a recall of those products as well.
FDA attributed the elevated lead levels in the recalled products to cinnamon imported from Ecuador, and the agency believes lead may have been intentionally added to the cinnamon due to economic motivations. In January 2023, as part of FDA’s investigation, testing of the recalled products and the cinnamon collected from the manufacturer of the implicated puree pouches also found chromium in the cinnamon. As of January 22, 2024, FDA has received 90 confirmed reports of adverse events potentially linked to recalled product, with complainants ranging 0–53 years of age and having a median age of one year old. As of January 19, the U.S. Centers for Disease Control and Prevention (CDC), which has a different reporting structure than FDA, has received reports of 97 confirmed cases, 253 probable cases, and 35 suspected cases for a total of 385 cases from 42 different states.
In a letter to FDA Commissioner Robert M. Califf, M.D., dated January 19, 2024, a bipartisan group of Congress members representing the House Committee on Energy and Commerce wrote: “Children [under the age of six] are more susceptible to lead poisoning, which makes our concerns about FDA’s ability to address intentional product adulteration along the global supply chain particularly urgent. Though FDA has in the past elevated concerns about unacceptably high levels of lead in some baby food, recent events raise whether more can be done to prevent and detect illicit food contamination. Therefore, the Committee urgently requests a detailed briefing on the FDA’s suspicion of intentional lead contamination in applesauce pouches, particularly the steps undertaken for its investigation and measures for future prevention. It is crucial to understand 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.”
The letter requests a briefing no later than February 2, 2024, and asks the agency to be prepared to address specific questions, including but not limited to:
- A timeline of events
- How FDA determined that the adulteration of the cinnamon may have been intentional
- How FDA is collaborating with both international/Ecuadorian authorities and domestic partners/state departments of health in its investigation
- Steps that have been taken to determine if other foods have been contaminated as a result of this supply chain vulnerability
- Ways in which FDA’s process for detecting lead contamination in food products produced domestically differ for foods produced abroad, if they differ at all
- What FDA has done since 2020 to identify lead-contaminated foods and prevent them from entering the market
- The number of recalls issued since 2020 related to lead-contaminated foods, both for domestic and imported goods
- FDA’s capabilities within its existing authorities to enhance monitoring and inspection processes to better detect and prevent intentional acts of lead contamination along the supply chain, including internationally, and FDA’s plans to use those authorities
- Additional resources or authorities required to better detect and prevent intentional acts of lead contamination along the supply chain.
The letter also asks FDA to provide the Committee with rolling updates on the status of the investigation, including findings related to the suspected international contamination. The letter was signed by Cathy McMorris Rogers (R-WA), Frank Pallone Jr. (D-NJ), Brett Guthrie (R-KY), Anna G. Eshoo (D-CA), Morgan Griffith (R-VA), and Kathy Castor (D-FL).