FDA shifts approach to investigation into lead poisoning outbreak traced to applesauce

Part of a federal investigation into lead in certain cinnamon applesauce products has been moved to follow-up status.

The Food and Drug Administration’s new approach is intended to take action after incidents. The agency will continue surveillance, prevention and compliance activities, according to an update the FDA posted on April 16.

The Centers for Disease Control and Prevention continues to monitor the lead poisoning outbreak and recently reported that 519 children were affected by the outbreak. The outbreak extends across 44 states. The FDA has collected 90 reports of “adverse incidents” during the outbreak. The two agencies use different reporting methods, so their figures may overlap somewhat and should not be added together. The CDC continues to add patients to its count.

Also, there may be a significant delay between consumption of the lead-contaminated cinnamon applesauce and the detection of elevated blood levels of the heavy metal.

Three brands of cinnamon applesauce sold in pouches and marketed to children have been recalled. They are Wanabana, Schnucks and Weis. Only products containing cinnamon applesauce are affected.

The FDA was first notified of the applesauce lead in mid-September 2023 by public health officials in North Carolina. On October 28, the FDA discussed with the manufacturer analytical findings of lead in cinnamon applesauce produced by Astrofoods in Ecuador. Also on October 28, the FDA issued a warning to US consumers.

It was ultimately determined that the lead came from contaminated cinnamon purchased from an outside supplier. The FDA has reported that the lead was likely added to the cinnamon to increase its weight and therefore its commercial value.

Other key dates in the study include:

• On October 29, 2023, Wanabana LLC notified their customers of the recall of the WanaBana Apple Cinnamon Fruit Puree products.
• On October 30, 2023, through continued collaboration with the FDA, Wanabana LLC issued a press release regarding their voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Bags.
• On November 2, 2023, after reviewing data provided by the company as part of their initial recall, the FDA found that other products (i.e., certain Schnucks and Weis cinnamon applesauce pouches) were involved in the recall and additional public notification requirements.
• On November 3, 2023, the FDA updated its safety alert to include certain Schnucks and Weis cinnamon applesauce sachets.
• On November 5, 2023, the FDA had a telephone conversation with the Wanabana LLC company. During the call, FDA officials discussed the investigation, requested additional information from the company, and asked the company to update their press release regarding their voluntary recall and to provide additional clarification on the scope of the recall of all Apple Cinnamon Fruit Puree products , which the company verbally agreed to.
• On November 6, 2023, Austrofoods Apple Cinnamon Fruit Puree products were added to Import alert 99-42.
• On November 9, 2023, Wanabana LLC announced their extended recall notice to include information about recalled Schnucks and Weis cinnamon applesauce pouches, which also impacts markets outside the United States. Customer information provided by Wanabana LLC shows that the product was also distributed to Cuba and the United Arab Emirates.

About lead poisoning
Parents and caregivers should consult a health care provider and request blood tests if they suspect a child may have been exposed to the recalled cinnamon applesauce products.

Short-term exposure to lead can cause the following symptoms: headache, abdominal pain/colic, vomiting and anemia.

Longer-term exposure may lead to additional symptoms: irritability, lethargy, fatigue, muscle pain or tingling/burning muscles, constipation, difficulty concentrating/muscle weakness, tremors and weight loss.

Lasting consequences can lead to developmental delays and brain damage.

(To sign up for a free subscription to Food Safety News,Click here)