Federal regulators are starting to reveal the scope of a nationwide lead poisoning outbreak that's linked to cinnamon applesauce pouches.
The outbreak includes three separate brands of applesauce puree pouches that were recalled in October and November: WanaBana apple cinnamon fruit puree pouches, Schnucks cinnamon-flavored applesauce and Weis cinnamon applesauce pouches.
As of Dec. 22, the Centers for Disease Control and Prevention has received 251 poisoning reports from state and local health departments. Of those, 73 are confirmed cases, 157 are probable cases and 21 are suspected cases.
Poisoning cases have been reported in 34 states, including: Alabama, Arkansas, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia.
In order to be considered in CDC's case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within three months after consuming a recalled WanaBana, Schnucks or Weis brand fruit purée product.
The Food and Drug Administration tested samples of the cinnamon used in the recalled applesauce pouches and collected from the Austrofoods manufacturing facility in Ecuador. The highest result was 5,110 parts per million (ppm), which was more than 2,000 times the level of 2.5 ppm being considered for bark spices (including cinnamon) by the international standard-setting body, Codex Alimentarius Commission.
Additionally, test results previously reported for a sample of recalled WanaBana pouches collected from Dollar Tree had a lead concentration of 2.18 ppm which, for context, is more than 200 times greater than the action level of 0.01 ppm that the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.
The FDA is investigating whether the presence of lead in the applesauce was intentional. One theory presented is that there was a financial motivation to altering the ingredients so that the products could be made more cheaply and generate more profit.
"We're still in the midst of our investigation. But so far all of the signals we're getting lead to an intentional act on the part of someone in the supply chain, and we're trying to sort of figure that out," FDA Deputy Commissioner for Human Foods Jim Jones told Politico.
WanaBana pouches are sold nationally and have been available through multiple retailers, including Amazon, Dollar Tree, Family Dollar/Dollar Tree combination stores, and other online outlets. Schnucks and Weis-brand pouches are sold at regional grocery chains in the Midwest and Mid-Atlantic.
Despite the recall, regulators say the contaminated products may still be for sale on store shelves. The FDA is aware that, as of Dec. 13, recalled WanaBana products were still on the shelves at several Dollar Tree stores in multiple states. As of Dec. 19, the FDA also received a report that recalled WanaBana products may still be on shelves at Family Dollar/Dollar Tree combination stores.
The FDA has tested multiple products and, based on the current evidence, there are no further products being added to the recall at this time. Officials have also tested at least 136 samples of non-cinnamon containing products and all have been negative for elevated lead levels.
As of Dec. 26, the FDA has received 82 confirmed reports of adverse events potentially linked to recalled product. The CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond.
Consumers should not eat, sell or serve recalled WanaBana, Schnucks or Weis-brand apple cinnamon pouches and should discard them. These products have a long shelf life; consumers should check their homes and throw the items away.
Short term exposure to lead could result in: headache; abdominal pain/colic; vomiting; anemia. Longer term exposure could result in additional symptoms, including: irritability; lethargy; fatigue; muscle aches or muscle prickling/burning; constipation; difficulty concentrating/muscular weakness; tremor; weight loss.
Children with lead exposure may have no apparent acute symptoms. However, even low levels of lead have been associated with learning and behavior problems, hearing and speech problems, and slowed growth and development, according to the CDC. This can show up as lower IQ, decreased ability to pay attention, and underperformance in school.
The health effects of exposure are more harmful to children less than six years of age because their bodies are still developing and growing rapidly, the CDC said. Young children also tend to put their hands or other objects, which may be contaminated with lead dust, into their mouths, so they are more likely to be exposed to lead than older children.
Parents who suspect that a child may have been exposed to lead should talk to a healthcare provider about getting a blood lead test.