December 09, 2023

Applesauce lead cases in kids surge amid questions on FDA oversight

A Post investigation found that states are examining 118 cases linked to lead-tainted cinnamon applesauce pouches

Source: The Washington Post

 

What he eventually found — that the two siblings had eaten contaminated pouches of cinnamon applesauce — sparked an international investigation by the Food and Drug Administration and a massive national recall of cinnamon applesauce pouches manufactured by an Ecuador-based company, Austrofood, and sold under the brand names WanaBana, Schnucks and Weis.

Dozens of other children around the country are believed to have been poisoned. A Washington Post investigation has found that the number of children affected is probably higher than official counts. As of Tuesday, the FDA said it has received reports of 64 children under age 6 who have suffered “adverse events” linked to the tainted cinnamon applesauce pouches.

But state health and environment officials have told The Post that they are investigating at least 118 confirmed or suspected cases in 31 states believed to be linked to the popular snacks. To determine the extent of the exposure, The Post contacted officials in 50 states and D.C., and received responses from all but Kansas.

The discrepancy in case counts is probably because of differences in how suspected and confirmed cases are reported at the state and federal levels. The FDA said its count is based on self-reported information submitted by health-care providers, consumers and some state partners. In some cases, parents of children with elevated lead levels don’t have old applesauce pouches to test, but they have reported that their children had eaten the snacks in recent months.

As the investigation has expanded, experts have grown alarmed at the potential level of lead in the pouches, some of which have tested at more than 500 times the acceptable thresholds, according to North Carolina health officials. Parents of exposed children told investigators that the applesauce pouches were a favorite treat, and some children reportedly consumed three, four or even as many as six pouches a day. Investigators say they expect case counts to continue rising in the coming weeks as more children get their blood tested and state health investigators revisit unsolved lead poisoning cases.

The recall has renewed questions about whether the FDA is doing enough to regulate toxic metals in baby and toddler foods. In 2021, two congressional reports found that many popular food products made for babies and toddlers contain significant levels of lead, arsenic, cadmium and mercury — yet an action plan to establish voluntary limits by April 2024 appears to have stalled.

While these metals are often in soil and can be found in trace amounts in many foods, there’s growing concern about contamination of baby and toddler foods because young children often eat a limited diet and metals such as lead can damage a developing brain.

“We know that lead has major impacts on child development and health,” said Sen. Tammy Duckworth (D-Ill.), who co-sponsored legislation in 2021 that would have strictly limited the levels of harmful heavy metals in baby food, in an emailed statement. “It’s clear our nation must do more to get lead out of the food we feed them, whether its baby food purées or the applesauce pouches we give to our toddlers.”

For parents of children who have eaten the applesauce, the discovery that the pouches were tainted has been a nightmare.

“I go back and forth between feeling guilty that I fed her this, and it had lead in it, and angry that this company sold me this product that I thought was safe,” said Heather Goolsby, 38, of Wake Forest, N.C.

The source of the contamination appears to be the cinnamon used to flavor the applesauce, according to the FDA.

The agency said it is doing an on-site inspection and collecting samples of ingredients from the manufacturing facility in Ecuador, where the apples and cinnamon were mixed together.

Austrofood, WanaBana, Schnucks and Weis have all said they are cooperating with the investigation. In a statement, Austrofood confirmed that it manufactured the product for all three brands. Weis and Schnucks referred questions to a product supplier, Purcell International of Pleasant Hill, Calif. A Weis spokesperson said Purcell International is an importer and was “responsible for testing and certifying the product test results.” Purcell International did not respond to multiple requests by email and phone for comment.

How cinnamon emerged as the likely culprit

Some state health investigators say the tainted applesauce may never have been discovered if not for the tenacious public health investigation by the North Carolina Department of Health and Human Services, which managed to solve the mystery of how two toddlers were exposed to high levels of lead despite living in a home with no significant lead hazards.

The worried parents, who officials said didn’t want to be identified, were also tested for lead, but their results were normal. Huneycutt began to suspect that the culprit lurked in the children’s diet, and the family was advised to track the foods the children ate.

A few days later, the mother called with an idea: The children, both toddlers under 3, loved to suck applesauce from fruit pouches, which they ate regularly.

“That was sort of the smoking gun,” Huneycutt said. “If the mother had not come up with that, we probably would have gone back out to the house and looked again.”

North Carolina health officials reported the discovery to the FDA. On Oct. 28, about 10 days after hearing from North Carolina investigators, the FDA issued a public health alert warning parents not to purchase WanaBana apple cinnamon fruit puree pouches or feed them to their children. WanaBana issued a voluntary recall of the pouches the same day.

In early November, the FDA broadened the scope of the investigation, leading to recalls of close to 3 million pouches of WanaBana, Schnucks and Weis cinnamon-flavored applesauce pouches. The recalled products from all three brands were manufactured in Ecuador.

North Carolina investigators so far have identified eight children in the state with lead poisoning linked to the applesauce. In testing the pouches, investigators have found startlingly high lead levels ranging from 1,900 to more than 5,000 parts per billion. By comparison, the FDA has proposed 10 parts per billion of lead as the “action level” at which the agency determines fruit products are adulterated and may initiate a recall.

One of the cases was found in October in the western part of the state. The investigator on that case, Carissa Moore, was conducting tests at the family home when she opened a cabinet and found about 100 pouches of applesauce inside. Test results showed that those apple cinnamon fruit puree pouches had high levels of lead, too. Tests of other WanaBana flavors — such as apple banana and pineapple fruit purees — didn’t detect elevated levels of lead.

The state health department began reviewing other unsolved cases of lead poisoning, finding that some of those children also had been eating WanaBana’s apple cinnamon fruit puree pouches, according to Ed Norman, an epidemiologist and head of the children’s environmental health unit for the North Carolina Department of Health and Human Services.

“We had one family who told us the child’s grandmother went to three different Dollar Tree stores in different counties nearby because they kept running out of this stuff and the kid loved it so much,” Norman said.

A Dollar Tree spokesperson said that after the recall was announced, it programmed its checkout registers to prevent sales of the pouches and instructed stores to remove the product from shelves.

Without North Carolina’s investigation, families across the country could still be feeding their toddlers apple puree laced with lead, said Jae Williams, a press secretary with the Florida Department of Health. Florida has so far identified at least five suspected cases.

“Let’s be honest, like how many physicians off the top of their head are going to be like, ‘I wonder if the applesauce has lead in it?’ It’s peculiar,” Williams said. “We may have seen a lot more toddlers with lead poisoning, and we wouldn’t know what the problem is.”

The FDA has announced that it’s screening incoming shipments of cinnamon from multiple countries but said it has so far not found any signs that the issue extends beyond the recalled products.

How the cinnamon got contaminated with lead isn’t known. Grown largely in Sri Lanka, China, India and Vietnam, cinnamon trees are cut back to stumps, which causes them to grow new shoots that are stripped and dried in the sun. The shoots curl into the characteristic brown “quills.” Research suggests that lead in cinnamon can leach from the soil where the trees are grown, becoming concentrated in the harvested parts of the cinnamon trees.

“Our members are committed to ensuring lead levels in spices directly imported into the U.S. are as low as feasible,” Shumow wrote. “Scientific studies demonstrate that spices purchased in the U.S. have notably lower heavy metal levels than those purchased in foreign markets.”

But Laura Shumow, the executive director of the American Spice Trade Association, wrote in an email that the amount of lead that the bark of a cinnamon tree can absorb from soil is “much lower” than the suspected levels of lead in the cinnamon used in the recalled products. She said the recall should not prompt worries about “the safety of cinnamon or spices imported into the U.S.” 

Last week, WanaBana and Austrofood issued a statement naming Ecuador-based company Negocios Asociados Mayoristas, operating as Negasmart, as its cinnamon supplier. Ecuadorian authorities have reported to the FDA that Negasmart’s cinnamon had higher levels of lead than allowed and that the authorities are trying to determine who is responsible for the contamination.

Negasmart said that it does not manufacture cinnamon and that the spice is typically imported from countries in Asia. The company also said it is doing an “exhaustive review” and will continue to cooperate with investigators.

Advocates and scientists alike have raised concerns about heavy metals in baby food. Healthy Babies Bright Futures, a children’s health advocacy group, released a report in 2019 showing that of more than 150 baby and toddler foods tested, 95 percent had detectable levels of heavy metals.

After the 2021 congressional reports on toxic heavy metals in baby food, the FDA announced Closer to Zero, an action plan to establish voluntary limits for lead, arsenic, cadmium and mercury, with a clear timeline outlined in three phases. Once established, if a company was found to exceed those “action levels,”, the FDA would declare the food in question to be “adulterated” and may ask the company to issue a recall.

Initially, the FDA proposed April as the goal for finalizing action levels for lead in foods consumed by babies and young children. But now the agency appears to be backing off that deadline. The proposed timeline for action items has been removed from the agency’s website altogether, and the FDA is no longer calling it an “action plan.”

“There are many aspects of the review process that are outside of our control,” an FDA spokeswoman wrote in a statement. “We felt that it was better to provide final guidance dates when we had more information and could make a more accurate estimate of timing.”

Brian Ronholm, director of food policy for Consumer Reports, said the recall highlights the need for the agency to continue focusing on the issue. “Finalizing action levels for lead by April 2024 is completely realistic and doable. All that is required is the will to do it,” he said.

In October, California passed a law requiring baby food companies to test their finished products monthly. It will take effect in January 2025. Companies will be required to post results on their websites and put QR codes on packages so that parents can check.

Raja Krishnamoorthi (D-Ill.), subcommittee chair of the House Oversight Committee, said the FDA should establish maximum levels of heavy metals in baby food “without further delay.”

“We must hold food manufacturers accountable, which includes establishing industry-wide protocols for food testing and sampling,” he said.

The scale of harm resulting from the contaminated apple cinnamon puree products is still unclear. An advisory from the New York State Department of Health stated that based on its own modeling analysis, children who ate just one pouch of applesauce a day could have elevated blood lead levels after a few weeks, and eating as little as two pouches a day for weeks could be enough for some children to need clinical intervention. New York is investigating nine cases.

The American Academy of Pediatrics recommends universal lead screening for children 12 to 24 months, but older kids often go unchecked. Health officials say they are now bracing for a possible influx of lead poisoning cases in older children following news of the recall. And among those with confirmed lead poisoning, the full impact may not be known for years.

The effects of lead are especially pronounced in children, who absorb more lead than adults. That is because the blood-brain barrier, a protective filter in the brain, is more permeable in infants and toddlers, said Kevin Osterhoudt, a pediatrician and the medical director of the Poison Control Center at Children’s Hospital of Philadelphia.

Over time, experts say high levels of lead can cause slowed growth, delayed puberty, lower IQ levels and learning disabilities. Parents who are concerned their children may have eaten tainted applesauce or have been exposed to lead should contact their pediatrician for testing. A child with high levels of lead poisoning may be treated with chelators, a prescription medication given orally or intravenously, that helps to remove lead from the blood.

At first, Goolsby, the Wakeforest mother, thought her child’s blood test results were a mistake. She and her husband, Eric, had obsessively read guidance on what to do to keep their daughter safe and tried to stick to healthier snacks.

But in June, a routine lead screening showed that the child had 20 micrograms of lead per deciliter of blood. Experts say there is no safe level of lead, but in screening tests, anything above 3.5 is considered a cause for concern.

One of their daughter’s favorite snacks happened to be applesauce — and offering it in a pouch meant that Goolsby could easily feed her daughter on the go. She said she often bought the WanaBana pouches at her local Dollar Tree because they were affordable, costing $1.25 for three, and the treat seemed healthy.

“It is like a steal,” she said. “I would run in there and wipe out all the WanaBana pouches they had.”

After she found out about the recall of the apple cinnamon puree pouches, she said she was appalled “that it was something I willingly and repeatedly fed her.”

The Maginnis Howard law firm in North Carolina said it has filed a proposed class-action lawsuit on Goolsby’s behalf, and they are talking to at least 22 other families. WanaBana didn’t respond to questions about the lawsuit.

Sarah and Ricky Callahan of Maryland said in an interview that they have already seen the effects of lead poisoning in their 15-month-old son, Rudy, who began eating the apple puree at about 9 months old. The pouches were a regular part of his diet from May through August, and he sometimes consumed as many as six a day, according to Sarah Callahan’s complaint to the FDA.

The Callahans attribute Rudy’s speech delays to eating the pouches over the summer and worry about the long-term physical and behavioral health consequences. They plan to visit his pediatrician before Christmas for another appointment and round of bloodwork, which Rudy hates.

“He cries. He gets really upset,” Sarah Callahan said. “It’s just really sad to watch him have to go through all of that.”

Lawyers from the Pensacola-based firm Aylstock, Witkin, Kreis & Overholtz said they are representing the Callahans in a Florida lawsuit against WanaBana based on what they argue are false claims that the apple puree pouches were safe and healthy. The company did not respond to requests for comment about the lawsuit.

The Goolsby family said that even though their daughter no longer eats the applesauce, the ordeal hasn’t ended. Her daughter’s blood levels are still over 10 micrograms per deciliter. And until she turns 3 years old, they will need to do regular blood testing as well as monthly and quarterly check-ins with developmental specialists, who will be watching for potential problems related to the lead poisoning.

At a recent checkup, Heather Goolsby was asked to list the words that her daughter, who is now 18 months old, could say.

“I listed off a few words, and in my mind, I’m thinking, ‘My God, should she be saying more?’” she said. “I’m already questioning and second-guessing everything.”

By:  Amanda Morris, Teddy Amenabar, Laura Reiley and Jenna Portnoy

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