Applesauce lead poisonings in children are on the rise, raising new questions about FDA oversight – The Washington Post

A Washington Post investigation found that states are investigating nearly 120 cases related to applesauce bags contaminated with lead

December 9, 2023 at 7:00 am EST

Eric and Heather Goolsby play with their daughter at their home in Wake Forest, NC. The toddler is one of at least eight children in the state with lead poisoning linked to the tainted applesauce. (Matt Ramey for The Washington Post) Comment on this storyCommentAdd to your saved storiesSave

It began as a routine investigation: Two young siblings in western North Carolina tested positive for lead poisoning in June. Alan Huneycutt, a longtime environmental health specialist with the state Department of Health and Human Services, persistently tried to find the source.

He had ruled out the usual suspects in and around the children’s home – old paint, contaminated water or soil – but the children’s lead levels continued to rise.

What he eventually discovered — that the two siblings had eaten contaminated bags of cinnamon applesauce — triggered an international investigation by the Food and Drug Administration and a massive nationwide recall of cinnamon applesauce bags made by an Ecuador-based company, Austrofood and the names WanaBana, Schnucks and Weis were sold under the brand.

Dozens more children across the country are believed to have been poisoned. A Washington Post investigation has found that the number of children affected is likely higher than official figures. As of Dec. 5, the FDA said it had received reports of 64 children under the age of 6 who had experienced “adverse events” related to the tainted cinnamon applesauce pouches.

But state health and environmental officials have told The Post they are investigating at least 118 confirmed or suspected cases in 31 states believed to be linked to the popular applesauce snacks. To determine the extent of the threat, the Postal Service contacted officials in 50 states and the District of Columbia and received responses from all but Kansas.

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

As the investigation expands, experts have become increasingly alarmed about the potential lead levels in the bags, some of which reached more than 500 times the acceptable limit, according to North Carolina health officials. Parents of exposed children told investigators that the applesauce pouches were a favorite snack and some children reportedly consumed three, four or even six pouches per day. Investigators expect the number of cases to continue to rise in the coming weeks as more children have their blood tested and state health investigators re-examine 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 foods for babies and young children contain significant amounts of lead, arsenic, cadmium and mercury. However, an action plan to set voluntary limits by April 2024 appears to have stalled.

While these metals are commonly found in soil and are present in trace amounts in many foods, there is growing concern about contamination of baby and toddler food because young children often eat restricted diets and metals such as lead can damage the developing brain.

“We know that lead has major impacts on children’s development and health,” said Sen. Tammy Duckworth (D-Illinois), who co-sponsored legislation in 2021 that would have strictly limited the levels of harmful heavy metals in baby food, said in an email -Explanation. “It’s clear that our nation needs to do more to remove lead from the food we feed them, whether it’s baby formula purees or the applesauce pouches we give our toddlers.”

For parents of children who ate the applesauce, the discovery that the bags were contaminated with lead was a nightmare.

“I’m vacillating between feeling guilty because I gave this to her and it contained lead, and anger that this company sold me this product that I thought was safe,” said Heather Goolsby, 38, of Wake Forest, North Carolina

The source of the contamination appears to be the cinnamon used to flavor the applesauce, according to the FDA. The agency said it was conducting an on-site inspection and collecting samples of ingredients from the production 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 the product was manufactured for all three brands. Weis and Schnucks referred their questions to a product supplier, Purcell International of Pleasant Hill, California. A Weis spokesman said Purcell International is an importer and is “responsible for reviewing and certifying product test results.” Purcell International did not respond to multiple email and telephone requests for comment.

How cinnamon turned out to be the likely culprit

Some state health investigators say the tainted applesauce may never have been discovered were it not for the persistent 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 . even though you live in a home without significant lead hazards.

The concerned parents, who officials said did not want to be identified, were also tested for lead, but their results came back normal. Huneycutt began to suspect that the culprit was lurking in the children’s diet, and the family was advised to keep an eye on the foods the children were eating.

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

“That was kind of the clincher,” Huneycutt said. “If the mother hadn’t thought of it, we probably would have gone back in the house and looked again.”

Bag of apple cinnamon fruit puree from WanaBana Were tested. The results showed that it was the children regularly eat applesauce that contained almost That’s 200 times the suggested level at which regulators consider a food adulterated with lead.

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 or give WanaBana apple cinnamon fruit puree pouches to their children feed. WanaBana issued a voluntary recall of its apple cinnamon fruit puree sachets on the same day.

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

Investigators with the North Carolina Department of Health and Human Services have so far identified eight children in the state with lead poisoning linked to the tainted applesauce. When testing the bags, researchers found alarmingly 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 discovered in the western part of the state in October. The investigator in the case, Carissa Moore, was conducting tests at the family’s home when she opened a closet and found about 100 bags of applesauce inside. Test results showed that these apple cinnamon fruit puree bags also had high levels of lead. Tests with other WanaBana flavors – such as apple-banana and pineapple fruit purees – showed no evidence elevated lead levels.

According to Ed Norman, an epidemiologist and chief of the North Carolina Department of Children’s Environmental Health, the state health department began investigating other unsolved cases of lead poisoning and found that some of those children had also eaten WanaBana’s apple cinnamon fruit puree pouches for Health and Human Services.

“We had a family tell us that the child’s grandmother went to three different Dollar Tree stores in different counties nearby because they were always running out of this stuff, and the child loved it so much,” said Norman.

A Dollar Tree spokesman said that after the recall was announced, the company programmed its checkouts to prevent sales of the bags and instructed stores to remove the product from shelves.

Without North Carolina’s investigation, families across the country could still give lead-containing applesauce to their young children, said Jae Williams, spokesman for the Florida Department of Health. Florida has identified at least five suspected cases so far.

“Let’s be honest, how many doctors will spontaneously say, ‘I wonder if that applesauce contains lead?’ It’s strange,” Williams said. “Maybe we saw a lot more young children with lead poisoning and we wouldn’t know what the problem was.”

The FDA has said it is reviewing incoming cinnamon shipments from several countries, but said so far it has found no evidence that the problem extends beyond the recalled products.

How the cinnamon became contaminated with lead is not known. Cinnamon trees, grown primarily in Sri Lanka, China, India and Vietnam, are cut back to the stumps, producing new shoots that are stripped and dried in the sun. The shoots curl up into the characteristic brown “feathers”. Research suggests that lead in cinnamon can leach from the soil in which the trees grow and become concentrated in the harvested parts of the cinnamon trees.

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

“Our members are committed to ensuring that lead levels in spices imported directly into the United States are as low as possible,” Shumow wrote. “Scientific studies show that spices purchased in the United States have significantly lower levels of heavy metals than those purchased in foreign markets.”

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

Negasmart said it does not produce cinnamon and that the spice is typically imported from countries in Asia. The company also said it was conducting a “comprehensive review” and would continue to cooperate with investigators.

Questions about FDA monitoring of lead in baby food

Advocates and scientists alike have raised concerns about heavy metals in baby foods. Healthy Babies Bright Futures, a child 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.

Following the 2021 congressional reports on toxic heavy metals in baby foods, the FDA announced Closer to Zero, an action plan to set voluntary limits for lead, arsenic, cadmium and mercury with a clear three-phase timeline. Once a company is found to be exceeding these “action limits,” the FDA would declare the food in question “adulterated” and potentially require the company to issue a recall.

The FDA originally proposed April 2024 as the target for finalizing limits for lead in foods consumed by babies and young children. But now the agency appears to be pushing back that deadline. The proposed action item schedule has been completely removed from the agency’s website, and FDA no longer refers to it as an “action plan.”

“There are many aspects of the review process that are beyond our control,” an FDA spokeswoman wrote in a statement. “We felt it would be better to provide definitive orientation dates when we had more information and could make a more accurate estimate of the schedule.”

Brian Ronholm, director of food policy at Consumer Reports, said the recall underscores the need for the agency to remain focused on the issue. “Setting lead action levels by April 2024 is completely realistic and feasible. 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 comes into force in January 2025. Companies must post the results on their websites and place QR codes on packages so parents can check.

House Oversight Committee Subcommittee Chairman Raja Krishnamoorthi (D-Illinois) said the FDA should set maximum levels for heavy metals in baby foods “without further delay.”

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

Parents are looking for answers

The extent of the damage caused by the contaminated apple cinnamon puree products is still unclear. A recommendation from the New York State Department of Health stated that children who ate just one bag of applesauce per day could have elevated blood lead levels after a few weeks, based on its own modeling analysis, and if they only ate two bags per day Weeks could be enough for some children to require clinical intervention. New York is investigating 9 cases.

The American Academy of Pediatrics recommends general lead screening for children ages 12 to 24 months, but older children often go unchecked. Health officials say they are now bracing for a possible influx of lead poisoning cases in older children after learning of the recall. And for people with confirmed lead poisoning, the full effects may not be known for years.

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

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

What to do if your child has been exposed to lead?

Goolsby, the Wakeforest mother, initially thought her child’s blood test results were a mistake. She and her husband, Eric, had been obsessively reading instructions about what to do to protect their daughter and trying to stick to healthier snacks.

But in June, a routine lead test showed the child had 20 micrograms of lead per deciliter of blood. Experts say there is no safe level of lead, but in screening tests, any level above 3.5 is considered worrisome.

One of her daughter’s favorite snacks happened to be applesauce—and when Heather Goolsby offered it in a bag, she was able to easily feed her daughter on the go. She said she often bought the WanaBana bags at her local Dollar Tree because they were affordable, costing $1.25 for three, and because the treat seemed healthy.

“It’s like a bargain,” she said. “I ran in there and wiped out every WanaBana bag they had.”

After learning of the apple cinnamon puree sachet recall, she said she was horrified “that it was something I gave her willingly and repeatedly.”

The North Carolina law firm Maginnis Howard said it has filed a class action lawsuit on behalf of Goolsby and is speaking to at least 22 other families. WanaBana did not respond to questions about the lawsuit.

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

One child loved cinnamon applesauce. Then he got lead poisoning.

The Callahans attribute Rudy’s speech delays to eating the pouches in the summer and worry about the long-term effects on physical and behavioral health. They plan to see his pediatrician before Christmas for another appointment and blood work, which Rudy hates.

“He’s crying. He’s really upset,” Sarah Callahan said. “It’s just really sad to see him go through all of this.”

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

The Goolsby family said the ordeal is not over, even though their daughter no longer eats the applesauce. Her daughter’s blood level is still above 10 micrograms per deciliter. And until she turns three, she’ll need regular blood tests as well as monthly and quarterly checkups with developmental specialists who will watch for possible problems related to lead poisoning.

At a recent research, Heather Goolsby was asked to list the words her daughter, now 18 months old, might say.

“I listed a few words and in my head I’m thinking, ‘My God, should she say more?’ ” She said. “I’m already questioning and overthinking everything.”

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