Pressure grows on FDA as lead-tainted applesauce sickens more kids:  Proposed guidelines to limit lead in foods likely will not be finalized until 2025

Last spring (2023), when Sarah Callahan’s son Rudy was 9 months old, he fell in love with WanaBana apple cinnamon fruit purée pouches.  The 39-year-old mother in Port Republic, Maryland, chose the apple purée pouches to help transition Rudy from breastmilk to solid foods.  It seemed like a healthy option at the time, marketed as preservative-free, kosher, and gluten-free.  However, three (3) months later, whenCallahan took Rudy in for his one-year checkup, she was shocked to learn that he had lead poisoning.

Inspectors didn’t find a clear culprit for the lead poisoning in Callahan’s home.  When she later heard that the WanaBana cinnamon apple purée was recalled, Callahan was floored.  “My heart sank,” said Callahan, who is planning on suing Florida-based WanaBana for alleged injuries caused by the apple purée.  “To know that [my husband] Ricky and I were the two people that he relied on for his food, and we fed that to him.  It just makes me feel really sad and it makes me feel guilty.”

Callahan was not the only parent caught by surprise:  As of 22 NOV 2023, there have been 52 reported cases in 25 states where children ages 1 to 4 had elevated blood lead levels potentially linked to the apple cinnamon purées, according to the US Food and Drug Administration (FDA).  One sample of the product, purchased at a Dollar Tree and tested by the FDA, contained 200 times more lead than proposed guidance from the Agency would allow.

On 30 OCT 2023, WanaBana recalled all lots of the product, followed on 09 NOV 2023 by several lots made by the company but sold under the brand names Schnucks Apple Sauce pouches with cinnamon and Weis Cinnamon Apple Sauce.  The FDA (in November 2023) said parents should not buy the product as it investigates the lead poisonings.  In its 22 NOV 2023 statement, the Agency said it was aware that the recalled product was still on shelves at several Dollar Tree stores in multiple states.

In response to a request for comment, WanaBana referred NBC News to a 19 NOV 2023 press release that said the company was “working closely with the FDA to investigate the source of the contamination.”

Dollar Tree said in a statement that it “is working with store operations teams to ensure the recalled WanaBana Apple Cinnamon Fruit Puree pouches are no longer in stores and destroyed according to FDA guidelines,” adding that the stores’ registers are programmed to not allow sales of the recalled product to go through.

Experts say the lead-contaminated applesauce pouches are just the latest development in the FDA’s ongoing struggles to regulate baby food.  Last year (2022), the FDA came under scrutiny after certain powdered baby formulas were recalled after three babies fell severely ill and one died from a bacterial infection.  The recall compounded an ongoing formula shortage that began in the early days of the COVID-19 pandemic and left many parents scrambling to feed their children.  The government was eventually forced to airlift millions of pounds of formula from overseas.

In 2021, a congressional investigation found that commercial baby food was tainted with significant levels of arsenic, lead, cadmium and mercury, prompting the FDA to draft industry guidelines to minimize harm to children.  In a statement to NBC News, an FDA spokesperson said the agency should be able to finalize the guidelines by early 2025.  Even in the absence of new guidelines; however, the Agency is able to take regulatory action if it determines specific products are unsafe, the spokesperson added.

Jane Houlihan, Research Director for Healthy Babies Bright Futures, a nonprofit focused on reducing babies’ exposure to harmful chemicals, said the FDA needs to do more to protect babies from heavy metals.  Houlihan co-authored a 2019 report that found that 95% of baby foods tested contained heavy metals.  “The fact that these problems occurred with applesauce is a sign of how many holes there are in the safety net,” Houlihan said.  “None of the labels we’re used to seeing have anything to do with heavy metals.  And that’s why it’s so important for the government to take action for food manufacturers.”

Lead exposure in young children

Lead exposure can cause serious health problems in children, including damage to the brain and nervous system; slowed growth and issues with hearing and speech; and lower IQ, according to the Centers for Disease Control and Prevention (CDC).  At high levels, it can cause lead poisoning or death.  Children younger than 6 are especially vulnerable to lead because their bodies are still developing, said Dr. Laura Breeher, an Occupational and Environmental Medicine Physician at the Mayo Clinic in Rochester, Minnesota.  “Lead is stored in the bone,” Breeher said.  “Children’s bones are growing, they’re absorbing nutrients, and so they’re much more likely to get toxicity if they’re exposed to lead.”

There is no known safe blood lead level in children, according to the CDC.  A level of 3.5 micrograms of lead per deciliter or above is considered higher than what’s seen in most children.  In the babies and toddlers who consumed the contaminated cinnamon apple pouches, blood lead levels ranged from 4 to 29 micrograms per deciliter, according to the CDC.

“There is some real reason to be concerned,” said Dr. Frederick Henretig, a Medical Toxicologist at the Children’s Hospital of Philadelphia’s Poison Control Center.  “These containers of applesauce that have been identified contain a potentially significant amount of lead, which certainly doesn’t belong in there.”

Lead in food is not entirely uncommon, according to Dr. Leonardo Trasande, Director of Environmental Pediatrics at NYU Langone Health, who added that the U.S. has made progress over the past few decades in reducing exposure from food and other more likely sources, like paint.  Lead is a naturally occurring metal found in the Earth’s crust.  It can seep into the food chain in various ways, including when plants we eat absorb it from soil or when livestock eat soil or plants laced with lead, Trasande said.

The FDA still does not know how lead ended up in the supply of the applesauce pouches.  The FDA spokesperson said the Agency’s “leading hypothesis” is that cinnamon used in the pouches is the likely source of the contamination; however, added that an investigation is ongoing.  The FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination.  The applesauce pouches are made in Ecuador.

Houlihan said that contaminated foods are “a big problem that requires solutions at all different levels. FDA needs to set protective standards.  Food manufacturers need to test what is coming in and what’s in their finished foods, and parents also need to pay attention and make choices to help lower their children’s exposures to these toxic metals,” she said.

Breeher, of the Mayo Clinic, said puree pouches have become very common in peoples’ households because of their convenience.  “They’re very easy to pop into school lunches for parents because you don’t need a spoon.  Right now, there is not a whole lot parents can do to make sure their children’s food is not contaminated with lead, beyond regularly checking the FDA’s recall page,” Breeher said.  “Parents shouldn’t have to worry that their children’s food is contaminated with something like lead,” she added.

Rudy, who Callahan said is showing signs of speech delays, is also getting his blood drawn periodically to monitor his lead levels.  “It’s really sad to see him sitting there and inflicting pain on him, knowing especially that the lead poisoning wasn’t the baby’s fault and it wasn’t our fault,” Callahan said.  Her husband, Ricky Callahan, said he worries about what comes next for Rudy.  “We have a lead-poisoned child.  But you’re perpetually waiting for that next shoe to fall,” Ricky said.  “So we know right now he has a speech delay.  But what does the future hold for him?  We don’t know.”

REFERENCE:  NBC News; 24 NOV 2023; Berkeley Lovelace Jr and Kenzi Abou-Sabe