Last Halloween, the FDA flagged a worrying discovery: High levels of lead were found in applesauce pouches meant for young kids. Parents were alarmed, because the heavy metal can cause irreversible damage to babies and young children.
Within a month of the Halloween warning, the recall had widened and dozens of illnesses were reported in kids age 4 and younger.
That was just the beginning: This year, the FDA issued three more public health alerts over lead in ground cinnamon, naming more than a dozen brands.
It's a startling shift, as the FDA's archives show no product recalls had been linked to lead and cinnamon for several years.
These recent alerts have prompted big questions for consumers: How and why did lead get into the cinnamon? Is it common? What can be done to prevent it from happening again?
Here are some answers.
Reports of more than 500 cases of elevated lead levels
State and local health departments have reported 519 cases of elevated blood lead levels linked to the pouches, the Centers for Disease Control and Prevention says, with 481 of those cases classified as confirmed or probable; lead exposure from other sources is suspected in the rest.
The cases were reported in all but six states (Alaska, Delaware, Hawaii, Maryland, Nevada and Wyoming), along with Washington, D.C., and Puerto Rico, according to the CDC.
The applesauce pouches in last fall's recall were sold in the U.S. under three brand names: WanaBana (sold on Amazon and other websites, and at Family Dollar and Dollar Tree stores) and two grocery brands: Schnucks and Weis.
That high-profile recall came after North Carolina officials investigating cases of children with elevated blood lead levels told the FDA that they identified apple cinnamon fruit puree pouches as the likely source. WanaBana USA initiated a voluntary recall, the FDA said.
Lead chromate is suspected
In last fall's recall, "lead chromate was detected in the cinnamon collected from the manufacturer in Ecuador of the WanaBana apple fruit puree pouches," an FDA spokesperson tells NPR. Lead routinely appears in foods due to its ubiquity in the environment. But the levels found in the puree raised both alarm and suspicion.
The recalled pouches "had between 2,270 ppm to 5,110 ppm lead in the cinnamon," according to the FDA. For perspective: 5,000 parts per million is equal to 0.5%. That is thousands of times higher than U.S. thresholds to recommend a recall.
The agency believes the lead chromate was purposefully used as a color additive and categorizes it as a likely act of economically motivated adulteration, or EMA.
In paints and artists' materials, lead chromate is known as "chrome yellow." In the past, it's been fraudulently added to spices to make their color more vivid so they look more fresh and flavorful.
"We're aware of this practice in turmeric, where lead chromate has been added to enhance the color," Laura Shumow, executive director of the American Spice Trade Association, tells NPR. But until last fall, her trade group had never heard of the pigment turning up in cinnamon, she says.
"That was really a very unusual incident," Shumow says of the cinnamon fruit pouches. "Cinnamon is not typically traded for color. … So everything about that incident was very strange."
Shumow says that no members of the American Spice Trade Association, which includes the majority of U.S. spice companies, were involved in any of the FDA recalls, and notes that both the cinnamon and the fruit puree pouches came from outside the U.S.
In Ecuador, the FDA says, a supplier named Negasmart sold cinnamon contaminated with lead chromate to the applesauce maker, Austrofood. Officials said the likely source of the contamination was a company named Carlos Aguilera, which processed the raw spice after it was imported from Sri Lanka. Ecuadoran authorities closed the business weeks after the initial recall.
Lead has damaging effects, especially in kids
"There is no level of exposure to lead that is known to be without harmful effects," the World Health Organization says.
Lead spreads to the brain, liver, kidney and bones — and if a pregnancy occurs, lead is released along with calcium and can potentially harm the fetus.
"Children six years old and younger are most susceptible to the effects of lead," the EPA says, adding that even at low levels, lead can cause lower IQ and hyperactivity, along with behavior problems and slowed growth.
While children absorb ingested lead more readily than adults, "The human body accumulates lead over a lifetime and normally releases it very slowly," according to the federal Agency for Toxic Substances and Disease Registry, noting that bodies store lead in bones and teeth.
Lead chromate's dangers are slightly different than those of lead. It's a carcinogen that can affect the lungs and gastrointestinal tract, along with the liver, kidneys and immune system, according to the National Institutes of Health.
Families are suing, and coping with lead's effects
For some families, the applesauce recall ended months of uncertainty over how their children had developed such high lead levels. Dozens of those parents are now suing.
"The good news is that most of the children's blood lead levels have begun to decline since the recall," attorney Nicholas Williams of Motley Rice, a law firm representing parents, tells NPR.
"That said, the levels of lead exposure pose significant concerns for the children's future health and behavioral development, requiring continued monitoring from health professionals," he adds.
In May, Florida-based WanaBana filed for Chapter 7 liquidation bankruptcy, complicating parents' hopes for restitution. As of now, Williams says, parents are pursuing claims — both personal injury and class actions — against companies in the manufacturing and distribution chain.
More alerts in 2024, but with lower lead levels
The FDA has issued three public health alerts in 2024 for ground cinnamon, from brands such as Spice Class, Supreme Tradition, Marcum and La Frontera. The agency tells NPR that these products had far less lead than in the earlier recall, and lead chromate wasn't detected.
Still, the FDA spokesperson says, the agency recommended a recall of products with "elevated lead levels ranging from 2.03 to 20 parts per million."
Much of the ground cinnamon flagged by the FDA this year was sold by specialty international groceries. Discount stores such as Save-A-Lot and Dollar Tree were also affected.
Alarm over lead in cinnamon spiked again in September, when Consumer Reports said it found that 12 of the 36 cinnamon products it tested had more than "1 part per million of lead — the threshold that triggers a recall in New York," the only U.S. state that regulates heavy metals in spices.
Recalls highlight efforts to improve regulation
In the months after last fall's bombshell recall, reports detailed how lead's presence in applesauce reflects the difficulties of policing a complex supply chain that sends food to U.S. shelves.
The FDA says companies importing foods into the U.S. bear a legal responsibility to ensure the items are safe under U.S. laws and regulations.
"If the FDA determines that the level of lead causes the food to be unsafe, the agency will take regulatory action," the agency says.
For years, American Spice Trade Association's members have screened the spices they import for lead, Shumow says.
The small amounts of lead that come into spices naturally through the environment tend to fall below two parts per million, which is the organization's guidance level of lead in cinnamon, she says.
She adds that while exporters such as India, Vietnam, Sri Lanka and China might have less rigorous regulations than the U.S., "we are a critical customer base for them," motivating them to work to meet U.S. standards.
"Based on the FDA investigations and the Consumer Reports article, consumers of spices in the United States can be confident that the spices that they're purchasing from reputable, well-known U.S. brands are safe and do fall below established thresholds of concern for lead," Shumow says.
Zero tolerance isn't possible — so what is?
"In reality, we don't test products to be safe. We test it for the presence of the most-known bad things in it," food fraud researcher John Spink says. "So for food safety, that's about 30 or so bad bugs or chemicals." Spink has seen peanut shells — a potential allergen — used as filler, and the industrial colorant Sudan Red used to make peppers more appealing. But in general, he says, the "vast majority of food fraud does not have a public health threat."
When it comes to lead, a zero-tolerance policy isn't practical, experts tell NPR, since it occurs naturally in the soil and water that nourish plants like cinnamon trees. Lead is also present in the environment due to its once-widespread use in paint and plumbing supplies, and gasoline.
The FDA says protecting the U.S. food supply is a main priority.
In 2023, the agency electronically screened 15 million food import lines, or shipments, with products coming from more than 200 countries. But it only physically examines a tiny fraction of that total, increasing its reliance on self-policing by industry.
"Food manufacturers and processors have the responsibility to take steps to ensure that the spices they manufacture are not contaminated with unsafe levels of heavy metals," the FDA spokesperson says, citing the Federal Food, Drug, and Cosmetic Act and FDA regulations.
In the 2024 fiscal year, "FDA physically examined 50,135 lines and sampled 11,780 lines of human foods coming into the U.S.," the spokesperson says. "While FDA physically examines less than 2% of shipments, we electronically screen 100% of all shipments and sample from the highest risk shipments."
The FDA says it has only limited tools for reducing exposure to toxic elements such as lead in the food supply. It's been asking Congress to give it new authority to establish binding contamination limits in foods, especially those consumed by infants and young children. But those efforts have not succeeded.
In the meantime, the agency has been working to update its guidance for levels of lead in foods meant for young children — a process that began more than two years ago. The FDA hopes to issue its final guidance in December.
Copyright 2024 NPR