The Atlanta Journal-Constitution
Probe of lead-tainted applesauce reveals gaps in food-safety system
Product sailed through series of checkpoints, poisoned hundreds.
WASHINGTON — Cinnamon-flavored applesauce pouches sold in grocery and dollar stores last year poisoned hundreds of American children with extremely high doses of lead, leaving anxious parents to watch for signs of brain damage, developmental delays and seizures.
The Food and Drug Administration, citing Ecuadorian investigators, said a spice grinder was likely responsible for the contamination and said the quick recall of 3 million applesauce pouches protected the food supply.
But hundreds of pages of documents obtained by The New York Times and the nonprofit health newsroom The Examination, along with interviews with government and company officials in multiple countries, show that in the weeks and months before the recall, the tainted applesauce sailed through a series of checkpoints in a food-safety system meant to protect American consumers.
The documents and interviews offer the clearest accounting to date of the most widespread toxic exposure in food marketed to young children in decades. Children in 44 states ate the tainted applesauce, some of which contained lead at extraordinarily high levels.
Time and again, the tainted cinnamon went untested and undiscovered, the result of an overstretched FDA and a foodsafety law that gives companies, at home and abroad, wide latitude on what toxins to look for and whether to test.
“It’s amazing in a bad sense what a catastrophic failure this was,” said Neal Fortin, director of the Institute for Food Laws and Regulations at Michigan State University. “Largely, the food supply regulatory system is based on an honor system.”
The cinnamon originated in Sri Lanka and was shipped to Ecuador, where it was ground into a powder. It was probably there, the FDA has said, that the cinnamon was likely contaminated with lead chromate, a powder that is sometimes illegally used to tint or bulk up spices.
The ground cinnamon was then sold, bagged and sold again to a company called Austrofood, which blended it into applesauce and shipped pouches to the United States. It was sold under the brand name WanaBana and various generic store labels.
Austrofood never tested the cinnamon or its tainted applesauce for lead before shipping it to the United States. The company said it relied on a certificate from a supplier saying the cinnamon was virtually leadfree, records show. In a statement, the supplier, Negasmart, did not discuss that certification but said it had complied with all regulations and quality standards.
The FDA can inspect overseas food companies that ship to the United States, but even as food imports soared to record levels in 2022, international inspections fell far short of targets set by law.
American inspectors had not visited Austrofood in five years, records show.
The FDA says it has no authority to investigate far down the international supply chain. Records show that the Ecuadorian government had the authority but not the capacity. Ecuadorian regulators had never before tested cinnamon for toxins and, when the FDA called looking for help, nearly half of the government’s lab equipment was out of service, said Daniel Sánchez, the head of Ecuador’s food safety agency.
Private safety audits commissioned by American importers are supposed to provide another layer of protection. But audits typically look only for the hazards that the importers themselves have identified.
None of the importers would say whether they considered lead a risk or tested for it and it is unclear what, if any, steps they took. But none blocked the applesauce. Records show one auditor gave the applesauce maker an A+ safety rating in December, as American children were being poisoned.
The FDA has the power to test food arriving at the border. There is no indication that anyone tested the applesauce when it arrived at ports in Miami and Baltimore. Inspectors conduct about half as many such tests as they did a decade ago.
The FDA said it planned to analyze the incident and whether it needs to seek new powers from Congress to prevent future outbreaks.
The FDA asked Congress in 2022 for the authority to set heavy-metal limits and require baby-food makers to test for them — changes that might have prevented last year’s poisoning. Congress did not act.
A mother demands answers
The tainted applesauce might have gone unnoticed for even longer had it not been for a family in North Carolina.
Early last summer, Nicole Peterson and Thomas Duong were alarmed by their young children’s blood-lead levels in a routine screening. Within weeks, the levels had doubled.
Peterson said the couple worked with the local health department as they tried to determine what could be hurting their children. She and her husband are suing Dollar Tree, where they bought the applesauce, and WanaBana, a U.S. distributor led by Austrofood officers.
A Dollar Tree spokesperson said the company is committed to the safety of the products it sells. Austrofood said that it had relied on its supplier’s certification and that none of its other products have been recalled.
Their 3-year-old daughter had a blood-lead level nearly seven times the Centers for Disease Control and Prevention’s level of concern.
Public health investigators searched their home and day care but failed to find the source. When the parents’ blood tests came back normal, they began to suspect one food that only the children ate: foil pouches of cinnamon applesauce.
North Carolina health officials tested them and found extraordinarily high lead levels. That prompted the FDA to act.
Searching for the source
In late October, Austrofood recalled millions of applesauce pouches. The FDA has said it believes this measure eliminated the tainted cinnamon from the U.S. food supply.
The CDC estimates that more than 400 infants and toddlers were poisoned. The median test result was six times the level found in the water crisis caused by lead pipes a decade ago in Flint, Mich.
The exposure in Flint was more sustained, and its longterm effects have proved difficult to quantify. But years later, the number of students in the city who qualified for special education doubled.
This month, the FDA said Ecuadorian investigators believe the cinnamon was likely contaminated by Carlos Aguilera, who ran a spice mill.
The Ecuadorian health agency filed an administrative complaint against Aguilera, saying he had operated without a permit and used broken machinery that increased the risk of impurities, records show. The complaint is pending.
Ecuadorian officials took packaged cinnamon from Aguilera’s customers that tested positive for lead, according to inspection reports and interviews.
But investigators found no contaminated cinnamon at Aguilera’s plant, records show. In an interview with reporters, he denied adding lead chromate.
Where was the FDA?
The industry was never supposed to entirely police itself. The food-safety law called for the FDA to increase overseas oversight and conduct about 19,000 international food inspections annually. The agency never came close to that target. Last year, records show that regulators conducted about 1,200 overseas inspections — visiting fewer than 1% of FDA-registered international food-makers.
When the Government Accountability Office flagged the problem in 2015, the FDA cited insufficient funding and questioned “the usefulness of conducting that many inspections.”
U.S. officials inspected Austrofood in 2019. It is not clear what testing they conducted, but trade records show the company was not exporting cinnamon products to the United States, so the spice was likely not a factor in the inspection. Regulators found no problems that they advised fixing, records show.
Inspectors did not return until the lead poisoning was discovered nearly five years later.
There is no record of the FDA ever inspecting the original source of the cinnamon, the Sri Lanka-based Samagi Spice Exports. Nanda Kohona, the company’s marketing director, said the company conducted its own lead tests.
None of the other companies in the cinnamon supply chain were eligible for FDA inspections because they do not ship directly to the United States.
The biggest day of this year’s primary campaign is approaching as 16 states vote in contests known as Super Tuesday. The elections are a crucial moment for President Joe Biden and Donald Trump, who are the overwhelming front-runners for the Democratic and Republican presidential nominations, respectively.
As the day with the most delegates at stake, strong performances by Biden and Trump would move them much closer to becoming their party’s nominee.
The contest will unfold from Alaska and California to Virginia and Vermont. And while most of the attention will be on the presidential contest, there are other important elections on Tuesday.
Some things to watch:
Does Trump keep rolling?
So far, the Republican presidential primary has been a snoozer.
The former president has dominated the race and his last major rival in the race, his onetime U.N. Ambassador Nikki Haley, is struggling to keep up. She lost the Feb. 27 primary in Michigan by more than 40 percentage points. She even lost her home state of South Carolina, where she was twice elected governor, by more than 20 percentage points.
As the race pivots to Super Tuesday, the vast map seems tailor-made for Trump to roll up an insurmountable lead on Haley. His team has been turning up the pressure on Haley to drop out, and another big win could be a major point in their favor.
Haley’s banked a considerable amount of campaign money and says she wants to stay in the race until the Republican National Convention in July in case delegates there have second thoughts about formally nominating Trump amidst his legal woes. But she’s seen some of her financial support waver recently — the organization Americans For Prosperity, backed by the Koch brothers, announced it’d stop spending on her behalf after South Carolina.
Do college grads keep turning against Trump?
Amid Trump’s commanding wins this primary season have been a notable warning sign for November: He’s performed poorly with college-educated primary voters.
In the New Hampshire and South Carolina primaries, APVoteCast found that college graduates picked Haley over Trump. Roughly two-thirds of voters in both states who went to graduate school after college voted for the former South Carolina governor.
In South Carolina, Trump won the suburbs but not by the same magnitude as his dominance in small towns and rural areas, essentially splitting the vote with Haley.
Weakness with college graduates and in the suburbs where they cluster is what doomed Trump in his 2020 loss to Biden.
Does Biden end doubts?
As sleepy as the Republican presidential primary has been, the Democratic one has been even quieter. Biden has many political problems dragging him down in public opinion polls, but not, so far, at primary polling stations. The one speed bump came in Michigan, where an organized attempt to vote “uncommitted” in the primary there to protest Biden’s support of Israel during the war in Gaza garnered 13% of the vote, a slightly higher share than that option got in the last primary under a Democratic president.
There are no similar organized anti-Biden efforts on the Super Tuesday calendar, just the president’s two longshot primary opponents who’ve yet to crack low single digits against him, U.S. Rep. Dean Phillips of Minnesota and self-help author Marianne Williamson, who revived her campaign after receiving a surprise 3% of the Michigan primary vote.
What happens in California’s Senate race?
There’s far more than the presidential primaries on the ballot Tuesday. One of the most consequential contests is the California primary for the U.S. Senate seat left open by the death of Democratic Sen. Dianne Feinstein.
Rather than having the winners of party primaries face off in November, California throws every candidate into a single primary and has the top two vote-getters make it to the general election.
Democrats have a lock on statewide races in the overwhelmingly blue state, and for months the speculation was that two prominent U.S. House members from that party, Reps. Katie Porter and Adam Schiff, would battle it out until Election Day. But that’s changed since former Dodgers great Steve Garvey threw his hat in the ring.
Garvey, 75, is a Republican and a novice at politics. Schiff has been airing ads slamming him — or, more accurately, promoting him — as most likely to carry out Trump’s wishes. The idea is to unite the state’s outnumbered conservatives behind Garvey so he and Schiff finish in the top two, denying Porter a spot in November.
Another GOP test in Texas
Texas Attorney General Ken Paxton last year survived an impeachment led by his own party. Now he wants payback, and Trump is helping him.
Paxton is targeting more than 30 Republican state lawmakers in the primary, including House Speaker Dale Phelan. Paxton is also trying to remove three Republican judges on the state’s conservative appeals court who voted to limit the attorney general’s powers.
Paxton has been a staunch supporter of Trump, including the former president’s attempts to overturn his own 2020 election loss, and Trump is helping Paxton in his primary campaign. The Texas purge will be a test of what Republican voters value the most in their elected officials.