As dozens of children in the United States suffer from lead poisoning, federal regulators are now investigating whether the culprit is cinnamon, which was added to some popular applesauce pouches, and whether lead was added somewhere in the global supply chain, either to increase the spice's reddish effects color or for weight gain.
In November, the Food and Drug Administration announced a nationwide recall of three million bags of cinnamon applesauce made in Ecuador and sold at dollar stores and other outlets under the brand names WanaBana, Schnucks and Weis.
Concern over the poisoning cases, which affected up to 125 children, has highlighted a major gap in the FDA's food oversight. There is no federal requirement to test for lead in foods produced domestically or imported into the United States. In this case, an investigation by the North Carolina Department of Health and Human Services determined the source of the contamination after receiving reports of high lead levels in children's blood tests.
That lead levels in children's blood tend to be the first line of detection for lead in food “effectively means using children as canaries,” said Tom Neltner, senior director of safer chemicals at the Environmental Defense Fund, an advocacy group. He said the FDA has not set enforceable limits for lead in foods, let alone spices.
“This shows a collapse of the agency and an industry that needs repair,” Neltner said.
Jim Jones, head of the FDA's food division, said in an interview with Politico that the lead contamination appeared to be an “intentional act.”
On Friday, the FDA said one theory it is investigating is the possibility “that the cinnamon contamination occurred as a possible result of economically motivated adulteration.” Put simply, this explanation could mean that the company producing the cinnamon used additives to make the spice more attractive and commercially profitable.
The agency stressed that its investigation was ongoing and offered additional theories.
Food safety experts said the addition of lead in spices with a reddish hue has long been a problem.
“If you sell spices by the pound or by the ton, you get a better price for leaded or lead-colored spices,” said Charlotte Brody, national director of Healthy Babies Bright Futures, which advocates for removing toxins from baby food. “But you will also poison children.”
Testing for lead in children's blood is required in some states and cities but voluntary in most areas, Neltner said. When elevated levels are found, lead in the paint is often assumed to be the culprit, he said, adding that thorough investigations like the one in North Carolina are exceptional.
Like most foods consumed in the United States, the various ingredients in applesauce pouches come from and were manufactured in different parts of the world before ending up on store shelves. The cinnamon applesauce sachets were manufactured in Ecuador by Austrofood, but the cinnamon supply came from another company, Negasmart.
This week, the FDA announced that it is conducting an on-site inspection of Austrofood's manufacturing facility in northern Ecuador and is collecting samples of the cinnamon used in the recalled products. Austrofood did not respond to an email seeking comment.
The FDA said Ecuadorian authorities had told U.S. regulators that Negasmart's cinnamon had higher lead levels than permitted in Ecuador and that the company was currently working on a process to determine who was responsible for the contamination. Negasmart did not respond to a request for comment.
Ms. Brody said the FDA's communications and company statements about the recall have so far left an important question unanswered: Which company shipped the cinnamon, which is typically imported from Asia, and where else is it used?
“Are we getting contaminated cinnamon from other companies?” she asked. “We have to know.”
The FDA said last month that it was investigating cinnamon imports from “multiple countries for lead contamination” and had no evidence that the contamination went beyond the recalled applesauce pouches. It added that investigations up to November 30 had not revealed any shipments with “higher levels of lead”.
FDA guidelines on lead in foods eaten by children are less stringent than government standards for the cribs in which they sleep, Ms. Brody said. Children are particularly vulnerable to the effects of lead, which can damage their nervous system and impair growth, learning and language development.
In 2017, the FDA issued recommendations for lead levels in children's candy after regulators in California discovered popular candies from Mexico that were contaminated either by lead oozing from the light-colored packaging or by the chili powder used in some treats.
And earlier this year, the agency proposed caps on lead in baby foods like fruit purees and dried cereals after years of studies showed many processed products contained high levels of lead. The draft guidelines, which would not be mandatory for food manufacturers to follow, have not yet been finalized.
The agency has asked Congress for more authority to address the problem, according to its 2024 legislative proposals. The requests include authority to set mandatory limits on food contamination, noting that under current law, “FDA has limited tools to reduce exposure to toxic elements in the food supply.”
In its congressional request, the agency also noted that the food industry “is not required to test ingredients or finished products” intended for consumption by infants or children and sought authority to require food manufacturers to test for toxic elements .
New York State enforces a lead limit in spices, which has led to a number of product recalls in recent years.
California is following New York's lead and taking a more aggressive stance on testing for heavy metals, particularly in baby food. Starting in January, manufacturers of food for children under two must test a sample of each product once a month for arsenic, cadmium, lead and mercury. Manufacturers must also report results to California health authorities upon request.
In January 2025, baby food manufacturers must publicly publish the results of their tests.
Weis Markets, which pulled the affected cinnamon applesauce bags from its shelves in late October, said in a statement that it was the manufacturer's responsibility to test the applesauce bags for “multiple items” and “confirm that the Products are healthy and genuine”.
Weis said another company, Purcell International in California, which imported the applesauce pouches from Ecuador, was also responsible for testing the product's safety. Purcell did not respond to an email seeking comment.