With dozens of children across the United States suffering from lead poisoning, federal regulators are now investigating whether the culprit is cinnamon that was added to some popular applesauce pouches, and if lead had been added somewhere along the global supply chain, either to enhance the spice’s reddish color or to add weight.
In November, the Food and Drug Administration announced a national recall of three million pouches of cinnamon applesauce made in Ecuador and sold at dollar stores and other outlets under the WanaBana, Schnucks and Weis brand names.
Concern about the poisoning cases, affecting as many as 125 children, has highlighted a broader gap in F.D.A. food oversight. There is no federal requirement to test for lead in food made domestically or imported into the United States. In this case, a North Carolina health department investigation pinpointed the source of contamination after receiving reports of high levels of lead readings in children’s blood tests.
That the levels of lead in children’s blood tends to be the first line of detection for lead in food is “effectively using kids as canaries,” said Tom Neltner, senior director of safer chemicals at the Environmental Defense Fund, an advocacy group. He said that the F.D.A. has not set enforceable limits for lead in food, much less in spices.
“What this shows is a breakdown in the agency, and an industry that has to be fixed,” Mr. Neltner said.
Jim Jones, the F.D.A.’s food division director, said in an interview with Politico that the lead contamination appeared to be an “intentional act.”
On Friday the F.D.A. said one theory it is exploring is the potential “that the cinnamon contamination occurred as a possible result of economically motivated adulteration.” In simpler terms, that explanation could mean that the company producing the cinnamon used additives to make the spice more appealing and commercially profitable.
The agency emphasized that its inquiry was not finished and included other theories.
Food safety experts said the addition of lead has long been a concern in spices with a reddish hue.
“If you’re selling spices by the pound or ton, you’re going to get a better price for lead-weighted or lead-colored spice,” said Charlotte Brody, national director of Healthy Babies Bright Futures, which advocates the removal of toxins from baby food. “But you’re also going to poison children.”
Tests for lead in children’s blood are required in some states and cities but are voluntary in most areas, Mr. Neltner said. When elevated levels are found, lead in paint is often assumed to be the culprit, he said, adding that investigations as careful as the one in North Carolina are exceptional.
Like most foods consumed in the United States, the various ingredients in the applesauce pouches came from and were manufactured in different parts of the world before landing on store shelves. The cinnamon applesauce pouches were manufactured in Ecuador by Austrofood, but its supply of cinnamon was provided by another company, Negasmart.
This week, the F.D.A. said that it was conducting an on-site inspection of Austrofood’s manufacturing facility in northern Ecuador, and was collecting samples of the cinnamon used in the recalled products. Austrofood did not respond to an email seeking comment.
The F.D.A. said that Ecuadorean authorities had told U.S. regulators that Negasmart’s cinnamon had higher levels of lead than those allowed by Ecuador and that the company is currently engaged in a process to determine who was responsible for the contamination. Negasmart did not respond to a query for comment.
Ms. Brody said the F.D.A.’s notices and company statements on the recall so far have left a major 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 need to know.”
The F.D.A. said last month that it was screening cinnamon imports from “multiple countries for lead contamination,” and had no indication that the contamination extended beyond the recalled applesauce pouches. It added that as of Nov. 30, the screenings had not turned up any shipments with “higher levels of lead.”
The F.D.A. policies on lead in food consumed by children are less rigorous than government standards for the cribs that they sleep in, Ms. Brody said. Children are particularly vulnerable to the effects of lead, which can damage their nervous systems, affecting growth, learning and speech development.
In 2017, the F.D.A. set recommendations for the amount of lead in children’s candy after regulators in California discovered popular candies from Mexico that had been tainted either by lead that seeped from the bright wrappers or from the chili powder used in some of the treats.
And earlier this year, the agency proposed maximum limits for lead in baby foods like mashed fruits and dry cereals, after years of studies that showed many processed products contained high levels of lead. The draft guidance, which would not be mandatory for food manufacturers to follow, has not yet been finalized.
The agency has asked Congress for more power to address the problem, according to its legislative proposals for 2024. The requests include authority to set binding contamination limits in food, noting that under current law, “F.D.A. has limited tools to help reduce exposure to toxic elements in the food supply.”
In its congressional request, the agency also pointed out that the food “industry is not required to test ingredients or final products” meant to be consumed by infants or children, and sought authority to require food makers to test for toxic elements.
New York State enforces a lead limit in spices, which has spurred a number of product recalls in recent years.
California is following New York’s lead, taking a more aggressive stance around testing for heavy metals, especially in baby food. Starting in January, manufacturers of food meant for children under 2 years will need to test a sample of each product once a month for arsenic, cadmium, lead and mercury. Manufacturers will also be required to share the results with California health regulators, if requested.
In January 2025, baby-food makers will be required to publicly post the results of their testing.
Weis Markets, which pulled the affected cinnamon applesauce pouches from its shelves in late October, said in a statement that it was the manufacturer’s responsibility to test the applesauce pouches for “multiple items” and to “certify the products are wholesome and unadulterated.”
Weis said another company, Purcell International in California, which imported the applesauce pouches from Ecuador, was also responsible for testing the safety of the product. Purcell did not respond to an email seeking comment.