FDA has confirmed that lead and chromium detected in the cinnamon in applesauce pouches imported from Ecuador are from lead chromate. Three brands of applesauce pouches, manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands, were recalled last November due to lead contamination.

Historically, lead chromate has been illegally added to certain spices increase to their weight and enhance their color, which increases the monetary value of the adulterated spices, the agency said in a February 29 statement. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.

FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Therefore, FDA has limited ability to take direct action with Negasmart, the supplier of cinnamon to Austrofoods, or Carlos Aguilera, the processor of the cinnamon sticks.

Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, is the likely source of contamination and is not in operation at this time.

The CDC has identified 468 total cases of contamination in 44 states. The investigation is ongoing.  

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FDA is providing additional context about the amount of lead in testing results from cinnamon used as an ingredient in the recalled applesauce pouches and in testing results of the recalled pouches. As of December 26, the agency has received 82 confirmed complaints/reports of adverse events potentially linked to recalled product, up from 69 complaints as of December 19. Those impacted are between zero and 53 years of age.

In an interview published on December 14 in Politico, Jim Jones, FDA’s deputy commissioner for human foods, said the agency is still investigating the lead-tainted cinnamon applesauce pouches, but adds that, “so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.” The agency’s investigation into how the lead was added is ongoing, and it has not given a conclusion as of December 28.

FDA tested samples of the cinnamon collected from the Austrofoods manufacturing facility in Ecuador and used in the recalled applesauce pouches. The highest result was 5,110 parts per million (ppm), which was more than 2,000 times the level of 2.5 ppm being considered for bark spices.

In addition, the testing results previously reported for the sample of recalled WanaBana cinnamon apple puree pouch collected from Dollar Tree had a lead concentration of 2.18 ppm which, for context, is more than 200 times greater than the action level of 0.01 ppm that the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

FDA and state partners have tested at least 136 samples of non-cinnamon containing products and all have been negative for elevated lead levels. Of those, 11 are the Smoothie Mango Passionfruit Banana flavor of WanaBana purees, three of these samples are of the same lot that ARCSA originally reported as positive for lead, and FDA results were negative for elevated lead for all samples. In addition, FDA collected a sample of WanaBana Organic Mango Puree at import and sample results are negative for elevated levels of lead.

The CDC is working in collaboration with state and local health department to investigate the situation as well. CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022.  As of December 22, CDC has received reports of 73 confirmed cases, 157 probable cases, and 21 suspected cases for a total of 251 cases from 34 different states through their reporting structure. CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond.

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Austrofood and Wanabana USA, distributors behind recalled applesauce pouches, say that cinnamon used to manufacture the products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador.

FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine whether the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S.

As of November 30, there have been 57 reports of adverse events potentially linked to recalled product submitted to FDA. To date, those who have been confirmed to be impacted are younger than 5 years old.

FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to FDA as an initial step in determining whether a product is a potential shared source of exposure amongst complainants. Unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, there is no method to link lead exposure to a specific source, which can make establishing a causal relationship complicated. 

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the agency has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination and, as of November 30, there have been no screening results that have tested positive for higher levels of lead.

The list of recalled products can be found on FDA’s website.

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FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to apple cinnamon fruit puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands. As of November 16, there have been 34 reports of illness potentially linked to recalled product submitted to FDA, most of whom they agency says are children. The company announced a recall of the products in early November.

The agency and other state partners collected and analyzed additional product samples of fruit puree and applesauce pouches and detected elevated levels of lead in one finished product sample of WanaBana apple cinnamon puree collected from Dollar Tree. The level detected in the sample is 2.18 parts per million, which is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

To date, sample analysis of WanaBana, Weis, and Schnucks fruit puree pouches that do not contain cinnamon and are not part of the recall, have not shown elevated levels of lead.

FDA’s leading theory is that cinnamon used in these recalled pouches is the likely source of contamination; however, the agency has not yet been able to collect and test samples of the cinnamon used in the recalled products. It continues to work with Ecuadorian authorities to investigate the source of the cinnamon. At this time, while FDA has no indication that this issue extends beyond these recalled products, it is screening incoming shipments of cinnamon from multiple countries for lead contamination.

In addition to determining the source of cinnamon, FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. As of November 17, the agency says it is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon or cinnamon-containing products.

Food Quality & Safety will update this advisory as information becomes available.

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On January 24, FDA unveiled a draft guidance for manufacturers to reduce lead levels in processed foods intended for children younger than 2 years of age. The move was made as part of FDA’s Closer to Zero program, which was created to help reduce young children’s exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible.

“For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods,” Robert M. Califf, FDA’s Commissioner, said in statement. “For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24% to 27% reduction in exposure to lead from these foods.”

Known as Action Levels for Lead in Food Intended for Babies and Young Children, the draft guidance calls for manufacturers to set new action levels of 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats; 20 ppb for root vegetables; and 20 ppb for dry cereals.

Although not binding under law, FDA could take these action levels into account when considering whether to bring enforcement action in a particular case.

Vineet Dubey, an environmental attorney based in Los Angeles, has been fighting to reduce lead levels in baby food for several years, pushing for the federal government to set levels for heavy metals in baby food, whether it be through the Closer To Zero effort or the Baby Food Safety Act. He does not believe the new draft guidance will affect much change, as the levels set forth by the proposal are not a mandate and there are no strict penalties for noncompliance. “The FDA’s own words point out that these proposed lead limits are not ‘legally enforceable responsibilities.’ In other words, consumers should continue to trust baby food makers to do the right thing, which is how we got here in the first place,” he says. “The FDA and Congress need to stop paying lip service about limiting baby and toddler exposure to excessive amounts of lead that’s in the processed food most American parents feed their kids.”

It should be noted that the timeline for FDA to release a draft guidance document is far less than the typical rule-making procedures requiring a notice and comment period, allowing FDA to alert industry more quickly for significant concerns.

Dubey also argues that a maximum allowable lead limit, per serving, needs to be mandated and must come with strict penalties for exceeding set levels. Further, he says that FDA needs to be funded in a way that allows for regular testing and monitoring of baby foods, especially those known to often carry lead, such as sweet potatoes, yams, spinach, and rice. “This guidance is long overdue in even starting to address the problem of lead found in baby food, so hopefully awareness will increase among parents and, possibly, cause some companies to start taking more seriously the danger of lead found in their products,” Dubey adds.

FDA is holding a webinar on this draft guidance for members of industry and the public on March 2. Visit the registration page for more information.

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While a number of studies have shown a connection between dark chocolate and heavy metals cadmium and lead, a new report by Consumer Reports has shed more light on the issue. In its research, the organization measured levels of heavy metals in 28 different dark chocolate products and detected cadmium and lead in all of them. The tested products included chocolate from Hershey’s, Theo, Trader Joe’s and other popular brands.

Too many as these two heavy metals have been linked to several health problems for both children and adults and the FDA notes that lead is toxic to humans and can affect people of any age or health status—though it is most problematic to children and pregnant women. By law, food manufacturers have a responsibility to implement controls to significantly minimize or prevent exposure to chemical hazards, lead included.

In January, Mars Inc. was hit with a proposed class action in New York federal court accusing the confectionery giant of failing to disclose lead and cadmium in several of its dark chocolate bars. A similar claim was made against The Hershey Co., which is facing a suit of its own.

In the latter case, the class action was brought by Christopher Lazazzaro, who cited the Consumer Reports study in the court documents, which tested a trio of Hershey’s dark chocolate bars—Hershey’s Special Dark Mildly Sweet Chocolate, Lily’s Extra Dark Chocolate 70% Cocoa, and Lily’s Extreme Dark Chocolate 85% Cocoa—and found them all to contain the heavy metals. The lawsuit is seeking $5 million from Hershey’s, claiming the chocolate giant’s advertising and marketing campaign for the dark chocolate bars were “false, deceptive, and misleading” since the labels said nothing about containing lead and cadmium.

A week after the suit against Hershey’s was filed, a similar one against Trader Joe’s came about, with the plaintiff saying that the company failed to disclose that the Trader Joe’s Dark Chocolate 72% Cacao and Trader Joe’s The Dark Chocolate Lover’s Chocolate 85% Cacao both contain lead and cadmium.

Still, the National Confectioners Association (NCA), which represents most of the major chocolate companies, claims that the levels found are not dangerous. In 2019, NCA partnered with As You Sow, an organization that pushes for corporate accountability, on a three-year study on the main sources of lead and cadmium in chocolate products and what can be done to lower the amounts. This came about after a 2018 settlement between As You Sow and 32 members of the confectionery industry. “Cadmium and lead are present in cocoa and chocolate due to the soil,” says Christopher Gindlesperger, a spokesperson for NCA. “The products cited in this study are in compliance with strict quality and safety requirements, and the levels provided to us by Consumer Reports testing are well under the limits established by our settlement [with As You Sow].”

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FDA has issued draft action levels for lead in single-strength (ready to drink) apple juice and other single-strength juices and juice blends. This action is intended to reduce the potential for negative health effects from dietary exposure to lead, and supports the Closer to Zero action plan that sets forth FDA’s aim to reduce exposure to toxic elements in foods.

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry, provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.

As part of its commitment in the Closer to Zero action plan to consider the biological effects from exposure to harmful elements in food, the draft action levels for lead in juice were guided by FDA’s interim reference level (IRL) for lead, a measure of the contribution of lead in food to blood lead levels. The agency estimates that establishing a 10 ppb action level could result in as much as a 46% reduction in exposure to lead from apple juice in children. For all other fruit and vegetable juices, establishment of an action level of 20 ppb is estimated to result in a reduction of 19% in exposure to lead from all other juices in children. FDA has issued a lower draft action level for apple juice because it is the most commonly consumed juice that young children drink.

“As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study, Toxic Elements in Food and Foodware program, and sampling assignments,” said Susan Mayne, PhD, director of FDA’s Center for Food Safety and Applied Nutrition, in a statement. “In addition, our work in this important area of food safety will progress with advancements in science. For example, action levels may be progressively lowered over time, as appropriate, to make continual improvements in reducing the levels of lead, arsenic, cadmium, and mercury in foods eaten by babies and young children.”

FDA is accepting comments on the draft guidance, and manufacturers may choose to implement the recommendations in the draft guidance before the guidance becomes final. FDA will work with manufacturers of these products to encourage the adoption of best practices to lower levels of lead in juice.

Because lead is in the environment as a naturally occurring element and from consumer and industrial products and processes, it is not possible to remove it entirely from the food supply; however, the action levels recommended in the draft guidance document will help limit consumer exposure.

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In response to a February 2021 report released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy, FDA has issued a letter to baby and toddler food manufacturers reminding them of their obligations under the FSMA Preventive Controls for Human Food Rule to consider chemical hazards in foods when engaged in their required hazard analysis of food products.

FDA says it will also seek “impactful solutions for reducing toxic elements in foods commonly consumed by babies and young children.” The agency also committed to engaging in a process to set standards and limits for the presence of heavy metals in baby foods.

The new actions include issuing guidance to manufacturers for “key foods,” planning to finalize its action level for inorganic arsenic in infant rice cereal, which it started working on in 2016; and working to finalize its draft guidance for an inorganic arsenic action level in apple juice and release a draft guidance for lead action levels in juices.

“The U.S. Food and Drug Administration takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population,” said Janet Woodcock, FDA’s acting commissioner of food and drugs, in its statement.

Laurie Beyranevand, director of the Center for Agriculture and Food Systems at Vermont Law School, notes that while this is an important first step and signals a stronger commitment to address the issue of heavy metals in baby foods than we’ve seen from FDA over the past few years, these actions are not enough.

“A few years ago, FDA convened a Toxic Elements Working Group to reduce exposure to toxic elements across FDA’s regulated product categories,” she tells Food Quality & Safety. “The working group prioritized lead, arsenic, cadmium, and mercury, as these metals present the highest public health risk when individuals are exposed at high levels. However, to date, FDA has only issued voluntary guidance to address inorganic arsenic in rice cereal, meaning it contains nonbinding recommendations that can’t be enforced by the agency in the same way a binding regulation can.”

Janilyn Hutchings with StateFoodSafety, a food safety education organization, says that, in addition to taking the new actions it just announced, FDA could also work on drafting action levels for inorganic arsenic and lead in other baby foods. “It could also consider appropriate action levels for cadmium and mercury,” she says. “As more testing and studies are available and more widely used, the FDA will likely implement more changes to ensure the safety of babies and children.”

In Beyranevand’s opinion, FDA should be developing binding standards with set limits that address the amount of heavy metals that can safely be present in infant, baby, and toddler foods, rather than developing nonbinding guidance. “This will require manufacturers to ensure their products are within those limits and enable FDA to enforce the limits against companies that fail to comply,” she says. “Given the vulnerability of this population and the fact that heavy metals are present in many of their first foods, this issue is of paramount importance for public health and safety.”

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A new study by Consumer Reports states that some fruit juices pose potentially harmful levels of heavy metals. In its analysis of 45 fruit juices sold nationwide, the nonprofit advocacy organization found that nearly half contained elevated levels of inorganic arsenic, lead, or cadmium.

According to Hannah Gardener, ScD, nutritional epidemiologist and founder of A Green Slate Consulting, Boston, Mass., foods and beverages can become tainted with heavy metals if they’re grown in contaminated soil and water. Due to past use of heavy metal-containing pesticides, many orchards and fields have become contaminated.

But many heavy metals naturally occur in the environment as well, says Alex Berezow, PhD, vice president of scientific affairs, American Council on Science and Health, New York, New York.

Children, who are particularly vulnerable to the harmful effects of heavy metals, consume a lot of fruit juice. More than 80 percent of parents of children three and under give their kids juice at least sometimes, according to Consumer Reports’ survey.

Gardener says consuming foods with elevated levels of lead, cadmium, and inorganic arsenic can have significant health effects, particularly for babies and children who are sensitive to their effects. “As a potent neurotoxin, lead is toxic to the brain, and especially developing brains,” she says. “Its effects are permanent and irreversible, and there is no safe level of lead consumption. It’s also considered a potent reproductive toxin. Cadmium is also a neurotoxin and reproductive toxin and has damaging effects on the liver. Inorganic arsenic is particularly concerning as it’s known to cause cancer.”

The Consumer Reports’ article encourages the FDA to limit levels of heavy metals in foods. “If the FDA established stricter health-protective limits for heavy metals in foods and beverages, it could mean that manufacturers would have to test their products more thoroughly and identify better growing practices, conditions, locations, orchards, and fields in an effort to limit heavy metal contamination,” Gardener says. “These efforts have grown in some areas, particularly in relation to rice and rice-based foods, for example, where the concern about inorganic arsenic contamination has increased over the past eight years or so.”

But Carl Winter, PhD, extension food toxicologist and vice chair, Department of Food Science and Technology, University of California, Davis, Calif., says it’s difficult to designate a “safe” level for heavy metals in specific foods and beverages because consumers are exposed to heavy metals in a wide variety of foods. In general, research indicates that exposure levels are typically below levels of health significance.

Dr. Berezow points out that regulation usually imposes extra costs, which are invariably passed on to consumers. “Therefore, the government should only impose new regulatory burdens if there is sufficient scientific reason to do so,” he says.

Regarding what steps the food and beverage industry can take to decrease levels of inorganic arsenic, lead, and cadmium in foods and beverages, Dr. Winter says there’s little that can be done at the post-harvest level to reduce metals in foods and beverages. “The primary way to reduce levels of heavy metals is to avoid using foods grown in environments possessing high levels of naturally occurring metals,” he says.

Along these lines, Dr. Berezow says that the best strategy is prevention, which means making sure that industry responsibly uses and disposes of materials that contain heavy metals. “If a site is unduly contaminated, it should be cleaned up,” he says.

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A new study by Clean Label Project, a national non-profit that analyzes consumer products for the purposes of public education, found that more than 25 percent of 500 infant formulas and baby foods it tested exceed state or federal safety guidelines. Lead, arsenic, mercury, bisphenol A (BPA), and acrylamide were among the contaminants.

“The World Health Organization reports that during the first 1,000 days of life, the foundation of optimal health, growth, and neurodevelopment across the entire lifespan are established, making the findings particularly alarming,” says Jaclyn Bowen, MPH, MS, executive director, Clean Label Project, Denver, Colo.

Disturbing Findings
The contamination found in the study was higher than anticipated, says Sean Callan, PhD, director of operations and quality for Denver, Colo.-based Ellipse Analytics, the third-party analytical chemistry laboratory that performed the testing. In fact, more than 35 percent of baby food products tested contained quantifiable levels of lead, a statistic more than 40 percent higher than the recent Environmental Defense Fund summary report of products published in June. “This is the most concerning finding because lead, in addition to being linked to cancer, impairs brain function,” he says. “Early life exposure to lead has been linked to a decline in IQ and other neurological contaminants.”

Furthermore, one in 10 tested products contained acrylamide, a neurotoxin and carcinogen. And over half of the products contained some level of arsenic. As many as one-third of the more than 500 products tested exceeded at least one state or federal guidance level.

While BPA was found in less than 5 percent of tested samples, the most interesting finding was that in 60 percent of BPA cases, the product in question made an on-pack claim of being BPA-free, Dr. Callan reports. BPA is an endocrine disrupter, meaning that it alters hormone levels.

Why Contamination Occurs
Bowen surmises that baby food products contain contaminants because heavy metals naturally occur in the environment. They may also be introduced into the environment as a result of human activity. Some foods pick up heavy metals during growth and as a result of harvesting, storage, and handling and manufacturing activities.

BPA, for example, has been used in a variety of plastic products since the 1960s. It is also present in the epoxy inner coating of many metal containers. “The main concern for exposure is based on the tendency of some acidic foods to leach BPA from the food packaging into the food,” Bowen says. “Heating food in plastic containers containing BPA may also result in BPA leaking into food.”

Possible Solutions
To prevent future contamination, the onus is on brands to do their own proactive due diligence before sourcing ingredients, Bowen says. Brands need to rethink product specifications on the maximum thresholds of contaminants such as heavy metals. Brands also need to consider whether their supplier should administer confirmation testing or if they will assume the time and expense of performing testing.

Furthermore, Bowen points out that it is especially critical to use a third-party analytical chemistry laboratory with very sensitive levels of detection to perform testing. If instrumentation doesn’t get into the single digit parts per billion (the threshold limits established by state guidelines like the California Office of Environmental Health Hazard Assessment), then test results won’t detect a contaminant and give brands a false sense of security. For brands that don’t have direct oversight of the sourcing, including brands that use co-packers, she recommends implementing strict quality assurance and control methods.

Bowen also says that strict supplier assurance programs and product specifications are needed; these elements need to be incorporated into Hazard Analysis Critical Control Point plans.

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