A study conducted by researchers at the University of Buffalo in New York and recently published in the journal Current Problems in Pediatric and Adolescent Health Care looked at gaps in the U.S. regulation of toxic metals in baby foods such as rice cereal, formula, purees, and puffs.

The researchers determined that the U.S. doesn’t have the kind of strict regulations for commercially produced baby foods that parents might expect. “It is concerning that there are gaps in food contaminant federal guidelines, particularly for baby foods. Parents might expect and trust that their infant’s commercially produced baby food is automatically protected by tightly regulated guidelines, but that is just not the case,” says the study’s lead author, Sarah J. Ventre, MD, clinical assistant professor in the department of pediatrics in the Jacobs School of Medicine and Biomedical Sciences at the university.

Gauri Desai, PhD, MPH, a clinical assistant professor in the department of epidemiology and environmental health at the university and who was part of the study’s research team, notes that there are few clear, evidence-based guidelines on the maximum tolerable limits of toxic metals in foods and little understanding of toxicant exposure or adverse health effects attributable to dietary exposure in the current regulatory guidelines. “Several foods consistently appear in the literature as potential sources of toxic element exposure,” she says. “Both homemade as well as store-bought foods are found to contain toxicants. Contaminated drinking and cooking water, including water used to prepare infant formula, could also be a major exposure source.”

The researchers found that, while there is an increase in the number of studies focused on the presence of contaminants in foods consumed by children, there is still a dearth of information on the topic. The researchers were also struck by the scarcity of clear guidance that takes into account the complexity of issues—that multiple toxic element exposures may be occurring, and that these stem from the same diets that provide health-promoting nutrients. “First, we do not have a comprehensive picture on the extent of exposure to toxic elements in young children,” Katarzyna Kordas, PhD, associate professor of epidemiology and environmental health at the university’s School of Public Health and Health Professions and senior author of the study, tells Food Quality & Safety. “Second, we do not know how exposure to toxic elements through the diet is affecting child health. We know that toxic elements are bad for children’s development and health, but healthy foods in themselves are good because they provide beneficial vitamins, minerals, bioactive components, etc. Will that counterbalance the effects of toxic elements? While that is the hope, there are no studies to allow us to say this for sure.”

She adds that clearer recommendations are needed for parents, but this is not an issue they can be expected to address alone. There is a need for broader, systemic protections supported by well-developed research studies to address the knowledge gaps. “More frequent inspection of manufactured foods [and] better labeling, combined with public messaging on what the labels mean, should be part of the strategy to limit exposures in young children.”

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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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Beech-Nut Nutrition has issued a voluntary recall of one lot of its infant rice cereal. The recall of Beech-Nut Stage 1, Single Grain Rice Cereal is a result of a routine sampling program by the State of Alaska, which found that samples from that production lot tested above the guidance level for naturally occurring inorganic arsenic set by FDA in August 2020, according to a notice posted on the agency’s website on June 8, 2021.

FDA has stated that exposure to elevated levels of naturally occurring inorganic arsenic can pose a health hazard to young children.

Beech-Nut has also decided to exit the market for single-grain rice cereal because the company is concerned about the ability to consistently obtain rice flour well-below the FDA guidance level and Beech-Nut specifications for naturally occurring inorganic arsenic, the company says.

“The safety of infants and children is Beech-Nut’s top priority,” said Jason Jacobs, the company’s vice president of food safety and quality. No illnesses related to these product codes have been reported to date, and no other production dates or Beech-Nut products are affected by this recall.

The specific Beech-Nut Single Grain Rice item (UPC Code# 52200034705) being recalled has an expiration date of 01MAY2022 and product codes: 103470XXXX and 093470XXXX. The expiration date and product numbers can be found at the bottom of the Beech-Nut Single Rice Cereal canister.

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 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. In April, the agency released an action plan aimed at reducing the toxic elements in foods commonly eaten by babies and young children.

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FDA is working to decrease exposure to toxic elements for babies and young children to as low as possible. The new action plan, entitled Closer to Zero, will aim to reduce the toxic elements in foods commonly eaten by babies and young children. The plan follows a February 2021 Congressional report calling on federal regulators to set stricter standards on baby food manufacturers after an investigation into these foods found toxic heavy metals, including arsenic, present.

FDA’s action plan will follow an approach that includes research, regulatory, and outreach efforts. It will start by evaluating existing data from routine testing of the food supply, exposure, risk assessments, and other relevant scientific information. The agency will also consult with stakeholders and experts and will take what it discovers to make any needed adjustments and finalize action levels.

It’s difficult to determine which foods are tainted with heavy metals. “Reducing levels of toxic elements in foods is complicated and multifaceted,” said Janet Woodcock, FDA’s acting commissioner, in a statement. “It is crucial to ensure that measures taken to limit toxic elements in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.”

Some believe that, since the plan is designed to produce recommendations and not final standards, FDA has set the bar too low. “Generally, it’s a good sign that FDA has developed a timeline to help guide their work, since it creates some accountability,” Laurie Beyranevand, director for the center for agriculture and food systems at Vermont Law School in South Royalton, tells Food Quality & Safety. “However, FDA is proposing setting action levels for these substances rather than enforceable tolerance levels. From a legal perspective, this may not go far enough ,since action levels are nonbinding—meaning they cannot be used as the basis for an enforcement action, whereas a tolerance level set by regulation can.”

Given the magnitude of this issue and the significant public health challenges this presents to a vulnerable population, she believes interim action levels may be appropriate as the agency develops tolerance levels through regulation, but the public may feel more comfortable with a stronger level of agency oversight.

“From a legal perspective, action levels present an additional challenge in the sense they may not be considered final agency action given their nonbinding nature,” Beyranevand says. “Consequently, if advocates seek to challenge the action levels ultimately set by FDA, they may run into obstacles in court preventing them from doing so.”

FDA says that its data shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods today, so, while there is a desire to decrease the amount, it believes its short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time is justified.

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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 congressional investigation by the House Subcommittee on Economic and Consumer Policy discovered toxic heavy metals, including arsenic, in popular baby foods Gerber, Beech-Nut, HappyBABY and Earth’s Best Organic, and called on federal regulators to set stricter standards on the food manufacturers.

“Baby food manufacturers hold a special position of public trust. But consumers mistakenly believe that these companies would not sell unsafe products,” Rep. Raja Krishnamoorthi (D-Ill.) chairman of the subcommittee, said in a statement. “The subcommittee’s staff report found that these manufacturers knowingly sell baby food containing high levels of toxic heavy metals. I hope companies will commit to making safer baby foods. Regardless, it’s time that we develop much better standards for the sake of future generations.”

Robert Durkin, counsel for Arnall Golden Gregory and former acting director and deputy director of the office of dietary supplement programs in FDA’s Center for Food Safety and Applied Nutrition, notes the report clearly shows that the potential, if not likelihood, exists for babies to be ingesting dangerous levels of these contaminants. “It is entirely possible that a careful examination of this information could establish that the companies in question knew, or should have known, that they were putting dangerous, adulterated products on the market,” he tells Food Quality & Safety.

FDA has declared that inorganic arsenic, lead, cadmium, and mercury are dangerous, particularly to infants and children, and this past August finalized new guidance to the industry, setting an action level of 100 parts per billion inorganic arsenic in infant rice cereal.

However, FDA doesn’t set limits on these other metals in baby food. The reasoning, Durkin says, is that although there is information available that describes the risks presented by various toxic elements, there is not always enough data to determine the relationship of that risk to a specific dose or dietary intake of what is toxic.

“In the case of inorganic arsenic, the FDA had years’ worth of data, from at least 2011, that help define the relationship between the daily intake or dose of inorganic arsenic and the risks it presented when present in rich cereal that was feed to babies,” he says. “The data FDA had also showed that regulated industry had the means to achieve products that would consistently meet an upper limit of 100 ppb. Essentially, FDA was able to relate a dose of inorganic arsenic present in rice cereal to a risk it presented to babies that ate it.”

Under the law as it exists now, Durkin adds, if a manufacturer is aware of a hazard associated with their product, they are required to put processes in place to monitor for the risk and to prevent it from occurring. “Moving forward, there is no excuse for this to not happen with toxic elements in baby food. I would expect that FDA gets involved with baby food manufacturers concerning the wholesomeness of their products and to be sure that everything that can be done is being done to ensure baby food contains the lowest achievable amount of toxic elements.”

FDA says it is reviewing the report’s findings and that it takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to children. According to Reuters, since the report was released, several proposed class-action lawsuits have been filed on behalf of consumers who have purchased  baby food.

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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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Infant rice cereal and rice snacks contain some arsenic, and babies who eat these products have higher levels of arsenic in their urine, a study shows.

It’s not clear yet whether the arsenic will affect their health down the line.

“We knew rice cereal was a typical first food for babies, but we knew very little about how common it is to feed infants rice cereal in the U.S., or about the timing of introduction of rice cereal,” said lead author Margaret Karagas, of the Geisel School of Medicine at Dartmouth College in Hanover, New Hampshire.

Rice grains can take up arsenic from their environment, and U.S. rice has some of the highest arsenic concentrations in the world, she said.

“Arsenic is a known carcinogen that can influence risk of cardiovascular, immune and other diseases,” Karagas told Reuters Health by email. “There’s a growing body of evidence that even relatively low levels of exposure may have adverse health impacts on young children including on growth, immunity, and neurodevelopment.”

She and her team are still investigating whether the infants in this study had any health effects due to arsenic exposure.

The researchers studied 759 infants born to mothers age 18 to 45. Parents reported their infant’s intake of rice products like rice cakes or puffs or dried breakfast cereals containing rice, or brands of cereal bars sweetened with brown rice syrup, in interviews when the baby was 4, 8, and 12 months of age. The researchers also collected infant urine samples to test for arsenic levels.

About 80 percent of the children were introduced to rice cereal before age one, and a third were eating rice snacks by their first birthday.

Among kids who did not eat fish or seafood, urinary arsenic concentrations were higher for those who ate infant rice cereal or snacks than for those who did not, according to results in JAMA Pediatrics, April 25.

The researchers also tested for arsenic levels in some of the more commonly reported rice snacks.

“We were surprised by the percentage of infants who ate rice snacks and that one of these products contained levels above the current EU standard of 100 parts per billion,” Karagas said. “This was a strawberry flavored puffed rice snack, which contained 40 percent inorganic arsenic, with the first two ingredients listed as brown and white rice flour.”

Inorganic arsenic exposure has been linked to cancer as well as other health problems such as neurological, cardiovascular, respiratory and metabolic diseases, said Dr. Antonio J. Signes-Pastor, of the Institute for Global Food Security at Queen’s University Belfast in Northern Ireland.

“This is of particular concern for young children, who are more sensitive to adverse health effects of inorganic arsenic and consume higher amount of inorganic arsenic from food compared to adults per kilogram of body weight,” said Signes-Pastor, who was not part of the new study.

It is important, he said in an email, “to reduce exposure by establishing maximum limits of inorganic arsenic in rice and rice-based products.”

The U.S. FDA had proposed a limit for inorganic arsenic in infant rice cereal of 100 parts per billion, which would mimic the current limit in the European Union, Karagas said.

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