5 Actions the FDA Can Take To Reduce Heavy Metal Toxins in Baby Food

Birth through age 5 is a period of more significant and more rapid brain and biological development than any other time in the human lifespan. During this period, children are uniquely vulnerable to environmental toxins that may detrimentally shape their development. Decades of research have shown that no amount of heavy metal in consumables marketed toward infants and children is considered safe. Indeed, the consumption of these toxins—including lead, cadmium, mercury, arsenic, and manganese—poses significant long-term and irreversible consequences for health and development. Yet, young children are still regularly exposed to a variety of dietary and environmental threats, including harmful heavy metals in not only their food but also their homes and communities.

In January 2023, the U.S. Food and Drug Administration (FDA) released draft guidance for industry producers around the levels of lead allowed in baby food, setting new action levels for lead levels in several packaged food items marketed for babies and young children, such as fruits, vegetables, custards, yogurts, and dry infant cereal.³ FDA action levels, although not legally enforceable, establish limits of contaminants that the FDA may use in deciding when to pursue legal action. These limits are intended to encourage industry to lower the amounts of contaminants in food, assuming some contamination is unavoidable. The comment period for this new guidance provides an opportunity to examine the risks of toxic heavy metal consumption during early childhood and to identify additional actions needed to reduce children’s dietary and environmental exposure, especially for populations that already face disproportionately high exposure to environmental toxins. While this guidance represents an important and necessary step forward in food safety protocols, the action levels set, the foods and toxins included, and agency capacity to ensure producer compliance still more closely reflect current industry capacity than they do true safety standards. For example, the guidance allows for generous lead limits of 10 parts per billion (ppb) for fruits, vegetables, mixtures, and yogurts, and 20 ppb for root vegetables and dry cereals. It also does not include grain- and rice-based teething snacks or biscuits. Further action is needed both within and beyond FDA regulations to reduce cumulative exposure to environmental toxins in early childhood that affect health and well-being well into adulthood.

This report discusses the health and equity implications of heavy metal exposure during infancy and early childhood, urges the strengthening and expansion of FDA guidance, and offers recommendations for additional federal actions to ensure the safety of food products marketed for babies and young children.

There is no minimum “safe” level of lead exposure; any amount has adverse health consequences, including damage to the brain, liver, and kidney. Lead is stored in the teeth and bones, where it accumulates over time.⁴ Exposure to lead and other heavy metals causes significant and irreparable harm to the development of infants and young children, leading to both acute impairment and longer-term damage that erodes IQ, educational attainment, and earnings and health in adulthood.⁵

Research has estimated that half the U.S. population is exposed to adverse lead levels during early childhood.⁶ Young children are at the greatest risk for lead poisoning, which can occur even with trace amounts and low blood lead levels. Because their developing digestive systems are more susceptible to absorbing toxins from foods and do so more efficiently, young children absorb, on average, four to five times as much of the metal as adults.⁷ Young children also eat many of these types of food concentrates, especially as they’re still working up to a diversified diet. Moreover, they are prone to putting their fingers, hands, and other objects in their mouths, which can introduce risk of exposure.⁸ In some communities, inadequate or outdated infrastructure may mean that children are exposed to lead through their home environment or water supply. Moreover, food insecurity and nutritional deficits of vitamin C, iron, and calcium may make children more susceptible to the adverse impact of lead on the central nervous system because, absent other nutrients, the malnourished body more readily absorbs lead.⁹

Exposure to lead and toxic pollutants disproportionately affects Black and Indigenous communities

A long history of systemic and environmental racism, redlining, and exploitation of sovereign Native American lands in the United States has resulted in Black and Indigenous people having disproportionately higher exposure to high levels of toxic pollution.¹⁰ This contributes to long-term health disparities:¹¹ Data from the 1999–2016 National Health and Nutrition Examination Survey showed that non-Hispanic Black children had significantly higher blood lead levels than non-Hispanic white children.¹² One nationally representative study conducted by the U.S. Environmental Protection Agency in 2018 found that, compared with the general population, people of color overall experienced a 28 percent higher environmental burden of pollution—and Black individuals experienced a 54 percent higher burden than white individuals.¹³ Many Indigenous communities also face extremely high levels of exposure to toxic pollutants; Native American people have been found to be 1.8 times more likely than any other ethnic group to live closer than 2 miles from toxic waste facilities.¹⁴

Communities of color and those in low-income areas often face the collective impact of numerous pollution sources as well as inadequate or poor-quality infrastructure, which leaves their children vulnerable to additional sources of exposure. Across the nation, race and income continue to be strong predictors of whether communities have access to clean drinking water. Water crises in predominantly Black communities such as Flint, Michigan; Newark, New Jersey; and Jackson, Mississippi, reveal long-standing inequities in infrastructure, community disinvestment, and residential segregation.¹⁵ Indigenous communities face many of these same issues, and 1 in 10 Indigenous Americans lacks access to safe drinking water or basic sanitation; this has contributed to these populations’ disproportionately high rates of illness and death due to COVID-19.¹⁶

Lenient regulatory standards that continue to allow infants and children to be exposed to heavy metals through food products contribute to the cumulative burden of environmental toxin exposure and exacerbate health inequities in communities that are already exposed to disproportionately high levels of toxins. Greater action is needed from both the Food and Drug Administration and other federal agencies to establish truly safe limits on heavy metals in consumables; work to reduce heavy metal pollution in the environment and in home and community infrastructure; and ensure greater industry compliance with these standards.¹⁷

The Food and Drug Administration’s draft guidance and its “Closer to Zero” initiative mark an important federal commitment to reducing early childhood exposure to toxic heavy metals.¹⁸ However, the FDA and other federal agencies must take greater action to fully address the harms of exposure to lead and other heavy metals.

1. Adopt more stringent FDA action levels for dietary lead exposure.

The FDA has a history of successfully spurring baby food producers—including those of infant rice cereal and apple juice—to reduce the amounts of toxic metals in their foods.²⁰ Yet the new draft guidance’s action limits of 10 parts per billion for fruits, vegetables, mixtures, and yogurts, and 20 ppb for root vegetables and dry cereals, allow for a generous degree of industry negligence around lead levels. Furthermore, FDA estimates for reduction in dietary exposure are based on narrow analyses that only consider specific store-bought foods and the 90th percentile of dietary exposures, reflecting the subpopulation of children who consume vastly more prepared foods than the average and are consequently at greater risk for cumulative dietary exposure.²¹ Reductions in lead exposure for the majority of children ages 0 to 2 are likely to be much lower—closer to 3.6 percent based on analyses from Abt Associates commissioned by Healthy Babies Bright Futures (HBBF).²² Another HBBF assessment found that only 16 of 1,000 baby foods on the market exceeded the FDA’s proposed action levels; the revised guidance therefore would likely not incentivize the industry to reduce levels below those of products already on the market.²³

In an alarming 2021 congressional report, prominent producers of baby food—including Gerber, Beech-Nut Nutrition Company, and Nurture—were found to have knowingly sold products containing significant amounts of heavy metals.²⁴ Several of the companies cited in the congressional report have made public statements, or added statements to their website, about recalling products deemed unsafe by review, and that they are complying with FDA guidance.²⁵ However, other companies, including Sprout Organic Foods, have not responded to comment and still have products available on the market containing high levels of contamination.²⁶ This points to the immediate need for stricter FDA regulations and enforcement capacity.

The foods on which infants and young children rely for adequate nutrition should not expose them to toxic elements harmful to their health and development. Designing one-size-fits-all guidance around current industry capacity does little to move producers toward necessary actions for safeguarding public health. The agency must move beyond industry achievability and toward pushing for strong and effective limits that reflect the agency’s dedication to infant and child safety. It should adopt a more aggressive position on lead limits that prioritizes the protection of vulnerable communities already most affected by high exposure to toxic pollution. Although it will be a steep task to protect the public from exposure to heavy metals now ubiquitous in the environment, the FDA has a responsibility to establish and enforce guidance that prioritizes consumer health over industry capacity. Stricter limits are needed on lead and other heavy metals, as is an increased focus on ensuring industry compliance with those limits.

2. Lower action limits for other heavy metals often found in food products marketed for children.

Despite more than a decade of public health research on the consequences of heavy metal exposure, the vast majority of baby foods included in a 2019 Healthy Babies Bright Futures study—88 percent—lacked any federal standards for maximum allowable levels of toxic heavy metals.²⁷ In a 2022 HBBF study, toxic heavy metal contamination was found in most tested baby foods. Included in the analysis were 288 foods on the market, in addition to data from more than 7,000 additional published studies; 94 percent were found to contain detectable levels of lead, arsenic, mercury, and cadmium, while more than one-quarter were found to contain all four heavy metals.²⁸

The FDA’s draft guidance focuses solely on action levels for lead, exclusive of other heavy metals, citing the need for additional research to evaluate these elements; it lays out a plan for future guidance on arsenic, cadmium, and mercury that extends into 2024.²⁹ However, an abundance of research already exists detailing the harmful effects of these heavy metals on early childhood development, and legislation attempting to significantly reduce their levels in baby food was introduced in Congress in 2021.³⁰

Rice cereals, one of the few food types subject to federal guidance, have a generous limit of 100 ppb on levels of arsenic—and more than half the rice cereals tested for metal contaminants in a 2019 HBBF study were found to exceed that limit.³¹ Arsenic—particularly its most toxic form, inorganic arsenic—is a significant contributor to the risk of developing cancer, even based on conservative estimates of exposure, as arsenic and lead are known carcinogens when ingested.³² Oral exposure to arsenic, cadmium, mercury, and lead has adverse effects on neurological, reproductive, cardiovascular, renal, and musculoskeletal systems. Recent research has also pointed to the need to focus on manganese, another heavy metal that has toxic effects on children’s health in excess.³³ Notably, manganese is often included as an additive in infant formula in an attempt to replicate the composite makeup of breast milk. This inclusion, however, is based on nearly 40-year-old research that did not examine the health impacts of high levels of exposure, particularly when the additive is mixed with water that also often contains manganese.³⁴ One 2019 study testing a sample of 44 popular infant formulas on the market found that manganese levels ranged drastically from 32 to 1,000 times the amount found in human breast milk.³⁵

Sufficient research exists detailing the harmful effects of these heavy metal toxins on early childhood development. In its revised guidance, the FDA should prioritize and expedite setting stricter limits on not just lead but also arsenic, cadmium, mercury, and manganese, even if levels are subsequently adjusted with additional research.

3. Expand the FDA draft guidance to include more infant consumables.

Although the FDA’s draft guidance includes a range of consumables marketed to young children, it excludes several notable products, including grain-based snacks and infant formula, which continue to be manufactured with no or lenient regulations on heavy metal levels. To further its commitment to reducing dietary heavy metal exposure among young children, the FDA should expand its guidance to include other commonly consumed foods such as teething biscuits and rice snacks, as well as move toward including infant formula in its Closer to Zero initiative.

Although grain-based snacks are absent from the FDA’s recent guidance, these products contain some of the highest levels of toxic metals in foods consumed by babies—accounting for 7 of the 10 most heavily contaminated foods.³⁶ Rice cakes and crisped rice cereal in particular have been found to contain dangerously high levels of inorganic arsenic.³⁷ The draft guidance on lead and other planned actions within the Closer to Zero initiative also fail to address infant formulas, which can be infants’ primary—or even only—source of nutrition for a long period of time during early development. While infant formulas have been found to contain low levels of lead overall, they are often the largest source of lead exposure for babies.³⁸ Current FDA lab facilities, however, are not equipped to accurately test for low levels of heavy metals in infant formula and other consumables. Having the capacity to accurately test these levels and setting stricter protective limits on these products is critical to protecting public health.

Critically, studies by HBBF also find that there is little difference between the amount of heavy metal contamination in store-bought baby foods and the amount in homemade purees. Contamination appears to vary by food type, rather than by whether it is prepared or pre-made.³⁹ Therefore, instituting regulations solely on store-bought foods does little to capture the subpopulation of children consuming heavy metal contaminants through foods prepared at home from basic ingredients, such as pureed or diced fruits and vegetables. Experts recommend that parents prioritize feeding their children a range of food types to diversify their diets and avoid high concentrations of contaminants.⁴⁰ Consequently, the FDA should consider expanding its guidance to include a range of consumables not currently listed, such that it covers ingredients used in baby foods prepared at home as well as foods consumed during pregnancy.

4. Increase investments in the FDA’s capacity to oversee food production and distribution and monitor compliance with standards.

Food manufacturers have a responsibility to implement preventive controls as needed to significantly minimize or prevent exposure to chemical hazards such as lead, arsenic, cadmium, and mercury. Recent and growing research on the impact of heavy metals on children’s health and development represents an opportunity for the FDA to uphold its mandate and commitment to the Closer to Zero initiative. However, in order for the FDA to set aggressive action levels and ensure that producers uphold them, it needs adequate fiscal support to conduct necessary oversight investigations, monitor production, and ensure that manufacturers meet their responsibilities to the public. The Consolidated Appropriations Act for fiscal year 2023 allocated an additional $41 million for food safety activities, but the FDA needs more research and technical staff, monitoring capacity, analytical tools, and further investments in order to meet its mandate.⁴¹

The ongoing infant formula shortage, as well as the impact of the COVID-19 pandemic on agency capacity, suggests that the FDA is under-resourced and will need to be restructured if it is to ensure that food safety protocols are met and that public health emergencies and critical market shortages are avoided.⁴² The agency needs greater capacity to accurately test food and drink products for lower levels of heavy metals and to ensure greater industry compliance of set action levels.

While action levels are a useful tool for driving down the levels of contaminants in food, the FDA also should consider other mechanisms for ensuring compliance, including allocating funding to advance lab testing capabilities, conducting more frequent facilities inspections, and adopting methods for ensuring manufacturer transparency. For example, the FDA could require that producers publicly disclose levels of heavy metals in their products. It could also institute a tiered labeling system that celebrates producers’ efforts to meet lower inclusion levels; a “blue-ribbon” system could be used to recognize companies that meet certain safety thresholds.

5. Fortify interagency collaboration to reduce avenues for heavy metal exposure.

Although instituting restrictions on heavy metal contamination in basic ingredients and prepared foods is a critical step toward reducing exposure, the FDA is not alone in its mandate to protect public health, especially for communities that have historically faced higher exposure to toxins in their homes and environments. Environmental contamination, borne out of years of unfettered use of lead-laden manufacturing and agricultural equipment, infrastructure and building materials, gasoline, and some industrial facilities, makes it incredibly difficult and costly to entirely remove lead and other contaminants from the soil, air, and water supply.⁴³ Because lead does not break down over time, federal agencies overseeing public health initiatives must make concerted efforts to address its ubiquity in the environment and its prevalence in base ingredients of their food products, including root vegetables such as sweet potatoes that absorb lead and other heavy metal contaminants directly from the soil.

The Environmental Protection Agency and the U.S. Department of Agriculture (USDA) both play an important role in mitigating toxic heavy metal exposure during critical periods of development. The FDA, having already established a partnership with the USDA in service of the Closer to Zero initiative to research techniques that mitigate the uptake of lead and other heavy metals in agricultural products, should consider how those existing technologies can be applied to a wider range of food products. The FDA can also work with the USDA to increase lab capacity to test for lower levels of contamination in raw and other produce as well as final store-bought products. The FDA should also strengthen its partnership with the National Institutes of Health and the Centers for Disease Control and Prevention, whose research details the toxic impact of these elements on children’s health and development and can be used to identify populations of children with the highest risk for heavy metal exposure.⁴⁴

The FDA is taking critical steps forward in promoting the health of young children across the country, but more aggressive action, broader restrictions on heavy metals across a range of foods, and greater agency regulatory capacity are critical to making baby foods truly safe. Exposure to these toxins in early childhood represents a preventable health crisis that only drives up health costs and consequences and deepens health disparities. Intervention during early childhood through scalable federal action that acknowledges existing disparities in exposure to toxic heavy metals is necessary to support children’s healthy development and promote their social and economic potential throughout their lives.⁴⁵