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  1. CFSAN Constituent Updates

FDA Letter to Industry on Chemical Hazards, including Toxic Elements, in Food and Update on FDA Efforts to Increase the Safety of Foods for Babies and Young Children

Constituent Update

March 5, 2021

The U.S. Food and Drug Administration (FDA) is providing an update on our work to further reduce toxic elements in foods for babies and young children. Toxic elements are in the environment, and therefore in the food supply. The levels of arsenic, lead, mercury, and cadmium in certain foods depends on many factors, including: growing conditions; manufacturing and agricultural processes; past or current environmental contamination; and the genetic capacity of food crops to take up elements. We share the public’s concerns for the health of America’s children, and want to reassure parents and caregivers that at the levels we have found through our testing, children are not at an immediate health risk from exposure to toxic elements in foods. The FDA routinely monitors levels of toxic elements in food, and if we find that they pose a health risk, the FDA takes steps to remove those foods from the market.

Research has shown that reducing exposure to toxic elements is important to minimizing any potential long-term effects on the developing brains of infants and children. As such, this issue is among FDA’s highest priorities and we are actively working to make progress on identifying and implementing impactful solutions to make foods commonly consumed by infants and young children safer.

Letter to Industry:

As the FDA advances its work in this area, so too must industry. Today, the FDA issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The letter reminds them of their existing responsibility to consider risks from chemical hazards, including toxic elements, when conducting a hazard analysis, including for products for babies and young children. The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control. For example, some manufacturers may conduct verification activities like testing the final product.

Advice for Parents and Caregivers:

The FDA recommends that parents and caregivers speak with their child’s pediatrician about a diet that includes a variety of age-appropriate, healthy foods in order to get needed nutrients. For proper growth and development, parents and caregivers should ensure they are feeding iron-fortified grain cereals or other iron-containing foods to babies over six months of age. The American Academy of Pediatrics has detailed advice for feeding infants and young children.

The FDA does not advise parents and caregivers to throw out their supply of packaged baby foods or to stop feeding their babies and children certain foods altogether. Eliminating food groups from your children’s diet in order to avoid certain toxic elements that occur in the food supply may result in deficiencies in certain nutrients and potential poor health outcomes.

For parents who choose to make their own baby foods, it is important to know that this is not likely to reduce potential exposure to toxic elements in baby foods and may instead result in higher concentrations, as food manufacturers have the capability to implement strategies that result in using ingredients with lower concentrations of toxic elements. Finally, we want to stress that it is critical that parents and caregivers not attempt to make and feed their infants homemade infant formula—as this is extremely unlikely to reduce exposure to toxic elements and has resulted in infants suffering life-threatening consequences, including severe nutritional deficiencies and microbial foodborne illness.

Update on FDA Activities:

The FDA is finalizing a comprehensive plan to further reduce levels of toxic elements in foods for babies and young children.

In the near term, the FDA is committed to:

  • Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
  • Focused compliance and enforcement activities, including inspections.
  • Providing guidance to industry on how to meet their obligations under current regulations.

The FDA will also continue our ongoing surveillance sampling assignment targeting these products.

We are eager to work with federal partners, academia, and other stakeholders to inform the development of action levels of lead, cadmium, mercury, and arsenic in foods for babies and young children. We will be looking to additional sources of data, as well as increasing our testing for these elements, to better understand their prevalence in foods commonly eaten by babies and young children. We will also continue to build our understanding of the variability of toxic element levels in different foods and the potential impacts, if any, of low exposures on childhood development. In addition, in the coming year, the FDA will host a workshop to bring together our stakeholders to share knowledge on these issues and discuss potential mitigation strategies.

As our work to establish an action level for inorganic arsenic in infant rice cereal demonstrates, the process of reducing levels of toxic elements in foods is complicated and multifaceted. It is crucial to ensure that measures to limit toxic elements in foods do not have unintended consequences—like eliminating foods with significant nutritional benefits or reducing the presence of one toxic element while increasing another. For this reason, the FDA’s process must be deliberative and inclusive, and in the coming weeks we will share our plan and provide more information on FDA’s future work on this important issue.

Additional Information for Consumers:


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