FDA issued a letter to industry reminding manufacturers of these types of foods of their existing responsibilities related to these efforts. Secondly, the agency is announcing that it will soon be putting together a course of action aimed at reducing toxic elements in foods for babies and young children to levels as low as is reasonably achievable.

FDA shares the public’s concerns for the health of America’s children and wants to reassure parents and caregivers that at the levels it has found through its testing, children are not at an immediate health risk from exposure to toxic elements in foods. FDA routinely monitors levels of toxic elements in food, and if it finds that they pose a health risk, 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. A report released last month by the U.S. House of Representatives Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy also highlighted important questions on what more can be done to reduce toxic elements in baby food.

FDA issued a letter to manufacturers of foods for babies and young children covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, as well as persons covered under other rules requiring a hazard analysis. The letter reminded 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. 

FDA intends to address the following areas, to build on its ongoing work with regulated industry in this subject area:

• Issuing guidance to identify action levels for contaminants in key foods, with plans to revisit those levels on a regular basis and lower them if appropriate, as well as providing guidance to industry on how to meet their obligations under current regulations;
• Increasing inspections and, as appropriate, taking compliance and enforcement actions;
• Boosting sampling of foods for babies and young children, including sharing results; and
• Working with government, academia, and industry to support research and development of additional safety information on toxic elements in foods for babies and young children and additional steps that industry can take to further reduce levels.

FDA's new activities will further efforts that the agency has continued to take in this area, including its work in 2020 to finalize an action level for inorganic arsenic in infant rice cereal. FDA will be working to develop additional action levels, finalize its draft guidance on reducing inorganic arsenic in apple juice, and publish a draft guidance that will establish action levels for lead in juices. These activities, along with an increase in sampling and reporting, will help continue to drive down levels of toxic elements in foods.

It’s important to understand that toxic elements are present in the environment, including in the air, water, and soil, and therefore are unavoidable in the general food supply. This is why another part of FDA's plan is to ramp up availability of consumer information and resources that underscore how the key to a healthy diet including for infants and young children is variety.

Additional Information:

• 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
• Key to a Healthy Diet Infographic