FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies
Baby Food
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FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies

The statement includes a letter to manufacturers, guidance on identifying contaminants in food and next steps the agency will take.

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March 8, 2021

FDA

WASHINGTON, D.C. — The Food and Drug Administration has released more info about the presence of toxic elements, such as arsenic, mercury, cadmium and lead, food for children. Last week, it announced new actions aimed at further preventing or reducing chemical hazards that may be present in foods for babies and young children.

On Friday, 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 into action a plan aimed at reducing toxic elements in foods for babies and young children to levels as low as is reasonably achievable.

As parents and caregivers themselves, FDA said it recognized and understood concerns about toxic elements and how they could impact the health of children. It shared the public’s concerns for the health of America’s children, and wanted to reassure parents and caregivers that at the levels found through its 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 it finds 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. 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.

The 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 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. Ultimately, FDA wants consumers to be reassured that manufacturers of foods for babies and young children have a legal responsibility under the Federal Food, Drug and Cosmetic Act to ensure the safety of their products.

To build on FDA's ongoing work with regulated industry in this area, it intends to address the following areas:

  • 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
  • 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 said its new activities will further efforts that the agency has continued to take in this area, including work in 2020 to finalize an action level for inorganic arsenic in infant rice cereal. It 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. FDA said these activities, along with an increase in sampling and reporting, will help continue to drive down levels of toxic elements in foods.

FDA said engaging stakeholders and its federal partners on issues such as developing and setting standards will help to identify impactful solutions for reducing toxic elements in foods commonly consumed by babies and young children. As such, it will also soon be announcing a public workshop to discuss the science surrounding levels of exposure that result in developmental impacts, and the foods that may contribute to those exposures, to identify solutions to protect its youngest consumers.