- FDA published a response (discussed here) within two weeks of a Congressional report released on February 4, 2021 on the finding of heavy metals— including arsenic, lead, cadmium, and mercury—in baby foods in the U.S. FDA’s initial response discussed the Agency’s programs for monitoring levels of toxic elements in baby foods (and other foods), the action levels set for inorganic arsenic in rice cereal for infants, multiple ongoing Import Alerts for toxic elements in food, and consumer education efforts regarding the importance of feeding infants a variety of foods.
- On March 5, 2021, FDA announced new activities aimed at reducing the levels of toxic elements in baby food including:
- A March 5, 2021 letter to baby and toddler food manufacturers and processors reminding the industry of their obligations to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control. FDA’s letter notes that some manufacturers may conduct verification activities like testing the final product for toxic elements.
- Making a commitment “in the near term” to review current action levels, as well as develop additional action levels for contaminants in key foods, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
- Boosting sampling of foods for babies and young children and sharing the results.
- Increasing inspections and, as appropriate, taking compliance and enforcement actions.
- Holding a workshop “in the coming year” to bring together stakeholders to share knowledge on the variability of toxic element levels in different foods and the potential impacts, if any, of low exposures on childhood development, and discuss potential mitigation strategies.
- Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.