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FDA has released an action plan, called Closer to Zero, that aims to reduce exposure to toxic elements in foods intended for babies and young children. This multi-phased approach focuses on levels of arsenic, lead, cadmium and mercury in these foods to the greatest extent possible while staying sensitive to the fact that requiring levels that are not currently feasible could result in significant reductions in the availability of nutritious, affordable foods that many families rely on for their children. FDA’s aim is to get the levels of these toxic elements, over time, closer to zero.

It is important to note that FDA’s testing shows that children are not at an immediate health risk and that because these elements occur in our air, water and soil, there are limits to how low these levels can be.

Phase one of Closer to Zero begins immediately. In this phase, FDA will:

Evaluate the scientific basis for action levels through research and testing and with input from advisory committees, public workshops, and consultation with scientific experts, federal agency partners, and other stakeholders. This evaluation will enable the agency to establish interim reference levels (IRLs) for certain toxic elements as appropriate and from which FDA may determine if the amount of exposure to an individual element across foods could result in a specific health impact.

Taking all of this into consideration, FDA will next develop proposed action levels for categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables, etc.) and other foods commonly eaten by babies and young children and assess the achievability and feasibility of the proposed action levels as well as timeframes for reaching them before finalizing action levels. Because most is known about arsenic and lead, these two elements will be prioritized.


If EAS can be of help as you develop foods intended for babies and young children, please reach out to us. Our team of toxicologists, microbiologists and regulatory experts can help to develop action plans including planning and execution of clinical studies, facilitate pre-meetings with FDA and develop dossiers for FDA submission. We invite you to learn more about our submission services through our quick-reference guide as well as those of infant formula and LACF including food safety through FSMA and California Proposition 65 requirements. If you are unsure about in-person consulting at this time, the majority of our consulting services can be conducted virtually. Learn more about our virtual consulting capabilities here.

Thank you for placing your trust in EAS. We look forward to being of service.

Posted in Client Update, Foods.