• On October 22, 2026, the U.S. Food and Drug Administration (FDA) announced several new actions under its Closer to Zero initiative, a multi-year effort aimed at reducing dietary exposure to heavy metals in foods consumed by babies and young children.
  • As part of the announcement, FDA issued draft guidance proposing action levels for cadmium in processed foods intended for children under two years of age. Cadmium is a naturally occurring heavy metal that can enter the food supply through soil, water, and environmental contamination. While low-level exposure is common, excessive exposure over time may be associated with adverse health effects, and infants and young children are considered particularly vulnerable due to their smaller body size and developmental stage.
  • Specifically, FDA has proposed action levels of 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient carrots), and mixed foods; 25 ppb for single-ingredient carrots; 45 ppb for dry infant cereals; 20 ppb for yogurts, puddings, and custards; and 25 ppb for single-ingredient meat products.
  • The draft guidance emphasizes that the proposed action levels are recommendations rather than legally binding requirements. However, FDA notes that it may consider the action levels, along with other factors, when evaluating whether enforcement action is warranted.
  • In addition to the cadmium proposal, FDA released draft guidance addressing the control of chemical hazards under the Food Safety Modernization Act’s Preventive Controls for Human Food regulation. The guidance is intended to help manufacturers identify, assess, and mitigate chemical hazards, including heavy metals, through preventive controls, current good manufacturing practices (CGMPs), and supply-chain management measures.
  • FDA also updated its Closer to Zero website to provide information on ongoing activities related to heavy metals in food and announced a public webinar scheduled for November 16, 2026, to discuss the new proposals and other food chemical safety initiatives.
  • Comments on the draft cadmium action levels may be submitted through December 22, 2026, while comments on the chemical hazards guidance will be accepted through January 21, 2027.
  • Keller and Heckman will continue to monitor for developments realted to FDA’s Closer to Zero initiative and the regulation of heavy metals in baby food.