FDA Proposes New Guidance for Chemical Hazards in Food

On Oct. 22, the U.S. Food and Drug Administration (FDA) announced two significant draft guidance updates addressing environmental contaminants including metals (e.g., arsenic, cadmium, and lead), per- and polyfluoroalkyl substances (PFAS), and other chemical hazards in food. The agency proposed new action levels for cadmium in certain processed foods intended for babies and young children and released Chapter 12, "Control of Chemical Hazards," of its draft guidance on hazard analysis and risk-based preventive controls for human food.

Together, the drafts provide food manufacturers with additional insight into FDA's current thinking on identifying, evaluating, and controlling chemical hazards. Both remain open for public comment, giving food manufacturers, processors, ingredient suppliers, food safety professionals, trade associations, and other industry stakeholders an opportunity to provide technical input before FDA develops the final guidance.

Proposed action levels target cadmium in foods for young children

FDA's draft cadmium guidance is part of its Closer to Zero initiative, which seeks to reduce dietary exposure to arsenic, lead, cadmium, and mercury while maintaining access to nutritious foods. The new draft establishes proposed action levels for cadmium in processed foods intended for babies and children younger than two years old. FDA states that the proposed levels are achievable when manufacturers apply measures to minimize cadmium in their products.

The action levels are significant from an enforcement perspective. FDA states that action levels represent concentrations at which the agency may determine a food to be adulterated, while also emphasizing its expectation that industry pursue continued reductions in cadmium over time.

For manufacturers of affected foods, the draft creates an opportunity to evaluate current cadmium data, ingredient and product profiles, and existing control measures against FDA's proposed approach.

FDA outlines a framework for controlling chemical hazards

Separately, FDA released draft Chapter 12 of its broader Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance. The chapter is designed to help manufacturers subject to 21 CFR Part 117 understand and evaluate potential chemical hazards and determine whether current good manufacturing practices (CGMPs) or preventive controls are appropriate.

The draft addresses a broad range of chemical hazards, including environmental contaminants, natural toxins, pesticide residues, animal drug residues, unapproved additives, process-related contaminants, and facility-related chemicals. It also provides guidance on control measures and the design, validation, monitoring, and verification of process controls for chemical hazards.

Importantly for companies managing chemical contaminants, including inorganic arsenic, cadmium, lead, and mercury, FDA states that the guidance may help manufacturers reduce levels and better meet action levels developed through Closer to Zero. 

Next steps for food manufacturers and other stakeholders

The two drafts provide food manufacturers, processors, ingredient suppliers, trade associations, and other industry stakeholders an opportunity to evaluate the alignment of existing hazard analyses and preventive-control programs with FDA's evolving approach to chemical contaminants. Companies may consider:

• Reviewing relevant data on analytical levels of chemical contaminants in food ingredients and finished products
• Assessing sources of cadmium and other chemical hazards
• Evaluating existing control measures
• Identifying potential data or program gaps

Industry stakeholders also have an opportunity to provide input on the final guidance. Comments on the proposed cadmium action levels are due Dec. 22, 2026, through Regulations.gov under docket FDA-2025-D-4023. Comments on Chapter 12 are due Jan. 21, 2027, under docket FDA-2016-D-2343.