On August 20, 2024, the US Food and Drug Administration (FDA) published a document outlining a proposed new process for the post-market assessment of chemicals used in food and food contact materials. With the process, the FDA hopes to “identify and target chemicals currently in the food supply for assessment in a structured manner based on risk.” This includes “food additives, color additives, generally recognized as safe (GRAS) substances, substances used in contact with food, and those chemicals present as unintentional (for example, environmental) contaminants.”
To be undertaken by the new Human Foods Program (FPF reported), this process would involve first reviewing the available information on food chemicals, performing “triage” to rate the quality of information available, and then decide what needs to be assessed. Assessments will be divided into less intensive “focused assessments” or if needed, a “comprehensive assessment.”
Focused assessments are meant to take 4-12 months and be done completely internally in the FDA. It would involve a review of newly available information to “determine if substances or ingredients intentionally added to food continue to meet the ‘reasonable certainty of no harm’ standard”. Depending on the outcome, substance(s) may be referred for comprehensive review.
Comprehensive reviews would involve stakeholder engagement, performing full risk and safety assessments, and considering larger risk management options including regulation. The FDA anticipates that comprehensive reviews may take years to complete.
The FDA will hold a public meeting to discuss the proposed assessment strategy on September 25, 2024. Public comment on the proposal is due by December 6, 2024.
References
US FDA (August 20, 2024). “Discussion paper development of an enhanced systematic process for the FDA’s post-market assessment of chemicals in food.”
US FDA (August 9, 2024). “FDA to Hold Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food.”
Read more
Keller & Heckman (August 6, 2024). “FDA to Hold Public Meeting on Post-Market Chemical Assessment.” The Daily Intake
Julia John (August 22, 2024). “US FDA eyes two-tiered revisitation of substances in food supply.” Chemical Watch News & Insight
