- On Wednesday, September 25, 2024, FDA held a public meeting inviting stakeholders to speak on the Agency’s development of an enhanced systematic process for the post-market assessment of chemicals in food. The meeting began with Deputy Commissioner Jim Jones explaining that the purpose of updating FDA’s post-market assessment is to ensure that safety determinations hold up over time and to replace the current ad hoc system with a more systematic process.
- FDA’s updated approach seeks to proactively initiate post-market assessments of GRAS ingredients, food additives, color additives, food contact substances, and contaminants under its new Human Foods Program.
- The new process will include three stages:
- (1) Food Chemical Signal Monitoring: FDA will monitor information across many sources including scientific publications and news reports for any new information raising concerns related to food chemical safety.
- (2) Triage: FDA will conduct a quality and impact assessment of the information using technology and AI to help determine whether to initiate an assessment; and
- (3) Fit for Purpose Decision: Depending on the quantity and quality of information received, FDA will conduct either a focused or comprehensive assessment. Focused assessments will be limited in scope in cases where FDA already has safety information on the chemical or a more discreet issue is involved, and will be conducted internally. A Focused Assessment may also lead to a Comprehensive assessment. Comprehensive
Assessments will be much more resource intensive and may take years to complete, including requests for data from stakeholders. FDA will publicize the final scientific assessment and initiate any risk management actions as needed, which could include revoking regulations that authorizethe use of a food additive. Factors that FDA will consider when deciding between a focused or comprehensive assessment include: changes in exposure, susceptible subpopulation exposure, toxicity, new scientific information, and external stakeholder activity.
- The meeting included presentations from representatives of both industry and consumer advocacy groups and questions and comments from the public in an ongoing effort to increase transparency and public input regarding food chemical safety.
- FDA plans to have the new process in place by the end of the calendar year 2025. Keller and Heckman will continue to monitor the development of the new post-market assessment process.
© 2025 Keller and Heckman LLP
National Law Review, Volume XIV, Number 274