FDA's New Human Foods Program: Enhancing Post-Market Safety Assessments of Chemicals in Food
Food chemical safety is among Food and Drug Administration ("FDA") top priorities as it rolls out a new Human Foods Program, amid a flurry of federal and state legislation addressing food additive safety, resulting in a patchwork of laws in this area.
FDA recently held a public meeting on the development of a systematic process for post-market assessment of chemicals in the food supply. While FDA conducts premarket activities to ensure substances added to the food supply are safe—including reviews of food and color additive petitions, Generally Recognized as Safe ("GRAS") ingredients, and new food contact substances, materials, and packaging—post-market assessment has historically been based on surveillance, submissions triggering reconsideration of an authorized use, or publication of new scientific information.
FDA's endeavors come in the midst of a rise in state and federal legislation as well as consumer litigation targeting additives and ingredients (e.g., class actions challenging the presence of titanium dioxide in food products). The pending Toxic-Free Food Act would require FDA to overhaul the current GRAS process and systematically reassess previously accepted substances. The Safe School Meals Act would require FDA to reevaluate food additives with known carcinogenic, reproductive, or developmental health harms and ban their use in school meals. Last year, California became the first state to ban four common food additives, a prohibition taking effect in 2027. New York has several pending bills, including one to ban certain food and color additives.
Deputy Commissioner for Human Foods Jim Jones acknowledged the increasing number of state activities, but noted "a strong national food safety system is not built state by state. The FDA must lead the way, but to do so, we need to do more." Jones stated that, despite a lack of resources and budget constraints, FDA remains committed to food chemical safety and welcomes public engagement. Select topics from the public meeting included:
- The scope of chemicals subject to the process, i.e., those intentionally added, indirect additives, and/or environmental contaminants.
- The type and amount of scientific data FDA should consider in post-market assessments, including hazard, exposure, and cumulative effects.
- When, how often, and mechanisms to engage stakeholders on post-market assessments.
Program parameters will undoubtedly impact most food manufacturers, including in particular the visibility of reassessments while products remain on market. Comments on program development are being accepted until January 21, 2025.
