- The U.S. Food and Drug Administration (FDA) has announced a three-day virtual public meeting and listening session series focused on food allergen thresholds and their potential applications, scheduled for November 18–20, 2025.
- Food allergies affect an estimated 32 million Americans, and even trace amounts of allergens can trigger severe reactions. To help consumers avoid unintended exposure, some food manufacturers voluntarily include allergen advisory statements (AAS), such as “may contain” or “produced in a facility that also processes” on product labels. However, there are currently no specific FDA requirements governing when or how AAS should be used.
- A 2024 Food and Agriculture Organization (FAO) consultation panel recommended adopting the use of risk-based thresholds, which refers to a scientifically determined level of an allergenic substance below which the vast majority of allergic individuals are unlikely to experience an adverse reaction. While FDA has issued guidance documents addressing allergen risk assessment and management, it has not established or endorsed any specific threshold levels to date.
- Registration for the public meetings is required for all sessions. While registration for the November 18 meeting will remain open until the event begins, those wishing to join the listening sessions must register by November 3, 2025.
- Keller and Heckman will continue to monitor developments related to allergen thresholds.