FDA Advances Initiative to Address Food Allergens Through Two Public Meetings

FDA’s Approach to Allergen Thresholds and Their Potential Applications

Recent advances in allergen risk assessments have demonstrated that certain low levels or “thresholds” of allergen exposure are unlikely to cause reactions in the majority of allergic individuals. Based on this research, FDA has recently begun exploring whether the use of thresholds in allergen risk management may improve the agency’s approach to inspections and enforcement related to allergen issues, as well as provide greater clarity and choice to food-allergic consumers. In 2023, FDA issued two draft guidance documents acknowledging that risk-based allergen thresholds can be appropriately used in food processing: a draft Compliance Policy Guide for Major Food Allergen Labeling and Cross-Contact³ and a chapter on food allergen programs in FDA’s draft guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food⁴. The February virtual public meeting was aimed at furthering these efforts by helping inform next steps and developing strategies for applying allergen thresholds to benefit public health.

In the virtual public meeting portion of the event, FDA hosted a number of panels featuring healthcare professionals, researchers, FDA subject matter experts, and industry, where experts discussed a variety of topics including the Codex Alimentarius Commission’s approach to allergens, the history of risk-based food allergen thresholds, the potential applications of allergen thresholds in the food industry, and risk communication strategies. Some key takeaways from these sessions included:

• FDA has identified the United Nation’s Food and Agricultural Organization’s (FAO) ED05 level as a potential threshold to use going forward, as this level does not elicit a reaction in 95% of allergic consumers and elicits only minor reactions in the remaining 5%.
• Adopting a threshold approach to allergens would represent a shift away from “zero tolerance” policies and toward risk-based management, which could provide manufacturers more flexibility.
• The threshold approach to allergens must include uniform use of precautionary allergen labeling so that consumers can be confident in the accuracy of allergen labeling.

After the virtual public meeting, FDA hosted several listening sessions where stakeholders had the opportunity to provide public comment on four topics:

1. Food Allergen Threshold Concepts
2. Applications of Food Allergen Thresholds – Labeling Perspectives
3. Applications of Food Allergen Thresholds – Manufacturing Perspectives
4. Practical Considerations for Adopting Allergen Thresholds

FDA is soliciting additional written comments on these topics through a docket established in relation to this event.⁵ Written comments are due May 19, 2026.

Expert Panel on Food Allergies

Following the virtual public meeting and listening sessions, FDA also hosted an expert panel on food allergies, in which medical experts and researchers discussed the underlying science of food allergies and risk factors, emerging therapies, and ongoing research. Panelists explained that early exposure to food allergens is the best way to reduce the chance of infants and young children developing food allergies later in life, and federal nutrition policy and consumer education should reflect this latest science. Panelists also discussed ongoing and future research efforts designed to explore alternatives to oral immunotherapy as well as to investigate the long-term outcomes of emerging therapies. The expert panel was recorded and is available for viewing on FDA’s website.

FDA is soliciting written comments through a separate docket established following the panel.⁶ Written comments are due April 25, 2026.

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These initiatives come after FDA recently issued a request for information (RFI) regarding labeling and preventing cross-contact of gluten for packaged foods, representing additional efforts in the agency’s broader allergen risk management and labeling initiatives. See our recent update on the RFI for more information.⁷ Comments are due March 23, 2026.

We will continue to monitor developments in FDA’s approach to allergen management and are available to assist interested stakeholders in drafting and submitting comments to these dockets. Please do not hesitate to contact us about this or any other matter.

Authored by Elizabeth Fawell, Veronica Colas, Rachel Buff, and Erin Pannek.