Meeting | Virtual

Event Title

Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications

November 18 - 20, 2025

Date:: November 18 - 20, 2025

Update
October 23, 2025
Due to the lapse in appropriations, FDA is postponing the virtual public meeting on November 18, 2025, and listening sessions on November 19 - 20, 2025 regarding food allergen thresholds and their potential applications in the U.S. The agency will communicate when these events are rescheduled.

FDA Virtual Mtg Allergen Thresholds and Their Potential Applications

Day 1:
Tue, Nov 18^th 10:45 a.m. - 4 p.m. ET
Day 2:
Wed, Nov. 19^th 10- 11:30 a.m. ET and 2-3:30 p.m. ET
Day 3:
Thu, Nov. 20^th 10- 11:30 a.m. ET and 2-3:30 p.m. ET

The FDA will host, in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, individual firms, retailers, and academic researchers, a virtual public meeting followed by virtual listening sessions to help inform the FDA’s next steps, prioritize potential options, and advance our food allergen threshold approaches to benefit public health.

The FDA will review input received at the public meeting, in listening sessions, and in response to a Regulations.gov docket to determine next steps.

Background

The prevalence of food allergies has increased in recent decades affecting millions of Americans and their families. The major food allergens in the U.S. are milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame; and they can cause immediate life-threatening reactions, i.e., anaphylaxis, if present at sufficient amounts in products. There is no cure for food allergy; thus, to prevent allergic reactions, consumers must avoid the allergen(s) of concern. Successful avoidance requires, among other things, that food labels provide clear, complete, and consistent information about allergen-containing ingredients and that unintended allergen presence in food from allergen cross-contact is significantly minimized or prevented.

Firms may choose to voluntarily use allergen advisory statements (AAS) to alert consumers to the possible presence of allergens. However, there are no other specific requirements about when and how to use AAS. Additionally, advances in allergen risk assessment have demonstrated that certain low level dose exposures, or thresholds, are not likely to elicit reactions in the vast majority of individuals allergic to those foods. Possible applications of thresholds include risk assessments to support the following: petitions for labeling exemptions; compliance and enforcement actions; development of policies for AAS; and development of guidance for industry on allergen cross-contact controls. Last year, a series of reports from an international expert consultation recommended the use of risk-based thresholds, and FDA has published several guidance documents that address various areas of allergen risk assessment and management in which allergen thresholds may be applied; however, we have not established or endorsed any allergen threshold levels.

Over the past year, FDA has met with several targeted stakeholders from industry, consumer, and health professional groups to gather input on the published allergen threshold data and to identify data gaps and scientific needs for establishing or applying thresholds. The sessions yielded valuable insights regarding the use of risk assessments and allergen thresholds.

Subsequently, we are hosting this virtual public meeting with all stakeholders to help inform next steps and develop strategies for applying allergen thresholds to benefit public health. While this public meeting will focus on food allergen thresholds for the major food allergens in the U.S., the concepts and strategies developed from this event may be considered as we address other food allergies and intolerances in the future.

Additional Resources for the Public Meeting

Participants may choose to read some of the reading materials below for additional information and background regarding some of the topics discussed during the first day presentations and panels on November 18, 2025.

Food and Drug Administration Threshold Working Group: “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food” (March 2006) - identifies various approaches for establishing thresholds for food allergens or for gluten and deems the quantitative risk assessment-based approach the “strongest, most transparent” approach and indicates that thresholds should be reconsidered periodically in light of new scientific knowledge and clinical findings.
Federal Register: Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket (Dec, 2012 – May, 2013) - purpose was to establish a docket to provide an opportunity for interested individuals to submit comments (including data) [in response to certain questions] that FDA can use to design and carry out a quantitative risk assessment for establishing regulatory thresholds for major food allergens. We received 405 submissions to docket with over 50% from consumers opposed to threshold concept; three patient organizations expressed caution as well; industry and trade groups were uniformly in favor of thresholds.
Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications (June 2015) - describes the data FDA will consider “risk assessment-based approach utilizing data on the distribution of minimal eliciting doses in food allergic population to make scientific argument for exemptions” when evaluating petitions and notifications seeking exemptions from the labeling requirements regarding ingredients derived from major food allergens.
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act (January 2025) - describes the approach FDA generally intends to take when evaluating the public health importance of a food allergen other than the major food allergens listed in the FD&C Act. Of the three main criteria for evaluating public health importance (prevalence, severity and potency), potency is “the amount of allergenic food protein required to elicit a food allergic reaction in an already sensitized individual” and can be derived through risk assessments of allergic population threshold data.
Draft Compliance Policy Guide: Major Food Allergen Labeling and Cross-contact (May 2023) - describes a “risk-based” compliance approach and provides factors FDA would use in the determination of allergen health hazard (e.g., estimated exposure of unintended allergen presence per eating occasion). HFP has for some time used published threshold information to assess allergen health hazards and recall classifications on a case-by-case basis.
Hazard Analysis and Risk-Based Preventive Controls for Human Food, Draft Guidance Chapter 11-Food Allergen Program (January 2024) - explains how to establish and implement a food allergen program under the preventive controls rule that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens. The guidance states that the Preventive Controls Qualified Individual (PCQI) determines the appropriate approach to potential for unintended allergen presence (UAP) in food product(s):
- Published data on population threshold dose responses to various food allergens exist and firms could evaluate such data for specific products, such as through risk assessments or other scientifically valid assessments.
- When using allergen advisory statements, PCQI should provide a written justification, in food safety plan, for why allergen cross-contact controls cannot ensure protection of food from allergen cross-contact.
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5, January 2025) - consists of questions and answers about food allergen labeling requirements, including the labeling of tree nuts, sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products, and certain specific packing and labeling situations, such as individual units within a multiunit package. A question in this guidance:
- A.4 Do the food allergen labeling requirements of the FD&C Act require FDA to set so-called “thresholds” for any food allergen?
- No, the food allergen labeling requirements of the FD&C Act do not require FDA to establish a threshold level for any food allergen. FDA has previously examined the topic of thresholds but has not established specific thresholds for any food allergens. See https://www.fda.gov/food/food-labeling-nutrition/approaches-establish-thresholds-major-food-allergens-and-gluten-food.

Purpose and Format of the Virtual Public Meeting and Listening Sessions

The purpose of the public meeting and listening sessions is to discuss strategies for approaching food allergen thresholds to benefit public health.

Virtual Public Meeting

Day 1: Presentations and panels sessions

Food Allergen Landscape and Insights

Overview of FDA’s Major Food Allergen Requirements
Risk Assessments and Food Allergen Thresholds
Potential Applications of Risk-based Food Allergen Thresholds and Communication
Codex Alimentarius Commission’s Approach to Global Food Allergen Management

Risk-based Food Allergen Thresholds – Panel discussions

Panel 1: Risk-Based Food Allergen Threshold Concepts
Panel 2: Risk Communications and Labeling
Panel 3: Potential Applications

Registration

Listening Sessions

Days 2 and 3: Virtual Listening Sessions

Day 2: Sessions A & B in am/Sessions C & D in pm

Day 3: Sessions C & D in am/Sessions A & B in pm

Session A: Food Allergen Thresholds Concepts
Session B: Applications of food allergen thresholds - labeling perspectives
Session C: Applications of food allergen thresholds - manufacturing perspectives
Session D: Practical considerations for adopting food allergen thresholds

For Further Information

For general questions about the public meeting or listening sessions, contact the Public Engagement Staff at PublicEngagement@fda.hhs.gov.