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  5. Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications - 02/18/2026
  1. Workshops, Meetings & Webinars on Food and Dietary Supplements

Meeting | Virtual

Event Title
Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications
February 18 - 20, 2026

Date:
February 18 - 20, 2026

The U.S. Food and Drug Administration (FDA), in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, individual firms, retailers, and academic researchers, held a virtual public meeting entitled “Food Allergen Thresholds and Their Potential Applications,” followed by virtual listening sessions. 

The purpose of the public meeting and listening sessions was to discuss strategies for approaching food allergen thresholds to benefit public health. The FDA will review the input received at the public meeting, in listening sessions, and in response to a Regulations.gov docket to determine next steps and prioritize potential options.

Background | Recording 

Resources (including instructions on How to Comment) 

Meeting Summary | Key Themes from the Listening Sessions 

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; these 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. Recently, 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.

Prior to this public meeting, FDA 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 hosted 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 focused 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.

Summary of the Public Meeting

On February 18-20, 2026, the U.S. Food and Drug Administration (FDA) in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, and academic researchers, held a virtual public meeting entitled “Food Allergen Thresholds and Their Potential Applications,” followed by virtual listening sessions We intended to gather input to help inform the FDA’s next steps, prioritize potential options, and advance our approach to food allergen thresholds to benefit public health. 

The virtual public meeting, held on February 18, featured presentations on the FDA's allergen requirements, risk assessments, and global approaches, along with panel discussions on threshold concepts, risk communication, and potential applications. 

On February 19-20, we held eight virtual listening sessions to hear from stakeholders on four separate topics:

  • Food Allergen Threshold Concepts: The purpose of this session was for individuals and organizations to share thoughts and perspectives on available data and concepts for establishing risk-based thresholds for application in various food allergen management and risk assessment situations. 
  • Applications of Food Allergen Thresholds – Labeling Perspectives: The purpose of this session was for individuals and organizations to share ideas and perspectives on how risk-based thresholds can provide options for effective communication and labeling strategies to ensure consumers can make informed decisions. 
  • Applications of Food Allergen Thresholds – Manufacturing Perspectives: The purpose of this session was for individuals and organizations to provide thoughts and ideas for how risk-based thresholds can be used in manufacturing, procurement, and assessment of product safety. 
  • Practical Considerations for Adopting Food Allergen Thresholds: The purpose of this session was for individuals and organizations to share perspectives and practical considerations for adopting and implementing food allergen thresholds.   

Nearly 1,800 people registered for the public meeting and listening sessions. To allow opportunities for stakeholder input and insights, there were multiple listening sessions for each topic, and we moderated each listening session with a set of questions to guide meaningful discussion. The FDA also offered multiple opportunities for stakeholders to submit questions and/or comments: during the registration process, at the virtual listening session, and to the Regulations.gov docket (docket number FDA-2026-N-1304). 

Key Themes From the Listening Sessions

The listening sessions were offered during four time frames, with two sessions held per time frame. There was a range of 300-550 participants (excluding FDA participants) for each time frame, and in total we heard views from about 130 individuals. Most speakers represented the food industry, but patient advocacy groups, consumers or patients, academics, and healthcare professionals also provided comments.  

FDA notetakers recorded listening session comments and discussions, which were then collectively summarized by topic areas as well as by relevance to the potential adoption of a science-based food allergen threshold framework in the United States. Participants raised many different themes, ideas, perspectives, and viewpoints during the listening sessions. We summarize some of the more consistent themes or viewpoints below, but this does not represent an exhaustive list of all ideas, views, or perspectives expressed and does not represent consensus. In certain cases, opposing viewpoints are highlighted. The order of the themes presented does not indicate its importance or relevance, and the summary should not be viewed as representing the FDA’s position or future actions. 

Broad Support for a Risk-Based Allergen Threshold Framework: Participants discussed their perspectives on further advancing food allergen thresholds to benefit public health in the U.S.

  • General support that the U.S. should transition to a harmonized, risk-based framework for food allergen thresholds. 
  • Current system (or lack of system—i.e., no federal regulations or guidance) identified as a primary driver of the overuse and inconsistent application of Allergen Advisory Statements (AAS)[1],  such as “may contain” statements, leading to consumer confusion, decreased trust in food labels, and unnecessarily restricted food choices for food-allergic consumers. 
  • Use of science-based thresholds, such as those proposed by the Food and Agriculture Organization (FAO) and World Health Organization (WHO), viewed by many as important to help provide clarity for consumers, create consistency for industry (globally), and implement a better framework for risk management. 
  • Participants identified the need to clearly define an allergen threshold not as an absolute guarantee of individual safety, but as a population-based risk management tool. 
    • The scientific term “reference dose” was preferred by many to signify a level of an allergen not expected to cause a reaction in a large majority of the allergic population. 
    • Most stakeholders described the reference dose as a workable public health tool designed to make the food supply safer for the greatest number of people. 
    • Setting a threshold to assure zero risk for every individual generally seen as unrealistic. 
  • A few stakeholders expressed concerns about using thresholds in general; some consumers, for example, noted concern for the most sensitive food-allergic individuals.

Labeling Considerations for Implementing Allergen Thresholds: Participants discussed the practical application of thresholds to labeling and expectations for AAS versus absolute “allergen-free” claims.

  • General support for a mandatory, risk-based framework for governing AAS for building consumer confidence and ensuring safety. 
  • Mixed opinions about whether the FDA should mandate a single, consistent protective standard or grant manufacturers the flexibility to choose a protective level within a given range. 
    • Some participants supported flexibility and argued that manufacturers are best equipped to make risk-based decisions for their unique processes.
    • Other participants concerned that such flexibility would lead to the very confusion and mistrust that thresholds aim to resolve. 
    • A few consumers raised concerns that using a threshold-based system intentionally leaves the most sensitive unprotected. This was noted as inappropriate, especially since individuals rarely know their personal reaction thresholds. 
    • Differing views emerged between most of the commenters’ desire for a simple, single-statement system that prioritizes consumer clarity and proposals from some for more complex, tiered systems that could communicate varying levels of risk.
  • “Allergen-free” claims identified as a topic highlighting these conflicting views.  
    • When asked to compare “allergen-free” with “gluten-free,” most participants acknowledged that a stricter standard than the <20 ppm threshold used for “gluten-free” claims may be necessary for “allergen-free,” in part because of the potential for severe, life-threatening anaphylaxis. 
    • Some stakeholders presented a viewpoint that “allergen-free” claims demand a zero-tolerance standard, not a risk-based one, because the prevailing consumer perception is that “free” means that there would be no allergen in a product, and deviating from this expectation would be misleading. 
    • Others suggested a risk-based approach could be viable for industry, but only if the threshold was set at an extremely low level to ensure safety.
    • A dual approach was discussed for implementing a mandatory, risk-based framework for AAS alongside a stricter, enforceable, standard for any “allergen-free” claim. 
  • Use of thresholds in the evaluation of potential exemptions from mandatory allergen labeling was generally supported, with some practical considerations raised—e.g., consistent allergen levels across all batches of a product that is granted an exemption, current limitations in analytical testing, and the importance of clear and trustworthy communication to consumers.

Operational and Technical Challenges in Implementing Allergen Thresholds: Participants detailed the challenges to allergen management within a food facility and in the supply chain.

  • Challenges include agricultural co-mingling and cross-contact in shared transportation.
  • Widespread agreement that thresholds are most effectively applied to the validation of preventive controls, particularly sanitation and cleaning procedures for shared equipment, rather than routine finished product testing. 
    • Considerations and limitations discussed around sampling and testing of finished products or to verify cleaning. 
    • Allergen cross-contact is not uniform, and sampling can easily miss particulates or clumps of allergens.
  • Some industry representatives identified a lack of data transparency in the supply chain, with quantitative information regarding cross-contact in the supply chain being needed to conduct accurate risk assessments but currently rarely provided. 
  • Some noted limitations in existing analytical testing methods and expressed a need for standardized, validated analytical methods and reference materials that are reliable across diverse and challenging food matrices (e.g., fermented, hydrolyzed, or oily products).  
  • Participants want clear and comprehensive FDA guidance to clarify the relationship between thresholds, AAS, and enforcement actions.  
  • Several participants noted that sesame labeling was a cautionary example of unintended consequences when there is regulatory uncertainty.
  • Some participants noted that any guidance in this area should translate clinical reference doses (milligrams of protein) into actionable limits (concentrations) to enable uptake by manufacturers. 

Strategic Path Forward for Potential Allergen Threshold Implementation: Participants discussed a strategic path forward, including consideration around implementing thresholds as an opportunity to increase consumer trust and improve quality of life by empowering consumers with reliable information, and identified two areas as necessary for moving forward:

  • Reforming the current AAS system. 
  • Establishing a comprehensive, collaborative public-private educational campaign.

Overall, discussions included the need for harmonization; however, they also highlighted policy considerations and technical barriers that must be addressed for any new approach to be successful. The overarching goal shared by all parties is to develop a food allergen strategy that empowers consumers, expands safe food choices, and improves the quality of life for the food allergic community through clear, consistent, and reliable information. 

For Further Information

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

[1]  Allergen Advisory Statements are often referred to as Precautionary Allergen Labeling (PAL) outside the FDA.

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