The bottom line: FDA may take future action on allergens that looks quite different from today's framework. While the current regime centers on ingredient disclosure, misbranding concepts, current good manufacturing practices (cGMPs), and preventive controls, a future framework could become more expressly risk-based and emphasize thresholds, reference doses, and validated cross-contact controls. 

The plaintiffs' bar is already active in allergen and food labeling disputes, and allergen controls, label substantiation, recalls, consumer complaints, and gluten cross-contact are also issues that can arise in food company due diligence. Allergen compliance may increasingly depend not just on what the label says, but on whether a company can substantiate the risk.

Regulatory Background and FDA Authority

FDA's current approach to regulating allergens is relatively straightforward. Food labeling must identify major food allergens when used as ingredients (currently milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame). FDA also addresses allergen cross-contact through food safety requirements, including cGMPs, hazard analysis, and risk-based preventive controls. A draft compliance policy guide sets out the agency's enforcement policy for major food allergen labeling and cross-contact. FDA has not established or endorsed allergen threshold levels, although it has identified possible threshold applications in areas such as labeling exemption petitions, compliance and enforcement actions, allergen advisory statements, and cross-contact guidance. 

Notably, FDA does not require allergen advisory statements such as "may contain [allergen]" or "produced in a facility that also uses [allergen]" when an allergen may be present because of cross-contact rather than intentional use as an ingredient; such statements are purely voluntary under current law. However, the practical risk of liability for undisclosed cross-contact exposure effectively drives their widespread use. As a result, companies often face a judgment call: over-warn, which may limit food choices for consumers; or accept the regulatory, recall, and litigation risk if cross-contact later occurs.

What the Sessions Covered

FDA's February 18 public meeting featured presentations on allergen requirements, risk assessment, global threshold approaches, risk communication, and potential threshold applications. The February 19 and 20 listening sessions covered four topics: threshold concepts, labeling perspectives, manufacturing perspectives, and practical considerations for adoption. FDA reported broad support for a harmonized, risk-based threshold framework, while noting that thresholds would function as population-based risk management tools rather than a guarantee of zero risk for every allergic consumer.

Participants focused heavily on advisory statements like "may contain," with many citing the absence of federal requirements as a driver of inconsistent labeling, consumer confusion, and unnecessarily restricted food choices. The sessions also addressed stricter standards for "allergen-free" claims, threshold-based validation of sanitation controls on shared equipment, the limits of finished product testing, supply chain data gaps, and translating clinical reference doses into actionable manufacturing limits. Stakeholders identified two prerequisites for any threshold implementation: reforming the current allergen advisory statement system and launching a comprehensive public–private educational campaign to rebuild consumer trust in food labeling.

Nearly 1,800 people registered across the three-day event, and approximately 130 individual speakers participated, spanning industry, consumer advocacy groups, consumers, academics, and healthcare professionals. On the technical side, participants broadly agreed that thresholds are most effectively applied to validate preventive controls, particularly sanitation and cleaning procedures on shared equipment, rather than to routine finished product testing. That view reflects the reality that allergen cross-contact is non-uniform, and sampling can easily miss particulates or clumps. 

Several participants cited the sesame labeling experience as a cautionary example: after sesame became a major food allergen, some companies reportedly addressed cross-contact and liability concerns by adding sesame to products and labeling it compliantly, rather than avoiding cross-contact through segregation, sanitation, or other controls, which reduced options for sesame-allergic consumers. Participants also emphasized that any future threshold framework should translate clinical reference doses into practical concentration limits or action levels that manufacturers can implement, validate, and verify. 

What Else is Happening at the State and Congressional Levels

FDA's allergen threshold work is moving alongside its separate gluten initiative, through which FDA sought information on labeling and preventing cross-contact of gluten in packaged foods. That initiative specifically identified rye and barley as non-wheat gluten-containing grains and flagged oats because of cross-contact concerns. At the state level, California's SB 68 requires covered food facilities, beginning July 1, 2026, to provide written notification of major food allergens that they know or reasonably should know are contained as ingredients in each menu item. New York has also enacted allergen labeling requirements for certain prepackaged foods that are prepared, prepacked, and offered or sold to customers on the same premises, effective November 2026.

In Congress, H.R. 9048, the Celiac Safety Act of 2026, would amend the Federal Food, Drug, and Cosmetic Act to include gluten-containing grain in the definition of "major food allergen." H.R. 8385, the Food Labeling Modernization Act of 2026, primarily a nutrient and front-of-package labeling bill, has also been introduced and referred to the House Energy and Commerce Committee, reflecting broader federal attention to food-label transparency. 

Current Compliance Obligations and Private Litigation Risk

FDA's recent discussions do not change existing binding compliance obligations. Companies must still comply with major food allergen labeling requirements, keep labels truthful and non-misleading, and maintain adequate cGMP and preventive control programs to prevent or significantly minimize allergen cross-contact. FDA's draft compliance policy guide is nonbinding but remains an important indicator of how FDA staff may assess labeling and cross-contact issues during inspections, recalls, and warning letter reviews.

Private plaintiffs are already active in this space and may also leverage FDA's threshold record, gluten Request for Information (RFI), and allergen guidance to challenge "may contain," "allergen-free," or "gluten-free" label statements. A plaintiff might argue that a label was misleading if a company used broad advisory language without a documented risk basis, made a "free-from" claim despite known cross-contact, or failed to align its label with supplier data and sanitation validation. These theories face significant defenses, including preemption, primary jurisdiction, standing, causation, and the absence of a private right of action, but FDA's public record can still shape demand letters, expert opinions, settlement dynamics, and courts' expectations of reasonable industry practice. These same issues can also surface in transactional diligence, where buyers and investors may scrutinize allergen-related recalls, complaints, label substantiation, supplier documentation, sanitation validation, and whether advisory statements are supported by a documented cross-contact risk assessment.

How FDA Compliance Obligations Could Change in the Future

FDA could act through guidance, a revised compliance policy guide, rulemaking, or some combination of these. The most likely near-term target is allergen advisory labeling, as FDA's listening session summary repeatedly flagged inconsistent "may contain" practices as a core problem. FDA could also set more specific expectations for documenting cross-contact risk assessments, validating sanitation controls, evaluating supplier allergen data, and determining when advisory statements are appropriate.

Gluten obligations could evolve as well, if FDA acts on the gluten RFI by requiring clearer disclosure of barley, rye, and cross-contact-affected oats beyond the current voluntary "gluten-free" framework. Over time, allergen compliance may shift from being label template-driven to documentation-driven, spanning product development, supplier approval, manufacturing, sanitation, quality assurance, and consumer communication.

What Food Companies Should Do Now

Food companies should use this period to build a defensible allergen and gluten risk management record before FDA sets clearer expectations:

• Audit label claims: Review "contains," "may contain," "allergen-free," and "gluten-free" language
• Map cross-contact risk: Identify shared equipment, rework, changeovers, suppliers, and transport risks
• Validate controls: Confirm sanitation, cleaning, sequencing, and testing programs are fit for purpose
• Tighten supplier records: Require allergen and gluten disclosures, change notices, supporting data, and diligence-ready documentation
• Monitor legal activity: Track FDA's threshold work, gluten RFI follow-up, state laws, and congressional bills.