FDA holds public meeting on food allergen thresholds to explore risk-based labeling and enforcement

The U.S. Food and Drug Administration hosted a virtual public meeting to gather scientific, clinical, industry and consumer input on the possible use of food allergen thresholds to inform precautionary allergen labeling, enforcement, and exemptions.

Diane Benjamin of FDA’s Human Foods Program opened the meeting, noting the agency’s interest in how thresholds could help consumers, guide industry decisions and inform regulatory actions. Deputy Commissioner Kyle Diamantis said FDA is exploring thresholds “to improve food safety, enhance labeling practices for transparency, and help consumers make informed and safe choices.”

FDA presenters reviewed current law and policy. Lehi Zibas summarized the Food Allergen Labeling and Consumer Protection Act (FALCPA) requirements for declaring major food allergens and noted that sesame was added as a major allergen under the FASTER Act. FDA speakers emphasized that, while guidance documents have discussed risk-based approaches, the agency has not officially endorsed numeric thresholds.

Agency officials described a risk-based enforcement posture: inspections and sampling prioritize products with allergen-free claims or known labeling concerns, and FDA evaluates cross-contact incidents case by case. FDA staff cited draft guidance and a Compliance Policy Guide (CPG) that frame when cross-contact may render a product adulterated under the Federal Food, Drug, and Cosmetic Act.

Scientists and clinicians reviewed the evidence supporting population reference doses. Presenters summarized FAO/WHO expert-consultation work that derived reference doses using dose-distribution models (for example, ED1 and ED5 metrics) and clinical challenge data; panelists noted that doses around ED5 have been associated primarily with mild-to-moderate symptoms and a very low probability of severe anaphylaxis in challenge settings.

Consumer advocates and behavioral scientists urged clear, simple and standardized PAL language and broad education. FDA behavioral researchers said planned focus groups will test label wording and consumer comprehension. Patient-advocacy representatives warned that a threshold-driven approach requires extensive communication and attention to equity (access to clinicians, testing, and information).

Industry speakers described practical applications and tradeoffs. Manufacturers and sanitation experts said thresholds can help prioritize controls, reduce unnecessary precautionary labeling, and enable risk-appropriate sanitation choices. Trade groups from baking and spice sectors described supply-chain realities (for example, seeded bakery lines and agricultural commingling of spices) that can make zero-tolerance approaches impractical.

Panelists identified implementation challenges: analytical-method shifts from limit-of-quantification to action-level testing, handling particulate carryover, creating consistent industry practices, and designing transparent exemption dossiers showing expected exposure and ingredient characterization.

FDA closed the session by announcing facilitated listening sessions (Feb. 19–20, 2026) and an open public docket with comments due May 19, 2026. Agency staff said recordings and transcripts will be posted and that additional behavioral research will inform any future policy development.