Patient and caregiver perspectives on threshold-based precautionary allergen labeling

Precautionary allergen labeling (PAL), such as "may contain" statements, remains unregulated in the United States, despite its widespread use and importance for individuals with food allergies.

To explore the perspectives of adults with food allergies and caregivers of children with food allergies on current PAL and propose policies to incorporate allergen thresholds.

Semi-structured interviews were conducted with 20 participants at the 2024 Food Allergy Research and Education Food Allergy Summit. Interviews covered PAL knowledge, allergen advisories, the VITAL (Voluntary Incidental Trace Allergen Labelling) program, and eliciting dose 5% threshold logistics. Transcripts were analyzed thematically by researchers using an inductively developed codebook.

The following 4 key themes emerged from the thematic analysis: (1) desire for a clear and standardized PAL system; (2) threshold-based PAL represents a vital step toward standardization; (3) concern for individuals highly to have allergy; and (4) personal decision-making with threshold labeling is guided by perceived risk.

Individuals with food allergy and caregivers of children with food allergy support reforming PAL through standardized, evidence-based approaches. Participants favored a 2-level PAL model, in which products with detectable allergen levels below the eliciting dose 5% threshold could either remain unlabeled or display a "low risk" PAL statement instead. However, current global regulatory bodies have not recommended the use of this 2-level PAL model, citing concerns over its potential misuse by manufacturers. Moving forward, consensus among stakeholders and additional research into food industry perspectives are essential to implementing threshold-based PALs that are effective and trusted by all.