Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications

Abstract

Background: There has been a dramatic proliferation of precautionary labeling by manufacturers to mitigate the perceived risk from low-level contamination from allergens in food. This has resulted in a significant reduction in choice of potentially safe foods for allergic consumers.

Objectives: We aimed to establish reference doses for 11 commonly allergenic foods to guide a rational approach by manufacturers based on all publically available valid oral food challenge data.

Methods: Reference doses were developed from statistical dose-distribution modeling of individual thresholds of patients in a dataset of more than 55 studies of clinical oral food challenges. Sufficient valid data were available for peanut, milk, egg, and hazelnut to allow assessment of the representativeness of the data used.

Results: The data were not significantly affected by the heterogeneity of the study methodology, including little effect of age on results for those foods for which sufficient numbers of adult challenge data were available (peanut and hazelnut). Thus by combining data from all studies, the eliciting dose for an allergic reaction in 1% of the population estimated for the following were 0.2 mg of protein for peanut, 0.1 mg for cow's milk, 0.03 mg for egg, and 0.1 mg for hazelnut.

Conclusions: These reference doses will form the basis of the revised Voluntary Incidental Trace Allergen Labeling (VITAL) 2.0 thresholds now recommended in Australia. These new levels will enable manufacturers to apply credible precautionary labeling and provide increased consumer confidence in their validity and reliability, as well as improving consumer safety.

Keywords: ED; Eliciting dose; FARRP; Food Allergy Research & Resource Program; Food allergy; GLRT; Generalized log-rank test; LOAEL; Lowest-observed-adverse-effect level; NOAEL; No-observed-adverse-effect level; VITAL; Voluntary Incidental Trace Allergen Labeling; allergen thresholds; cow's milk; egg; hazelnut; peanut; precautionary labeling; soy.