From Registry Safety Records to Consumer Warnings: Concordance in Japanese and Korean Functional Foods with Label-Identified Natural Sources

Abstract

Safety information recorded upstream in a functional-food registry may not be represented in the downstream product-warning field. This cross-sectional study estimated registry-field concordance for Japanese and Korean functional foods with label-identified natural sources using separate country-specific estimands. Label-identified natural origin was assigned only when an official ingredient label named a plant, fungal/algal, microbial, or animal/marine source; it did not assert verified product provenance. The sole author manually reviewed all 932 distinct Japanese labels and 328 distinct Korean official ingredient labels in the analytical cohorts against locked rules before the final concordance rerun. Japan contributed 1,731 label-identified notifications. Among 310 notifications with an interaction indicator and a detected assessment-field warning cue, after detected no-warning cues were excluded, 236 contained strict medication wording (76.1%; 95% company-cluster bootstrap confidence interval 70.5–81.5) and 257 met the liberal professional-advice definition (82.9%; 77.6–87.8). Korea contributed 4,295 label-identified products; 3,377 of 3,762 eligible products contained wording representing every applicable official caution domain (89.8%; 87.5–91.6). Registry-wide contextual estimates were 79.1% in Japan and 88.1% in Korea. The low Korean fungal/algal estimate was concentrated in two recognition codes. These estimates describe concordance between registry fields, not legal compliance, consumer comprehension, or causal regulatory performance. The antecedent-aligned framework identifies records for contextual review.