[A Study on the Scientific Reliability of Notification Data in the Foods with Function Claims]

We conducted a comprehensive survey of Foods with Function Claims (FFC) submitted from April to August 2022 to examine the scientific reliability of the systematic review (SR), which is the basis for functional claims. The results of the review of 611 functional claims for 398 products showed that there were 121 functionally active substances and 87 health claims (Hc) that were labeled, with some functionally active substances having multiple functions. SRs, meta-analyses, and clinical studies were submitted as the basis of functionality for 87%, 10%, and 3% of the reports, respectively. Of these SRs, 39% of the SRs included a single paper. In 67% of the SRs with a single paper included, some of the authors of the included paper and the person who conducted the SR had the same affiliation, which raises concerns about conflicts of interest. The median of clinical trial participants in papers included for SR was relatively small, 38, and the smallest total number of SRs was 6. Thus, it was shown that there are many SRs for FFC that are based on only a single paper or a small-scale clinical trial and that lack reliability as scientific evidence.