[Current Status and Issues on the Foods with Function Claims System in Japan: Evidence of Functionality of the Foods]

The purpose of this narrative review was to clarify the current status and issues of scientific evidence for functionality in the Foods with Function Claims system based on previous research. From the introduction of the system in April 2015 to January 1, 2023, there were 6606 notifications, of which 6297 (95.3) were systematic reviews (SRs) and 309 (4.7%) were clinical trials (CTs). SRs were identified the following problems: i) inadequate description based on the first version of PRISMA checklist, and ii) very low levels of quality assessment in the first version of AMSTAR checklist and AMSTAR 2. CT was reported to have the following problems: i) inconsistencies between the protocol and the content in the paper (non-compliance), ii) high risk of bias, and iii) not described based on the CONSORT 2010 checklist. Since SRs and randomized controlled trials (RCTs) often have low-quality notifications, it is necessary to correctly communicate this information to consumers in order to make appropriate purchasing decisions.