A Cross-Sectional Study Based on Forty Systematic Reviews of Foods with Function Claims (FFC) in Japan: Quality...

Area of Science:

• Food Science
• Health Claims Regulation
• Evidence-Based Medicine

Background:

• Japan introduced Foods with Function Claims (FFC) in 2015 to increase product availability.
• FFC requires scientific evidence, primarily from systematic reviews (SRs), to support health claims.
• The methodological quality of SRs used for FFC has not been previously assessed.

Purpose of the Study:

• To assess the methodological quality of SRs submitted for FFC in Japan.
• To identify common deficiencies in SRs supporting FFC products.

Main Methods:

• A database search was conducted from April to October 2022.
• The Appraisal of Methodological Standards tool 2 (AMSTAR 2) checklist was used to evaluate SR quality.
• Forty SRs were randomly extracted for analysis.

Main Results:

• 95% of SRs were rated as "critically low" quality (N=38), and 5% were "low" quality (N=2).
• The average AMSTAR 2 score was 51.1%, indicating significant quality issues.
• Common deficiencies included lack of protocol registration, inadequate search strategies, and insufficient risk of bias assessment.

Conclusions:

• The methodological quality of SRs supporting FFC in Japan is very poor.
• Critical deficiencies were noted in protocol registration, comprehensive literature searches, and risk of bias evaluation.
• These findings suggest a need for improved standards in evidence generation for FFC products.