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@article{185426,
        author = {Arshiya Begum Amjad and Dhanshree Lakudkar and Yashmin Khan and Md Quamruz Zafar},
        title = {Evidence - Based Claim Substantiation for Red Yeast Rice (RYR) : A Narrative Review},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {5},
        pages = {1422-1437},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=185426},
        abstract = {This project presents a structured mock dossier for claim substantiation of Red Yeast Rice (RYR) in alignment with the Food Safety and Standards Authority of India (FSSAI) guidelines. The dossier was developed across 15 modules, covering regulatory frameworks, nutritional composition, mechanisms of action, safety, clinical evidence, pharmacovigilance strategies, and identified research gaps. Eight peer-reviewed clinical and safety studies were critically analysed to evaluate the efficacy of RYR in lowering LDL cholesterol and its safety profile. Supporting evidence demonstrated LDL reductions of 15–34% in short-term randomized controlled trials, with nutrivigilance data from ~3.9 million consumers confirming overall safety when products are citrinin-free and standardized. While traditional use has long established RYR’s cultural acceptance, modern regulatory substantiation requires product-specific clinical equivalence, labeling safeguards, and nutrivigilance oversight. The final proposed health claim — “Helps maintain healthy cholesterol levels when consumed as part of a balanced diet” — is scientifically supported, regulator-compliant, and consumer-oriented. This project highlights the importance of evidence-based claim substantiation and proposes directions for future research to strengthen regulatory confidence.},
        keywords = {Red Yeast Rice, FSSAI, claim substantiation, cholesterol, LDL, nutrivigilance, functional foods},
        month = {October},
        }