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@article{186919,
        author = {Miriyala Gayathri Devi and Md Quamruz Zafar},
        title = {Regulatory Intelligence Dossier – Historical Enforcement & Precedent Analysis},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {6},
        pages = {3218-3235},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=186919},
        abstract = {This project, Regulatory Intelligence Dossier – Historical Enforcement & Precedent Analysis, focuses on the role of regulatory enforcement in ensuring compliance within the dietary supplement and pharmaceutical sectors. Regulatory enforcement is essential to safeguard consumer health, maintain industry transparency, and ensure fair trade practices.
The project aims to compile case studies of regulatory warnings, recalls, claim rejections, and enforcement actions from global authorities such as the Food Safety and Standards Authority of India (FSSAI), the United States Food and Drug Administration (FDA), the European Food Safety Authority (EFSA), and ASEAN regulatory bodies. Each case is analysed to identify the key issues, actions taken, and lessons learned, which together form a comprehensive understanding of precedent-setting enforcement.
By comparing approaches across regions, this work highlights the similarities and differences in global regulatory practices. While enforcement actions strengthen compliance and provide legal and scientific benchmarks, significant challenges remain, including fragmented standards, limited harmonization, and uneven enforcement capacity.
The findings emphasize that historical enforcement not only prevents unsafe or misleading products from reaching consumers but also builds a repository of precedents that can guide industry stakeholders in regulatory decision-making. This project contributes to regulatory intelligence by offering a structured framework for analysing past enforcement actions and by identifying key areas where harmonization could support global product safety and launch-readiness.},
        keywords = {Regulatory Enforcement, Dietary Supplements, FDA, FSSAI, EFSA, ASEAN, Precedent Analysis, Compliance},
        month = {November},
        }