Journal of Nutraceuticals and Health

ABSTRACT

Nutraceuticals, including dietary supplements and functional foods, are increasingly used for health promotion and disease prevention. However, inconsistent denitions and varying regulatory frameworks across countries create challenges in ensuring product safety, ecacy, and transparency. Ethical issues such as misleading health claims, insucient clinical validation, and regulatory loopholes further complicate consumer protection. This Systematic review examines regulatory systems in the USA, Europe, Australia, Canada, Japan, China, Brazil, Mexico, and India. Using a structured PRISMA-based methodology, peer-reviewed literature and ocial documents were analyzed to assess regulatory gaps and market practices. Key concerns include inadequate quality control, inconsistent categorization, and lack of post-market surveillance. Findings highlight the need for science-based standards, global harmonization, and stricter oversight. Policy recommendations include uniform classication, mandatory clinical substantiation, and improved product traceability. Addressing these gaps is crucial to safeguard public health, enhance transparency, and build trust among consumers and healthcare professionals in the growing nutraceutical sector.

KEYWORDS

1. Nutraceuticals
2. Food-based therapeutics
3. Regulatory frameworks
4. Safety
5. Efficacy
6. Product transparency
7. Harmonization