Abstract

A COMPREHENSIVE REVIEW OF NUTRACEUTICAL LABELLING COMPLIANCE AND REGULATORY FRAMEWORK IN INDIA

Mansi Dipak Bhosale*, Aishwarya Bhandare

ABSTRACT

Nutraceuticals, or food-derived products that provide health benefits beyond basic nutrition, are increasingly being utilised to treat lifestyle-related disorders, prevent disease, and promote health. It is now essential to maintain product transparency and protect consumer health through proper regulatory monitoring and labelling compliance due to the nutraceutical market's fast growth in India. This study examines the regulatory framework controlling nutraceutical products in India, with an emphasis on labelling laws and compliance standards established by the Food Safety and Standards Authority of India (FSSAI). The study covers two significant regulations: the Food Safety and Standards (Health Supplements, Nutraceuticals, Functional Foods, and Novel Foods) rules, 2016 and the Food Safety and Standards (Advertising and Claims) Regulations, 2018. It draws attention to required labelling elements such asrecommended daily intake, nutritional data, ingredient disclosure, and allergen notifications. Storage instructions and cautions, such as "NOT FOR MEDICINAL USE" Other regulatory frameworks, like the Consumer Protection Act and the Legal Metrology Act, as well as directives from agencies like the Ministry of AYUSH, ASCI, and BIS, are also evaluated. Current concerns are also discussed, such as quality control problems, regulatory overlap, and fraudulent health claims. It is essential to bolster regulatory enforcement, promote ethical marketing practices, and boost labelling clarity in order to safeguard consumer safety and support the long-term growth of India's nutraceutical business. 

Keywords: Nutraceuticals, Nutraceutical regulation, Food Safety and Standard Authority of India (FSSAI), Nutraceutical Labelling Compliance.