FSSAI Nutraceutical

The FSSAI Nutraceutical framework is the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations 2016, issued under the Food Safety and Standards Act 2006 and substantially amended in 2022 and 2024 to tighten ingredient lists, dose limits, claim controls and labelling. The regulations carve seven categories: Health Supplements, Nutraceuticals, Foods for Special Dietary Use (FSDU), Foods for Special Medical Purpose (FSMP), Specialty Food containing Plant or Botanical Ingredients, Foods containing Probiotic Ingredients, and Foods containing Prebiotic Ingredients.

The category choice is regulatory, not marketing — Nutraceuticals are held to a higher ingredient-purity and dose-evidence bar than Health Supplements, and the label must declare the category. Misclassification is the most common FSSAI compliance finding on imported lines. The technical core sits in the eight Schedules: Schedule I (vitamins and minerals with RDA-based dose limits), Schedule II (essential amino acids), Schedule IV (plant or botanical ingredients with monograph references — Indian Pharmacopoeia, USP, EP, Ayurvedic Pharmacopoeia, BP), Schedule VI (probiotic strains with culture collection deposit numbers), Schedule VII (prebiotics) and Schedule VIII (other novel substances). The 2022 amendment substantially tightened these; the 2024 amendment refined flavouring declaration and front-of-pack HFSS (high fat/sugar/salt) warnings.

Approval runs through the FSSAI Central Licence on FoSCoS (Food Safety Compliance System), with pre-market Product Approval through the Product Approval Branch additionally required when an ingredient is not on any Schedule, a claim is outside the closed FSS Advertisement and Claims Regulations 2018 list, or the product is FSMP for a specific medical condition. Labels are bilingual at minimum (English plus Hindi or a regional language) with the FSSAI logo and licence number, the mandatory warnings 'Not for medicinal use' and population-specific warnings. In V5 the FSSAI category, the Central Licence, the Schedule pointer per ingredient, the Product Approval reference (if applicable) and the multilingual label live on one SKU spine, so a regulation update or a port-of-entry FSSAI query opens to assembled evidence.