We ensure your nutraceutical and supplement products comply with FSSAI norms – from RDA and ingredient validation to
Comprehensive regulatory support for nutraceuticals, dietary supplements, and functional foods – from formulation to market launch.
At Regulatory Nation, we help nutraceutical brands, health supplement companies, and contract manufacturers navigate the complexities of FSSAI regulations and global compliance standards. Our services cover everything from ingredient validation to claims review, ensuring your products are safe, legally compliant, and ready for sale in India or abroad.
Nutraceuticals fall under strict regulations defined by FSSAI (Food Safety & Standards Authority of India) and require:
Accurate classification (Food vs. Drug vs. Health Supplement)
Ingredient validation as per FSSAI schedules (IV–IX)
RDA (Recommended Dietary Allowance) checks and dosage approvals
Correct labeling, claims, and disclaimers to avoid penalties
Failure to comply can lead to license suspension, product rejection, or market recalls – something we ensure doesn’t happen to your business.
Verify each ingredient against FSSAI’s permitted list
Check dosage limits as per ICMR/FSSAI RDA standards
Identify non-compliant or restricted components
Suggest formulation modifications for approval
Develop accurate nutrition and supplement facts panels
Align with FSSAI Schedule II (Nutritional & Health Supplements)
Ensure clarity on serving size, nutrient values, and daily intake
Review marketing claims (e.g., “boosts immunity,” “supports digestion”)
Ensure compliance with FSSAI health claims guidelines
Draft appropriate disclaimers (“This is not intended to diagnose or cure…”)
Tablets, capsules, gummies, powders, and liquids
Evaluate dosage formats for stability and labeling requirements
Support for innovative formats (chewables, effervescent tablets, shots)
Validate plant-based ingredients as per Ayush/FSSAI standards
Cross-check botanical names, plant parts, and extraction ratios
Ensure compliance for herbal blends and botanicals
Assist with FSSAI Import License for supplements
Review imported product formulations and COA
Support with Food Import Clearance System (FICS) documentation
Determine correct product classification to avoid legal risks
Advisory on whether product falls under FSSAI, AYUSH, or CDSCO
Guide through correct license and approval pathways
Nutraceutical & dietary supplement brands
Health & wellness startups
Contract manufacturers & private label marketers
Importers of functional foods & supplements
Herbal and botanical product companies
Expertise in nutraceutical & supplement compliance
End-to-end support – formulation to market
PAN-India presence with global import/export advisory
Fast turnaround & minimal documentation hassles
Proven success with startups and large FMCG brands
Launching or scaling your nutraceutical products? Ensure 100% compliance with FSSAI and global standards before you hit the shelves.
👉 Contact Us today to book a consultation with our regulatory experts.
