FSSAI Product Approval for Nutraceuticals and Proprietary Foods
Nutraceuticals, health supplements, and proprietary food products need FSSAI Product Approval before sale. Here's the complete process, fees, and timeline.
Not all food products can go straight to market with just an FSSAI license. Nutraceuticals, health supplements, foods for special dietary uses, and proprietary foods (products with no existing FSSAI standard) require a separate Product Approval from FSSAI before commercial production and sale.
Which Products Need FSSAI Product Approval?
- Nutraceuticals (vitamins, minerals, amino acids, antioxidants)
- Dietary supplements
- Protein supplements and powders
- Herbal and botanical food supplements
- Prebiotics and probiotics
- Energy drinks with novel ingredients
- Proprietary foods (new formulations with no existing FSSAI standard)
- Foods for special medical purposes (FSMP)
- Infant formula and baby food
Product Approval Application Process
- Submit application through FSSAI's online portal (with product formulation, ingredients, and safety data)
- Pay application fee
- FSSAI Product Approval Committee reviews the formulation
- May request additional safety data or clinical studies
- Approval granted or rejected (60–90 days typically)
- Approved product may be manufactured and sold commercially
Documents Required
- Complete product formulation with ingredient quantities
- Safety and efficacy data for each ingredient
- Clinical/scientific studies supporting health claims (if any)
- Label draft for review
- Manufacturing process description
- Certificate of Analysis for raw materials
FSSAI Fees for Product Approval
Product approval application fees range from ₹5,000 to ₹1 lakh depending on product category. Velco Legal India's consultancy for product approval starts at ₹9,999.
What Claims Can You Make After Approval?
FSSAI-approved products can make specific health claims as permitted by FSSAI standards. However, disease claims ("cures diabetes", "prevents cancer") are never permitted regardless of approval.
Conclusion
Product approval is a significant compliance milestone for nutraceutical and health food brands. Velco Legal India's product approval specialists guide you through the complex documentation and application process.
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