Specialist Service | Nutraceuticals

FSSAI Product Approval

For proprietary foods, nutraceuticals, health supplements, and non-standardized products

FSSAI Product Approval is required for food products that do not conform to prescribed standards under the Food Safety and Standards Regulations. This includes proprietary food products, nutraceuticals, health supplements, functional foods, novel foods, and products with special dietary uses. The approval is obtained through FSSAI's E-PAAS system (now integrated with FoSCoS Product Approval module). Velco Legal India has specialized food technologists who handle these complex applications.

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Service Summary

Our Fee₹9,999

Govt Fee₹10,000–₹25,000 (varies by category)

Timeline60–90 working days

PortalFoSCoS — Product Approval Module

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Pay only after license delivery

Who Needs This?

Nutraceutical companies and health supplement brands

Proprietary food product manufacturers

Functional food and fortified food companies

Novel food product developers

Herbal food supplement manufacturers

Sports nutrition brands

Baby food and infant formula manufacturers

Food for special dietary uses producers

Organic food product companies with unique formulations

Food businesses importing non-standard products

Documents Required

Product formulation / recipe with exact ingredient percentages

Technical / safety data sheet for each ingredient

Proposed label design with all mandatory declarations

Certificate of analysis (CoA) from NABL-accredited lab

Manufacturing process flowchart

Scientific references / clinical evidence for health claims

FSSAI Central License of applicant

Authorized signatory details and power of attorney

Country of origin certificate (for imported ingredients)

GMP/GHP certificate of manufacturing facility

Note: Our team sends you a custom document checklist based on your business type. Exact requirements may vary.

How the Process Works

Product Category Assessment

Our food technologist reviews your product to determine if it needs Product Approval or falls under existing standards.

Formulation & Label Review

We review and guide on the product formulation, ingredient safety, and label compliance before application submission.

Dossier Preparation & Submission

We prepare the complete product dossier and submit it through FSSAI's Product Approval module on FoSCoS.

Follow-up & Approval

We handle all FSSAI queries, additional document requests, and follow up until product approval is received.

Expected Timeline

60–90 working days

After successful document submission. Timeline depends on FSSAI portal processing.

Frequently Asked Questions

What is a proprietary food product under FSSAI?

A proprietary food is any food product that is not covered by the food standards prescribed under FSSAI regulations. These products require specific approval before they can be manufactured or sold in India.

Do all nutraceuticals need FSSAI product approval?

Not all. Nutraceuticals and health supplements that conform to FSSAI's Nutraceuticals Regulations (2022) don't need product approval but must follow the standards. Only products that deviate from these standards or make specific health claims need the Product Approval process.

How long does FSSAI product approval take?

Typically 60–90 working days, but it can take longer if FSSAI requests additional data or if the product is novel/complex. Our team proactively manages the process to avoid unnecessary delays.

Is product approval the same as product registration?

No. Product approval is for non-standard/proprietary foods. Most standard food products don't need individual product registration — only the business needs an FSSAI license.

Can imported nutraceuticals be sold without product approval?

Imported nutraceuticals and health supplements that don't conform to FSSAI standards need product approval before they can be sold in India. The importer needs a Central License plus product approval for non-standard imported products.