Not every supplement formulation can simply be manufactured and sold. If an ingredient, dosage or combination falls outside the standards already recognised by FSSAI, the product needs a defined approval pathway — and choosing the wrong one (or assuming none is needed) is how launches slip by quarters.
We review formulations against the applicable schedules, identify exactly which SKUs need approval and which do not, and prepare complete, defensible submissions for those that do.
Who is this service for?
- Brands launching novel or imported formulations in India
- Manufacturers whose ingredients or dosages exceed scheduled limits
- Companies receiving FSSAI queries or rejections on existing applications
- Contract manufacturers validating customer formulations before production
What is included?
- Formulation compliance screening against the nutraceutical schedules
- Approval-pathway determination (standardised vs non-specified food)
- Complete application dossiers: safety data, usage history, specifications
- Query and clarification handling through to decision
- Post-approval labelling and licence-alignment support
How does the process work?
- 1Formulation review and gap report
- 2Pathway decision with documentation checklist
- 3Dossier preparation and submission
- 4Regulator query handling until decision
Which documents will you need?
- Full quantitative formulation with ingredient sources
- Ingredient specifications and certificates of analysis
- Safety/usage evidence for non-scheduled ingredients
- Manufacturing licence details of the production site
How long does it take?
Formulation screening is typically completed in about a week. Approval timelines for non-specified products depend on the regulator and the strength of the safety dossier — plan in months, not weeks; we set realistic expectations per product at scoping.
Common mistakes we correct
- Launching first and seeking approval after a marketplace or FSO challenge
- Assuming an ingredient permitted abroad is automatically permitted in India
- Dosages above scheduled RDA limits without an approval pathway
- Safety dossiers built on marketing material instead of primary evidence
Frequently Asked Questions
Does my supplement need FSSAI product approval?
Only if it falls outside the recognised standards — for example an unscheduled ingredient, an above-limit dosage, or a novel combination. Products fully within the schedules need correct licensing and labelling but not separate product approval. Our screening tells you definitively, SKU by SKU.
What is a "non-specified food" application?
It is the FSSAI pathway for foods or ingredients without existing standards, requiring a safety dossier — identity, manufacturing process, usage history, safety evidence and proposed conditions of use — assessed by FSSAI before the product can be sold.
Can you rescue a rejected application?
Frequently, yes. Most rejections trace to incomplete safety evidence or a mis-chosen pathway. We diagnose the rejection, rebuild the dossier and refile where the product has a viable route.
Regulations that apply
- FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use…) Regulations
- FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017