Quick Answer
Nutraceutical businesses producing functional foods, dietary supplements, and products with health-promoting properties beyond basic nutrition require Central FSSAI License. FSSAI has comprehensive regulations for nutraceuticals under its 2022 health supplement and nutraceuticals regulations.
Who Needs FSSAI License for Nutraceuticals Business?
- Functional food and nutraceutical manufacturers
- Probiotic and prebiotic product producers
- Omega-3 and specialty nutrient supplement brands
- Medical food and clinical nutrition manufacturers
💡 The 14-digit FSSAI License number must be displayed at your premises and printed on all packaging, bills, and menus.
Which License Type Do You Need?
| Annual Turnover | License Type | Issued By |
|---|
| Below ₹12 Lakh | Basic FSSAI Registration | State Food Authority |
| ₹12 Lakh – ₹20 Crore | State FSSAI License | State Food Authority |
| Above ₹20 Crore | Central FSSAI License | FSSAI Central Office |
⚠️ If your business operates across multiple states, a Central FSSAI License is required regardless of turnover.
Documents Required
- PAN & Company registration
- Manufacturing facility proof
- Product formulations with all active ingredients
- Clinical evidence and safety data for health claims
- Third-party lab testing certificates
- HACCP documentation
- Central FSSAI License application
- Labelling with all mandated disclosures
Step-by-Step Application Process
- Determine License Type — Based on annual turnover decide Basic, State, or Central.
- Register on FoSCoS Portal — Visit foscos.fssai.gov.in and create an applicant account.
- Fill Application Form — Complete Form A (Basic) or Form B (State/Central).
- Upload Documents — Attach all required documents in prescribed formats.
- Pay Government Fee — Pay online via UPI, net banking, or debit/credit card.
- Await Inspection — An FSSAI officer may inspect your premises within 30 days.
- Receive License — Download your FSSAI License certificate from the FoSCoS portal.
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Fees & Timeline
| License Type | Government Fee | Processing Time |
|---|
| Basic Registration | ₹100/year | 7–10 working days |
| State License | ₹2,000–₹5,000/year | 15–30 working days |
| Central License | ₹7,500/year | 30–60 working days |
Frequently Asked Questions
What is FSSAI definition of a nutraceutical?
FSSAI defines nutraceuticals as products isolated or purified from foods that are generally sold in medicinal forms — tablets, capsules, powders — and that demonstrate physiological benefits or protection against chronic disease.
What ingredient list does FSSAI maintain for nutraceuticals?
FSSAI maintains a positive list of permitted ingredients for nutraceuticals. Using ingredients not on this list requires prior FSSAI approval. The list includes vitamins, minerals, amino acids, enzymes, and approved botanical extracts.
Can nutraceutical products make disease prevention claims?
FSSAI permits certain science-based disease risk reduction claims for nutraceuticals, subject to prior approval. Claims must be from the FSSAI-approved claims list and supported by scientific evidence. Disease treatment claims are prohibited.
How does FSSAI regulate probiotics in nutraceuticals?
FSSAI has specific regulations for probiotic products requiring minimum viable counts at end of shelf life. Probiotic strains must be safe for human consumption and from the FSSAI-approved strain list. Clinical evidence supporting probiotic claims must be available.
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