Quick Answer
Health supplement manufacturers producing vitamins, minerals, protein supplements, and dietary supplements must obtain a Central FSSAI License and comply with FSSAI Regulations for Nutraceuticals, Health Supplements, and Dietetic Foods. This is a highly regulated sector in India.
Who Needs FSSAI License for Health Supplement Manufacturing?
- Vitamin and mineral supplement manufacturers
- Sports nutrition and protein supplement brands
- Weight management supplement producers
- Herbal and botanical supplement 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 documents
- Manufacturing facility proof
- Product formulations with ingredient quantities
- Clinical and safety evidence for health claims
- Third-party laboratory test reports
- HACCP-based FSMS documentation
- Central License application
- Labelling samples with all mandatory information
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 are FSSAI regulations for health supplements?
FSSAI regulates health supplements under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022.
Can health supplements make disease treatment claims?
No. FSSAI strictly prohibits health supplements from making claims to treat, cure, or prevent diseases. Only permitted nutrient function claims and general well-being claims that have FSSAI approval can be made.
What testing is mandatory before launching a health supplement?
Manufacturers must conduct product stability testing, heavy metal testing, microbiological testing, and verify that all ingredients are from the FSSAI-approved ingredient list for health supplements.
Do health supplements need product approval from FSSAI before sale?
Certain categories of health supplements require product approval or notification to FSSAI before sale. Novel ingredients or ingredients not on the FSSAI positive list require specific FSSAI approval.
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