The Food Safety and Standards Authority of India (FSSAI) regulates every nutraceutical sold in India. No license, no legal sale — and FSSAI raids in 2024–25 shut down dozens of unlicensed brands across Amazon, Flipkart, and quick-commerce platforms. If you’re starting a brand or using a nutraceutical contract manufacturer, this guide covers what you need to get and keep your license.

What FSSAI Considers a Nutraceutical

Under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, etc.) Regulations 2022, products fall into health supplements, nutraceuticals, food for special dietary use (FSDU), food for special medical purpose (FSMP), functional foods, and novel foods. Each category has separate compositional standards, label requirements, and approval pathways.

The Three FSSAI License Tiers

Basic Registration: Annual turnover under ₹12 lakhs. Fee ₹100/year. Validity 1–5 years.
State License: ₹12 lakhs to ₹20 crores. Fee ₹2,000–5,000/year. Validity 1–5 years.
Central License: Above ₹20 crores or pan-India / import-export. Fee ₹7,500/year. Validity 1–5 years.

Most launching nutraceutical brands need a State License. Going pan-India through Amazon/Flipkart fulfilment? You’ll need a Central License at the central warehouse, plus state licenses where you store stock.

Documents You Need

For State or Central License: Form B duly filled, photo ID of proprietor/partners/directors, proof of business premises, NOC from owner if rented, incorporation certificate, list of food category products with composition, blueprint/layout of premises (manufacturer category), water test report (manufacturer), equipment list (manufacturer), NOC from Municipality, authority letter, Form IX nominating Food Safety Officer.

For brand owners using contract manufacturing, you typically apply as a “Marketer” — your application doesn’t need plant blueprints (that’s the manufacturer’s burden) but you must include the manufacturing agreement.

How to Apply

Register on foscos.fssai.gov.in with mobile + email OTP. Fill Form B online. Upload all documents in PDF (each under 1 MB). Pay fees online. FSSAI inspector may visit premises (especially Central License). License issued in 30–60 days.

Label Compliance — Where Most Brands Fail

Mandatory label elements: FSSAI logo with 14-digit license number (min 5mm height), product name, category (“Health Supplement” or “Nutraceutical”), list of ingredients in descending order of weight with INS numbers for additives, nutritional information panel, net quantity, manufacturer details, marketed-by details if different, country of origin, date of manufacture and best before/use by, batch/lot/code number, vegetarian (green) or non-vegetarian (brown) symbol, allergen declarations, storage instructions, recommended daily allowance (% RDA), maximum daily intake warnings.

For health supplements: “This product is not intended to diagnose, treat, cure or prevent any disease.” is mandatory.

Claims You CAN and CANNOT Make

Allowed: nutrient content claims, comparative claims, function claims for nutrients with established function, reduction of disease risk claims (only FSSAI-approved combinations).

Not allowed: disease treatment or cure claims, claims that imply prescription replacement, comparisons with drugs, “doctor recommended” without verifiable basis, before/after photos implying medical efficacy, testimonials describing disease reversal. Violations attract penalties from ₹2 lakhs to ₹10 lakhs and license suspension.

Working with a Manufacturer’s License

When you use a nutraceutical contract manufacturer, the manufacturer’s plant has its own FSSAI license number. On your label, both license numbers should appear: “Manufactured by: [Manufacturer + FSSAI No.]” and “Marketed by: [Your brand + FSSAI No.]”. This dual-licensing is mandatory and protects both parties during inspections.

Annual Returns

Every FSSAI license holder must file annual returns (Form D1) by 31 May each year. Non-filing leads to penalties and license non-renewal.

Common Rejection Reasons

Incomplete documentation, mismatched address between proof and form, product list not aligned with FSSAI category codes, missing FSO nomination, inadequate premises for declared category, outstanding penalties.

Renewal

Apply for renewal at least 30 days before expiry. Lapsed licenses require fresh application — you cannot trade in the gap period.

What Biofril Healthcare Provides

Brand owners launching through our nutraceutical manufacturing facility get FSSAI application guidance, label compliance review before printing, manufacturer license details for dual-license labeling, documentation for annual returns, and support during FSSAI inspections.

Bottom Line

FSSAI compliance is non-negotiable. Get the license right at launch, build label compliance into every SKU, file annual returns on time, and avoid disease-treatment claims. The brands that scale past ₹50 crores all run airtight FSSAI compliance — it’s table stakes, not a competitive edge.

Request a manufacturing quote with full FSSAI compliance support →