FSSAI License for Dietary Supplements in India

1. Introduction: The Rise of Dietary Supplements in India

India is witnessing a health revolution.

More people are hitting the gym, tracking their protein intake, and focusing on immunity, gut health, and overall wellness. As a result, the demand for dietary supplements — like protein powders, multivitamins, herbal capsules, and omega-3 oils — is growing fast.

The Indian nutraceutical market was valued at ₹60,000 crores in 2023 and is expected to grow at 15% annually over the next five years. With rising fitness culture, aging populations, and post-pandemic health awareness, this trend is here to stay.

But with growth comes responsibility.

Every capsule, tablet, or sachet of supplement must be safe, pure, and truthfully labeled. That’s where the FSSAI License for Dietary Supplements becomes essential.

The Food Safety and Standards Authority of India (FSSAI) regulates all food products — including dietary supplements — to ensure they meet strict safety, quality, and labeling standards.

Whether you’re launching a new brand of ashwagandha gummies or manufacturing whey protein at scale, you must have an FSSAI license to legally produce, sell, or distribute your product in India.

This guide will walk you through everything you need to know about:

What counts as a dietary supplement under FSSAI
Why licensing is mandatory
Which type of license you need
How to apply online via the FoSCoS portal
Required documents and costs
Labeling rules and compliance tips

By the end, you’ll be fully equipped to get your Dietary Supplement FSSAI Registration and build a trusted, compliant brand.

Let’s get started.

2. What is FSSAI? Your Partner in Food Safety

The Food Safety and Standards Authority of India (FSSAI) is the national body responsible for ensuring that all food products in India are safe to consume.

Established in 2006 under the Food Safety and Standards Act, 2006, FSSAI replaced outdated laws like the Prevention of Food Adulteration Act. Its mission is simple: protect public health by regulating food safety from farm to fork.

Key Functions of FSSAI

Sets science-based standards for food and supplements
Licenses and registers all food businesses
Monitors food safety across manufacturing, storage, and distribution
Conducts inspections and product testing
Educates consumers and businesses about food safety
Takes action against unsafe or misbranded products

Think of FSSAI as the quality watchdog for everything you eat or drink — including dietary supplements.

How FSSAI Applies to Supplements

Many people think supplements are medicines. But under Indian law, most dietary supplements are classified as specialized food products, not drugs.

This means they fall under FSSAI’s jurisdiction — not the Drugs Controller General of India (DCGI), unless they make medicinal claims.

So, if you’re selling a vitamin C tablet to support immunity, it’s regulated by FSSAI. But if you claim it “cures colds”, it may be treated as a drug — which requires different approvals.

For FSSAI for Nutraceutical Products, the rules are clear: no license, no sale.

Every manufacturer, importer, distributor, or seller of dietary supplements must have a valid Food Safety License for Supplements.

Without it, your business is illegal — and you risk fines, product seizures, or even jail time.

3. What Are Dietary Supplements Under FSSAI?

Not all health products are the same.

To get the right FSSAI License for Dietary Supplements, you first need to understand what FSSAI considers a “dietary supplement.”

Official Definition

According to FSSAI, a dietary supplement is:

“A product intended to supplement the diet and contains one or more dietary ingredients such as vitamins, minerals, herbs, amino acids, or other substances, sold in dosage form (capsule, tablet, powder, liquid, etc.) with a nutritional or health benefit claim.”

In simpler terms:
If your product is meant to boost nutrition or support body function — but isn’t a full meal or medicine — it’s likely a dietary supplement.

Common Types of Dietary Supplements Regulated by FSSAI

Category	Examples
Vitamins & Minerals	Vitamin D3, B-complex, calcium, iron, zinc
Protein & Amino Acids	Whey protein, plant protein, BCAAs, creatine
Herbal & Plant-Based	Ashwagandha, turmeric, giloy, brahmi, moringa
Omega Fatty Acids	Fish oil, flaxseed oil, krill oil
Digestive Health	Probiotics, prebiotics, fiber supplements
Weight Management	Fat burners, appetite suppressants (non-drug)
Energy & Focus	Ginseng, caffeine blends, nootropics
Sports Nutrition	Pre-workout, post-workout, electrolyte powders

All of these require Dietary Supplement FSSAI Registration.

Dietary Supplements vs. Nutraceuticals vs. Drugs

These terms are often used interchangeably — but they mean different things.

Term	Definition	Regulated By
Dietary Supplement	Food-based product for nutritional support	FSSAI
Nutraceutical	Food-derived product with health benefits (e.g., fortified foods)	FSSAI
Drug/Medicine	Product that diagnoses, treats, or prevents disease	DCGI (Drugs Controller)

Key Difference:

If you say your turmeric capsule “supports joint health”, it’s a supplement (FSSAI).
If you say it “treats arthritis”, it’s a drug (DCGI).

FSSAI strictly prohibits therapeutic claims on supplement labels.

Are All Supplements Allowed?

No.

FSSAI maintains a list of approved ingredients and banned substances.

For example:

✅ Allowed: Curcumin, L-theanine, collagen peptides
❌ Banned: Ephedrine, steroids, prescription drugs in supplements

You must ensure your product formula complies with FSSAI guidelines for health supplements.

4. Why Dietary Supplement Manufacturers Need an FSSAI License

You might ask: “Can I sell supplements without a license if I’m a small business?”

The answer is no.

Just like any food product, dietary supplements must be licensed under the FSS Act, 2006.

Here’s why getting a Food Safety License for Supplements is not optional — it’s essential.

1. Legal Requirement Under FSS Act, 2006

Section 31 of the FSS Act states:

“No person shall commence or carry on any food business except under and in accordance with the validity of a license.”

This includes:

Manufacturing
Packaging
Selling
Importing
Distributing

Even if you run a small home-based business making herbal teas or protein bars, you must have at least a Basic FSSAI Registration.

Operating without a license is a criminal offense.

2. Avoid Heavy Fines and Shutdowns

FSSAI conducts regular raids and product testing.

If you’re caught selling supplements without a license:

Fine up to ₹5 lakh
Imprisonment up to 6 months
Product seizure
Business closure

In 2023, over 8,000 unlicensed supplement sellers were penalized across India — many were e-commerce startups unaware of the rules.

Don’t let ignorance ruin your brand.

3. Build Consumer Trust

Today’s buyers are smart.

Before buying a protein powder or vitamin D supplement, they check:

Is there an FSSAI license number?
Is the label clear and complete?
Does the brand look trustworthy?

The FSSAI logo on your pack signals that your product is safe, tested, and approved.

It builds instant credibility — especially in a market full of fake or low-quality supplements.

4. Required for Retail and E-Commerce Sales

Want to sell on Amazon, Flipkart, PharmEasy, or 1mg?

All major platforms require a valid FSSAI license before listing your product.

Supermarkets, pharmacies, and fitness stores also ask for it during vendor onboarding.

No license = No sales.

5. Enables Export Opportunities

Planning to export your ashwagandha capsules or plant protein to the UAE, USA, or UK?

Most countries require proof of FSSAI certification as part of import documentation.

Without it, your products won’t clear customs.

6. Ensures Product Safety and Quality

An FSSAI license forces you to:

Use safe, approved ingredients
Follow good manufacturing practices
Test products regularly
Label truthfully

This protects your customers — and your reputation.

One case of contamination or false claims can destroy years of hard work.

5. Types of FSSAI Licenses for Dietary Supplements

FSSAI offers three types of licenses, based on your annual turnover and production capacity.

Choosing the right one is critical. Get it wrong, and you could face penalties.

Here’s how to pick the correct FSSAI License for Dietary Supplements.

1. Basic FSSAI Registration

For: Small-scale or home-based supplement makers.

Applicable if:

Annual turnover is up to ₹12 lakh
Manufacturing capacity is up to 100 kg or 100 liters per day
Operating from a home kitchen or small facility

Examples:

Home-based herbal tea or churna makers
Small startups producing herbal capsules
Individuals selling supplements online in small batches

License Number Format: Starts with “1XXXXX”

Validity: 1 to 5 years

Fee: ₹100 per year

Inspection: Usually not required

This is the entry point for most new supplement entrepreneurs.

2. State FSSAI License

For: Medium-sized supplement manufacturers.

Applicable if:

Annual turnover is between ₹12 lakh and ₹20 crore
Production capacity is between 100 kg/liter and 2 MT per day
Operating in a single state

Examples:

Local supplement brands
SMEs with small factories
Startups scaling up production

License Number Format: Starts with “2XXXXX”

Validity: 1 to 5 years

Fee: ₹2,000 to ₹5,000 per year (varies by state)

Inspection: Required by State Food Safety Officer

Note: States like Maharashtra and Tamil Nadu charge higher fees.

3. Central FSSAI License

For: Large-scale or multi-state supplement manufacturers.

Applicable if:

Annual turnover is above ₹20 crore
Production capacity is above 2 MT per day
Operating in multiple states or exporting
Running a 100% Export Oriented Unit (EOU)

Examples:

National brands like HealthKart, TrueBasics, or MuscleBlaze
Companies supplying to pharmacies, gyms, or hospitals
Exporters of supplements to the Middle East or USA

License Number Format: Starts with “3XXXXX”

Validity: 1 to 5 years

Fee: ₹7,500 per year

Issued by FSSAI headquarters in Delhi, not the state authority.

How to Choose the Right License

Use this simple table:

Criteria	Basic	State	Central
Turnover	≤ ₹12 lakh	₹12 lakh – ₹20 cr	> ₹20 cr
Daily Production	≤ 100 kg/L	100 kg/L – 2 MT	> 2 MT
Operations	Single location	Single state	Multiple states/export
Inspection	Rarely	Yes	Always

Pro Tip: If you plan to grow fast, apply for a State or Central license early. Upgrading later takes time and effort.

Also, importers of dietary supplements must have a Central FSSAI License, even if turnover is low.

6. FSSAI Regulations for Dietary Supplements

Getting a license is just the start.

To stay compliant, you must follow FSSAI guidelines for health supplements.

These rules cover:

Approved ingredients
Labeling
Advertising claims
Testing and shelf life

Let’s break them down.

1. Approved Ingredients & Formulations

FSSAI maintains a list of permitted ingredients for dietary supplements.

You cannot use banned or unapproved substances.

Allowed Ingredients

Vitamins (A, C, D, E, B-complex, etc.)
Minerals (calcium, iron, zinc, magnesium)
Herbal extracts (ashwagandha, tulsi, brahmi)
Amino acids (L-arginine, creatine, BCAAs)
Probiotics (Lactobacillus, Bifidobacterium)
Omega-3, 6, 9 fatty acids
Fiber (psyllium, inulin)

Banned Ingredients

Ephedrine, steroids, stimulants
Prescription drugs (sibutramine, fenfluramine)
Heavy metals (lead, mercury, arsenic above limits)
Unapproved synthetic compounds

Rule: Always check the FSSAI Food Regulations before finalizing your formula.

2. Labeling Requirements (Critical!)

Every supplement label must follow FSSAI labelling requirements for supplements.

Missing information can lead to fines or product bans.

Mandatory Information on Label

Name of product (e.g., “Ashwagandha Capsules – 500mg”)
FSSAI license number (e.g., 123456789012)
FSSAI logo and mark
Name and address of manufacturer/importer
Batch or lot number
Date of manufacture and expiry
Best Before date
Net content (e.g., 60 capsules, 500g)
List of ingredients (in descending order)
Nutritional information (per serving)
Vegetarian/Non-vegetarian symbol (green or brown dot)
Allergen declaration (e.g., “Contains milk, soy”)
Usage instructions (e.g., “Take 1 capsule daily”)
Storage conditions (e.g., “Store in a cool, dry place”)
Disclaimers (see below)

Mandatory Disclaimers

FSSAI requires specific warnings on supplement labels:

“This product is not intended to diagnose, treat, cure or prevent any disease.”
“Not for use by pregnant or nursing women.” (if applicable)
“Consult your physician before use if you have a medical condition.”
“Keep out of reach of children.”

For herbal supplements:

“Excess consumption may lead to laxative effects.” (for aloe, senna, etc.)

For protein powders:

“Not a sole source of nutrition.”

Font & Language Rules

Text must be clear, legible, and in English or Hindi
Minimum font size: 1.5 mm (for small packs)
No misleading fonts or colors

3. Claims & Advertising Restrictions

You can’t say anything you want about your supplement.

FSSAI has strict rules on health claims.

✅ Allowed Claims (with proof)

“Supports immunity”
“Helps in muscle recovery”
“Rich in vitamin D”
“Contains antioxidants”

❌ Banned Claims

“Cures diabetes”
“Lowers cholesterol like statins”
“Better than medicine”
“Lose 10 kg in 1 month”

Rule: All claims must be scientifically substantiated and truthful.

FSSAI can ask for research papers or test reports to prove your claim.

4. Quality Testing & Shelf-Life Declaration

You must ensure your supplements are safe and stable.

Lab Testing Requirements

Test raw materials and finished products
Use NABL-accredited labs
Check for:
Microbial contamination
Heavy metals
Pesticide residues
Active ingredient potency

Shelf-Life Validation

You can’t guess the expiry date.
Must conduct stability testing under real conditions.

5. Good Manufacturing Practices (GMP)

All supplement manufacturers must follow GMP and GHP (Good Hygiene Practices).

Key requirements:

Clean, pest-free facility
Stainless steel equipment
Trained staff with health checks
Water quality as per BIS standards
Proper waste disposal

Large units must implement HACCP (Hazard Analysis and Critical Control Points).

7. Step-by-Step Process to Apply for FSSAI License

You can apply for FSSAI License for Dietary Supplements 100% online via the FoSCoS portal.

Here’s your complete guide.

Step 1: Visit the FoSCoS Portal

Go to: https://foscos.fssai.gov.in

This is the official FSSAI portal for all registrations and licenses.

Avoid fake websites — they may steal your data or charge extra.

Step 2: Create an Account

Click on “Register” and select:

Food Business Operator (FBO)
Enter your email and mobile number
Verify via OTP

You’ll get a User ID and password.

Step 3: Log In and Start Application

Select:

FBO Category: Manufacturer/Importer
Food Category: Dietary Supplements
License Type: Basic, State, or Central

Step 4: Fill the Application Form

The form has 5 parts:

Part A: Basic Details

Business name
Full address (with PIN code)
GST number (if any)
Email and phone
Business type (Proprietorship, Pvt Ltd, etc.)

Part B: Premises Details

Layout plan of facility
Water source details
List of machinery (mixers, capsule fillers, packaging machines)
Storage capacity

Upload:

Site plan (hand-drawn or digital)
Equipment list

Part C: Food Category

Select:

Primary Category: “Nutraceuticals & Dietary Supplements”
Sub-category: e.g., “Herbal Supplements”, “Protein Powders”
List all products (e.g., “Whey Protein Isolate 80%”, “Ashwagandha Capsules”)

Part D: Declaration

Confirm all information is true
Sign digitally or upload signature

Part E: Document Upload

Attach scanned copies of:

ID proof (Aadhaar, PAN)
Address proof (electricity bill, rent agreement)
Partnership deed or MOA (for companies)
NOC from municipality (if required)
Food Safety Management Plan
Lab test reports (for Central License)

We’ll cover documents in detail next.

Step 5: Pay the Fee

Fees depend on license type:

License	Annual Fee
Basic	₹100
State	₹2,000 – ₹5,000
Central	₹7,500

Payment options:

Debit/Credit Card
Net Banking
UPI

After payment, you’ll get an Application Reference Number (ARN).

Step 6: Inspection (If Required)

Basic Registration: Usually no inspection
State License: Inspection by Designated Officer (DO)
Central License: Inspection by Central Food Safety Officer (CFSO)

The inspector will:

Visit your facility
Check hygiene, equipment, and records
Submit a report

You’ll be notified 2–3 days in advance.

Step 7: Approval & License Issuance

If no inspection: License issued in 7–10 days
If inspection: Within 30 days of report submission
You’ll get a digital license certificate via email and FoSCoS account

License Validity: 1 to 5 years (choose during application)

Tips for Faster Approval

Fill the form correctly
Upload clear, legible documents
Ensure your facility meets hygiene norms
Respond quickly to queries

Avoid rushing at the last minute. The process can take 2–6 weeks for State/Central licenses.

8. Documents Required for FSSAI License for Dietary Supplements

You can’t apply without the right documents.

Here’s a complete list.

For All Applicants

Photo ID Proof (Any one):

Aadhaar Card
PAN Card
Voter ID
Passport

Address Proof of Premises:

Electricity Bill
Rent Agreement + NOC from owner
Property Tax Receipt
Municipal Trade License

Passport-Size Photograph of the FBO
List of Food Products to be manufactured (e.g., “Multivitamin Tablets”, “Herbal Detox Capsules”)
Food Safety Management Plan (SOP for hygiene, testing, storage)

Proprietorship/Firm

PAN Card of Business
Partnership Deed (for firms)
Declaration Form (signed by proprietor)

Companies (Pvt Ltd, LLP, etc.)

Certificate of Incorporation (COI)
Memorandum & Articles of Association (MOA & AOA)
Board Resolution authorizing the FBO
PAN Card of Company
List of Directors with IDs

Additional Documents (If Applicable)

NOC from Municipality or Panchayat
Layout Plan of Premises (showing production, storage, packaging areas)
Equipment List (with capacity)
Water Test Report (from NABL lab)
Source of Raw Materials (supplier licenses)
Import Export Code (IEC) (for importers/exporters)

For Central License Only

Recall Plan (how you’ll handle defective batches)
Lab Test Reports for 2–3 product batches
GMP/HACCP Certification (for large units)

Pro Tip: Keep scanned copies ready in PDF or JPG format (max 2 MB each).

Upload everything neatly. Missing documents cause delays.

9. Cost of FSSAI License for Dietary Supplement Units

How much does it cost to get FSSAI for Nutraceutical Products?

Here’s a clear breakdown.

1. Government Fees

License Type	Annual Fee	Max Validity	Total Cost (5 Years)
Basic Registration	₹100	5 years	₹500
State License	₹2,000 – ₹5,000	5 years	₹10,000 – ₹25,000
Central License	₹7,500	5 years	₹37,500

Note: Some states charge more (e.g., Karnataka: ₹4,000/year).

2. Additional Costs

a) Consultant Fees

₹5,000 – ₹15,000 (optional but helpful for first-timers)

b) Lab Testing

Ingredient testing: ₹2,000 – ₹5,000 per batch
Shelf-life testing: ₹5,000 – ₹15,000 per product

c) Equipment & Facility Setup

Capsule filling machine: ₹1–5 lakh
Packaging machines: ₹50,000+
GMP-compliant facility: ₹5–20 lakh+

d) Label Design & Printing

Professional labels: ₹10,000 – ₹50,000

e) NOC & Approvals

Fire NOC, Pollution Board NOC (for large units): ₹5,000 – ₹20,000

Total Estimated Cost

Business Size	Total Setup + License Cost
Home-based (Basic)	₹10,000 – ₹50,000
Small Factory (State)	₹2 – 5 lakh
Large Plant (Central)	₹10 lakh+

You can start small and upgrade later.

10. Renewal & Modification of License

Your license expires after 1–5 years.

You can renew it before expiry.

Renewal Process

Log in to FoSCoS portal
Go to “Renew License”
Fill the form
Pay renewal fee
Submit

Timeline:

You can apply up to 30 days before expiry
If your License expired, renew within 180 days with a late fee (₹100/day)
After 180 days, reapply from scratch

Modifying Your License

Need to make changes? You can modify your license.

Change	Process
Add new products	Submit updated product list
Increase capacity	Upgrade to higher license
Change address	Submit new address proof
Change business name	Provide registration certificate
Switch from State to Central	Reapply under new category

All modifications are done online via FoSCoS.

11. Penalties for Non-Compliance

Ignoring FSSAI rules can cost you big.

Common Violations

Selling without license
Mislabeling ingredients
Making false health claims
Using banned substances
Selling expired supplements

Fines & Punishments

Offense	Penalty
No license	₹5 lakh fine or 6 months jail
Misbranded product	₹3 lakh fine
Substandard product	₹5 lakh fine
False advertisement	₹10 lakh fine
Repeat offense	Double penalty + license cancellation

12. Benefits of Getting FSSAI License for Dietary Supplements

Why go through the process?

1. Legal Protection

Operate without fear of raids

2. Builds Brand Trust

Consumers prefer FSSAI-marked products

3. Easier Market Access

Listed on Amazon, Flipkart, PharmEasy

4. Export Readiness

Required for international sales

5. Funding Eligibility

Banks prefer licensed businesses

6. Digital Credibility

Boosts SEO and online trust

13. Common Mistakes to Avoid

1. Using Banned Ingredients

Always check FSSAI’s approved list.

2. Not Testing Products

Never skip lab tests.

3. Making False Claims

Say “supports” — not “cures.”

4. Poor Labeling

Missing disclaimers = penalty.

14. Tips for Smooth Approval

Keep ingredient records
Conduct regular lab tests
Train staff in compliance
Use NABL labs
Update FoSCoS profile

15. FAQs: FSSAI License for Dietary Supplements

Q1. Is FSSAI license mandatory for selling imported supplements?

Yes. Importers need a Central FSSAI License.

Q2. Can small home-based supplement makers get FSSAI registration?

Yes. Apply for Basic Registration if turnover ≤ ₹12 lakh.

Q3. How long does the process take?

Basic: 7–10 days
State: 15–30 days
Central: 30–60 days

Q4. Is BIS certification also required?

No. Only FSSAI is mandatory for supplements.

Q5. Can I sell on Amazon without FSSAI license?

No. Amazon requires a valid FSSAI license.

16. Conclusion: Get Licensed, Grow Confidently

The FSSAI License for Dietary Supplements is your gateway to a safe, legal, and scalable business.

From home-based herbal sellers to national supplement brands, compliance is non-negotiable.

We’ve covered:

What counts as a supplement
Which license you need
How to apply online
Labeling rules and penalties
How to avoid common mistakes

Now, take action.

Get your Dietary Supplement FSSAI Registration today and build a brand that stands for quality, safety, and trust.

Need Help with FSSAI License?

Applying for the first time? Facing compliance issues?

We offer expert FSSAI consultancy for supplement businesses — from document prep to FoSCoS filing and inspection support.

📞 Call us or ✉️ Email today for a free consultation.

Let’s make your supplement dream safe, legal, and successful.

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