How To Formulate A Nutraceutical Product With FSSAI Approval

The wellness market is booming.
People no longer want sugar-packed drinks or empty-calorie capsules.
They want smart nutrition and clean-label nutraceuticals that work.

But here’s the truth:

• A good product idea is not enough.
• If it’s not FSSAI-compliant, it won’t go far in India or even internationally.

So, if you’re a startup, food brand, or health entrepreneur looking to launch a nutraceutical product, or searching for how to formulate a nutraceutical product, this guide will walk you through the real process—from formulation to full FSSAI approval—most simply and smartly as possible.

Step 1: Understand What Counts As A Nutraceutical

Let’s clear it up first.
Nutraceuticals are not just supplements or protein powders.
They include:

• Functional drinks (energy, immunity, sleep)
• Herbal extracts
• Fortified foods (with vitamins, minerals, omega-3s, etc.)
• Capsules, tablets, bars, sachets with health 

In India, all of this falls under FSSAI’s Food for Special Dietary Use (FSDU) or Nutraceutical Category 13.6.

2025 Update:
The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2022, are now being enforced with updated ingredient limits, label scrutiny, and new submission portals.

Step 2: Choose Ingredients That FSSAI Approves

Not every “healthy” ingredient is legal.
You can only use ingredients listed in Schedules I to VIII of the FSSAI regulations.

For example:

• Ashwagandha, Ginseng, Curcumin, Garcinia – Approved herbs
• Vitamins A, B, C, D, E – Approved within RDA limits
• Yohimbe or other restricted stimulants – Not allowed

Key Rule:
Your ingredients must stay within the RDA (Recommended Daily Allowance) limits defined by the Indian Council of Medical Research (ICMR).
Overdosing—even on a vitamin—can get your product rejected.

Step 3: Work On A Smart, Stable, And Effective Formulation

How to formulate a nutraceutical product is not something to worry about when you have the right food consultant by your side. Now comes the magic. Formulation.

This is where your product must:

• Tastes good (especially if it’s a drink)
• Stay stable (no separation or settling)
• Stay potent (ingredients must not degrade over time)
• It is safe to consume daily

Tips:

• Use standardized herbal extracts (not raw powders)
• Choose natural sweeteners like stevia or dates
• Add functional blends like adaptogens + vitamins + fibers for better value
• Always maintain scientific backing for any ingredient

Don’t try to do this alone; formulation consultants and food scientists can help you get it right from day one.

Step 4: Lab Testing Is A Must

Once your sample of nutraceutical product formulation is ready, test it through an NABL-accredited lab.

They’ll check:

• Nutrition profile (does it match the label?)
• Stability (how long will it last?)
• Heavy metals, toxins, and microbial safety.
• Caffeine levels (if added)—shouldn’t exceed 145 mg per 300 ml.

Note:
If you claim “Supports immunity” or “Boosts energy”, FSSAI expects supportive data or peer-reviewed studies.

Step 5: Get Your FSSAI Product Approval

Here’s what you’ll need:

• FBO (Food Business Operator) License – Register on FoSCoS portal
• Product Dossier – Includes ingredient details, testing reports, label samples
• Declaration – That you follow FSSAI and GMP (Good Manufacturing Practices)

FSSAI checks everything:

• Are your ingredients approved?
• Are you within RDA limits?
• Does your label have any misleading claims?

Once approved, your product gets listed as FSSAI-licensed, and you can go to market!

Step 6: Create A Compliant Label (Don’t Skip This!)

Your label is more than just design. It’s a legal document.

You must show:

• Ingredient list (common names + botanical names for herbs)
• Nutritional table (per serving)
• “Nutraceutical Product” is mentioned
• FSSAI License number
• Shelf life
• Serving size and directions

Avoid These Mistakes:

•  Don’t say “cures” or “treats” diseases
• Don’t hide caffeine or sweetener types
• Don’t copy foreign labels without checking Indian rules

Step-by-Step FSSAI Approval Process for Nutraceuticals

Getting FSSAI approval for nutraceuticals is essential, but can feel confusing. This step-by-step guide makes it simple, showing you exactly what to do at each stage. From paperwork to license approval, learn how to launch your products smoothly, safely, and successfully in the market.

1. Check Your Product Category

• Nutraceuticals fall under categories like Health Supplements, Nutraceuticals, Food for Special Dietary Use (FSDU), and Food for Special Medical Purpose (FSMP.
• If your product has complex formulations or claims to treat/cure diseases, it may need approval from the Central Drugs Standard Control Organisation (CDSCO) instead. 

Use Only Approved Ingredients

• Ingredients must be listed in Schedules I to VIII of the FSSAI Nutraceutical Regulations.
• Nutrients (like Vitamin C, Iron) must follow ICMR RDA limits.
• No pharmaceutical ingredients are allowed.
• Any herbal/botanical ingredient should be backed by traditional or scientific evidence.

2. Gather All Required Documents

You’ll need:

• Product formula and ingredient list. 
• Safety and efficacy data (scientific studies, lab reports)
• Details of the manufacturing facility and quality controls
• Packaging and labeling drafts (with nutrition facts, claims, warnings)
• Proof of business (company documents, address, license)

3. Apply Online via the FoSCoS Portal

• Visit the FSSAI FoSCoS portal.
• Select your business type and product category.
• Fill out Form B with all product, business, and manufacturing details
• Upload documents and pay the application fee (Rs. 50,000 for nutraceutical registration as of 2025)

4. Product Review and Safety Assessment

• FSSAI reviews your application, focusing on ingredient safety, scientific backing, and label compliance
• For new or novel ingredients, you must provide extra safety and efficacy data.
• FSSAI may ask for clarifications or additional documents.

Claims Must Be Backed by Science

• You can’t claim to treat or cure any illness (e.g., “cures diabetes”)
• You can claim support like “Helps boost energy” or “Supports immune health.” 
• Claims should be supported by scientific studies or published data.

5. Inspection and Approval

• Your facility may be inspected for hygiene, GMP (Good Manufacturing Practices), and record-keeping
• If all requirements are met, you’ll receive an FSSAI license or product registration certificate.

Label: According to FSSAI

Your product label must include:

• “Nutraceutical” is clearly stated
• FSSAI License Number
• Serving size and usage instructions
• Nutritional values per serving
• Ingredients list (with botanical names if herbs are used)
• Expiry and manufacturing date
• Warning or caution, if applicable (e.g., not for pregnant women, kids, etc.)

6. Ongoing Compliance

• After approval, you must follow all FSSAI rules, including periodic audits, updated labeling, and quality checks.
• Any change in the formula or claims needs FSSAI notification and sometimes fresh approval.

2025 FSSAI Updates You Should Know

• Nutra Regulations are under review, but until finalized, follow the 2016 guidelines and interim orders.
• Broadcast ads for nutraceuticals must be self-certified via the Ministry of Information & Broadcasting portal.
• Mandatory self-certification for video ads through MIB’s Broadcast Seva platform
• Influencer marketing is now monitored — claims must be compliant.
• FSSAI is now actively removing non-compliant products from shelves and e-commerce platforms
• FSSAI now uses the Indian Nutraceutical Regulatory Portal (INRP) for product approval
• Any product with grey-area herbs or borderline medicinal claims will need AYUSH clearance too.

Updated Blog 2025: Nutraceutical Beverage Formulation Guide (2025–26)

Want The Ultimate FSSAI Compliance Checklist For Nutraceuticals (2025 Edition)?

Get your FREE FSSAI Compliance Checklist for Nutraceuticals! 

Build A Brand That’s Trusted, Tested, And Approved

The Nutraceutical market in India is on fire, but also under the microscope.
FSSAI is serious about quality, safety, and truth. So, if you want to launch a successful nutraceutical product, do it right— Not just for approval, but for the people who will trust your label every day.

No more worries about how to formulate a nutraceutical product, lab testing, or FSSAI filing? Contact us now at +91 8130404757 and get the approach to your formulation and successful product launch.  Our expert consultants at Foodsure are here to guide you, so launch your nutraceutical products now. Get the step-by-step and bottle-to-shelf smart solutions. Book your free consultation now. 

FAQs

What is the FSSAI approval process for nutraceuticals?
The process involves formulating a compliant product, preparing necessary documents, submitting an application via FoSCoS, and FSSAI review. Approval is granted if all regulatory requirements are met.

What documents are required for FSSAI nutraceutical approval?
Key documents include product formulation details, Certificates of Analysis for raw materials and final product, manufacturing process info, draft labeling, and FSMS declaration.

How long does it take to get FSSAI approval for a nutraceutical?
Typically, approval takes 3–6 months, depending on application completeness and product complexity. Accurate documentation helps speed up the process.