How To Register Your Functional Food Or Nutraceutical Product with FSSAI?

FSSAI registration for nutraceutical and functional food products

June 26, 2025

India’s wellness market is at its peak, and with it, the demand for functional foods and nutraceuticals is also rising. They have become a regular part of the consumer’s routines. But before any such product can be sold, it needs to meet the standards set by the apex body, Food Safety and Standards Authority of India (FSSAI).

Because these food products include concentrated nutrients, bioactives, or health-related claims, the process for getting them approved is more detailed.

This guide will help you know everything related to FSSAI registration for nutraceutical and functional food products, from product classification and formulation to testing, documentation, and final approval.

Key Regulations For Nutraceutical And Functional Food Products

The Food Safety and Standards Authority of India (FSSAI) looks after food safety nationwide. It sets the standards for all the food products, including nutraceuticals and functional foods, under the Food Safety and Standards Act, 2006. The main FSSAI regulations are:

All nutraceuticals and functional food regulations in India are regulated by the FSSAI under the Food Safety and Standards Act, 2006.
The FSSAI Nutra Regulations (2016, updated 2022/2024) define product categories, permissible ingredients, labeling, and claims.
Only approved ingredients can be used; new ingredients require FSSAI approval with safety data.
Products must fit into defined categories, like, health supplements, nutraceuticals, foods for special dietary or medical use, probiotics, or prebiotics.
Labels must follow FSSAI guidelines and include all required information.
Disease prevention or cure claims are not allowed; only general well-being or function claims with scientific facts are permitted.
Good Manufacturing Practices (GMP) are mandatory.
Apply online via the FoSCoS portal with all required documents and scientific evidence.
FSSAI reviews safety, labeling, and claims before granting a functional food or nutraceutical license in India.
Maintain standards, update FSSAI on changes, and expect regular audits.

Related Blog: FSSAI Compliance For Food Startups

How To Do FSSAI Registration For Nutraceutical And Functional Food Products?

The process of licensing and FSSAI registration for nutraceutical and functional food products is conducted through the Food Safety Compliance System (FoSCoS) portal. The FSSAI registration and licensing process includes:

Understand The Categories As A Functional Food Or Nutraceutical

Before registering, brands must first categorize their product correctly under FSSAI’s Food Safety and Standards, like health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional foods, and novel foods.

Categories Include:

Functional Foods: Products that provide health benefits more than basic nutrition.
Nutraceuticals: Products extracted or purified from food sources that provide physiological benefits (e.g., omega-3 capsules, curcumin tablets).
Health Supplements: FSSAI compliance for health supplements, like vitamins, minerals, amino acids, botanicals, enzymes, or probiotics meant to supplement diet.

Choose the Correct Type of FSSAI License

Depending on your business size, turnover, and manufacturing type, you will need to select the FSSAI license type:

Basic FSSAI Registration: For businesses with an annual turnover of less than ₹12 lakh.
State FSSAI License: For turnover between ₹12 lakh and ₹20 crore, or if operating in one state.
Central FSSAI License: For manufacturers, exporters, or importers with turnover more than ₹20 crore or operations in multiple states.

For any functional food or nutraceutical product with novel ingredients or health claims, you must apply for product approval under FSSAI’s Nutraceutical Division in addition to the FSSAI license.

Formulate the Food Product As Per The FSSAI Ingredient Guidelines

The food recipe formulation consultants make sure that all the ingredients in the food meet the FSSAI ingredient guidelines:

Use approved ingredients and additives listed under Schedule VI of the 2016 regulations.
Respect maximum permissible limits for vitamins, minerals, and bioactives.
Make sure that there is no use of prohibited substances like hormones, steroids, or psychotropic compounds.

Conduct Lab And Stability Testing Of Nutraceutical Or Functional Food

FSSAI needs the nutraceutical or functional food products to be proven scientifically and to be safe for human consumption. Therefore, the lab and stability testing are important for

Microbial contamination
Heavy metal residues
Nutritional composition verification
Shelf life and stability under different conditions

Prepare Documentation For FSSAI Food Product Approval

If your nutraceutical or functional food product contains novel ingredients, exceed permissible limits, it falls under the FSSAI product approval system.

Checklist Of Documents Required For FSSAI Food Product Approval

Photo ID of the Food Business Operator
Proof of premises (like a rent agreement or sale deed)
Company formation documents (Partnership Deed, Certificate of Incorporation)
List of all products (ingredients and finished goods)
Food safety management plan
Layout of your processing unit
List of machinery and equipment
Water analysis report (if water is an ingredient)
Details of food product formulation and manufacturing process (with active ingredients and dosages)
Scientific evidence of safety and efficacy (published studies, clinical trials)
Certificate of analysis (COA) from NABL-accredited labs
Ingredient sourcing and quality documents
Packaging and labeling details
Declaration of conformity to FSSAI regulations

Submit Your Application Through FoSCoS Portal

Once your documents are ready, submit your application on:

Register your business on https://foscos.fssai.gov.in
Select food product category- Health supplement, Nutraceutical, Functional food, and more.
Upload documents and pay the required fees.
Track your application status online.

Always cross-check your documentation with the latest FSSAI advisories and Q&A circulars. The authority regularly updates norms, particularly for botanicals, probiotics, and dosage limits. Get in touch with the food formulation experts as they help you to remain updated with the new FSSAI rules and regulations.

Review And Respond To Queries From The FSSAI Panel

FSSAI may raise queries or ask for clarification during the verification process. These can be:

Scientific evidence for health claims
Ingredient safety (ADI, NOAEL, toxicity reports)
Product stability or manufacturing standards

Have a nutraceutical formulation consultant who is ready to respond to all these queries, as poorly framed responses can delay approvals or result in rejections.

Final Approval and License Granting

If everything is perfect:

You’ll receive a product approval certificate, valid for the approved formulation.
You can proceed with manufacturing, packaging, and marketing using your FSSAI Central or State License.
Approved products get a Unique Product Code (UPC), which must be quoted on the label.

Make Sure Of The Labelling Compliance

Labelling is important, especially for functional foods and nutraceuticals. FSSAI mandates the following:

Ingredient list with active concentrations
Recommended daily intake (RDI)
“Not for Medicinal Use” disclaimer
Storage instructions
Allergen declarations

Post-Market Surveillance And Renewals

After registration, you must:

Conduct periodic testing of batches.
Maintain manufacturing and batch records.
Renew your FSSAI license every 1–5 years, depending on type.
Stay updated with regulatory amendments.

A quality assurance system (HACCP, GMP) in place increases credibility and ensures continued compliance.

Still Have Queries? Book Your Free Consultation With FSSAI Consultants Today!

Bringing a functional food or nutraceutical to market is not just about having a great product that is tasty and appealing; it’s about getting every detail right with FSSAI. If you’re unsure about where to start, what documents you need, or how to avoid delays in registration, we’re here to simplify it all.

At Foodsure, our food formulation consultants don’t just advise, they walk with you from concept to compliance. In one free session, you’ll get answers customized to your product, your category, and your goals. Send us your queries on +91 8130404757

Book your free consultation today and take the first step toward FSSAI approval, done properly.

FAQs

What is the process to register a functional food or nutraceutical with FSSAI?

Classify your product correctly, make sure it uses approved ingredients, conduct lab testing, prepare scientific documents, and apply via the FoSCoS portal. Products with novel ingredients or health claims also need separate FSSAI product approval.

When is FSSAI product approval required?

Approval is required if your product uses unlisted ingredients, exceeds nutrient limits, or includes health claims. You’ll need to submit safety data, testing reports, and scientific references.

Can a consultant help with FSSAI registration?

Yes. A consultant makes sure the correct classification, prepares documents, supports testing, and handles FSSAI queries, helping you avoid delays and improve approval success.