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, the Food Safety and Standards Authority of India (FSSAI).
Because these food products contain concentrated nutrients, bioactives, or health-related claims, the approval process is more detailed.
This guide will provide you with comprehensive information on FSSAI registration for nutraceutical and functional food products, covering product classification, formulation, 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 purposes, 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 the 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 a turnover of 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, exceeds 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 the 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.
Read More: How Food Consultants Simplify Food Safety Regulations For You
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 products need FSSAI registration under nutraceutical and functional food rules?
Products like nutraceuticals, functional foods, health supplements, FSDU, probiotics, prebiotics, and novel foods require FSSAI registration.
Which type of FSSAI license is required for nutraceutical manufacturing?
Depending on turnover and scale, you may require Basic Registration, State License, or Central License.
What testing is needed for nutraceutical products before FSSAI approval?
Microbial testing, heavy-metal residue testing, nutritional verification, and stability/shelf-life testing are required.
Are all ingredients allowed in nutraceutical products under FSSAI?
Only ingredients from FSSAI’s approved list are allowed. Novel or unlisted ingredients require special approval.
Can nutraceutical products claim to cure diseases?
No. FSSAI prohibits disease-cure or therapeutic claims for nutraceutical and functional food products.
What information must be on a nutraceutical product label?
Labels must include nutritional information, ingredient list, allergens, serving size, license number, and required disclaimers.
What documents are required for FSSAI nutraceutical licensing?
Documents include formulation details, ingredient list, COA/test reports, premises proof, label drafts, and manufacturing details.
What is the process for FSSAI approval of nutraceutical products?
Submit an application on the FoSCoS portal, upload all documents, respond to queries, and receive approval after compliance checks.
Do startups also need FSSAI registration for nutraceutical products?
Yes. Every nutraceutical manufacturer, including startups, must obtain FSSAI registration or license.
What are the consequences of non-compliance with FSSAI regulations?
Non-compliance can lead to license rejection, cancellation, product recall, penalties, or restrictions on sale.
