What is FSSAI Registration?
The requirement for every Food Business Operator to obtain an FSSAI license or registration is explicitly stated in Section 31(1) of the Food Safety and Standards Act, 2006, which states that "No person shall commence or carry on any food business except under a License". This applies to all businesses, regardless of size, from large manufacturers and importers to petty retailer. Food Safety and Standards Act, 2006 for businesses involved in manufacturing, importing, marketing, distributing, relabelling, storing, or selling food products in India, including nutraceuticals, health supplements, and dietary products.
Why It Matters and When Do You Need
FSSAI compliance supports lawful market access, labeling accuracy, and smoother distribution for nutraceutical and health supplement products.
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Ensures Legal Operation & Avoids Penalties
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Builds Consumer Trust & Market Credibility
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Enables Listing on Major E-commerce & Retail Platforms
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Essential for Import Clearance & Interstate Distribution
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Ensures Label, Ingredient & Claim Compliance
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Protects Public Health
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Manufacturing nutraceuticals or health supplements
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Importing dietary supplements into India
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Repacking or relabelling food supplements
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Selling products online or offline
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Conducting third-party manufacturing
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Operating warehouses or distribution units
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Launching protein powders, herbal supplements, gummies, vitamins, probiotics, etc.
Types of FSSAI Approval
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Basic Registration: Small food businesses with low turnover (up from ₹12 lakh)
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State License: Medium-scale manufacturers, marketers, traders (up from ₹12 lakh – ₹20 crore)
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Central License: Importers, large manufacturers, multi-state operators, e-commerce food businesses (above ₹50 crore)
Key Challenges and Our Approach
We help nutraceutical and health supplement businesses address classification, documentation, labeling, and FoSCoS filing issues with a structured compliance approach.
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Incorrect product classification
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Non-permitted ingredients under nutraceutical regulations
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Excessive vitamin/mineral dosage issues
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Non-compliant claims such as “treats diabetes” or “cures arthritis”
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Label non-conformities
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Import clearance delays
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Incomplete technical documentation
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FoSCoS application rejection
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Regulatory queries from authorities
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Confusion between drug and nutraceutical categories
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Product and Ingredient Compliance Assessment
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Regulatory Documentation Preparation
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FoSCoS Application Filing and Submission
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Regulatory Query Management and Approval Support
What You Will Get and Case Example
End-to-end support for FSSAI registration, FoSCoS filing, classification, documentation, and labeling readiness.
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Assistance with FSSAI Registration applications
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Support for filing on the FoSCoS portal
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Preparation of documentation checklists
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Assessment of applicable business category and licensing requirements
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Guidance on nutraceutical product classification
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Review of label compliance
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Support for ingredient and claim assessments
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Regulatory consultation services
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Application tracking and follow-up
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Recommendations for compliance improvements
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Challenge: A startup nutraceutical company planned to launch herbal health supplements through online marketplaces but faced challenges in identifying the correct FSSAI product category, understanding documentation requirements, and ensuring labeling compliance with applicable regulations.
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Our Approach: Tacit MedTek reviewed the product portfolio, assessed ingredient applicability under FSSAI regulations, prepared the required registration documents, and guided the client on compliant label declarations and FoSCoS submission procedures.
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Outcome: The client successfully obtained the applicable FSSAI registration/licence, implemented compliant product labeling, and launched products in the Indian market with improved regulatory readiness and confidence.
Why Choose Tacit Medtek
Reliable support for nutraceutical and food regulatory compliance, from documentation to submission and follow-up.
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Expertise in nutraceutical and food regulatory compliance
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In-depth knowledge of FSSAI regulations and FoSCoS system
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Complete support for documentation and submission
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Tailored regulatory solutions for startups and manufacturers
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Efficient and professional coordination
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Assistance with labeling and product compliance
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Dedicated consulting support throughout the process
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Extensive experience with health supplements and nutraceuticals
FAQ
Frequently Asked Questions
A Risk Management Plan (RMP) is a regulatory document describing identified and potential safety risks associated with a product along with proposed risk minimisation activities.
PSUR (Periodic Safety Update Report) and PBRER (Periodic Benefit-Risk Evaluation Report) are periodic safety reports prepared for marketed products to evaluate ongoing product safety and benefit-risk balance.
No. Our support is focused on pharmacovigilance documentation and regulatory reporting support activities.
Yes. We support preparation and review of pharmacovigilance SOPs and process documentation.
Yes. Existing PV documentation can be reviewed for consistency and regulatory alignment.
Yes. We support preparation and compilation of PSUR / PBRER documentation.
Yes. Support is available for updating safety-related documentation during product lifecycle activities.
Support can be provided for pharmaceutical products requiring post-marketing safety documentation activities.
Yes. We support review and gap assessment of available PV documentation and procedures.
Support can be provided for preparation of pharmacovigilance documentation aligned with applicable market requirements.
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