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Food safety and compliance obligations are not only a legal requirement, but a prerequisite to any food or nutraceutical business in India. The Food Safety and Standards Authority of India (FSSAI) demands strict adherence to comply with the FSS Act, 2006 particularly through the regulator's registration license for the manufacture, distribution, storage, sale or import of a food product. Therefore, regardless of whether you are launching a ready-to-drink supplement, an herbal nutraceutical product, a protein bar, or any other health product, FSSAI compliance is a must before launching the product in the market, even when exporting outside India.

FSSAI Compliance Services for Food, Beverage & Nutraceutical Startups in India

Regulation, June 07, 2025

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Food safety and compliance obligations are not only a legal requirement, but a prerequisite to any food or nutraceutical business in India. The Food Safety and Standards Authority of India (FSSAI) demands strict adherence to comply with the FSS Act, 2006 particularly through the regulator’s registration license for the manufacture, distribution, storage, sale or import of a food product. Therefore, regardless of whether you are launching a ready-to-drink supplement, an herbal nutraceutical product, a protein bar, or any other health product, FSSAI compliance is a must before launching the product in the market, even when exporting outside India.

What is FSSAI Compliance?

FSSAI compliance means complying to the safety, quality and labelling guidelines set out under the Food Safety and Standards Act, 2006. All entities that perform food, beverage, nutraceutical, or functional product formulations needs to comply with FSSAI and have a registration or license prior to entering the market.

Consequences of non-compliance with FSSAI may include:

  • License cancellation or rejection
  • Product recalls
  • Financial penalties
  • Criminal prosecution where serious breaches have occurrence [1]

Who Needs FSSAI Compliance Services?

FSSAI registration or licensing is mandatory for

All manufacturers, marketers and brand owners, traders and wholesalers, food business operators (FBOs), nutraceutical companies, functional beverage startups, importers and exporters, cloud kitchens, and direct-to-consumer (D2C) food brands must register or be licensed by the FSSAI. Whether you are a start-up or a business of size, FSSAI Compliance cannot be avoided.

Types of FSSAI Licenses

Depending on the size and kind of food operation businesses will need to apply for:

Quality Guidelines (Q Series)

The ICH guidelines cover every pharmacist quality element from manufacturing, analytical validation, risk management and Good Manufacturing Practice (GMP). The major documents are:

  • Basic Registration: For small-scale operators and home businesses or local vendors with annual turnover less than INR 12 lakhs.
  • State License: For medium enterprises, annual turnover between INR 12 lakhs and INR 20 crores, that operates in only one state.
  • Central License: For large businesses, annual turnover exceeding INR 20 crores, importers and exporters.
 
FSSAI Compliance Services for Food, Beverage & Nutraceutical Startups in India

It is important to know what license you need, because an incorrect classification would lead to delayed responses and unnecessary legal ramifications. [2]

Key FSSAI Compliance Services Offered

  1. License Application and Documentation Support
  • Preparation and submission of Forms A or B
  • Collect and validate supporting documents: ID proof, proof of premises, layout plan, food items category list, equipment list, etc.
  • Filing of online application through the FSSAI portal
  1. Product Label and Packaging Review
  • Completing a compliance verification assessment against FSSAI’s Food Safety and Standards (Packaging and Labeling) Regulations, 2011.
  • Review for compliance with FSSAI logo and license number, ingredient declaration, nutritional information, allergens
  • Review and assistance with barcoding and batch coding
  1. Ingredient and Product Dossier Preparation
  • Review of ingredients for scientific evaluation for approval by FSSAI under their norms as outlined in the Standards
  • Preparation of technical dossier containing CoA, clinical studies, and safety data
  • Nutraceutical compliance under Section 22 provision under the FSS Act
  1. Facility and Hygiene Audits
  • Internal audits against GMP and GHP compliance.
  • Risk assessment and risk mitigation plans prepared
  • A training module for understanding how best to inform your staff to comply with food safety standards.
  1. Import/Export Compliance Support
  • Documentation for import clearance
  • Compliance for imports in labelling
  • Regulatory mapping for a product with dual jurisdiction (e.g., FSSAI + AYUSH), if applicable
  1. Ongoing Compliance and License Renewal
  • Annual periodic compliance checks
  • Filing for renewal and paying fees
  • Queries from FSSAI and show cause notices responded to. [3] [4]

FSSAI for Specialized Sectors

Nutraceuticals and Health Supplements

  • Products classified as Schedule VI of Nutraceutical Regulations will require additional scrutiny
  • Only approved additives and nutraceutical ingredients may be permitted
  • Labeling claims must be backed up by science

Functional Beverages

  • Water based drinks, energy drinks, and probiotic beverages fit into different categories
  • Stability studies, pH, microbiological and shelf-life validations are needed.

Ayurvedic & Herbal Products

  • There is often dual compliance jurisdiction (FSSAI + AYUSH) to be aware of.
  • Qualified help is required to classify and register properly [5]

Documentation Checklist

  • Form A/B
  • Layout and Equipment Plan
  • List of Directors/Partners
  • Food Category/Product List
  • Water Test Report (for manufacturers)
  • Food Safety Management Plan
  • Authorisation Letter to Consultants
  • Product Labels and Specifications

Common Compliance Challenges

  • Ingredient Non-Approval: Using non-permitted additives or herbal extracts
  • Labeling Issues: Non-FSSAI logo, no license number, misleading claims
  • Improper Licensing: Obtaining a lower-level license while running a large-scale operation
  • Renewal Issue: There are renewal compliance issues with getting your renewals done (don’t miss the 30-day renewal before your license expiry).
  • Cross regulatory misclassification: Particularly in relation to products that can be both AYUSH and FSSAI [6]

Why Choose Us for FSSAI Compliance?

Our compliance team provides:

  • Complete regulatory support: License acquisition to post approval
  • Cross-sector experience: Nutraceuticals, functional beverages, and Ayurveda products
  • Scientific documentation: Technical Dossiers, CoA handling and ingredient rationales
  • Audit support: Facility visits, mock inspections, and compliance checklist
  • Labeling design review: Packaging proof(s) that are 100% compliant

We will not just get you meet FSSAI compliance but put you on a fast track for approval and market-ready timing.

Get Started Today

FSSAI compliance is the legal foundation of your food business and marketplace legitimacy. Whether you are bringing out a new product, or scaling your existing operation, our FSSAI Compliance Services will make sure you meet your compliance obligations on time.

Contact Us today for a free consultation, or to download our complete compliance checklist.

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