Food and Food Supplements Regulatory Services in India


The food industry in India is expected to witness unprecedented growth in the coming years due to many factors that may vary from increased health consciousness, changes in the eating habits, and the rise in demand for sedentary lifestyle. Despite the market growth, food business operators face multiple challenges to obtain the Food Safety and Standards Authority of India– FSSAI license, Food Import and Food product approval.

FSSAI, over the years, has been trying to set up a self-compliant culture in the food industry where the FBO is responsible for the product safety and information available on his product label including having strong data on manufacturing, control and claims. Although the regulations are in place for FSSAI food license, the challenge lies in comprehending the regional compliance requirements related to food composition, sourcing ingredients and advertising restrictions on special foods and infant foods.

Recently, the FSSAI has revised nutraceutical regulations, which covers 8 categories of functional foods i.e., Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Novel Foods, Foods containing Probiotics and Prebiotics, Speciality food containing plant or botanicals. All of the Food Business Operators need to comply with the recent regulation with effect from 1st April, 2022.

To make a compliant market-entry, the food or food supplements are obliged to be validated in compliance with Indian regulations. If the product is not a novel food and is able to comply with the requirements listed in the regulations along with the product composition in terms of the ingredients used, additives and their limits, then it can be simply launched in the Indian market without any need of official product approval from Indian Food Authority (FSSAI).

Freyr with in-depth knowledge of FSSAI regulations, provides Regulatory support to food and food supplement manufacturers. Freyr’s Regulatory assistance span across various compliance requirements starting from food product classification, product compliance, label and claims compliance along with submitting dossier for FSSAI product approval, food license, Food product approval and food registration.


Freyr Expertise

  • Vegan Food Compliance
  • Food Product Classification
  • Formula Review/Ingredients Assessment
  • Food Label and Claims Review
  • Compliance as per New Labelling Regulation
  • Claims Consultation and Substantiation
  • FSSAI License Support
  • Novel Food or Non-specified food/ ingredient Approval
  • Regulatory Intelligence Reports/Training Manuals – FSSAI regulations and standards
  • Product-specific Updates on the Regulatory Guidelines/Standards
  • Product Specification Review (Gap analysis)
  • Import Support - Documentation and License
  • Onsite Training Program for Senior Management & Food Handlers
  • Re-Formulation Strategies to switch from OTC to Dietary Supplements
  • FSSAI Schedule IV and GMP Audits for Manufacturing Premises
  • Compliance as per New ICMR RDA
Freyr Advantages


Freyr Advantages


End-to-end Regulatory consultation for FSSAI License


In-house Food Safety Supervisors (FSS) certified from FSSAI


Complete Regulatory consulting and advise for food products, dietary supplements and Nutraceuticals launch in India


Expertise in Importing Food products and nutraceuticals in India


Competencies in total Regulatory and FSSAI approval support Food product categories like Infant Nutrition, Sports Supplements/ Sports Nutrition, Food and Beverages (Chocolates and Cookies), FSDU (Foods for special dietary Use), FSMP (Food for special medical purpose), Novel foods


Guidance for Advertising and Promotional material


On-Site/ Online Training on FSSAI requirements for FBOs (Food Business Operators)


Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc. specifically for India market


Support for region-specific Regulatory complexities


Extensive partner network across the globe


Strong relationship with FSSAI and FSSAI approved laboratories