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 multiple factors like Increased health consciousness, changes in eating habits, and a sedentary lifestyle. Despite the market growth, Food Business Operators (FBOs) face multiple challenges in obtaining the Food Safety and Standards Authority of India (FSSAI) license, food import approval, and food product approval. 

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

Recently, the FSSAI revised the nutraceutical regulations, which have been in effect since April 01, 2022. According to the new update, the classification of food supplements and other compliance criteria are modified. Food supplements are categorized into six (06) categories of functional foods, i.e., health supplements, nutraceuticals, Food for Special Dietary Use (FSDU), Food for Special Medical Purposes (FSMP), prebiotic foods, and probiotic foods.  

To make a compliant market entry, food and food supplements must be validated in compliance with Indian regulations. If the product is not a novel food and can 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 easily launched in the Indian market without the need of an official product approval from the Indian food authority - the FSSAI. 

The FSSAI has also included alcoholic beverages under its jurisdiction, and a separate regulation was rolled out by the authority in 2018. Manufacturers of alcoholic beverages need to comply with these regulations before launching their products in the Indian market.

Freyr, with an in-depth knowledge of the FSSAI regulations, provides Regulatory support to food, food supplements, and alcoholic beverage manufacturers. Freyr’s Regulatory assistance spans various compliance requirements starting from food product classification, product compliance, label, and claims compliance, along with dossier submission for FSSAI product approval, food license, and food product registration in India.


Freyr Expertise

  • Classification of Food Products/Food Product Classification
  • Formula Review/Ingredients Assessment 
  • Food Label Review and Claims Assessment as per the New Labeling Regulation 
  • Claims Consultation and Substantiation  
  • FSSAI Registration and Licensing
  • Novel Food or Non-specified Food/FSSAI Product Ingredient Approval 
  • Regulatory Intelligence Reports/Training Manuals – FSSAI Regulations and Standards and Onsite Training Program for Senior Management and Food Handlers 
  • Product Specification Review (Gap Analysis) 
  • Import Support - Documentation and License 
  • Re-formulation Strategies to Switch from Over-the-Counter (OTC) to Dietary Supplements 
  • FSSAI Schedule IV and GMP Audits for Manufacturing Premises 
  • Compliance with the New Nutraceutical Regulation 2022 and the New Indian Council of Medical Research’s (ICMR’s) Recommended Dietary Allowance (RDA) 
  • Compliance with Sports Supplements
  • Compliance with the Alcoholic Beverages Regulations
  • Vegan Food Compliance and Using the Vegan Logo
Freyr Advantages


Freyr Advantages


End-to-end Regulatory consultation for food products, dietary supplements, and nutraceuticals launched in India and obtaining FSSAI License 


Complete Regulatory consulting and advice for alcoholic beverages launched in India


Expertise in importing food products and nutraceuticals in India 


Competencies in total Regulatory and FSSAI-approval support for food product categories like infant nutrition, sports supplements/sports nutrition, food and beverages (chocolates and cookies), FSDU, FSMP, and novel foods


Guidance for advertising and promotional material


On-site/Online training on the FSSAI requirements for FBOs


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 the Indian market


Support for region-specific Regulatory complexities


Extensive partner network across the globe


A Strong relationship with the FSSAI