Food and Food Supplements Regulatory Services in India


The food industry in India is expected to witness an unprecedented growth in the years ahead due to multiple factors like an increase in health consciousness, changes in eating habits, and a general move towards a sedentary lifestyle. Despite 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.

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

FSSAI has revised the regulations on nutraceuticals, which have come into effect since April 01, 2022. Under this revision, the classification of food supplements and other compliance criteria have been modified. Food supplements are categorized into six (06) categories of functional foods, which are the following:

  • Health Supplements
  • Nutraceuticals
  • Food for Special Dietary Use (FSDU)
  • Food for Special Medical Purposes (FSMP)
  • Prebiotic food
  • Probiotic foods

Food and food supplements must be validated in compliance with Indian regulations for them to make a compliant market entry. If the product is not a novel food and along with the product composition in terms of the ingredients used, additives, and their limits, it can comply with the requirements listed under the regulations, it can be easily launched in the Indian market without the need for an official product approval from the FSSAI.

Product approval is required for novel or non-specified foods. As per regulations, a non-specified food is one for which standards have not been specified under any FSSAI regulation. The novel categories for which a novel registration procedure is required are novel foods or novel food Ingredients processed with the use of novel technology, new additives, new processing aids, including enzymes, and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi, or algae. The FSSAI has also included alcoholic beverages under its jurisdiction; and it rolled out a separate regulation for this in 2018. Thus, 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 FSSAI regulations, provides Regulatory support to food, food supplements, and alcoholic beverage manufacturers. Freyr’s Regulatory assistance spans various compliance requirements, ranging from food product classification, product compliance, label and claims compliance, to dossier submission for FSSAI product approval, obtaining of food license, food product approval, and food registration. 


Freyr Expertise

  • Food Product Classification
  • Formula Review/Ingredients Assessment 
  • Food Label and Claims Reviewas Per the New Labeling Regulation
  • Claims Consultation and Substantiation
  • FSSAI License Support (Obtaining New License/Modification of License)
  • Novel Food or Non-specified Food/Ingredient Approval
  • Dossier Review (Gap Analysis) and Dossier Compilation for Novel Food or Non-specified Food/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 (Good Manufacturing Practice) Audits in the Manufacturing Premises
  • Compliance as Per the New Nutraceutical Regulation 2022 and Compliance as Per the New Indian Council of Medical Research (ICMR)’s Recommended Dietary Allowance (RDA) 
  • Compliance for Sports Supplements
  • Compliance for Health supplements and Nutraceuticals
  • Compliance for the FSDU and FSMP Categories
  • Compliance for Prebiotics and Probiotics
  • Compliance for the General Food Category
  • Compliance with 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 the FSSAI license


Complete Regulatory consulting and advice on alcoholic beverages launched in India


Expertise in importing food products and nutraceuticals in India


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


Guidance for advertising and promotional material


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


A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, FSDU, etc., specifically trained for the Indian market


Support in region-specific Regulatory complexities


An extensive partnership network across the globe


A strong relationship with the FSSAI