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FSSAI Guidelines For Food Supplements & FSSAI License For Food Supplements


Introduction: FSSAI License For Food Supplements

The notification regarding Health Supplements, Food for Special Dietary Use, Nutraceuticals, Functional Food, Food for Special Medical Purposes and Novel Food has been communicated with the Food Safety and Standards Regulations 2016 by FSSAI on 23rd December 2016 Official Gazette. This regulation will come into force when gets published in the Official Gazette. The compliance of these regulations will come into effect from 1st January 2018.

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It is important to note that FSSAI regulations cover eight food categories and carry information like composition, labels, claims, etc., as required. These food items are:

  • Health Supplements
  • Novel Foods
  • Foods for Special Dietary Use
  • Foods containing Prebiotics
  • Food for Special Medical Purpose
  • Foods containing Probiotics
  • Nutraceuticals
  • Speciality Food containing plants or botanicals

The food products produced/manufactured under this category can be sold in the form of capsules, tablets, syrups and more. These food items must fulfil quality standards and requirements as stated in Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia.

It is imperative that the food articles and its preparation should be based on sound nutrition and medicinal principles and must be supported by scientific data that has been properly authenticated. A simple grouping of minerals and vitamins formulated in the form of capsules, tablets, or syrup cannot be considered as food unless an appropriate food format is followed by adding specific minerals and vitamins. These food items must not encompass steroids, hormones, or any psychotropic ingredients.

The number of nutrients that are added to the food articles must not exceed RDA or recommended daily allowance as elucidated and quantified by the Indian Council of Medical Research. If the specification regarding these standards is not clear, the Codex Alimentarius Commission standards shall apply.

Approved additives and colours can be used by the FBOs as mentioned in Schedule VF regulations. Food Safety and Standards(Food Product Standards and Food Additives) Regulations, 2011 also permit nature identical, natural or synthetic flavors to be used.

FSSAI Schedules

Clear and detailed schedules divide regulations with complete provisions where information about the use of minerals, amino acids, food additives, nutraceutical ingredients, vitamins, botanical ingredients, prebiotics and probiotics is shared. There is a list of 400 ingredients of botanically origin plant in one of the schedules that are permitted to be used as food ingredients which are covered in the regulations. As per the regulatory provisions, the ingredients that have been specified in schedules from 1 to VIIth may be used. Similarly, in accordance with the above regulations, the additives can also be used as applied to the categories specified in Schedule VA to VF.

Nutritional or Health Claims

Health or nutrition claims can be made by FBOs for ingredients that have been definite in Schedules I-VI. These health claims can be made depending on the benefits to the health of a person. Following can be included in the health claims made regarding food:

  • enhanced function
  • ingredients or nutritional or nutrient function
  • health maintenance claims
  • disease risk reduction
  • immunity or increased resistance
  • anti-ageing

It is important to validate health claims made by FBOs with the help of accurate and adequate documentation and human studies conducted on the same. In case other claims are made, it is important to get them approved through the Food Authority. Obscure claims regarding curing diseases or making efficacy, claims like prevention of disease or cure of cancer through pictures or by name, symbols or vignettes, lipid profile or electrocardiogram are strictly prohibited by FSSAI.

FSSAI Restrictions

The FSSAI has the authority to restrict or suspend the sale of certain food articles that are available in the market with incomplete labelling on products like.

  • Food products that lack clear distinction on labelling instructions.
  • Food products that do not serve the claimed nutritional purpose
  • Food products that may impact human health

FSSAI Labelling Requirements

Food Labelling is one of the essential components of public nutrition. It acts as one of the key links between the food packer, manufacturer, seller, distributor, and consumer. Labelling is one of the ways through which a manufacturer or the seller presents his product to the target consumer by sharing relevant information about the product in clear and precise manner.

FSSAI Labeling and its Significance

It is mandatory to obey food labelling requirements as per FSSAI guidelines. It is not only essential as per laws of the country but also gives a lot of advantages to the manufacturers. Below are some of the food labelling requirements defined by FASSI.

The packaged food product must have proper labelling as per FSSAI regulations.

Simple, clear and to-the-point food labelling on packages help manufacturers to make a deep impact on customers' mind.

A proper and correct label is the key for a manufacturer to promote the sale of his product.

A perfect label helps customers to take a quick decision about buying a specific product.

If a food product is being manufactured for exported purposes, it must be labelled as per the food laws and regulations of the country where the product is being exported. Food laws & regulations of export country need to be taken care while labelling the product.

According to Food Safety Standards (Packaging and Labelling) Regulations, 2011, every food product that is being packaged to sell in the market must contain a label containing following information-

The food name, Ingredients List, Nutritional Information, Food Additives Declaration Non-veg or veg Declaration, Packers or manufacturer’s complete name and address, Net quantity, Packing or Manufacturing date, Lot No./Code No./Batch No., Best Before Date or Use Before Date, For Imported Food, Country of Origin, Instructions for use.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.


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Vinay Thakur is Managing Partner in Corpseed. He focused on payments, digital transformation, and financial technology for over 15 years and holds strong expertise on fintech startups, banking innovation, and investors with a keen understanding of...
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