Home > Food Safety and Standards Nutraceutical Regulation

A nutraceutical is a food or food related component that intends for health benefits even in treatment and prevention of aliments. Many people rely on dietary supplements as alternative therapy that are medicinal herbs and nutraceuticals. There is rising demand for nutraceuticals worldwide. The annual growth of nutraceuticals was found to be 25% in India which is similar to the developed country Japan. In this view, many new companies have begun manufacturing nutraceuticals in India.

The pharmaceutical companies and FMCG (fast moving consumer goods) suppliers placed a key role in the success of Indian nutraceuticals market. The Indian nutraceuticals market is divided into functional foods and beverages and dietary supplements. Over 64% of nutraceuticals market in India is occupied with vitamin and mineral supplements.

Nutraceuticals are considered as foods by the FSS Act, 2006, Rules and Regulations, 2011. The Food Safety and Standards Authority of India (FSSAI) has issued regulations with respect to licensing and registration of food business, manufacturing, packing and labelling, food product standard and so on.

In the Nutraceuticals Regulations, 2016, under the ‘General Requirements,’ the FSSAI has stated mere combination of vitamins and minerals formulated in tablets, capsules, syrup formats shall not be covered in any of the categories of these regulations except when vitamins and minerals are added.

FSS issued regulations for food or health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purpose, functional foods, and novel food in 2015.

Nutraceuticals shall contain any of the ingredients specified in Food Act Schedule

Schedule I – Vitamins and minerals

Schedule II – Essential amino acids and other nutrients

Schedule IV – List of plants and botanical ingredients

Schedule VI – List of ingredients as nutraceuticals

Schedule VII – List of strains as probiotics

Schedule VIII – List of prebiotic compounds

No ingredient other than those specified in Schedule VI shall be used as nutraceuticals with standardisation to marker compounds specified and at daily usage levels specified therein. Only nutraceuticals or extracts of ingredients specified in Schedule IV can be used in nutraceuticals. Ingredients of plant or botanical origin specified in Schedule IV and Schedule VI may be used either in the given form or their extract, subject to the extractive ratios in relation to the daily usage value. Only additives specified in Schedule VA or Schedule VE or Schedule VF should be used for nutraceuticals formulation.

FSSAI has directed Nutraceutical Regulations to stop using 14 ingredients lacking scientific data for safe usage. The country’s apex food regulator ordered FBOs to discontinue the use of raspberry ketone, silica, angelica sinensis, paullinia cupana, saw palmetto, notoginsing, chlorella growth factor, pine bark extracted to pinus radiate, pine bark extracted from pinus pinaster, Vitamin D3-veg, chaga extract, oxalobacter formigenes, phytavail iron and tea tree oil.

The label of nutraceuticals products should mention “Nutraceuticals” Recommended Usage Warning for the risk of excess consumption. Prohibitions on labelling claims must mention for Nutraceuticals Products Cure of disease claims, e.g. “Prevents bone fragility in post menopausal women,” implied cures for disease claims through pictures, vignettes or symbols.

General Requirements:

• The articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia.
• For the purposes of sub-regulation (1) the food business operator may declare the addition of flavour on labels of such products in accoradance with the provisions of Food Safety and Standards (Labelling and Packaging) Regulations, 2011.
• The tablets, capsules and syrups shall fulfil the general quality requirements and standards as specified in Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia.
• The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the ICMR and in case such standards are not specified, the standards
  laid down by international food standards body, namely, Codex Alimentarius Commission, shall apply.
• In case of food products falling under health supplement categories, the individual nutrient content shall not be less than fifteen per cent of the recommended daily allowance where a nutrient content claim is being made . Provided that, if claim of higher nutrient content is made, the nutrient content shall not be less than thirty per cent of the recommended daily allowance.
• For the articles of food specified in these regulations, the Food Authority may permit the food business operator to add food colours subject to the level restrictions as mentioned in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.
• The articles of food with standard nutrient or nutritionally complete formulation shall consist of a composition delivering the desired level of energy, protein, vitamins and minerals, and other essential nutrients required for respective age group, gender and physiological stage in accordance with the guidelines made by the Indian Council of Medical Research.
• The purity criteria for the ingredients used in the categories of articles of food covered under these regulations shall be as determined and notified in the official gazette by the Food Authority from time to time.
• In case such standards are not specified, the purity criteria generally accepted by pharmacopoeias, namely, Indian Pharmacopoeia, Ayurvedic Pharmacopoeia of India, relevant Bureau of Indian Standards Specifications, Quality Standards of Indian Medicinal Plants, Indian Council of Medical Reseach, British Pharmacopoeia, United States Pharmacopoeia, Food Chemical Codex, Joint Food and Agriculture Organization or World Health Organisation Expert Committee on Food Additives or CODEX Alimentarius may be adopted by food Business operators.
• The food business operator shall intimate the purity criteria adopted for ingredients to the Food Authority including any change when adopted.
• The tolerance limit for variation in case of articles of food covered in these regulations during analysis of samples of finished products, shall not be more than (-) ten per cent from the declared value of the nutrients or nutritional ingredients on the label.
• The manufacturing of ingredients and products covered under these regulations shall be carried out in compliance with the established good manufacturing practices.
• The formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required.
• No hormones or steroids or psychotropic ingredients shall be added in any of the articles of food specified in these regulations.

Health supplements:

• Health supplements may be used to supplement the normal diet of a person above the age of five years.
• The health supplements shall contain concentrated source of one or more nutrients, namely, amino acids, enzymes, minerals, proteins, vitamins, other dietary substances, plants or botanicals, prebiotics, probiotics and substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, which are presented as such and are offered alone or in combination, but are not drugs as defined in the Drugs and Cosmetics Act, 1940 and the rules made thereunder.
• The health supplements shall be marketed in single use packaging as appropriate to maintain integrity and quality of the product, or in dosage forms namely, capsules, tablets, pills, sachets; jelly or gel, semi-solids and other similar forms or any other forms of liquids and powders designed to be taken in measured unit quantities.
• The health supplements shall not include any of the food products or categories of articles of food for which specific standards have been laid down in any other parts of these regulations.

Labelling of Health Supplement:

• The labelling, presentation and advertisement shall not claim that the health supplement has the property of preventing, treating or curing a human disease, or refer to such properties;
• The statement by the food business operator relating to the structure or function or the general well being of the body may be allowed by the Food Authority if the statement is supported by the generally accepted scientific data;
• Every package of health supplement shall carry the following information on the label, namely.-
  • the words “HEALTH SUPPLEMENT”;
  • the common name of the health supplement, or a description sufficient to indicate the true nature of the health supplement including the common names of the categories of nutrients or substances that characterise the product;
  • a declaration as to the amount of the nutrients or substances with a nutritional or physiological effect present in the product;
  • an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
  • the quantity of nutrients, where applicable expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research and bear a warning, “Not to exceed the recommended daily usage”;
  • a statement that the health supplement is not be used as a substitute for a varied diet;
  • a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable; and
  • a statement that the product is required to be stored out of reach of children.

Nutraceuticals:

• The nutraceuticals shall provide a physiological benefit and help maintain good health.
• A food business operator may extract, isolate and purify nutraceuticals from food or non-food sources, that is preparing amino acids and their derivatives by bacterial fermentation under controlled conditions.
• A food business operator may prepare and sell the nutraceuticals in the food-format of granules, powder, tablet, capsule, liquid, jelly or gel, semi-solids and other formats and may be packed in sachet, ampoule, bottle, and in any other format as measured unit quantities except those formats that are meant for parenteral administration.
• The quantity of nutrients added where applicable, shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standard laid down by international food standards body, namely Codex Alimentarius Commission shall apply;
• A nutraceutical which is not provided in these regulations but its safety has been established in India or in any other country, shall be manufactured or sold in India only on prior approval of the Food Authority;
• The Food Authority may from time to time specify the nutraceuticals as approved by it after undertaking proper scientific evaluation.

Labelling of Nutraceutical:

• The labelling, presentation and advertisement shall not claim that the nutraceutical has the property of preventing, treating or curing a human disease, or refer to such properties;
• The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data;
• Every package of food containing nutraceutical shall carry the following information on the label, namely:-
  • the word “NUTRACEUTICAL”;
  • the common name of the nutraceutical;
  • a declaration as to the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect;
  • where it is appropriate, the quantity of nutrient shall be expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research even when the nutrient is present along with a nutraceutical as an adjunct and shall bear an advisory warning ‘not to exceed the stated recommended daily usage’;
  • an advisory warning for ‘recommended usage’ ;
  • an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
  • an advisory warning in cases where a danger may exist with excess consumption;
  • an advisory warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;
  • a statement that the product is required to be stored out of reach of children;

Food for special dietary use:

No food business operator shall manufacture, formulate or process an article of food for special dietary use unless-

• specially processed or formulated to satisfy particular dietary requirements which may exist or arise because of certain physiological or specific health conditions, namely:-
  • low weight, obesity, diabetes, high blood pressure;
  • pregnant and lactating women; and
  • geriatric population and celiac disease and other health conditions.
• The food business operator shall clearly indicate on the label whether or not the food for special dietary use is to be taken under medical advice;
• A food business operator may manufacture or sell an article of food for special dietary use in single use packaging or in dosage form, namely, granules, capsules, tablets, pills, jelly, semi-solid and other similar forms, sachets of powder, or any other similar forms of liquids and powders designed to be taken in measured unit quantities with a nutritional or physiological effect;
• A food business operator may formulate an article of food for special dietary use in formats meant for oral feeding through a enteral tubes but shall not be used for parenteral use;
• An article of food for special dietary use shall not include the normal food which is merely enriched or modified with nutrients and meant for mass consumption, intended for improvement of general health for day to day use and do not claim to be targeted to consumers with specific disease conditions and also not include the article of food intended to replace complete diet covered under food for special medical purpose specified in regulation

Labelling of Food for special dietary use:

• No statement or claim shall be made on the label implying prevention, cure or treatment of any specific disease or its diagnosis or otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, unless otherwise approved by the Food Authority;
• The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data;
• Every package containing food for special dietary use shall carry the following information on the label, namely:-
  • the words “FOOD FOR SPECIAL DIETARY USE” followed by “Food for………” (mentioning the particular physiological or health condition)”;
  • a statement “For weight control and management” in close proximity to the name of the articles of food specially prepared for weight management and control;
  • a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children, adolescents and elderly, except when medically advised;
  • a statement on the target consumer group, rationale for use of the product and a description of the properties or characteristics that make it useful;
  • if the product has been formulated for a specific age group, a prominent statement to that effect;
  • a statement specifying the nutrient which is reduced, deleted, increased or otherwise modified, relating to normal requirement, and the rationale for the reduction, deletion, increase or other modification;
  • an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
  • a warning in cases where a danger may exist with excess consumption;
  • a warning that the product is not for parenteral use;
  • a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;
  • the quantity of nutrients expressed in terms of percentage of the recommended daily allowance where it is appropriate;
  • information on osmolality or osmolarity or on acid-base balance where appropriate; and
  • a statement that the product shall be stored out of reach of children.

Food for special medical purpose:

• Food for special medical purpose shall include food specially prepared for weight reduction and intended as total replacement of normal diet.
• A food business operator may formulate food for special medical purpose in format meant for oral feeding through a enteral tubes.
• The articles of food for special medical purpose shall not be used for parenteral use.
• The articles of food for special medical purpose, other than those intended for infants, may either be nutritionally complete food which, when used in accordance with the manufacturer’s instructions, shall constitute the sole source of nourishment for the persons for whom they are intended or nutritionally incomplete food with formulation specific for a disease, disorder or medical condition, but are not suitable to be used as the sole source of nourishment.
• For the purposes of these regulations, the food for special medical purpose may be classified in to following three categories, namely:-
  • ‘nutritionally complete food with a standard nutrient formulation’, which when used in accordance with the manufacturer’s instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
  • ‘nutritionally complete food with a nutrient-adopted formulation specific for a disease, disorder or medical condition’, which when used in accordance with the manufacturer’s instructions, may constitute the sole source of nourishment for the persons for whom they are intended; and
  • ‘nutritionally incomplete food with a standard formulation or a nutrient-adopted formulation specific for a disease, disorder or medical condition’, which is not suitable to be used as the sole source of nourishment.

Labelling of Food for special medical purpose:

Every package of food for special medical purpose shall carry the following information on the label, namely:-

• The words ‘FOOD FOR SPECIAL MEDICAL PURPOSE’ printed in the immediate proximity of the name or brand name of the product;
• An advisory warning “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” appearing on the label in bold letters in an area separated from other written, printed or graphic
  information;
• The statement “For the dietary management of ________” (with the blank to be filled in with the specific disease, disorder or medical condition for which the product is intended, and for which it has been shown to be effective) supported by appropriate scientific, and clinical or epidemiological data, and subject to its approval by the Food Authority;
• A statement ‘NUTRITIONALLY COMPLETE’ if the food is intended to be used as a nutritionally complete food;
• A statement on the rationale for use of the product by the target consumer group and a description of the properties or characteristics that make it useful;
• A statement if the product has been formulated for a specific age group;
• A statement specifying the nutrient which have been reduced, deleted, increased or otherwise modified, relatiing to normal requirements, and the rationale for the reduction, deletion, increase or other modification;
• The quantity of nutrients expressed in terms of percentages of the recommended daily allowances, where it is appropriate;
• Information on osmolality or osmolarity, Renal Solute Load, Potential Renal Solute Load or acid-base balance, wherever applicable;
• Instructions for appropriate preparation, feeding, use and storage of the product after the opening of the container;
• A warning that the product is not for parenteral use; and
• A statement that the product required to be stored out of reach of children.

Food with added probiotic ingredients:

• No food business operator shall use probiotic ingredients in food except the probiotic culture of the microorganisms or those probiotic microorganisms approved by the Food Authority from time to time. Probiotic preparations may contain added prebiotics permitted under these regulations.
• The viable number of organisms in food with added probiotic ingredients shall be ≥108 CFU/g: Provided that a lower viable number may be specified with proven studies on health benefits with those numbers subject to the prior approval of the Food Authority.
• The Food Authority may, from time to time, specify the probiotic microorganisms approved by it after proper scientific evaluation: Provided that the presence of the commonly used starter cultures of lactic acid producing bacteria such as Lactococcus spp., earlier known as Streptococcus spp., Lactobacillus spp. and other such microorganisms used in the preparation of fermented milk (dahi) and related products shall not be considered as probiotics, if the probiotic properties have not been substantiated.

Note.- The guidelines issued by the Indain Council of Medical Research and Department of Biotechnology with respect to probiotics provide additional information on their use.

• The labelling, presentation and advertisement shall not claim that the probiotic food has the property of preventing, treating or curing a human disease, or refer to such properties.
• The statement by the food business operator relating to structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data.

Labelling of Food with added Probiotic Ingredients:

Every package of probiotic food shall carry the following information on the label, namely:-

• The words “PROBIOTIC FOOD”;
• Genus and species including strain designation or culture collection number, where applicable, in brackets where probiotics are mentioned in the list of ingredients;
• Viable numbers at the end of the shelf-life of probiotic strain corresponding to the level at which the efficacy is claimed;
• The recommended serving size which shall deliver the effective viable dose of probiotics related to health claims and recommended duration of use, proper storage temperature conditions, and time limit for ‘Best Use’ after opening the container;
• An advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; and
• A warning or any other precaution to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable

Food with added prebiotic ingredients:

• No food business operator shall use prebiotics in manufacturing food containing prebiotics or those prebiotics approved by the Food Authority from time to time.
• The prebiotic component, not an organism, to which the claim of being made, shall be characterised for a given product by providing the source, origin, purity, chemical composition and structure, vehicle, concentration and amount in which it is to be delivered to the host.
• The labelling, presentation and advertising shall not claim that the prebiotic has the property of preventing, treating or curing a human disease, or refer to such properties.
• The statement by the food business operator relating to structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data.

Labelling of Food with added Prebiotic Ingredients:

Every package of food containing prebiotics shall carry the following information on the label, namely:-

• The words “PREBIOTIC FOOD”;
• Name of prebiotic;
• The suggested or recommended serving size which shall deliver the effective dose of prebiotic related to the health claim;
• An advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
• A warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable.

Specialty food containing plant or botanical ingredients with safe history of usage:

• A food business operator shall use only plant or botanical ingredients for the preparation of specialty food containing plant or botanical ingredients.
• The plant or botanical ingredient which is not specified in these regulations but its safety has been established in India or in any other country, may be manufactured or sold in India only after taking prior approval of the Food Authority.
• The application for approval to the Food Authority shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin.
• Every manufacturer or importer shall prepare and maintain a product information file, which shall contain information on the ingredients used, finished product quality confirmation, and the test methods to demonstrate the presence of the active ingredient in the food.
• To use any other plant or botanical ingredient, the food business operator shall seek prior approval of the Food Authority by submitting-
  • A product information file containing information on the material used;
  • Quality confirmation, test methods to demonstrate the presence of the ingredient in the food;
  • Relevant published literature providing scientific and technical information of the material or product related to safety and health benefits; and
  • Any human intervention study published or conducted, and other relevant information.
• The product information file shall be produced for inspection and review by the Food Authority as and when called for.
• The product information file shall primarily consist of technical and scientific information covering the following, namely:-
  • Information on quality of all raw ingredients with official scientific or botanical name;
  • Details of formulation or block diagram and brief description of the processing methods or steps adopted;
  • Shelf life study data;
  • Quality specifications and test methods for analysis of the finished product;
  • Safety and pharmacological information, literature base, and additional study, if any conducted;
  • Information on human studies, if any;
  • Regulatory status in other countries, if any; and
  • Any other relevant product information.

Novel Food:

• For the purposes of these regulations novel food is a food that-
  • may not have a history of human consumption; or
  • may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption; or
  • a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances.
• No novel food shall be manufactured or imported for commercial purpose without the prior approval of the Food Authority by filing an application along with all relevant documents and details as specified by the Food Authority from time to time.

Labelling of Novel Food:

The labelling of novel food shall be-

• In accordance with the specific labelling requirements, if any; or
• Specific to claims relating to the novel product; or
• As per the category notified by the Food Authority in the specific regulations.

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