Worldwide nutraceuticals are defined as ingredients that have health benefits beyond basic nutrition. They are also defined as parts of a food or a whole food that have a medical or health benefit, including the prevention and treatment of disease. However, according to the definition in the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, it has been stated that nutraceuticals shall provide a physiological benefit and help maintain good health. The Regulation also states that “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.
The nutraceutical industry in India is one of the fastest growing markets in the Asia-Pacific region and is worth about $ 2.2 billion and is projected to grow at 20% to $ 6.1 billion by 2019-2020. According to Assocham in terms of ingredients, vitamins and minerals hold a 36% share of the Indian nutraceuticals market, followed by probiotics and omega-3 fatty acids with 9% and 5% respectively. The rest of the market includes probiotics, amino acids, peptides, fibers, antioxidants and plant extracts.
Nutraceuticals till recently were used to define any product derived from food sources that provide extra health benefits in addition to the basic nutritional value found in foods. There was, however, a thin line between defining nutraceuticals as “food” or “drug.” Since there is now a separate regulation for nutraceuticals, FBOs manufacturing nutraceuticals will need to follow the new FSSAI standards. FSSAI has standardized nutraceuticals so they may contain only any of the ingredients as specified in Schedule I or Schedule II or Schedule IV or Schedule VI or Schedule VII or Schedule VIII of the Nutraceutical regulations.
- Schedule I contains a list of Vitamins and minerals
- Schedule II contains the list of essential amino acids and other nutrients
- Schedule IV List of plant or botanical ingredients
- Schedule VI List of ingredients as nutraceuticals
- Schedule VII List of strains as probiotics (live micro-organisms)
- Schedule VIII List of prebiotic compounds
If nutraceuticals contain nutrients then the number of nutrients added to the nutraceuticals must be as per recommended daily allowance (RDA) as specified by the Indian Council of Medical Research (ICMR) and in case such standards are not specified, the standard as laid down by international food standards body, namely Codex Alimentarius Commission shall apply. Since the general public is unaware of RDA in nutraceuticals, it is important for the manufacturer to ensure that nutraceuticals contain nutrients as prescribed by ICMR.
No ingredient other than those specified in Schedule VI shall be used as
nutraceutical with standardization to marker compounds specified and at daily usage levels specified therein. If extracts of ingredients are used then only those specified in Schedule IV may be used in the nutraceutical. Also regulation says that if an ingredient of plant or botanical origin specified in Schedule IV and Schedule VI are used then they may be used either in the given form or their extract and extracted ratios must be in relation to the daily usage value.
For the ingredient for which the daily minimum and maximum usage levels have not been specified, the food business operator shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data and submit the documented scientific data to the Food Authority as for and when called for;
If additives are used in nutraceutical formulations then they must only be those additives as specified in Schedule VA or Schedule VE or Schedule VF in the nutraceutical regulation.
A nutraceutical which is not mentioned 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. For this purpose, the FBO will need to apply to the FSSAI which will be accompanied by a documented history of usage of at least
- fifteen years in India
- thirty years in the country of origin
Labeling of Nutraceuticals
FSSAI has laid down specific labeling requirements and they state that the labeling, presentation, and advertisement must not claim that the nutraceutical has any property that prevents treats or cures any human disease and may make no reference to such properties.
Every package of food containing nutraceutical shall carry the following information on the label
- the word “NUTRACEUTICAL”;
- a common name of the nutraceutical
- declare the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect
- If applicable, 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’
Advisory warnings on labels must have
- ‘recommended usage’
- ‘NOT FOR MEDICINAL USE’ written prominently
- Any danger which may exist with excess consumption
- Any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable
The label must also bear the statement that the product is required to be stored out of reach of children.