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FSSAI Nutraceuticals Guidance and Notification – An Insight

A nutraceutical is a portion related to food or food that even in the treatment and prevention of foods intends for health benefits. As an alternative therapy, many people rely on dietary supplements which are medicinal herbs and nutraceuticals. Globally, demand for nutraceuticals is growing. In India, which is close to developed country Japan, the annual growth of nutraceuticals was found to be 25 percent. Many new companies have started producing nutraceuticals in India, in this view.

The pharmaceutical companies and suppliers of FMCG (fast-moving consumer goods) placed a key role in Indian nutraceuticals market success. The Indian market for nutraceuticals is divided into functional foods, drinks, and dietary supplements. Vitamin and mineral supplements occupy over 64 percent of the nutraceuticals market in India. The Indian nutraceuticals market, which grew from $1bn in 2008 to $1.8bn in 2013, crossed $2bn in 2014 and is expected to top $4bn by 2018.

The FSS Act, 2006, Rules and Regulations, 2011 recognize nutraceuticals as foodstuffs. The Food Safety and Standards Authority of India (FSSAI) has released regulations for food business licensing and registration, production, packaging and marking, food product quality and so on.

Regulatory guidelines for the approval of nutraceuticals on the Indian market were defined in FSSA in India ( FSSAI). This Act consists of 21 chapters and in that the 4th Article, meaning 22 of the Act, refers to nutraceuticals, dietary supplements and various functional foods and these products can be produced/manufactured, marketed, that means that they can be sold or distributed, meaning that imports can be made through any kind of food.

Under the ‘General Specifications’ of the Nutraceuticals Regulations, 2016, the FSSAI clarified that (21) the mere combination of vitamins and minerals formulated in tablets, capsules and syrup formats shall not be protected in any of the categories of these regulations except when vitamins and minerals are included.

The following details shall be included in any claimed novel foods-( a) chemical composition of the engineered food; (b) surface alteration/surface chemistry; (c) primary particle size; (d) solubility; (e) digestibility; (f) amount of nanomaterial, if any, in the food product; (g) precise argument, if applicable.

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


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 standardization 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. Nutraceuticals should be formulated using only the additives specified in Schedule VA or Schedule VE or Schedule VF.

On Dec 31, 2018, the FSSAI released a notice disallowing the use of certain ingredients in nutraceutical products. The third notification on the subject of the Nutraceutical Foods Regulation noted the following: (i) Authorizing the use of the ingredient ‘Vitamin D3’ from lichen (Cladonia rangiferina) as a vegetable source in the products specified under the Nutraceutical Regulations until the finalization and notification of the proposed amendments to the Nutraceutical Regulations. (ii) the mustard powder shall continue to be used as an ingredient in products covered by the Nutraceutical Regulations, subject to compliance. (iii) Continue with certain ingredients specified in the Notice. (iv) Require food business operators (FBOs) to sell existing formulations with simple combinations of vitamins and minerals, in dosage forms such as tablets, capsules and syrups, up to one recommended dietary allowance only. This shall be effective for a period of three months from the date of the current notice or until the issuance of further orders, whichever is earlier.

FSSAI directed the Nutraceutical Regulations to stop the use of 14 ingredients that lack scientific data to ensure safe use.The apex food regulator in the country directed FBOs to avoid using raspberry ketone, silica, angelica sinensis, paullinia cupana, saw palmetto, notoginsing, chlorella growth factor, pine bark extracted from pinus pinaster, vitamin D3-veg, Chaga extract, oxalobacter formigenes, phytavail iron and tea tree oil.

The label of nutraceuticals items will list Suggested Use Warning “Nutraceuticals” for the risk of excessive use. For Nutraceuticals Products Cure claims of disease, e.g. “Prevents bone fragility in postmenopausal women,” implied cures for claims of disease through images, vignettes or symbols, must be mentioned.

Increased demand for nutraceuticals products in India demonstrated its potential rate of success in disease prevention and treatment. Therefore, to mitigate adverse effects, contamination, adulteration, misuse, overdose during human use, it requires regulatory authorities on drug quality and health. As food products reach from one country to another, it becomes important to maintain safety and quality standards according to the different regulatory guidelines set by the respective governments. To preserve nutraceuticals quality and safety issues both new firms and existing firms will adopt FSSAI’s regulatory guidelines for better usage.

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