{"id":36468,"date":"2021-10-12T12:48:42","date_gmt":"2021-10-12T07:18:42","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=36468"},"modified":"2025-12-10T18:20:47","modified_gmt":"2025-12-10T12:50:47","slug":"fssai-regulations-for-nutraceuticals","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/fssai-regulations-for-nutraceuticals\/","title":{"rendered":"FSSAI Regulations for Nutraceuticals : A Complete Overview"},"content":{"rendered":"\n<p>Nutraceuticals are now serving as a primary dietary supplement for health-conscious masses in India. Nutraceuticals (aka nutritional supplements)  have fast become a staple in the healthcare market in numerous forms, including tablets, syrups, gummer is and capsules. As a repercussion of the Covid-19 pandemic, the nutritional supplements market is projected to witness a growth of 35 per cent (CAGR), to 18 billion in 2025, from $4 billion now. This write-up aims to render a brief overview of FSSAI regulations for Nutraceuticals.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Nutraceuticals Market Analysis from Indian Perspective<\/h2>\n\n\n\n<p>The global demand for nutritional supplements is rising every passing day. Presently, India is witnessing the yearly growth of 26 percent which is identical to that of Japan. In this purview, most new enterprises have commenced manufacturing nutraceuticals in India. The drug companies &amp; FMCG suppliers played a vital role in the success of the Indian nutritional supplements market. The nutraceuticals market in India is divided into beverages (including dietary supplements) and functional foods.<\/p>\n\n\n\n<p>Almost 64 per cent of the Indian nutritional supplements market is dominated by mineral and vitamin supplements. The nutraceuticals market in India, which has crossed the $1.5 billion mark in 2013, has attained the valuation of $2 billion in 2014. Further, this market is projected to cross $18 billion by 2025. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important\"><a href=\"https:\/\/corpbiz.io\/learning\/fssai-on-cleaning-of-fruit-and-vegetable-market-initiative\/\">Guidelines by FSSAI on Cleaning of Fruit and Vegetable Market Initiative <\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What are the FSSAI regulations for Nutraceuticals?&nbsp;<\/h2>\n\n\n\n<p>In this purview, the <strong><em>Food Safety and Standards Authority of India<\/em><\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_Safety_and_Standards_Authority_of_India\"><strong><em>[1]<\/em><\/strong><\/a><\/sup> have laid down norms pertaining to licensing and <strong><a href=\"https:\/\/corpbiz.io\/fssai-license\" title=\"FSSAI Registration Apply Online\">FSSAI registration<\/a><\/strong> of business operating in the food sector.<\/p>\n\n\n\n<p>The FSSAI has underpinned some regulatory guidelines pertaining to the approval of nutraceuticals in the Indian market. The said Act comprises 21 chapters and the 4th Article talks about nutraceuticals and various functional foods.<\/p>\n\n\n\n<p>FSSAI has clearly mentioned in the Nutraceuticals Regulations, 2016, under the \u2018General Requirements,\u2019 that the (21) mere combination of mineral &amp; vitamins formulated in capsules, tablets, syrup formats shall not be encompassed in any of the categories of such norms expected where minerals &amp; vitamins are added.<\/p>\n\n\n\n<p><strong><em>Note:  Nutritional supplements are deemed as food by the Food Safety and Standards Act, 2011. <\/em><\/strong><\/p>\n\n\n\n<p><strong><em>FSS Regulations, 2011, rolled out extensive norms for licensing &amp; registration for;<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>FBOs (Food Business operators)<\/li>\n\n\n\n<li>Food product standards and food\nadditives<\/li>\n\n\n\n<li>Packaging and labelling<\/li>\n\n\n\n<li>Toxins and residues<\/li>\n\n\n\n<li>Contaminants<\/li>\n\n\n\n<li>laboratory and sampling\nanalysis<\/li>\n<\/ul>\n\n\n\n<p>FSSAI has laid down norms for nutritional\nsupplements, dietary supplements, functional foods, health supplements, and\nnovel food in 2015.<\/p>\n\n\n\n<p><strong><em>The following detail shall be enclosed in any claimed novel foods \u2013<\/em><\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter is-resized\"><img decoding=\"async\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/10\/What-are-the-FSSAI-regulations-for-Nutraceuticals.png\" alt=\"What are the FSSAI regulations for Nutraceuticals\" class=\"wp-image-36487\" width=\"425\" height=\"436\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/10\/What-are-the-FSSAI-regulations-for-Nutraceuticals.png 971w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/10\/What-are-the-FSSAI-regulations-for-Nutraceuticals-292x300.png 292w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/10\/What-are-the-FSSAI-regulations-for-Nutraceuticals-768x789.png 768w\" sizes=\"(max-width: 425px) 100vw, 425px\" \/><\/figure><\/div>\n\n\n<p><strong><em>Nutraceuticals must have any of the ingredients cited\nin the Food Act<\/em><\/strong><\/p>\n\n\n\n<p>Schedule<\/p>\n\n\n\n<p>Schedule I Vitamins and minerals<\/p>\n\n\n\n<ul>\n<li>Schedule II<\/li>\n<\/ul>\n\n\n\n<p>Essential amino acids and other nutrients<\/p>\n\n\n\n<ul>\n<li>Schedule IV<\/li>\n<\/ul>\n\n\n\n<p>List of plants and botanical ingredients<\/p>\n\n\n\n<ul>\n<li>Schedule VI<\/li>\n<\/ul>\n\n\n\n<p>List of ingredients as nutraceuticals<\/p>\n\n\n\n<ul>\n<li>Schedule VII<\/li>\n<\/ul>\n\n\n\n<p>List of strains as probiotics<\/p>\n\n\n\n<ul>\n<li>Schedule VIII<\/li>\n<\/ul>\n\n\n\n<p>List of prebiotic compounds<\/p>\n\n\n\n<p>No ingredient except those cited in Schedule\nVI shall be utilized as dietary supplements with standardization to marker\ncompounds cited &amp; at daily usage level cited therein. Only nutraceuticals\ncited in Schedule IV can be added in nutritional supplements.<\/p>\n\n\n\n<p>Ingredients of botanical origin or plant\ncited in Schedule IV and Schedule VI might be used either in the provided form\nor their extract, exposed to the extractive ratios pertaining to the daily\nusage value. Only additives cited in Schedule VA, VE, or VF should be utilized\nfor nutritional supplements formulation.<\/p>\n\n\n\n<p>On Dec 31, 2018, the FSSAI rolled out a\nnotification that prevents the manufacturer from using several ingredients in\nnutritional supplements.<\/p>\n\n\n\n<p><strong><em>The third notice pertaining to the Nutraceutical Foods\nRegulation;<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Permitted the utilization of\nthe ingredient \u2018Vitamin D3\u2019 from lichen as a vegetable source in the items\ncited under the Nutraceutical Regulations until the proposed Nutraceutical\nRegulations or amendments are finalized.<\/li>\n\n\n\n<li>Imposed no restriction on the\nusages of the mustard powder in the food items cited under the Nutraceutical\nRegulations.<\/li>\n\n\n\n<li>Ensured discontinuation of\ncertain ingredients cited in the notification<\/li>\n\n\n\n<li>Permitted FBOs to sell\nprevailing formulation with a combination of minerals &amp; vitamins, only to\none advisable dietary allowance, in dosage form such as capsules, tablets,\n&amp; syrups<\/li>\n<\/ul>\n\n\n\n<p>This is effective for duration of 3 months\nfrom the date of the present notification or until further orders are\npromulgated, whichever is earlier. FSSAI has revised nutritional supplements\nnorms to prevent manufacturers from using 14 ingredients that are potentially\ndangerous for human health. Further, FSSAI has directed the FBOs to ensure the\ncomplete prevention of the usages of the following ingredients:<\/p>\n\n\n\n<ul>\n<li>Silica<\/li>\n\n\n\n<li>Raspberry ketone<\/li>\n\n\n\n<li>notoginsing,<\/li>\n\n\n\n<li>paullinia cupana<\/li>\n\n\n\n<li>saw palmetto<\/li>\n\n\n\n<li>Angelica Sinensis<\/li>\n\n\n\n<li>pine bark extracted from pinus\npinaster<\/li>\n\n\n\n<li>pine bark extracted to pinus\nradiate<\/li>\n\n\n\n<li>phytavail iron<\/li>\n\n\n\n<li>oxalobacter formigenes<\/li>\n<\/ul>\n\n\n\n<p>In addition to the products above, FSSAI has\nalso directed the FBOs to stop using the following ingredients as health\nsupplements.<\/p>\n\n\n\n<ul>\n<li>tea tree oil<\/li>\n\n\n\n<li>kale powder<\/li>\n\n\n\n<li>kiwi fruit extracts<\/li>\n\n\n\n<li>pectinase<\/li>\n\n\n\n<li>broccoli and enzymes<\/li>\n\n\n\n<li>Salvia hispanica<\/li>\n\n\n\n<li>passion fruit<\/li>\n<\/ul>\n\n\n\n<p>The utilization of the ingredients above\nseeks prior consent from the authority or else the manufacturer will be\npenalized accordingly.<\/p>\n\n\n\n<p>Moreover, the FBOs are obligated to share\ndetail pertaining to these ingredients within a one-month duration. The label\nof nutraceuticals-based items should reflect \u201cNutraceuticals\u201d Recommended Usage\nWarning.<\/p>\n\n\n\n<p>Nutraceuticals products must reflect the claimed medicinal benefits  through labelling.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p>Widespread demand for nutritional supplements in India witnessed their success rate in the treatment &amp; prevention of diseases. Therefore, it needs FSSAI to curb the adverse events, misuse, adulteration, toxicity, overdose during human consumption. The increasing demand for dietary supplements in India is compelling regulatory authority to underpin relevant norms to curb the availability of poor products. Let us know if you have any queries regarding FSSAI regulations for Nutraceuticals in India.&nbsp;<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important\"><a href=\"https:\/\/corpbiz.io\/learning\/fssai-registration-fees-and-various-aspects\/\">FSSAI Registration Fees and Various Aspects <\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nutraceuticals are now serving as a primary dietary supplement for health-conscious masses in India. Nutraceuticals (aka nutritional supplements) have fast become a staple in the healthcare market in numerous forms, including tablets, syrups, gummer is and capsules. As a repercussion of the Covid-19 pandemic, the nutritional supplements market is projected to witness a growth of [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":36490,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[150],"tags":[1990],"acf":{"service_id":"318"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":18092,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/36468"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=36468"}],"version-history":[{"count":34,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/36468\/revisions"}],"predecessor-version":[{"id":70682,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/36468\/revisions\/70682"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/36490"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=36468"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=36468"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=36468"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}