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Pankaj Tyagi
| Updated: 12 Oct, 2021 | Category: FSSAI License

FSSAI Regulations for Nutraceuticals : A Complete Overview

FSSAI Regulations for Nutraceuticals

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. 

Nutraceuticals Market Analysis from Indian Perspective

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 & 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.

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.

Read our article:Guidelines by FSSAI on Cleaning of Fruit and Vegetable Market Initiative

What are the FSSAI regulations for Nutraceuticals? 

In this purview, the Food Safety and Standards Authority of India[1] have laid down norms pertaining to licensing and registration of business operating in the food sector.

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.

FSSAI has clearly mentioned in the Nutraceuticals Regulations, 2016, under the ‘General Requirements,’ that the (21) mere combination of mineral & vitamins formulated in capsules, tablets, syrup formats shall not be encompassed in any of the categories of such norms expected where minerals & vitamins are added.

Note: Nutritional supplements are deemed as food by the Food Safety and Standards Act, 2011.

FSS Regulations, 2011, rolled out extensive norms for licensing & registration for;

  • FBOs (Food Business operators)
  • Food product standards and food additives
  • Packaging and labelling
  • Toxins and residues
  • Contaminants
  • laboratory and sampling analysis

FSSAI has laid down norms for nutritional supplements, dietary supplements, functional foods, health supplements, and novel food in 2015.

The following detail shall be enclosed in any claimed novel foods –

What are the FSSAI regulations for Nutraceuticals

Nutraceuticals must have any of the ingredients cited in the 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 except those cited in Schedule VI shall be utilized as dietary supplements with standardization to marker compounds cited & at daily usage level cited therein. Only nutraceuticals cited in Schedule IV can be added in nutritional supplements.

Ingredients of botanical origin or plant cited in Schedule IV and Schedule VI might be used either in the provided form or their extract, exposed to the extractive ratios pertaining to the daily usage value. Only additives cited in Schedule VA, VE, or VF should be utilized for nutritional supplements formulation.

On Dec 31, 2018, the FSSAI rolled out a notification that prevents the manufacturer from using several ingredients in nutritional supplements.

The third notice pertaining to the Nutraceutical Foods Regulation;

  • Permitted the utilization of the ingredient ‘Vitamin D3’ from lichen as a vegetable source in the items cited under the Nutraceutical Regulations until the proposed Nutraceutical Regulations or amendments are finalized.
  • Imposed no restriction on the usages of the mustard powder in the food items cited under the Nutraceutical Regulations.
  • Ensured discontinuation of certain ingredients cited in the notification
  • Permitted FBOs to sell prevailing formulation with a combination of minerals & vitamins, only to one advisable dietary allowance, in dosage form such as capsules, tablets, & syrups

This is effective for duration of 3 months from the date of the present notification or until further orders are promulgated, whichever is earlier. FSSAI has revised nutritional supplements norms to prevent manufacturers from using 14 ingredients that are potentially dangerous for human health. Further, FSSAI has directed the FBOs to ensure the complete prevention of the usages of the following ingredients:

  • Silica
  • Raspberry ketone
  • notoginsing,
  • paullinia cupana
  • saw palmetto
  • Angelica Sinensis
  • pine bark extracted from pinus pinaster
  • pine bark extracted to pinus radiate
  • phytavail iron
  • oxalobacter formigenes

In addition to the products above, FSSAI has also directed the FBOs to stop using the following ingredients as health supplements.

  • tea tree oil
  • kale powder
  • kiwi fruit extracts
  • pectinase
  • broccoli and enzymes
  • Salvia hispanica
  • passion fruit

The utilization of the ingredients above seeks prior consent from the authority or else the manufacturer will be penalized accordingly.

Moreover, the FBOs are obligated to share detail pertaining to these ingredients within a one-month duration. The label of nutraceuticals-based items should reflect “Nutraceuticals” Recommended Usage Warning.

Nutraceuticals products must reflect the claimed medicinal benefits through labelling.

Conclusion

Widespread demand for nutritional supplements in India witnessed their success rate in the treatment & 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. 

Read our article:FSSAI Registration Fees and Various Aspects

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Pankaj Tyagi

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.

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