FSSAI proposed Draft on regulating sale of Health Supplements and Nutraceuticals

There is need for safety norms as about 60-70 per cent supplements in the nutraceuticals market, which has potential to grow to 12.2 billion US dollars in the next five years, is fake.

Created On: Jul 24, 2015 17:17 IST

Food Safety Standards Authority of India (FSSAI) on 23 July 2015 proposed draft Food Safety and Standards Regulations, 2015. The draft in its ambit seeks to regulate Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food.

FSSAI may ban the trade of these foods if it is found that the food being placed in the market is nor clearly distinguishable from the foods for normal consumption or are not suitable for their claimed nutritional purpose or may endanger the human health.

Key points in proposed draft

  • No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any food products referred to in the draft regulations unless they comply with the requirements laid down under these regulations.
  • The formulation of the foods shall be based on sound medical or nutritional principles and supported by validated scientific data, wherever required.
  • Every package of food or health supplements shall carry the words FOOD or HEALTH SUPPLEMENT and the term ‘NOT FOR MEDICINAL USE’ shall be prominently written on the label.
  • It is proposed to fix the limit on maximum usage levels per day for the milk of cow, buffalo and camel, ghee, curd, butter, honey, gold, gold foil, silver, pearl in ayurveda, siddha and unani ingredients based products.
  • Benefits of specialty foods containing ingredients based on ayurveda, unani and siddha and other traditional health systems of India, should be shown by science based evidence.
  • No hormones or steroids or psychotropic ingredients shall be added in these foods.
  • The labels shall clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address, apart from the specific labelling requirements as mentioned against each type of food.
  • A food, which has not been particularly modified in any way but is suitable for use in a particular dietary regimen because of its natural composition, shall not be designated as “Food Supplements” or “Special Dietary” or “Special Dietetic”

The proposals will be finalised by FSSAI after receiving comments from all stakeholders on the draft note.

Earlier in a paper released on 22 July 2015 by industry body Assocham, it was suggested that FSSAI should come up with safety norms for nutraceuticals and dietary supplements.

As the paper noted, there is need for safety norms as about 60-70 per cent supplements in the nutraceuticals market, which has potential to grow to 12.2 billion US dollars in the next five years, are fake and such unregistered and unapproved products should be recalled.

India accounts for 1.5 per cent of the global nutraceuticals market. Heinz, Kellogg's, Nestle, Hormel, Unilever, Johnson & Johnson and GlaxoSmithKline Pharmaceuticals are key players in this segment.

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