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FSSAI Releases Draft on Health Supplements Standard (India)

August 17, 2015

Food Safety and Standards Authority of India (FSSAI) has released a draft on the proposed “Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations.”

No person is to manufacture, pack, sell, offer for sale, market, distribute or import any food products under this regulation unless they comply with the following requirements.

  • Every package of food or health supplements shall carry the words “FOOD or HEALTH SUPPLEMENT” and the term “NOT FOR MEDICINAL USE” must be prominently written on the label
  • Formulation of the foods must be based on sound medical or nutritional principles and supported by validated scientific data, wherever required
  • No hormones, steroids or psychotropic ingredients should be added in these foods
  • The labels should clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address, aside from the specific labeling requirements as mentioned against each type of food
  • Labels, accompanying leaflets/or other labeling and advertising of all types of foods, should provide sufficient information on the nature and purpose of the food as well as detailed instructions and precautions for their use
  • 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, should not be designated as “Food Supplements” or “Special Dietary” or “Special Dietetic” or by any other equivalent term and such food may bear a statement on the label that “this food is by its nature “X”

The Food Authority has the authority to:

  • Suspend or restrict the trade of foods in the market that are not clearly distinguishable from foods for normal consumption nor are suitable for their claimed nutritional purpose, or may endanger the human health
  • Ask a food business operator manufacturing and selling special types of foods to submit details regarding the history of use of nutrients added or modified and their safety evaluation
  • Propose maximum usage levels for cow’s milk, buffalo’s milk, camel’s milk, ghee, curd, butter, honey, gold, gold foil, silver, pearl in ayurveda, siddha and unani ingredients based products have also been included

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