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POLICY & REGULATIONS

Draft on nutraceuticals redefines dosages, use of chemical ingredients
Saturday, 28 November, 2020, 08 : 00 AM [IST]
Ashwani Maindola, New Delhi
The Food Safety and Standards Authority of India (FSSAI) has issued a draft on regulations called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Amendment Regulations, 2020, aimed at redefining the dosages for consumption along with setting provisions for use of chemical or botanical ingredients.

The draft says that for claiming specific health benefits, prior approval from the Food Authority is needed. Also, flavours for products covered under these regulations may be used in accordance with the prescribed provisions and any single purified chemical entity listed in these regulations, except extracts of botanicals, which are to be sold as Health Supplement/Nutraceutical/Food for Special Dietary Use/Food for Special Medical Purpose, is not permitted without prior approval of the Food Authority, reads the draft.

Further, any products which are to be sold as Health Supplement/Nutraceutical /Specialty food containing plant or botanical ingredients with safe history of usage/food with added probiotic ingredients/ food with added prebiotic ingredients for the age above 6 months till 24 months is not permitted without prior approval of the Food Authority.

Meanwhile, the regulations also prescribe norms for selling health supplements to sportspersons. The draft says that the FBOs need to add a statement ?’For Sportsperson Only’ in close proximity to the name of the articles of food along with the statement ?Recommended to be used under medical advice or dietetic supervision only, and the logo as specified by these regulations.

The FBOs are even restrained from advertising such articles meant for sportspersons in public.

The draft prescribes that in case of Nutraceutical, the food business operator shall apply to the Food Authority for approval which shall be accompanied by documented history of safe usage of at least 15 years in India and 30 years in the country of origin. And the food business operator shall clearly indicate on the label whether or not the food for special dietary use is to be taken under medical advice.
 
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