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FSSAI operationalises nutraceutical regulations to bring more clarity.
Apr 07, 2022

The food regulator has issued a direction to operationalise the FSS (Health Supplement, Nutraceuticals, Food for Special Dietary Use, Food For Special Medical Purpose and Prebiotic & Probiotic Food) Regulations, 2022, or FSS (Nutra) Regulations, 2022.  
 
The nutra regulations will supersede the previous regulations of 2016 and any amendment made thereunder, says the FSSAI direction and will commence from April 1, 2022.
 
According to the FSSAI, it was done to remove ambiguity and bring more clarity on regulations governing such products. This regulation covers schedules applicable to different categories and list of additives and purity criteria, as applicable along with general definitions and conditions applicable to Health Supplement, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose And Prebiotic & Probiotic Food.
 
FSSAI has stated that the draft regulations are in process of publication and its final notification is likely to take some time. Therefore, it has been decided to operationalise the provisions of these regulations with effect from April 1, 2022.
 
The scope of these regulations says that articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition.
 
These foods are intended for population above the age of 2 years and shall fulfil the characteristics as laid down in these regulations. They are intended to be consumed orally in defined quantities and duration and shall not include products intended for parenteral use.
 
And the products falling under these regulations shall not include a drug as defined in clauses (a), (b) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder and the products falling under these regulations shall not contain hormones or steroids or a narcotic drug or a psychotropic substance.
 
Further, mere food forms such as vegetables, for example, bhindi, karela and other vegetables; cereals, for example, ragi, jowar, millets and other cereals; legumes, for example, rajmah and other legumes; spices, for example, pepper, jeera, turmeric and other spices; fruits, for example, amla, jamun, grapes and other fruits; and other plants or botanicals, minimally processed (cleaned, de-weeded, sorted, dried or powdered), in either as juice or cooked form, shall not constitute ‘health supplement’ or ‘nutraceutical’ or ‘food for special dietary use’ or ‘food for special medical purpose’, Also, foods intended for infants up to the age of 2 years shall comply with FSS (Food for Infant Nutrition) Regulations, 2020.
    
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