FSSAI issues direction regarding Operationalization of FSS (Nutra) Regulations, 2022.

The Food Safety and Standards Authority of India vide its notification dated 29th March 2022 has drafted a new framework to be called as FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.

The FSS (Nutra) Regulation 2022 shall supersede FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, functional food and novel food) Regulation 2016.

As per the Draft regulation, no person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any food products referred to in these regulations unless they comply with the requirements laid down in these regulations.

The products covered under these regulations may be in the form of powders, granules, tablets, capsules, liquids, semi solids, drops, pills, gummies, jelly, chewable and mouth dissolving strips, bars, biscuits, candies that are intended to be consumed orally in defined quantities and duration unless otherwise restricted for specific categories under these regulations. In addition, Food Authority may also specify any other formats from time to time.

The products shall contain approved ingredients as applicable to different categories of foods to be specified separately by the Food Authority in the form of Schedules as listed below:

 A. Schedule I: Nutrients (vitamins, minerals, amino acids and other nutrients)

 B. Schedule II: Plant or botanicals

C. Schedule III: Molecules/isolates/extracts other than Schedule II

D. Schedule IV: Prebiotics and Probiotics.

Further, the products falling under these regulations by means of labelling, presentation and advertisement shall not claim to treat, cure, mitigate or prevent any specific disease, disorder or condition or refer to such properties, unless specifically permitted by Food Authority.

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