The Food Safety and Standards Authority of India (FSSAI) has issued a direction regarding the re-operationalization of the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022. These regulations were set to come into effect on April 1, 2023.
The FSSAI had previously issued a notice stating that the provisions of the draft regulations, as specified in the direction dated March 29, 2022, along with the provisions specified in the direction dated May 10, 2022, were re-operationalized on October 1, 2022, as per the direction dated October 18, 2022.
However, as the finalization of these draft regulations is expected to take some time before being notified, the FSSAI has decided to re-operationalize the provisions specified in the direction dated October 18, 2022, with effect from April 1, 2023.
The FSSAI has framed the draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022, superseding the previous FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016.
The direction issued on March 29, 2022, was further revised by the direction dated May 10, 2022, to allow for additional food additives and enzymes or proteins for health supplements.
The purpose of these new regulations is to overhaul the segment and make it more “stakeholder-friendly.” The articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purposes and should be clearly distinguishable from foods intended for normal consumption. These regulations aim to provide clear guidelines for the nutraceutical sector and enable better compliance at the ground level by field functionaries.
It is important to note that the information provided is based on the available information up until my knowledge cutoff in September 2021. There may have been further developments or updates regarding these regulations since then.