Food for special medical purposes (FSMC) are special dietary preparations, people consume it in treating some ailments or bodily issues and gain benefits at its earliest.

Food for special medical purposes were in waiting list of approval by FSSAI. FSSAI has come up with much awaited guidance note on the matter stating that this is a matter of concern and must be consumed under strict guidance of registered physicians or medical practitioners.

There was a lot of applications pending for the matter and FSSAI also made it clear that the issue falls under the FSS (Health Supplement, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) RegulationsRegulations not in the ambit of the regulations made under Non-specified food and food ingredient category (NSF).

“Most of the FSMP formulations are made up of one or more purified and well characterised ingredients from botanical source or synthetic molecule having pharmacological activity and can be formulated in tablets, capsules or liquid,” the document clarifies and adds that these products are to be used under the direction of a medical practitioner.

Admist screening the products to be fallen under the category of drug regulations or food regulations, FSSAI clarifies that a strict scrutinized mechanism is working to align the boundary of regulations.

‘In case of ambiguity, the authority will err on the side of caution and categorise such ingredients/ products to be more akin to drugs. Their use will not be permitted under the FSS Regulations, as a caution to protect consumers,” reads the statement by FSSAI.

Following the guidance note, FSSAI also released informations about the products to be ascertained in their respective category.


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