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Directions Regarding RDA Compliance for Licensed Products Under Nutraceutical Regulations

FSSAI has found that some products exceeding RDA values are being sold in the market under FSSAI License, for which appropriately the manufacturer should have obtained a license from the Central Drugs Standard Control Organisation (CDESCO) as per the provisions of Drugs & Cosmetics Act, 1940 and rules/regulations framed thereunder.

All the Central, as well as State Licensing Authorities, are advised to strictly implement the limitation of ’Not More than one RDA’ for nutrients as per Section-22 of the FSS Act, 2006 and aforesaid Regulations while granting licenses to the FB0s except for Food for Special Medical purposes and Foods for Special dietary uses, where the use of more than one RDA is permitted (as per Schedule-III of the Nutraceuticals Regulations).

Recommended Daily Allowance (RDA), as specified by ICMR, and in case, such standards are not specified, the standards laid down by international food standards body, namely, Codex shall apply.

In addition to above, they are also advised to undertake a review of RDAs mentioned by the FB0s in the existing licenses issued by their offices for health supplements, Nutraceuticals, etc. and issue notices to such manufacturers to direct them to undertake necessary modifications in compliance with the FSS Act, 2006 and the Regulations framed thereunder immediately. The Licensing Authorities need to ensure that such products need to comply with RDA limitation. Stringent action may be taken against the defaulters.

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