Through a notification dated 11 June, 2020 the FSSAI has issued directions about compliance with respect to Recommended Daily Allowance (RDA) values for license issued to products, covered under the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016. As per the FSS Act, 2006 the use of nutrients is permitted in products such as health supplements, Nutraceuticals, etc. in amounts not exceeding Recommended Dietary Allowances (RDA) prescribed by Indian Council of Medical Research (ICMR).
Further, the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016 also specify that the quantity of nutrients added to food shall NOT exceed the 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.
FSSAI had issued directions dated 07.01.2020 specifying the RDA values of each of the vitamins, minerals and amino acids for ease of reference of the regulatory staff and a guidance document is also placed on FLRS website for ’Filing of license applications for products under Nutraceuticals Regulations’, wherein it is stated that all Designated Officers shall refer to the directions dated 07.01.2020, issued by FSSAI regarding RDA values of nutrients.
Even though FSSAI has taken the above-mentioned measures, it has come to their notice that licenses for the food products as per Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016 are being issued by the Licensing Authorities without duly scrutinizing the RDA values of vitamins, mineral and amino acids in the products to be manufactured by the FBO applying for the license.
In this regard, several instances/references have been brought to the notice of FSSAI, where it has been noticed that some products exceeding RDA values are being sold in the market under FSSAI License, for which appropriately the manufacturer should have obtained license from the Central Drugs Standard Control Organisation (CDESCO) as per the provisions of Drugs & Cosmetics Act, 1940 and rules/regulations framed thereunder.
Accordingly, all the Central as well as State Licensing Authorities are hereby 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 use of more than one RDA is permitted (as per Schedule-III of the Nutraceuticals Regulations).
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.
Source: FSSAI
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