Through directions issued on 31 December 2018 the FSSAI has clarified its decision regarding 14 ingredients listed under Appendix 1 of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2016 (Nutraceutical Regulations).

In continuation of the directions issued previously in June and August 2018, the FSSAI has further decided on the following:

FBOs are allowed to continue to use the ingredient namely ‘Vitamin D3’ from lichen (Cladonia rangiferina) as a veg source in the existing products covered under the Nutraceutical Regulations, till such time the proposed amendment of the Nutraceutical Regulations are finalized and notified.

FBOs are directed to discontinue the use of ingredient namely Raspberry ketone, Silica, Angelica Sinensis, Chlorella growth factor, Chaga extract, Tea tree oil (Melaleuca alternifolia) in the products covered under Nutraceutical Regulations with immediate effect as no additional information has been provided by the applicant. No further manufacturing of products containing these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported under the aforesaid regulations before 29 June 2018 are allowed to be sold only up to a period of 30 days from the date of this direction.

FBOs are directed to discontinue the use of ingredients namely ‘Oxalobacter Formigenes’in the products covered under the Nutraceutical Regulations with immediate effect since they exhibit properties of a drug and no further manufacturing of products using these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported under the aforesaid regulations before 29 June 2018 are allowed to be sold only up to a period of 30 days from the date of this direction.

FBOs are directed to discontinue the use of ingredients namely Paullinia cupana(Gaurana), Saw Palmetto, Notoginseng, Pine bark extract from Pinus radiata, Pine bark extract from Pinus pinaster in the products covered under the Nutraceutical Regulations with immediate effect due to lack of adequate data such as history of safe usage in India for 15 years and also the specific advantage of these plants over the already listed India plants/ botanicals. No further manufacturing of products using these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported under the aforesaid regulations before 29 June 2018 are allowed to be sold up to a period of 30 days from the date of this direction.

Based on the clarification provided by FBO that phytavail iron is mustard powder from Brassica juncea, which is already covered under Schedule IV of the Nutraceutical Regulations, it has been decided that no specific inclusion is required and the ingredient mustard powder can be continued to be used in products covered under the Nutraceutical Regulations subject to compliance with the aforementioned regulations.

Further, FBOs are allowed to continue the food business of existing formulations containing mere combinations of vitamins and minerals only up to one RDA in dosage formats such as tablets, capsules, and syrups for a period of three months from the date of this direction or till further orders whichever is earlier.

Reference:

https://foodsafetyhelpline.com/2018/08/fssai-issues-new-directions/