India's FSSAI issues year-end direction to discontinue slew of nutraceutical ingredients
In a document dated December 31 2018, the regulator elaborated on which ingredients were permitted for continued use and which ingredients were to be discontinued.
The regulations — which cover health supplements, nutraceuticals, food for special dietary uses, food for special medical purposes (FSMP), and functional and novel foods — have been updated several times in recent months, according to directions issued in June and August last year.
Direction to discontinue
Most of the ingredients mentioned in the clarification were to be discontinued, including raspberry ketone, silica, Angelica sinensis, Chlorella growth factor, Chaga extract, tea tree oil (Melaleuca alternifolia).
The FSSAI instructed that the usage of these ingredients be discontinued in the aforementioned product categories "with immediate effect", as there has been no additional information provided by their suppliers or manufacturers on their usefulness or effects on health.
While any further manufacturing of products containing these ingredients is now disallowed, similar products that had already been manufactured or imported under the regulations before June 29 2018 are still permitted for sale for up to 30 days from December 31 2018, i.e., the date of the direction.
Oxalobacter Formigenes must also be discontinued immediately, since "they exhibit properties of a drug". Products containing these ingredients are not to be manufactured anymore, though existing products with said ingredients that were manufactured before June 29 2018 can still be sold until January 30 this year.
The last batch of ingredients to be discontinued are Paullinia cupana (Gaurana), saw palmetto, Notoginseng, pine bark extract from Pinus pinaster and pine bark extract from Pinus radiata 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".
As with the previously mentioned ingredients, no further products containing such ingredients are allowed to be manufactured, but such products that were manufactured or imported before June 29 last year can be sold until January 30 this year.
On the other hand, vitamin D3 from lichen (Cladonia rangiferina) are permitted for continued use as a vegetable source in the product categories under the FSSAI's nutraceutical regulations, "till such time the proposed amendment of the Nutraceutical Regulations are finalised and notified".
In addition, the FSSAI stated in its direction that it had received sufficient clarification from food business owners on phytavail iron is in fact mustard powder from Brassica juncea, an ingredient already covered under Schedule IV of the Nutraceutical Regulations.
The regulatory body noted its decision 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".
Additionally, manufacturers are permitted to continue using existing formulations that contain simple combinations of vitamins and minerals in formats such as capsules, syrups and tablets, so long as each dosage in does not exceed one RDA (recommended daily allowance).
This allowance will last for a period of three months from December 31 2018, or until "further orders, whichever is earlier".