Through a letter dated 16 July 2020 the FSSAI has requested Commissioners of Food Safety of all States and UTs to ramp up surveillance and enforcement so as to prohibit the sale of Health Supplement and Nutraceutical products containing PABA (Para Amino Benzoic Acid) as it is a banned ingredient.
The FSSAI had through its order dated 29 June 2018 banned the use of PABA (Para Amino Benzoic Acid) in the products covered under Nutraceutical Regulations due to safety concerns with immediate effect. In the same order FSSAI directed that further manufacturing of products using PABA is prohibited. They also asked manufacturers/ importers to immediately withdraw from the market, any product containing such ingredients.
However, it has come to notice of the FSSAI that several health supplements and nutraceutical products containing PABA are still being sold in the market as well as on e-commerce platforms. The FSSAI has requested all Commissioner of Food Safety of States/UTs to carry out surveillance and enforcement and ensure compliance of Order dated 29 June 2018. The Commissioners of Food Safety must also communicate the action taken report on surveillance and enforcement on above issue to Executive Director Compliance Strategy at the earliest.
The previous order dated 29 June 2018 is as under
Implementation of Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
In this order the FSSAI had provided clarification on the implementation on the Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (referred to hers as ‘Nutraceutical regulations’). The following timelines had been laid down with respect to compliance to these regulations to ensure smoother transition for food businesses.
(i) New ingredients and additives recommended by the Scientific Panel for inclusion in Nutraceutical regulations and proposed to be included in the existing Schedules as per Annexure I of the earlier direction are allowed to continue to be used in the existing formulations after 30th June, 2018 till such time the proposed amendment of the Nutraceutical regulations in this regard are finalized and notified. However, the Food Business Operators (FBOs) shall comply with the provision with respect to permissible limits of ingredients/additives as given at Annexure- I of the earlier direction. (dated 29 12. 2017)
(ii) The earlier direction dated 29.12.2017 contained list of 33 ingredients, which were not recommended by the Scientific Panel for inclusion in the Nutraceutical regulations due to lack of data. The Scientific Panel has again reviewed the use of these ingredients based on the additional data made available by the FBOs and the following decisions have been taken accordingly
(a) FBOs are allowed to continue to use the ingredients namely ‘S-acetyl glutathione (50-600 mg/day, Max)’ and ‘alpha cyclodextrin’ (already covered under ‘other fibre sources’ as mentioned in Schedule VI, Part B of the Nutraceutical regulations) in the existing products covered under Nutraceutical Regulations, till such time the proposed amendment of the Nutraceutical regulations in this regard are finalized and notified.
(b) FBOs are directed to discontinue the use of ingredients namely ‘Succinic acid’ and ‘Inosine’ in the products covered under Nutraceutical regulations with immediate effect as they are withdrawn by the applicant and no further manufacturing of products using these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/imported are allowed to be sold till 30th September, 2018.
(c) FBOs are directed to discontinue the use of ingredients namely ‘Para-amino benzoic acid (PABA).’ ‘Vanadium’, ‘Prenolit’ and ‘Selenium dioxide’ in the products covered under Nutraceutical Regulations with immediate effect due to safety concerns and no further manufacturing of products using these ingredients are allowed. Any product containing these ingredients which are already manufactured/imported shall be withdrawn from the market immediately.
(d) FBOs are directed to discontinue the use of ingredient named ‘D-ribose’ in health supplements/nutraceuticals with immediate effect and no further manufacturing of health supplements/nutraceuticals containing this ingredient for consumption by general population in unsupervised usage is allowed. For use of D-ribose in Food for Special Medical Purpose or Food for Special Dietary Use, prior approval shall be obtained from Food Authority. However, any such products containing this ingredient which is already manufactured/imported are allowed to be sold till 30th September, 2018.
(e) FBOs are directed to discontinue the use of ingredients namely ‘Ipriflavone’ and ‘Polypodium leucotomos’ in the products covered under Nutraceutical Regulations with immediate effect since they exhibit properties of a drug and no further manufacturing of products using these ingredients which are already manufactured/imported are allowed to be sold till 30th September, 2018.
(f) FBOs are directed to discontinue the use of ingredients/enzymes namely ‘Artichoke’. ‘Kale Powder’, ‘Salvia hispanica’,’Cashew fruit’, ‘Passion fruit’, ‘Kiwi fruit extract’, ‘Broccoli’, ‘Enzymes (Pectinase and Xylanase)’ as health supplements/nutraceuticals. However, FBOs may use these ingredients /enzymes in the products as general ingredients, if permitted under Food Safety and Standards Regulations, without claiming any benefits as health supplements/ nutraceuticals for such ingredients. Further, any such products containing these ingredients which are already manufactured/imported making any such claims are allowed to be sold till 30th September, 2018.
(g) FBOs are directed to discontinue the use of ingredients listed under Appendix- I (given below) of this direction in the products covered under Nutraceutical Regulations with immediate effect due to lack of adequate data and no further manufacturing of products using these ingredients is allowed until these ingredients are assessed and approved by the Authority. Further, FBOs are directed to furnish information/data in respect of these ingredients within one month from the date of this direction for further assessment by the Food Authority.
(iii) 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 six months from the date of this direction or till further orders, whichever is earlier.
(iv) FBOs are allowed to continue the food business of their existing formulations containing vitamins and minerals in Food for Special Dietary Use without referring to the energy value (kcal/k) as specified under Schedule III, till such time the proposed amendments of the said regulations are finalised and notified.
Appendix – 1
- Raspberry ketone
- Silica
- Angelica Sinensis
- Paullinia cupana
- Saw palmetto
- Notoginseng
- Chlorella Growth factor
- Pine bark extracted from Pinus radiata
- Pine bark extract from Pinus pinaster
- Vitamin D3 (Veg)
- Chaga extract (Inonotus obliquus)
- Oxalobacter formigenes
- Phytavail iron
Tee tree oil
Source: FSSAI
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