The Food Safety and Standards Authority of India (FSSAI) recently directed the food business operators (FBOs) to discontinue running businesses involving foods containing two ingredients, namely fluoride and potato protein isolate, with immediate effect and withdraw the same from the market keeping in view the safety concerns.

Further, it also ordered the discontinuation, with immediate effect, of products containing ingredients like willow bark extract, pyrrol quinoline quinone and lemon bam, as they have been identified to exhibit the properties of drugs. However, the sale of products already manufactured or imported is permitted until June 30, 2018.

The country’s apex food regulator further instructed FBOs to continue the business of their existing products containing mere combinations of vitamins and minerals only up to one recommended dietary allowance (RDA) in dosage formats such as tablets, capsules and syrups and also to continue their existing formulations containing vitamins and minerals in food for special dietary uses without referring to the energy value (Kcal/KJ) as specified under the regulation for the period of six months or till further orders, whichever was earlier.

It was pertinent to mention here that FSSAI had notified the implementation of the Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016. As per the notification, FBOs were required to ensure compliance of their existing and new products with all the provisions of these regulations by January 1, 2018.

However, FSSAI has received several representations from stakeholders to include other ingredients and additives in these regulations since several ingredients/ products containing these ingredients are already in the market based on criteria that the formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required.

The scientific panel of FSSAI had met several times to discuss the matter, and after due consideration, has recommended the inclusion of some new ingredients in the regulations.

However, some ingredients were excluded due to inadequate data, safety issues or because they exhibited properties of drugs.

As per the document, some of these issues were still under consideration and the finalisation of the amendments of these regulation would take time. The apex regulator laid down a timeline with respect to compliance, ensuring smoother transition for food businesses.

Ingredients and additives

The ingredients and additives that have recently been approved by the scientific panel and included in the existing schedules have been allowed to continue to be used in existing formulations. In cases where new or revised permissible limits of ingredients or additives have been specified, FBOs have been given time till June 30, 2018 to reformulate their products. In case of the same being prescribed later, a period of six months from the date of specifying new/revised limits to reformulate their products was given to FBOs.

In case of the ingredients that have not been approved by the scientific panel because of inadequate data, FBOs will be given a deadline of four weeks from the date of issuance of direction to submit the data required by the scientific panel. They will be permitted to continue their businesses of existing food products containing ingredients as per Annexure-II under the regulation till further orders. Any product for which data has not been submitted within four weeks from the date of the issuance of this direction must be withdrawn immediately from the market.

Commenting on the same, Vaibhav Kulkarni, chairman, technical and regulatory committee and board member, Health and Dietary Supplement Association (HADSA), informed, “The confusion of not including vitamins and minerals in combination only up to one RDA does not make any sense.”

“The logic behind excluding this needs to be clarified by FSSAI. However, in all, it is a positive move, as the industry has got more clarity now, because the categorisation has become clearer,” he added.

Meanwhile, FSSAI has also made amendments in the Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purposes, Functional Foods and Novel Foods) Regulations, 2016.

Under Regulation 3 of General requirement, Clause 1 needs to be substituted with, and can be read as, “The article of food sold in capsule format, hard or soft or vegetarian, shall comply with the General Monograph, wherever applicable and quality requirements specified for them in Indian Pharmacopoeia, if applicable.”

Clause 21 too has been amended. It will now read as, “Mere combinations of vitamins, including use of single vitamins, including use of single vitamin, in dosage formats such as tablets, capsules, syrups, at levels equal to one RDA or below, shall be covered under these regulations.”

Under the general requirement, three new clauses – Clause 26, 27, and 28- have been added.

Clause 26 states that the products covered under these regulations for children below the age of five years shall be given only under medical advice by a physician/certified dietitian/nutritionist.

Clause 27 states that cereals, grains, legumes, fruits and vegetables mentioned in the Indian Food Composition Tables published by the National Institute of Nutrition (NIN), Hyderabad, or the Indian Council of Medical Research (ICMR), New Delhi, and spices included in the list published by the Spices Board of India, Kochi, may be used either as such or as processed ingredients, including extracts, as a supplement or nutraceutical, as applicable. However, to claim specific health benefits, prior approval from FSSAI shall be obtained.

Clause 28 states that flavours for products covered under these regulations may be used in accordance with the provisions of Regulation 3.3.1 of the Food Safety Standards (Food Products Standards and Food Additives) Regulations, 2011.

The title of Regulation 8 has been changed to Foods for Special Dietary Use (FSDU), other than infants, and those products intended to be taken under medical advice of a physician/certified dietitian/nutritionist. Under this regulation, a few changes were also made in its clauses.

For advisory warning under Regulation 9, pertaining to foods for special medical purpose, in Clause 3, the following have been substituted. The advisory warning states that, “Recommended to be used only under the medical advice of a physician/certified dietitian/nutritionist” must appear in bold letters in an area separated from other written, printed or graphic information.

The viable number of micro-organisms in the food with added probiotic ingredients shall be =108 CFU in the recommended serving size per day have been replaced under Regulation 10, pertaining to foods with added probiotic ingredients.

*Original article online at http://www.fnbnews.com/Top-News/fssai-directs-fbos-to-discontinue-fluoride-use-due-to-safety-concerns-41612