With the country's health supplement and nutraceutical industry poised to grow to USD 10 billion by 2025, food regulator FSSAI has said it is gearing to strengthen the regulatory ecosystem through cross-border collaboration and learning from global best practices.

"India's health supplement and nutraceutical industry is rapidly growing and is poised to be USD 10 billion industry by 2025. As this sector grows, FSSAI is gearing itself to strengthen the regulatory ecosystem through cross-border collaboration and learning from international best practices," it said in a statement.

In December 2016, FSSAI notified 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. These regulations cover eight categories of foods and carry detailed requirements about their composition, claims and labels, among others.

These foods are health supplements, nutraceuticals, foods for special dietary use, food for special medical purpose, speciality food containing plants or botanicals, foods containing probiotics, foods containing prebiotics and novel foods. "The regulations allow the manufacturing and selling of the above category of foods in the form of tablets, capsules and syrups and must fulfil quality requirements and standards as specified in the Indian Pharmacopoeia," it said.

As per these regulations, the formulation of articles of food will be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required. A mere combination of vitamins and minerals formulated into tablets, capsules or syrup is not food unless vitamins and minerals are added to an article of food based on a food format.

These foods are not permitted to contain hormones, steroids or psychotropic ingredients. "These foods may use approved colours and additives as permitted in...these regulations, natural, nature identical or synthetic flavours as permitted in the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011," it said. The quantity of nutrients added to the articles of food will not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and accepted by the FSSAI, it said adding that these regulations have into force from 1 January, 2018.

"Since, this is new and emerging area, FSSAI has begun its efforts to bring in global best practices towards harmonisation of regulations on the issue, particularly on vitamins and minerals content in health supplements and nutraceuticals in India," it said. For this purpose, FSSAI had nudged CII to establish Resource Centre for Health Supplements and Nutraceuticals (ReCHaN) in partnership with International Alliance of Dietary/Food Supplement Associations (IADSA).