The Food Safety and Standards Authority of India, some time back, had set up a task force to put in place some sort of a regulatory mechanism for special food products like nutraceuticals and food supplements marketed in the country. The 17-member task force submitted its report to FSSAI last week. The recommendations of this panel are basically a set of guidelines for the approval of dietary supplements and nutraceuticals manufactured and marketed in the country. The report is prepared based on a detailed study of these products conducted in consultation with all the stakeholders. Currently there are no set of specific rules in the country to regulate these products although some state health authorities occasionally monitor their therapeutic claims. A large number of ayurvedic products are sold as nutraceuticals or dietary supplements in the country today although there is no reliable statistics of the size of the market and the product classification. The need for such basic data is significant considering the fact that these products belong to direct to consumer segment. The government, therefore, felt the need for bringing a set of standard regulations in the manufacturing and marketing of nutracuticals as there has been a big spurt in the number of these products with exaggerated health claims.
Nutraceuticals are natural or bioactive chemical compounds that are promoted and marketed, world over, claiming to be health promoting and disease preventing products with some medicinal properties. This category comprises of vitamins, minerals, herbal supplements and certain animal products. Nutraceuticals also include functional foods claimed to offer a specific health benefit based on their ingredients. In the US, the FDA regulates nutraceuticals under a different set of regulations. As per the Dietary Supplement Health and Education Act 1994 (DSHEA), it is the manufacturer's responsibility to ensure that a nutraceutical is safe before it is marketed. FDA is empowered to take action against any unsafe product only after it reaches the market. Manufacturers have to make sure that the information on the product label is truthful and not misleading, but they are neither obliged to register their products with the FDA nor get FDA approval before producing or marketing nutraceuticals. In European Union, food legislation covering nutraceuticals is largely under the European Food and Safety Authority (EFSA). New products from Europe are presumed to have passed stringent European development and quality requirements. In Canada and Australia, nutraceuticals are regulated more like a drug than food products. In India, there has been a steady growth in marketing of these products including ayurvedic products by several Indian and international companies with health claims. Enforcement of the guidelines of the task force should not only help in effectively regulating the market but also maintain a proper data of these products. Such regulatory supervision is critical in India considering the fact that there were many incidents of improper manufacturing conditions of these products. Free sales of such products without any regulatory control or medical supervision could pose huge health risks to the general public.