Through an order issued on 30 March 2016 the FSSAI has said that enforcement activities on Food Business Operators (FBO) manufacturing nutraceuticals, food supplements, and health supplements will be restricted to testing the products only.
In its order, the FSSAI has stated that it has received a large number of representations from those FBOs that are engaged in the manufacture of nutraceuticals, food supplements, and health supplements. The FBOs have stated that the State Food Safety Departments are undertaking large-scale enforcement activities against these food manufacturers.
The FSSAI order says that it has been decided that until such time as standards for nutraceuticals, food supplements, and health supplement are notified, enforcement activities will be restrained only to the testing of these foods. The basis for testing will be in accordance with the draft notification for nutraceuticals, health supplements and food supplements as uploaded on the FSSAI website on 9 September 2015.
The FBOs manufacturing these products will not have to face any enforcement activities if their products fulfill certain criteria that the FSSAI has set. Enforcement activity will not apply if
- the impugned nutraceuticals, health supplements, and food supplements were available in the market prior to the FSS Act, Rules and Regulations(before 2006)
- FBO’s wishing to manufacture these products had applied for product approval before 19 August 2015 and for which approval was still pending when the Product Approval Advisory system became non-operational in keeping with the judgment given by the Hon’ble Supreme Court
- such products have been explicitly covered in the draft notification on nutraceuticals, food supplements, and health supplements
About Nutraceuticals
The word Nutraceutical has been derived from the words “nutrition” and “pharmaceutical”. The word implies that the product provides both health and medical benefits. Nutraceuticals generally contain extracts of food that could have a medicinal impact on human health. According to the Market Research Report, the nutraceutical industry in India is expected to grow to USD 6.1 billion by 2020 and at present is USD 2.2 billion. The reasons for this growth have been attributed to rising health awareness, fitness and changing lifestyles along with increased disposal incomes. In the urban areas, the demand is mostly for protein supplements which are taken to maintain fitness and physique.
The proposed FSSAI ‘Draft’ notification is called the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food) Regulations, 2015. These Draft Regulations cover foods containing prebiotic/probiotic ingredients, foods for special dietary uses (other than infant foods and those taken under medical advice), food or health supplements, foods for special medical purposes, nutraceuticals, novel foods etc. These are also called non-standardized foods and are covered under Section 22 of the FSS Act, 2006.
At the informal level nutraceuticals are foods that overlap in meaning with health supplements, food supplements, functional foods and beverages, dietary supplements even though they might not all be nutraceuticals. Collectively they cover foods like oats, probiotics, yogurt, sports and energy drinks and bars, supplements of proteins vitamins, minerals, fibers and fatty acids, in the form of powders, tablets, and capsules. Nutraceutical products are manufactured by the FMCG and pharmaceuticals sectors but the products fall under the purview of the FSSAI for food safety concerns.
There is a perception among some customers that dietary supplements, sold in the Indian market, are either fake or not safe. The FSSAI is working to define standards so that the nutraceutical, health supplement and food supplement market can be streamlined so that consumers can be assured of the safety of raw materials, labeling claims and safe manufacturing of these “health” products.
Prowise Healthcare says
Hi,
Excellent information about Health Supplements and food Supplements in details. keep up your good work thanks….
FSH Team says
Thank You!