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Supplements are intended to provide nutrients to provide all the necessary nutrients and also non-nutrient chemicals which are biologically beneficial to human body. Supplements include proteins, vitamins, minerals, amino acids, and many other substances. At present, there are more than 50,000 dietary FSSAI Food suppliments available in the market.
India’s growing the market for supplement industry with a massive market size which stood around USD1-2 billion in 2016. With the increase in purchasing power of customers and changing lifestyles, there has been an increase in the use of health supplements in India for preventing diseases like Diabetes, Blood Pressure, Obesity, Cardio-Vascular diseases and also for maintaining a balanced nutrition and for enhancing their physical appearance, mental sharpness and to become more dynamic and conscious.
Looking at this the FSSAI notified the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, and Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016 in its Official Gazette on 23 December 2016. All the Food Business Operators will need to comply with these regulations from 1 January 2018.
Section 22 of the Act deals with genetically modified foods, organic foods, functional foods, proprietary foods, etc. which also includes supplements. It provides foresight categories of foods are covered under these Regulations:
- Health Supplements
- Foods for Special Dietary Use
- Food for Special Medical Purpose
- Specialty Food containing plants or botanicals
- Foods containing Probiotics
- Foods containing Prebiotics
- Novel Foods
These supplementary foods are usually manufactured and sold in the form of powders, tablets, capsules and are required to fulfill the quality requirements and standards specified by in the Indian Pharmacopoeia, British Pharmacopoeia or the United States Pharmacopoeia. Use of hormones, steroids and other psychotropic ingredients in such supplements are prohibited.
The nutrients added to the food articles are not supposed to exceed the Recommended Daily Allowance (RDA) as provided by the Indian Council of Medical Research. As per the Indian Council of Medical Research, the food products falling under the category of health supplement, the individual nutrient content shall not be less than 15% of RDA. But, If the product claims to have higher nutrient content, the nutrient content shall not be less 30% of RDA Also the use of colors (natural, nature identical), synthetic flavors and additives are permitted only after complying the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.
Also, the criteria regarding purity for ingredients used in such supplements shall be as determined and notified in the official gazette by the Food Authority from time to time. The FBO is required to intimate the purity criteria adopted for ingredients to the Food Authority. Any Change in purity criteria shall be made only after giving a prior intimation to the Food Authority.
Packaging and labeling of Supplementary foods
The labels put on such food articles shall be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 and also comply with other specific labeling requirements required for different types of food as provided in the regulations. The labels affixed to package must specify the following information:
- Should have the word ‘HEALTH SUPPLEMENT’ or ‘NUTRACEUTICAL’
- The purpose of the foods and the age group for which they are meant
- The contents used in such supplements
- An advisory warning ‘NOT FOR MEDICINAL USE’
- The statement saying that the health supplement is not be used as a substitute for diet;
- Target consumer group
- The disease or disorders for which they are used
- Warning, precautions and the manner in which they are to be used
- Physiological benefits (only for Nutraceuticals)
- Any other specific labeling requirements
Apart from this, the leaflet or advertisement for such food Supplements must provide sufficient information for their nature and purpose and provide detailed instructions about its use & precautions to be taken while using it, in such a format that is appropriate for the intended consumer.
Before selling such articles it is necessary to comply with the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011. Every FBO contravening these provisions shall be punished under Chapter IX of the Act.
The label should specify the Nutritional Information or nutritional facts for per 100 gm or 100ml or per serving of the product in the following manner:—
- energy value in kcal
- the amounts of protein, carbohydrate (specify a quantity of sugar) and fat in gram (g) or ml;
- the amount of any other nutrient for which a nutrition or health claim is made:
Also, any claim made regarding fatty acids, cholesterol, and saturated, monounsaturated and polyunsaturated fatty acids is required to be provided as follows:
- Fatty Acids in grams (g)
- Cholesterol in milligram (mg)
- Trans fatty acid in gram (g)
However, where the nutritional declaration is made on per serving basis, the amount in gram (g) or milliliter (ml) should be provided beside the serving measure along with the details of nutrients, proteins, vitamins, amino acids, enzymes, and such other added nutrients.
Restrictions on Sale of Supplements / Nutraceuticals
The FSSAI license Act has made a provision for suspension or restriction of the sale of articles which cannot be:
- distinguished from food articles used for normal consumption
- are unsuitable / or do not match their claimed nutritional purpose
- harmful to human health
The department may require FBO to furnish all the past details regarding the use of modified ingredients added and their safety evaluation.
The notification of the nutraceutical regulation, as it is called, in short, will help FBOs to manufacture, sell and import these products in the domestic market keeping food safety in mind. It will also allow the regulatory body to monitor such products with more efficacy especially as there is a huge demand for them among consumers.