Licenses You Are Required To Obtain For Health Supplements

by Divya S. Content Writer

As you all know it is mandatory to follow FSSAI guidelines by a food business operator for starting a food supplement business. In this article we will discuss the key regulatory requirements for the manufacturing and trade of functional foods and supplements in India.

Food Safety and Standards Regulations, 2016 and FSSAI have set rules and regulations regarding the health supplements, special dietary foods, foods required for special medical purpose and all other functional and novel food products. Also, the FSSAI license has been made a mandatory requirement for all Food Business Operators.The FBOs are seeking the help from experts to comply with the regulations and obtain required license. The regulations does not only provide the guidelines for different types of functional food but also lists the approved form of ingredients and additives with their maximum permitted level in different types of dosage formats.

According to FSSAI, these food products can be manufactured and sold in the form of syrups, capsules, tablets etc. FSSAI has stated that all food articles and its formulation should be comprised of sound nutrition and medicinal principles and should be strongly backed by scientific data with proper validation. All these food articles should not contain any kind of hormones, psychotropic ingredients hormones or anything else. Moreover, the quantity of nutrients present in the food products should not exceed RDA i.e.the Recommended Dietary allowance as specified by Indian Council of Medical Research (ICMR). Food Additives and colours can be used by the Food Business Operators according to permitted level as specified in the regulations.

Labelling requirement for Food supplements

There are certain rules and regulations to follow regarding the labelling of food products, according to Food Safety and Standards Regulations, 2011. In addition to the general labelling requirements, the labels of food supplements must have information like the purpose of food product, its target age group, or any kind of medical/disease condition that it addresses. Also it is mandatory to declare the, Instructions for use, and recommended usage of the product.The label should explain the nature of the food and all differentiating characteristics. Utmost care should be taken to see that the information is not misleading the consumers.

FSSAI has approved the use of only specific sources of vitamins and minerals, nutraceuticals, probiotics, prebiotics and about 400 ingredients of plant/botanical origin for use in food supplements.

The claims on supplements, as made by food business operator should comply with the functional food regulations, as well as the advertisement and claim regulations. The claims must be substantiated with the help of generally accepted scientific studies. The compliance to FSSAI regulations is a mandatory requirement for all Food Business Operators. The experts in the industry are supporting food businesses to comply with the regulations.

Ingredient Approval FSSAI

Dietary Supplement License

Nutritional Supplement License

Nutraceutical Compliance FSSAI