To manufacture the Ayurvedic/Herbal products in India, we need a license from AYUSH and not fro...
Food supplements are not new for India. With elongated working hours, increased stress, and an increasingly sedentary lifestyle has enhanced its importance. Food supplements in India fall under the purview of the Food Safety and Standards Authority of India and are governed under FSS Act 2006. It may be noted that an FBO who intends to sell food supplements should apply for FSSAI License.
Food supplements are concentrated sources of nutrients or other substances with nutritional or a physiological effect that is marketed in dose form. A wide range of nutrients and other ingredients are present in these food supplements. It includes vitamins, minerals, amino acids, fatty acids, fibre, and plants, and herbal extracts.
They are intended to correct nutritional deficiencies and maintain adequate intake of certain nutrients. They are not medicinal products therefore its use is not expected to treat or prevent diseases in humans.
A food business operator looking to manufacture or sell food supplement should get a license to do the same. The regulation for that is new. It is called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for special dietary use, Food for Special medical purposes and Functional Food and Novel Food) Regulations, 2016. The regulation has been in effect since January 1st, 2018.
It covers the following foods:
This is just a brief description of the classifications to give you an idea on what constitutes food supplements.
The above section provides the classification of foods which can be sold as supplements. However, there are things that prospective food supplement sellers should keep in mind that it can be sold in powder, capsule, tablet, and in syrup form. The amount of nutrients added to supplements can’t go beyond the recommended daily allowance that has been set by Indian Council of Medical Research. When it comes to health supplements, the individual nutrient content can’t be less than 15% of the recommended daily allowance. However, in case the claim is of higher nutrient content, it can’t be less than 30% of the recommended daily allowance.
Plants or botanicals in naturally occurring manner shall not be considered as food supplements. Further, their minimal process forms, juice or cook, cannot be considered a health supplement, nutraceutical, FSDU or FSMP. The supplements formulation has to be on sound medical principles and their benefits should be backed by valid data. It may be noted that hormones, steroids and psychotropic drugs can’t be added to it.
The labelling requirements are mentioned below and should be followed:
Firstly you are required to choose the type of license/registration that goes as per your business. If your food business has been newly established, it will require FSSAI Registration, and if the business is an old one, then the license shall depend upon your business turnover.
You can log into the official website of FSSAI and fill the application form and attach the relevant documents. Once the form is filled, make payment for the application.
The criteria for the purity of ingredients used in such food supplements in India is determined and notified by the food authority from time to time. An FBO should intimate the purity criteria to the Food Authority.
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