FSSAI Registration

Do selling Food Supplements in India require FSSAI License?

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.

What are Food Supplements?

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.   

Categories of Food Supplements that can be sold

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^[1].  The regulation has been in effect since January 1^st, 2018.

It covers the following foods:

• Health Supplements– It is made up of concentrated sources of one or more than one nutrient with established nutritional effect. It is formulated to supplement the regular diet of a person and may be taken in case the diet isn’t enough. Health supplements can be taken by healthy people.
• Nutraceuticals– It is naturally occurring ingredients that can be extracted or isolated, or purified from food or non-food sources. They can help in maintaining good health if it’s taken in a measured manner. It can be taken by healthy people.
• Food for special dietary use– It is formulated specially to satiate dietary requirements for specific physiological or health conditions. Physiological conditions can include sports personalities, pregnant women, ageing population, etc. Further, health conditions can consist of underweight and obese people, hypertension etc.
• Food for Special Medical Purposes– It is expected to help people suffering with reduced ability to digest, absorb, or metabolize regular food. It also works to supplement the nutritional requirements of such people. It can be used only under medical supervision.
• Functional Foods– It is processed specially to go beyond fulfilling nutritional requirements. It enhances a physiological response and /or reduces the risk of diseases and disorders.  
• Novel foods– These are those foods, ingredients or methods that were previously not used for human consumption. 
• Food with added pre-biotic ingredients– They include pre-biotic ingredients that are not food themselves, but they are beneficial as they modulate gut microbiota.
• Food with added pro-biotic ingredients– Pro-biotics are live microorganisms that can provide certain demonstrated health benefits. 
• Speciality food containing plant or botanical ingredients– These are foods that have a history of safe usage.

This is just a brief description of the classifications to give you an idea on what constitutes food supplements.

Factors to be considered before Selling 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. 

FSSAI Labelling Requirements for Food Supplements

The labelling requirements are mentioned below and should be followed:

• The words Health Supplement;
• The word nutraceutical, if the product is nutraceutical;
• In case of other categories of food supplement then label with- Food for special Dietary Use, Food for Special Medical Purpose, Probiotic Food etc;
• A warning- Not for Medicinal Use, should be written;
• Its content, purpose, and target age group; and
• A statement specifying that the supplement can’t be used as a substitute for a regular diet.

Documents and Licenses Required for Food Supplements Business in India

• A Food Business Operator who wishes to sell food supplements and understands what they classify, would be required to apply for FSSAI License;
• It should have a NOC from the Centre;
•  It should use Form B with the application;
• The registration and PAN; and
• Tax documents of directors and partners.

How to get FSSAI License for Food Supplements?

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.

Conclusion

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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