FSSAI Guidelines for Food Supplements Business in India

The notification regarding Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food has been shared with the Food Safety and Standards Regulations, 2016 by FSSAI on 23rd December 2016 Official Gazette. When this regulation is published in the Official Gazette, it will come into force. The compliance of these regulations has been made mandatory for the food business operators by FSSAI from 1st January 2018. FSSAI License for food Supplement business can be obtained online from FSSAI.GOV.In.

It is significant to note that FSSAI regulations cover eight food categories and carry information like composition, labels, claims, etc., as required. These food items are:

Health Supplements

Foods for Special Dietary Use

Nutraceuticals

Speciality Food containing plants or botanicals

Food for Special Medical Purpose

Foods containing Prebiotics

Foods containing Probiotics

Novel Foods

In recent years the FSSAI Guidelines for food supplements has been modified keeping in mind of health issues and inferior supply of food supplements in India. The food products under this category can be produced, manufactured, and sold in the form of capsules, tablets, syrups and more. These food items must fulfill quality standards and requirements as mentioned in British Pharmacopoeia, Indian Pharmacopoeia, or United States Pharmacopoeia. In India, As an FBO you may apply for Basic FSSAI Registration if your turnover is less than Rs. 12 Lac, State license in Case your turnover is More than 12 Lac and less than 20 Lac.

It is important that food articles and its formulation should be based on sound nutrition and medicinal principles and must be supported by scientific data that has been properly validated. A simple combination of minerals and vitamins formulated in the form of capsules, tablets, or syrup cannot be considered as food unless a proper food format is followed by adding specific minerals and vitamins. These food items must not contain steroids, hormones, or any psychotropic ingredients.

The number of nutrients that are added to the food articles must not exceed RDA or recommended daily allowance as clarified and specified by the Indian Council of Medical Research. If the specification regarding these standards is not clear, the Codex Alimentarius Commission standards shall apply.

Approved additives and colors can be used by the FBOs as permitted in Schedule VF regulations. Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 also allow nature identical, natural or synthetic flavors to be used.

FSSAI Labelling Requirements for Food supplement Business?

There are certain regulations regarding labeling on the food article as per the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 and other precise labeling necessities mention on each food type. The labels must offer the following information: If you are starting a Food Supplement business in India and then you must know the FSSAI Labelling requirement before applying for Food License.

Food purpose must be specified

Target consumer group

The disease or physiological condition addressed by the food group

The direction of use as directed

Precise labeling requirements that shall be mentioned for each type of food article

Sufficient information must be provided on the accompanying leaflet or label, or other advertisement or labeling on each type of food article as per regulations regarding the purpose and nature of food article along with the detailed precautions and instructions regarding its use.

A food article that has not been modified in any way and is perfectly suitable for use as per a specific dietary regimen for its natural composition shall not be considered as “special dietary”, “health supplement” or “special dietetic” or any other equivalent term. This food will come along with a statement on its label explaining the nature of the food (this food is by its nature X). Here X explains the mandatory distinguishing characteristics as verified by scientific data that is generally accepted. Care should be taken that the statement is not at all misleading for the buyers.

FSSAI Guidelines for Food Supplements about Additives & Product Ingredients?

Clear and precise schedules divide regulations with detailed provisions where information about the use of minerals, vitamins, botanical ingredients, amino acids, food additives, nutraceutical ingredients, prebiotics, and probiotics is shared. There is a list of 400 ingredients of botanically origin plant in one of the schedules that are permissible to be used as food ingredients which are covered in the regulations. As per the regulatory provisions, the ingredients that have been specified in schedules from Ist to VIIth may be used. Similarly, in accordance with the above regulations, the additives can also be used as applied to the categories specified in Schedule VA to VF.

FSSAI Guidelines for Food Supplements or Sale of Health or Nutritional Claims

Nutritional or health claims can be made by FBOs for ingredients that have been specified in Schedules I-VI. These health claims can be made depending on:

Benefits to the health of a person

Nutritional or nutrient ingredients

The following can be included in the health claims made regarding food:

enhanced function

ingredients or nutritional or nutrient function

health maintenance claims

disease risk reduction

immunity or increased resistance

anti-aging

It is important to validate health claims made by FBOs with the help of accurate and adequate documentation and human studies conducted on the same. In case other claims are made, it is important to get them approved by the Food Authority. Implied claims regarding curing a variety of diseases or making efficacy claims like prevention of disease or cure of cancer through pictures or by name, symbols or vignettes, lipid profile or electrocardiogram are strictly prohibited by FSSAI.

FSSAI Guidelines for Food Supplements business in India provided some reasonable Restrictions on Sale of Certain Food Supplements in India?

The FSSAI also facilitates restriction or suspension of the sale of certain food articles that are available in the market:

Food products that lack a clear distinction between food articles available for normal consumption

Food products that do not serve the claimed nutritional purpose

Food products that may damage human health

Further details must be sought from the FBOs regarding the past use of the modified or new ingredients that have been added along with their thorough safety evaluation. The nutraceutical notification helps the FBOs in manufacturing, selling and importing products to be launched in the domestic market so as to ensure food safety. It also permits the regulatory body monitoring such products with increased efficacy as the demand for these products is steadily increasing among the consumers.