FSSAI Guidance for Health Supplements and Nutraceuticals

FSSAI Guidance for Health Supplements and Nutraceuticals
20 December 2021

FSSAI Guidance for Health Supplements and Nutraceuticals

FSSAI Guidance for Health Supplements and Nutraceuticals


Nutraceutical are those foods or food related components that benefit the health and also used in treatment and prevention of several ailments, now a day’s people rely on health supplements and nutraceuticals as alternative for medicines. Several new companies have come up with the manufacturing of nutraceuticals in India and growth of this particular industry has increased by 25% in India. Health supplements and nutraceuticals are considered as foods by the Food Safety and Standard Act, 2006, Rules and Regulations. Nutraceuticals and health supplements containing any of these ingredients specified in Food Act, ingredients like: vitamins, minerals, essential amino acids and other nutrients, list of strains as probiotics and list of pre-biotic compounds.

General instructions for Food Business Operators (FBOs) 

FBOs Health supplement are used to supplement normal diet of a person who is above the age of 5 years and nutraceuticals are those that provide physiological benefit and maintain good health, FSSAI has directed Nutraceutical Regulations to stop using 14 ingredients lacking scientific data for safe usage. The Food Safety and Standard Authority of India ordered Food Business Operators to discontinue the use of raspberry ketone, silica, angelica sinensis, paullinia cupana, saw palmetto, notoginsing, chlorella growth factor, pine bark extracted to pinus radiate, pine bark extracted from pinus pinaster, Vitamin D3-veg, chaga extract, oxalobacter formigenes, phytavail iron and tea tree oil.

Labeling specifications

Every package of Nutraceuticals food must carry the following information on its label:

(a) The word “NUTRACEUTICAL” must be written in its package

(b) The common name of the Nutraceuticals must be mentioned so that common people are aware of what they are consuming.

(c) Amount of each Nutraceuticals ingredient as to in what quantity it is used, must be mentioned on the product that either it has a nutritional or physiological effect;

(d) if it is needed and appropriate to mention then the quantity of nutrient must be expressed in terms of percentage of the relevant recommended daily dosage as specified by the Indian Council of Medical Research even when the nutrient is present along with a Nutraceuticals as an addition,

(e) An advisory warning regarding ‘recommended dosage’, it must have an advisory warning ‘not to exceed the stated recommended daily usage

(f) An advisory warning ‘NOT FOR MEDICINAL USE’ must be prominently written on the labeling.

(g) If there are any chances that the product can cause harm to the health of the person, an advisory warning in such cases also be mentioned that danger may exist if consumed in excess amount.

(h) If there are any other precautions to be taken or any awareness warning to be mentioned that must be taken care while consuming, or any known side effects, or if there are any, contraindications, and product-drug interactions, as applicable;

(i) A statement shall also be written mentioning that the product is required to be stored out of reach of children;

(j) No food business operator shall use additives for Nutraceuticals formulation except those specified in Schedule VA or Schedule VE or Schedule VF