Last Updated on May 28, 2024 by The Health Master
What are nutraceuticals?
Nutraceuticals is a broad term that is used to define Nutraceuticals which is derived from food sources and have extra health benefits in addition to the basic nutritional value found in foods.
They can be considered non-specific biological therapies used to promote general well-being, control symptoms, and prevent malignant processes.
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Definitions
As per the FOOD SAFETY AND STANDARDS ACT, 2006 (FSSAI) the definitions are as under:
(1) “foods for special dietary uses or functional foods or nutraceuticals or health supplements” means:
(a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:-
- (i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
- (ii) minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);
- (iii) substances from animal origin;
- (iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake;
(b)
(i) a product that is labelled as a “Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods” which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;
(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder;
(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;
(iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made thereunder and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;
(2) “genetically engineered or modified food” means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology;
(3) “organic food” means food products that have been produced in accordance with specified organic production standards;
(4) “proprietary and novel food” means an article of food for which standards have not been specified but is not unsafe: Provided that such food does not contain any of the foods and ingredients prohibited under this Act and regulations made thereunder.
Regulations and Guidelines
Click on the links below for Regulations for nutraceuticals in India. These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016.
CDSCO-DBT-and-ICMR-Joint-Guidelines-October-2019-for-Evaluation-of-Nanopharmaceuticals-in-India
ICMR-DBT-2011-Guidelines-for-evaluation-of-probiotics-in-food
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