Nutraceutical Products
- American ginseng (Panax quinquefolius L.)
- Astaxanthin (from Haematococcus pluvialis), powder or oleoresin
- Boswellia serrata - gum resin extract
- Caffeine
- Cimicifuga racemosa (or Actaea racemosa). Extracted from rhizomes and roots
- Citrus bioflavonoids (Citrus paradisi, C. reticulate, C.maxima, C. sinensis and Citrus limon)
- CoQ10 from non GM source and Ubiquinol acetate
- Creatine (source Creatine monohydrate, Creatine hydrochloride and Creatine nitrate)
- Cryptoxanthin / Mesoxanthin
- Echinacea (E. angustifolia, E. purpurea, and E. pallida) Liquid/powder extract
- Ginkgo biloba extract obtained from dried leaves of Ginkgo (Ginkgo biloba. L.).
- Glucosamine Hydrochloride
- Glucosamine sulphate
- Gymnema sylvestre extract powder
- Lactase (βgalactosidase)
- L-carnosine
- L- theanine
- Melatonin
- Panax ginseng ( Syn;Korean Ginseng) extract - (obtained from 0.6 to 2.0 g of Ginseng root, (Panax ginseng.C A. Meyer, Araliaceae)
- Phycocyanin fromSpirulina plantesis (Aethrospira plantesis) Dried powder
- Piper nigrum / Piper longum extract
- Schizandra berry extract
- Selenium Yeast
- Silybum marianum extract (silymarin extract)
- Zeaxanthin
- Aloe vera – juice /concentrate /powder of sap /gel
- Alpha amylase
- Alpha mangostin
- Alpha-galactosidase
- Alpha-lipoic acid
- Amaranthus tricolor – leaf powder / extract
- Amylase
- Amyloglucosidase
- Anthocyanin
- Asparagus densiflorus - extract
- Bacopa monnieri - leaf extract
- Berberis vulgaris/ B. aristata/B.asiatica – stem/root extract
- Beta carotene – standardized soft concentrate / emulsified concentrate / powder
- Beta vulgaris – root extract
- Betula platyphylla/B.utilis - bark extract
- Capsicum annum- extract / standardized to capsicin content
- Caricus papaya– leaf extract
- Centella asiatica – leaf/aerial parts standardized extract
- Matricaria chamomilla (Matricaria recutita) – aerial parts extract
- Chondroitin sulphate
- Cinnamomum verum–bark powder / extract
- Citrus aurantium – peel extract / bioflavonoids standardized
- Citrus naringenin
- Syzygum aromaticum Clove powder & oil
- Cnicus benedictus –aerial parts extract / root extract
- Theobroma cacao Cocoa (chocolate) bean - extract
- Collagen and its hydrolysed peptides and chelates
- Conjugated linoleic acid concentrate
- Crataeva nurvala - extract
- Cuminum cyminum L – oil / extract
- Curcuma longa – rhizome powder / extract standardized
- Curcuminoids – soft extract / powder and curcumin complex
- Cyperus rotundus - extract
- Protein isolates/concentrates/hydrolysates
- Ellagic acid
- Emblica officinalis – dried fruit extract / spray dried pulp powder
- Eriocitrin (from citrus fruit)
- Oenothera biennis Evening primrose oil
- Fagopyrum esculentum - seed
- Fish oil
- Foeniculum vulgare - fruit - oil / extract
- Freeze-dried banana powder
- Gallic acid
- Gamma-linoleic acid (GLA )
- Gamma-oryzanol
- Garcinia gummi-gutta and Garcinia cambogia/G.indica –fruit rind extract standardized to hydroxyl citric acid, powder)
- Garcinia mangostana – seed extract standardized
- Glucoamylase
- Glucomannan
- Glycyrrhiza glabra - extract
- Grape seed extract
- Coffea arabica, C. robusta- Green coffee seed extract standardized, including decaffeinated coffee bean powder/extract
- Grifola frondosa – standardized extract
- Guar gum and gum arabic and its derivatives as a source of fibers; Maltodextrin/Resistant maltodextrin/ Limit Dextrin; chia seed fiberand fibers from other food sources
- Hemicellulase
- Hesperidin
- High oleic sun flower oil and other vegetable oils with high oleic content
- Hippophae rhamnoides – leaf/fruit dried powder/extract / juice
- Humulus lupulus L – powder / extract
- Hydrolysed whey peptide
- Inula racemosa - root extract
- Isoflavones (genistein, daidzein)
- Lagerstroemia speciosa L (leaf extract)
- Lutein
- Lutein/zeaxanthin complex
- Lycopene
- Mangifera indica – mangiferine, leaf extract
- Millets and their powder
- Momordica charantia - fruit / seed extract
- Monodora myristica (Gaertn.) Dunal – oil / extract
- Morinda citrifolia extract
- Moringa oleifera leaf / pods / seed extract powder
- Morus alba- Mulberry tea– leaf / fruit extract
- Ocimum tenuiflorum /Ocimum sanctum – aerial parts / seed extract
- Pancreatin
- Pancrelipase
- Papain
- Passiflora foetida - extract
- Arachis hypogaea - (roasted) powder
- Pectin
- Pepsin
- Perna canaliculus (Green lipped mussel / Mussel Oil)
- Phyllanthus amarus - extract
- Picrorhiza kurroa Picrorhiza - extract
- Piper longum - extract
- Piper nigram - green extract
- Policosanol
- Protease
- Prunus serotina - extract
- Plantago ovata (major) – Psyllium (Isaphula)- seed husk
- Cucurbita pepo, C. maxima- Pumpkin seed oil /meal
- Punica granatum – fruit /seed /skin extract /leaf /powder
- Raphanus sativus var. niger - root powder/ extract
- Red wine - extract /concentrate
- Resveratrol
- Rice bran
- Rose hips
- Rosmarinus officinalis – leaves/ needles extract /oil
- Rutin from fruit peels
- Salvia officinalis – leaf extract
- Sambucus nigra - extract
- Shiitake mushroom - extract
- Solanum lycopersicum/ S. esculentum – fruit powder/ extract
- Soy sprouts – dried powder
- Soya protein isolate/ edible legume seed protein isolate
- Spearmint – leaf and distillate
- Sterols/Stanols including their esters
- Tagetes sp. – petals oleo resin / extract
- Terminalia arjuna- bark /leaf extract (standardized extract)
- Terminalia bellerica - fruit extract
- Terminalia chebulia - fruit extract
- Theobromine
- Trigonella -foenum - graecum – seeds extract
- Triticum sativum - bran
- Vaccinium corymbosum - fruit - dried powder / concentrate standardized
- Vaccinium oxycoccos/Vaccinium macrocarpon - fruit - dried powder / concentrate standardized
- Vitis alba and Vitis vinifera - fruit - dried powder / concentrate standardized
- Zingiber officinale - rhizome standardized extracts
Scope
- (a) Scope : The nutraceuticals are meant to provide a physiological benefit and help maintain good health and not intended to treat or cure any medical condition, disease, or disorder
- (b) Nutrients/Ingredients allowed : Molecules/ isolates/extract from the Schedule III as specified by Food Authority from time to time. In addition, it may also contain nutrients and ingredients from other schedules as approved and specified by Food Authority from time to time as an optional ingredient.
- (c) Nutrients/Ingredients usage level : (i) Ingredients: Limits as specified in Schedule III with standardisation to marker compounds specified and at daily usage levels specified therein. In case daily minimum and maximum usage levels have not been specified, the FBO shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data. The ingredient for which the standardisation of the marker compound has not been specified shall comply with manufacturer specifications or quality requirements and purity criteria as specified in regulation. FBO shall submit such data to the Food Authority as and when called for. (ii) Nutrients: Usage levels shall not be more than the level specified by the Food Authority. In case, the levels are not specified by the food Authority, usage level shall be minimum 15 % of RDA as specified by ICMR, where a nutrient content claim is being made, provided that, if claim of higher nutrient content is made, the nutrient content shall not be less than thirty per Page 9 of 76 cent of the recommended daily allowance and shall not exceed one RDA in any case. In case such standards are not specified, the standards laid down by an international food standards body namely, Codex Alimantarius Commission shall apply.
- (d) Delivery format(s) : Shall comply with general requirements 5(1).
- (e) Additive(s) : (i) For products in tablet/capsule/pills/liquid format: Only additives as specified by the FA from time to time. (ii) For products other than tablet/capsule/pills/liquid format: Only additives within the limits specified as permitted for category 13.6 and GMP table of Appendix ‘A’ of FSS (FPS & FA) Regulations, 2011 are permitted
- (f) Labelling requirement(s) : Shall comply with general requirements 5(11)