TURMERIC - CURCUMA LONGA - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
As enhanced absorption formulations are often used for Turmeric, this is a reminder that enhanced absorption dosage forms/formulations are not covered by Natural and Non-prescription Health Products Directorate's monographs and should be submitted as Class III submissions.
This monograph supports native extracts of Turmeric rhizome (also termed crude or genuine extracts). The traditional references and herbal medicine textbooks used to build this monograph support the use of native extracts with a maximum extract ratio of 10:1 (dry extracts) or 1:10 (liquid extracts). It should be noted that the 'Concentrated Turmeric extracts and isolates (curcuminoids/curcumin)' monograph supports concentrated extracts containing ≥ 75% curcuminoids based on non-traditional methods of preparation and modern scientific evidence.

Date

March 28, 2024

Proper name(s), Common name(s), Source Information

Table 1.Proper name(s), Common name(s), Source Information
Proper name(s)	Common name(s)	Source Information
Proper name(s)	Common name(s)	Source material(s)	Part(s)
Curcuma longa	Common turmeric Curcuma Indian-saffron Jianghuang Turmeric Yellow ginger	Curcuma longa	Rhizome

References: Proper name: USDA 2023; Common names: USDA 2023, PPRC 2015; McGuffin et al. 2000; Source information: PPRC 2015, ESCOP 2003, Blumenthal et al. 2000.

Route of administration

Oral (ESCOP 2003; Blumenthal et al. 2000)

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Source of antioxidants/Provides antioxidants (ESCOP 2003; Blumenthal et al. 2000; Mills and Bone 2000).
Source of antioxidants/Provides antioxidants that help fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals (ESCOP 2003; Blumenthal et al. 2000; Mills and Bone 2000).
Used in Herbal Medicine to aid digestion (ESCOP 2003; Williamson 2003; Blumenthal et al. 2000; Mills and Bone 2000).
(Traditionally) used in Herbal Medicine to help relieve flatulent dyspepsia (carminative) (Mills and Bone 2005; Blumenthal et al. 2000; Wren 1907).
Used in Herbal Medicine as a hepatoprotectant/liver protectant (Boon and Smith 2004; Williamson 2003).
Used in Herbal Medicine to increase bile excretion by the liver (choleretic) and stimulate contraction of the gallbladder (cholagogue) (Mills and Bone 2005; Boon and Smith 2004; Wichtl 2004; Blumenthal et al. 2000; Mills and Bone 2000).
(Traditionally) used in Herbal Medicine to help relieve joint pain (Winston and Kuhn 2008; Blumenthal et al. 2000; WHO 1999).
Used in Traditional Chinese Medicine (TCM) to eliminate blood stasis, promote the flow of qi, relieve pain of menstruation due to blood stasis (PPRC 2015; Bensky et al. 2004).

Notes:

The above claims can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g. Used in Herbal Medicine to help relieve flatulent dyspepsia (carminative) and to help relieve joint pain).
For multi-ingredient products:
- To prevent the product from being represented as a "traditional medicine," any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g. Turmeric is traditionally used in Herbal Medicine to help relieve flatulent dyspepsia (carminative)).
- When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Note: 'decoction' or 'infusion' is listed as an acceptable method of preparation, 'decoction concentrate' or 'infusion concentrate' is also allowed. This would also apply to standardized methods of preparations.

Antioxidant

Methods of preparation: Dry, powder, Non-Standardized Extracts (Dry extract*, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 9 grams of dried rhizome, per day; For dry extracts, maximum ratio is 10:1 (ESCOP 2003; Williamson 2003; Blumenthal et al. 2000).

*Note: Solvents allowed for the method of preparation “Non-Standardized Extracts (Dry extract)” as part of this monograph are ethanol and/or water only.

Methods of preparation: Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Extract providing up to 35% Curcuminoids; Quantity crude equivalent: not to exceed 9 grams of dried rhizome, per day (Meng et al. 2018; Bagchi 2012; Li et al. 2011; ESCOP 2003; Williamson 2003; Blumenthal et al. 2000).

Note: Optional: The potency constituent, curcumin, can be included.

Digestive aid; Relief of flatulent dyspepsia; Hepatoprotectant; Bile excretion; Joint pain

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract*, Tincture, Fluid extract, Decoction, Infusion)

1 - 9 grams of dried rhizome, per day; For dry extracts, maximum ratio is 10:1 (Mills and Bone 2005; Wichtl 2004; ESCOP 2003; Williamson 2003; Blumenthal et al. 2000).

*Note: Solvents allowed for the method of preparation “Non-Standardized Extracts (Dry extract)” as part of this monograph are ethanol and/or water only.

Methods of preparation: Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Extract providing up to 35% Curcuminoids; Quantity crude equivalent: 1-9 grams of dried rhizome, per day (Bagchi 2012; EMEA 2009; Mills and Bone 2005; Wichtl 2004; ESCOP 2003; Williamson 2003; Blumenthal et al. 2000)

Note: Optional: The potency constituent, curcumin, can be included.

TCM

Methods of preparation: Decoction, Decoction concentrate

3 - 9 grams of dried rhizome, per day; For dry extracts, maximum ratio is 10:1 (PPRC 2015; Bensky et al. 2004).

Direction(s) for use

No statement required.

Duration(s) of use

No statement is required.

Risk information

Caution(s) and warning(s)

All products

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding, have gallstones, a bile duct obstruction, stomach ulcers or excess stomach acid (ESCOP 2003; Brinker 2001; McGuffin et al. 1997).

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a biliary disorder (EMA 2018; Brinker 2010; ESCOP 2003; McGuffin et al. 1997).

All uses except for Source of antioxidants and Hepatoprotectant

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
The medicinal ingredient must comply with the requirements outlined in the NHPID.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References cited

Bagchi 2012. Extraction of Curcumin. IOSR Journal of Environmental Science, Toxicology and Food Technology 1(3):1-16.
Bensky D, Clavey S., Stöger 2004. Chinese Herbal Medicine Materia Medica. 3rd Edition. Seattle (WA): Eastland Press, Incorporated.
Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
Boon H, Smith M. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs. Toronto (ON): Robert Rose Inc.
Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
EMA 2018. European Medicines Agency. European Union herbal monograph on Curcuma longa L., rhizome. London (GB): EMA Committee on Herbal Medicinal Products (HMPC); 25 September 2018. [Accessed 2023 October 14] Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-curcuma-longa-l-rhizoma-revision-1_en.pdf
ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. 2003. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
Li S, Yuan W, Deng G, Wang P, Yang P, Aggarwal B. 2011. Chemical composition and product quality control of turmeric (Curcuma longa L.). Faculty Publications.
McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton (FL): CRC Press.
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2^nd edition. Silver Spring (MD): American Herbal Products Association.
Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
Meng FC, Zhou YQ, Ren D, Wang R, Wang C, Lin LG, Zhang XQ, Ye WC, Zhang QW. 2018. Turmeric: a review of its chemical composition, quality control, bioactivity and pharmaceutical application. In: Natural and Artificial Flavouring Agents and Food Dyes. Academic Press.
Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
PPRC 2015: Pharmacopoeia of the People's Republic of China, Volume 1, English edition 2015. Beijing (CN): The State Pharmacopoeia Commission of the People's Republic of China.
USDA 2023: United States Department of Agriculture, Agricultural Research Service, National Genetics Resource Program. Germplasm Resources Information Network (GRIN). Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2023 October 14]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
WHO 1999: World Health Organization. WHO monographs on selected medicinal plants, Volume 1. Geneva (CHE): World Health Organization.
Wichtl M, editor. 2004. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3^rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.
Williamson EM. 2003. Potter’s Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited.
Winston D, Kuhn MA. 2008. Winston and Kuhn’s Herbal Therapy and Supplements. A Scientific and Traditional Approach, 2^nd edition. Philadelphia (PA): Lippincott Williams and Wilkins.
Wren RC. 1907. Potter’s Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References reviewed

Aggarwal BB, Goel A, Kunnumakkara AB. 2008. Curcumin as “Curecumin”: From kitchen to clinic. Biochemical Pharmacology 75:787-809.
Araújo CA, Leon LL. 2001. Abstract: Biological activities of Curcuma longa L. Mem Inst Oswaldo Cruz 96(5):723-728.
Deodhar SD, Sethi R, Srimal RC. 1980. Preliminary studies on antirheumatic activity of curcumin (di-feruloyl methane). Indian Journal of Medical Research 71:632-634.
Felter HW. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications [Reprint of 1922 original].
Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 2, 18^th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
Funk JL, Oyarzo JN, Frye JB, Chen G, Lantz RC, Jolad SD, Sólyom AM, Timmermann BN.
Turmeric extracts containing curcuminoids prevent experimental rheumatoid arthritis. Journal of Natural Products 69(3):351-355.
Gerard J. 1975. The Herbal or General History of Plants. The Complete 1633 Edition as Revised and Enlarged by Thomas Johnson. NY (NY): Dover Publications.
Grieve M. 1971. A Modern Herbal, Volume 2. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
Hatcher H, Planalp R, Cho J, Torti FM, Torti SV. 2008. Curcumin: From ancient medicine to current clinical trials. Cellular and Molecular Life Sciences 65:1631-1652.
Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
Jurenka JS. 2009. Anti-inflammatory properties of curcumin, a major constituent of Curcuma longa: a review of preclinical and clinical research. Alternative Medicine Review 14(2):141-153.
Khory RN, Katrak NN. 1999. Materia Medica of India and their Therapeutics. Delhi (IN): Komal Prakashan.
Kiso Y, Suzuki Y, Watanabe N, Oshima Y, Hikino H. 1983. Antihepatotoxic principles of Curcuma longa rhizomes. Journal of Medicinal Plant Research 49:185-187.
Kohli K, Ali J, Ansari J, Raheman Z. 2005. Curcumin: a natural antiinflammatory agent. Indian Journal of Pharmacology 37(3):141-147.
Kulkarni RR, Patki PS, Jog VP, Gandage SG, Patwardhan B. 1991. Treatment of osteoarthritis with a herbomineral formulation: a double-blind, placebo-controlled, cross-over study. Journal of Ethnopharmacology 33:91-95.
Mills S. 1985. The Dictionary of Modern Herbalsim. Wellingborough (GB): Thorsons Publishers Ltd.
Moerman DE. 1998. Native American Ethnobotany. Portland (OR): Timber Press.
Rivera-Espinoza Y, Muriel P. 2009. Pharmacological actions of curcumin in liver diseases or damage. Liver International 29(10):1457-1466.
Satoskar RR, Shah SJ, Shenoy SG. 1986. Evaluation of anti-inflammatory property of curcumin (diferuloyl methane) in patients with postoperative inflammation. International Journal of Clinical Pharmacology, Therapy and Toxicology 24(12):651-654.
Srimal R, Dhawan B. 1973. Pharmacology of diferuloyl methane (curcumin), a non-sterodal antiinflammatory agent. Journal of Pharmacy and Pharmacology 25:447-452.