CONCENTRATED TURMERIC EXTRACTS AND ISOLATES (CURCUMINOIDS/CURCUMIN)

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) 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 and its constituents, 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.

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
		Source material(s)	Part(s)	Preparation(s)
Curcuma longa	Common turmeric Curcuma Indian-saffron Jianghuang Turmeric Yellow ginger	Curcuma longa	Rhizome	Dry
Curcuminoids	Curcuminoids	Curcuma longa	Rhizome	Isolate
(1E,6E)-1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione	Curcumin	Curcuma longa	Rhizome	Isolate
		N/A	N/A	Synthetic

References: Proper names: Curcuminoids: USP-NF 2023; EFSA 2017; Curcumin: RSC 2023; Turmeric: USDA 2023; Common names: Curcuminoids: USP-NF 2023; EFSA 2017; Curcumin: Goel et al. 2008; Boon and Smith 2004; Deodhar et al. 1980; Turmeric: USDA 2023; PPRC 2015; McGuffin et al. 2000; Source information: PPRC 2015; Goel et al. 2008; Boon and Smith 2004; ESCOP 2003; Blumenthal et al. 2000; Deodhar et al. 1980.

Route of Administration

Oral

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 (an) antioxidant(s)/Provides (an) antioxidant(s) (ESCOP 2003; Blumenthal et al. 2000; Mills and Bone 2000).
• Source of (an) antioxidant(s)/Provides (an) antioxidant(s) that help(s) 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).
• Helps relieve joint pain and inflammation (Kuptniratsaikul et al. 2014; Panahi et al. 2014; Deodhar et al. 1980).

Note: For source of antioxidant(s) claims, the singular should be used on the label when the product only contains one medicinal ingredient (MI) (single compound) associated with the claim (e.g. curcumin); the plural form should be used when the product formulation contains more than one MI with such properties or one MI containing several compounds with antioxidant properties such as curcuminoids.

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Concentrated Turmeric Extracts

Methods of preparation: Standardized Extracts

Antioxidant

Extract standardized to 75% Curcuminoids or more; Not to exceed 1500 milligrams curcuminoids per day and 500 milligrams per single dose (USP-NF 2023; Kuptniratsaikul et al. 2014; Panahi et al. 2014).

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

Relief of joint pain/inflammation

Extract standardized to 75% Curcuminoids or more; Providing 1500 milligrams curcuminoids, per day; Not to exceed 500 milligrams per single dose (USP-NF 2023; Kuptniratsaikul et al. 2014; Panahi et al. 2014).

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

Curcuminoids

Antioxidant

Not to exceed 1500 milligrams curcuminoids per day and 500 milligrams per single dose (USP-NF 2023; Kuptniratsaikul et al. 2014; Panahi et al. 2014).

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

Relief of joint pain/inflammation

1500 milligrams curcuminoids, per day; Not to exceed 500 milligrams per single dose (USP-NF 2023; Kuptniratsaikul et al. 2014; Panahi et al. 2014).

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

Curcumin

Antioxidant

Not to exceed 1200 milligrams curcumin per day and 400 milligrams per single dose (Deodhar et al. 1980).

Relief of joint pain/inflammation

1200 milligrams curcumin, per day; Not to exceed 400 milligrams per single dose (Boon and Smith 2004; Deodhar et al. 1980).

Direction(s) for use

No statement required.

Combination rules

• The finished product should not exceed a total amount of curcuminoids of 500 mg per dose and 1500 mg per day.
• The finished product should not exceed a total amount of curcumin of 400 mg per dose and 1200 mg per day.

Duration(s) of Use

No statement 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.
• Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a biliary disorder (Brinker 2010; ESCOP 2003; McGuffin et al. 2000).
• Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking blood thinners (Brinker 2010; Mills and Bone 2005).

Relief of joint pain/inflammation

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 (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the NHPID.
• The medicinal ingredients may comply with pharmacopoeial monographs. For example, as per USP-NF 2023, curcuminoids is defined as a partially purified natural complex of diaryl heptanoid derivatives isolated from Turmeric, Curcuma longa L. The ingredient contains NLT 95.0% of curcuminoids, calculated on the dried basis, as the sum of curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin. It contains not less than 70% and no more than 80% curcumin, NLT 15.0% and NMT 25.0% of desmethoxycurcumin, and NLT 2.5% and NMT 6.5% of bisdesmethoxycurcumin.

EXAMPLE OF PRODUCT FACTS:

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

References Cited

• 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.
• 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.
• EFSA 2017: European Food Safety Authority. Scientific opinion: Curcumin and normal functioning of joints: evaluation of a health claim pursuant Article 13(5) of Regulation (EC) No 1924/2006. Vol 15(5). [Accessed 2023 September 28]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4774
• ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. 2003. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
• Goel A, Kunnumakkara AB, Aggarwal BB. 2008. Curcumin as "Curecumin": From kitchen to clinic. Biochemical Pharmacology 75:787-809.
• Kuptniratsaikul V, Dajpratham P, Taechaarpornkul2 W, Buntragulpoontawee M, Lukkanapichonchut P, Chootip C, Saengsuwan J, Tantayakom K, Laongpech S. 2014. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study. Clinical Interventions in Aging 9:451-458.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
• Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
• Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
• Panahi Y., Rahimnia AR., Sharafi M., Alishiri G., Saburi A., Sahebkar A. 2014. Curcuminoid treatment for knee osteoarthritis: a randomized double-blind placebo-controlled trail. Phytotherapy Research 28(11):1625-1631.
• RSC 2023: Royal Society of Chemistry: The Merck Index Online [Accessed 2023 August 14]. Available from: https://merckindex.rsc.org/
• USP-NF 2023: United States Pharmacopeia and the National Formulary. Rockville (MD): United States Pharmacopeial Convention, Inc.; 2023.
• Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 2018 June 14]. Available at: http://www.medicinescomplete.com/mc/merck/current/monographs.htm

References Reviewed

• Araújo CA, Leon LL. 2001. Abstract: Biological activities of Curcuma longa L. Mem Inst Oswaldo Cruz 96(5):723-728.
• 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, 18th 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.
• 2006. 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.