GOLDENSEAL - HYDRASTIS CANADENSIS - Buccal

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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.

Date

June 3, 2019

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

Table 1. Proper name(s), Common name(s), Source material(s)

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)	Preparation
Hydrastis canadensis	Goldenseal Orangeroot Yellow-puccoon Yellow root	Hydrastis canadensis	Root and rhizome	Dried

References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, Wiersema and Le?n 1999; Source material: Blumenthal 2003, Hoffmann 2003, Bradley 1992.

Route of Administration

Buccal

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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Note
Dosage forms must be suited for buccal administration which allow for direct contact between the affected tissue and the medicinal ingredient (i.e. liquid preparations, gargles and mouthwashes).

Use(s) or Purpose(s)

Traditionally used in Herbal Medicine to help relieve mucous membrane inflammations of the mouth (Bradley 1992; Ellingwood 1983; Grieve 1971).

Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

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

0.6 - 3 grams of dried root and rhizome, per day (Bradley 1992).

Direction(s) for use

• Rinse as needed.
• Do not exceed maximum daily dose.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

• Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have a kidney disorder or blood pressure problems (Brinker 2018; Hoffmann 2003; Brinker 2001).
• Avoid taking with alcohol, other medications and/or natural health products with sedative properties (Boon and Smith 2004; Brinker 2001).

Contraindication(s)

Do not use this product if you are pregnant or breastfeeding (Barnes and al. 2007; Mills and Bone 2005; Boon and Smith 2004; Hoffmann 2003; Brinker 2001; Bradley 1992).

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

No statement required.

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.
• The manufacturer must have proof of sale or a permit of the cultivated Hydrastis canadensis (Goldenseal) because the wild population is threatened:
  • Hydrastis canadensis is listed in Schedule 1 of the Species at Risk Act (SARA) as a "threatened" species and is afforded protection under this Act. Under section 32(2) of SARA, no person shall possess, collect, buy, sell or trade an individual of a wildlife species that is listed as an extirpated species, an endangered species or a threatened species, or any part or derivative of such an individual (JC 2003). Proof of purchase of cultivated Hydrastis canadensis is require
  • The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) sets controls on the movement of animal and plant species that are, or may be, "threatened" due to excessive commercial exploitation. To import Hydrastis canadensis (including the whole, part of, or the powdered root and/or rhizome) into Canada requires an accompanying CITES export permit from exporting countries. For permit information see https://www.canada.ca/en/environment-climate-change/services/convention-international-trade-endangered-species/permits.html.

References Cited

• Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3^rd edition. London (GB): The Pharmaceutical Press.
• Blumenthal M. 2003. ABC Clinical Guide to Herbs. New York (NY): Theime.
• Boon H, Smith MJ. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2^nd edition. Toronto (ON): Robert Rose Inc.
• Bradley PR, editor. 1992. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
• Brinker F. 2018. Online Updates and Additions to Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2019 May 15]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions
• Brinker F. 2001. Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications.
• Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
• Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
• Hoffmann D. 2003. Medical Herbalism. Rochester (VT): Healing Arts Press.
• JC 2003: Department of Justice Canada. Species at Risk Act [online]. Ottawa (ON): Department of Justice Canada. [Accessed 2019 May 15]. Available from: https://laws-lois.justice.gc.ca/eng/acts/s-15.3/FullText.html
• 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.
• Moerman DE. 1998. Native American Ethnobotany. Portland (OR): Timber Press.
• USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Hydrastis canadensis L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 15]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• Wiersema J, Le?n B. 1999. World Economic Plants: A Standard Reference. Boco Raton (FL): CRC Press LLC.
• Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References Reviewed

• Barnes J, Anderson LA, Philipson JD. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2^nd edition.. London (GB): The Pharmaceutical Press.
• Bown D. 1995. The Herb Society of North America Encyclopedia of Modern Herbs & Their Uses. New York (NY): Dorling Kindersley Publishing Incorporated.
• Chevallier A. 1996. The Encyclopaedia of Medicinal Plants. New York (NY): Dorling Kindersley.
• Duke JA, Bogenschutz-Godwin MJ, DuCellier J, Duke PK. 2002. Handbook of Medicinal Herbs, 2^nd edition. Boca Raton (FL): CRC Press.
• Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18^th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
• McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
• Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
• Small E, Catling PM. 1999. Canadian Medicinal Crops. Ottawa (ON): National Research Council of Canada Monograph Publishing Program, NRC Research Press.