Bearberry - Arctostaphylos Uva-Ursi

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 label at the applicant's discretion.
  • The solidus (/) indicates that either term and/or statement may be selected on the label.

Date

January 30, 2026

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)
Arctostaphylos uva-ursi
  • Bearberry
  • Bear-grape
  • Kinnikinnick
  • Uva ursi
Arctostaphylos uva-ursi Leaf Dry

References: Proper name: USDA 2024; Common names: USDA 2024; Source information: Grieve 1971; Felter 1922.

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)

(Traditionally) used in Herbal Medicine (as a mild diuretic) to help relieve symptoms associated with mild recurrent lower urinary tract infections, such as burning sensation and/or frequent urination (EMA 2018; Godfrey and Saunders 2010; Hoffman 2003; BHP 1983; Grieve 1971; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).

Notes

  • 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., Bearberry is traditionally used in Herbal Medicine to help relieve symptoms associated with mild recurrent lower urinary tract infections, such as burning sensation or frequent urination).
    • 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)

Traditionally used in Herbal Medicine/Used in Herbal Medicine

Methods of preparation: Powdered, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

0.3 - 1.33 grams of dried leaves, 2 to 3 times per day (Newall 1996; Bradley 1992; BHP 1983; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).

Methods of preparation: Dry*, Decoction, Decoction concentrate, Infusion, Infusion concentrate

1.5 - 8 grams of dried leaves, per day; not to exceed 1.5 grams of dried leaves per single dose (EMA 2018; WHO 2002; Blumenthal 2000; Newall 1996; Bradley 1992; BHP 1983; Felter and Lloyd 1898).

*Note: Dried leaves should be prepared as an infusion or decoction by consumers prior to use (see direction for use).

Used in Herbal Medicine (non-traditional claim only)

Methods of preparation: Standardized Extracts (Dry Extract)

500 - 700 milligrams of dry extract standardized to 20% - 30% of Arbutin, 2 to 4 times per day (EMA 2018; ESCOP 2003; WHO 2002; Blumenthal 2000).

Note: The standardized dry extract dose is equivalent to 100 - 210 milligrams of Arbutin, 2 to 4 times per day.

Direction(s) for use

All products

  • Take a few hours before or after taking medications or health products (Brinker 2010; Mills and Bone 2000).
  • Do not take with foods or medications that can acidify the urine (Gardner and McGuffin 2013; Brinker 2010; ESCOP 2003; Duke 2002; WHO 2002; Blumenthal 2000; Mills and Bone 2000; Bradley 1992).

Loose dosage form (for infusion/decoction)*

Place [insert volume to be measured by consumer, e.g., X teaspoons] of dried leaves in [insert the volume of water, e.g., ½ cup (125 mL)] of boiling/cold water. Infuse for [e.g., 5-15 minutes]/Bring to a boil and let simmer for [e.g., 10-20 minutes]. Strain and drink.

*Note: This direction of use statement can be modified on the label provided that it gives clear instructions to consumers.

Duration(s) of Use

Products providing 60 milligrams or more of dried leaves and/or products providing 20 milligrams or more of Arbutin, per day

  • For occasional use only.
  • Ask a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 1 week (EMA 2018; Brinker 2010; WHO 2002; Blumenthal 2000; Mills and Bone 2000; Bradley 1992).

Risk Information

Caution(s) and warning(s)

All products

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

Products providing 60 milligrams or more of dried leaves and/or products providing 20 milligrams or more of Arbutin, per day

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a liver disorder, fever, painful urination (dysuria), spasms, or blood in urine (EMA 2018; Duke 2002; Newall 1996).

Contraindication(s)

Do not use if you are pregnant or breastfeeding (EMA 2018; Brinker 2010; ESCOP 2003; WHO 2002; Blumenthal 2000; Mills and Bone 2000; 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

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

  • BHP 1983: British Herbal Medicine Association's Scientific Committee. British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1983.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications; 2000.
  • Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs - Companion Volume 1 of the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
  • Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • Dr. Duke's Phytochemical and Ethnobotanical Databases. [Accessed 2024 June 11]. Available from: https://phytochem.nal.usda.gov/
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1998 [Reprint of 1919 original].
  • EMA 2018: EMA/HMPC/750269/2016. European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC); 2018 January 30. [Accessed 2024 June 11]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-revision-2_en.pdf
  • ESCOP 2003: European Scientific Cooperative of Phytotherapy. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition completely revised and expanded. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 2003.
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. 2nd edition. Boca Ration (FL): Taylor and Francis Group; 2013.
  • Godfrey A, Saunders PR, Barlow K, Gilbert C, Gowan M, Smith F. Principles and Practices of Naturopathic Botanical Medicine, Volume 1: Botanical Medicine Monographs. Toronto (ON): CCNM Press; 2010.
  • Grieve, M. A Modern Herbal, Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • Mills S, Bone K. Principles and Practice of Phytotherapy, Modern Herbal Medicine. Edinburg (GB): Churchill LYes Soivingston; 2000.
  • Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A guide for health-care professionals. London (GB): The Pharmaceutical Press; 1996.
  • USDA 2024: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2024 June 11]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
  • WHO 2002: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 3. Geneva (CH): World Health Organization; 2002.

References reviewed

  • Sayre LE. A Manuel of Organic Materia Medica and Pharmacognosy 4th edition. Philadelphia (PA): P. Blakiston's Son & Co.; 1917. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2024 June 11]. Available from: http://www.swsbm.com/SayreMM/SayreMM.html

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