BOLDO - PEUMUS BOLDUS

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)
Peumus boldus
  • Boldo
  • Boldo tree
  • Boldu
Peumus boldus Leaf Dry

References: Proper name: USDA 2024; Common names: Gardner and McGuffin 2013; Wiersema and León 1999; Source information: Blumenthal et al. 2000.

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 to help relieve digestive disturbances/dyspepsia (EMA 2016; Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Felter and Lloyd 1983; Wren 1907).
  • Traditionally used in Herbal Medicine to stimulate digestion (Bradley 2006; Felter and Lloyd 1983).

Notes

  • The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g., Traditionally used in Herbal Medicine to help relieve digestive disturbances and stimulate digestion).
  • 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., Boldo is traditionally used in Herbal Medicine to stimulate digestion).
    • 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)

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

0.15 - 3 grams of dried leaf, per day (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).

Methods of preparation: Dry*, Non-Standardized Aqueous Extracts (Dry extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)

2 - 6 grams of dried leaf, per day (EMA 2016; ESCOP 2003; Blumenthal et al. 2000).

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

Direction(s) for use

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

Ask a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks (ESCOP 2003).

Risk Information

Caution(s) and warning(s)

  • Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a kidney or liver disorder (Brinker 2010; Barnes et al. 2007; Bradley 2006).

Contraindication(s)

Do not use if you are pregnant or breastfeeding (EMA 2016; Brinker 2010; Bradley 2006; Mills and Bone 2005).

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

  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): Pharmaceutical Press; 2007.
  • Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
  • Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • EMA 2016. European Medicines Agency. European Union herbal monograph on Peumus boldus Molina, folium. London (UK): EMA Committee on Herbal Medicinal Products (HMPC), November 22, 2016. [Accessed 2025 December 24]. Available from: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-peumus-boldus-molina-folium_en.pdf
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 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. Second Edition. Boca Ration (FL): Taylor and Francis Group; 2013.
  • Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • 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 May 22]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
  • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
  • Wren RC. Potter's Cyclopedia of Botanical Drugs and Preparations. London (UK): Potter and Clark; 1907.

References reviewed

  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (UK): The Pharmaceutical Press; 2002.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
  • Bisset NG, Wichtl M, editors. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 2nd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2001.
  • Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.

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