NATURAL HEALTH PRODUCT

SAGE – SALVIA OFFICINALIS

Buccal

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 October 30, 2018

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

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

Source information
Proper name(s) Common name(s)
Source material(s) Part(s) Preparation(s)
Salvia officinalis • Common sage Salvia officinalis Leaf Dried
• Dalmatian sage
• Garden sage
• Sage
References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin
et al. 2000; Source information: Blumenthal et al. 2000, BHP 1983, Cook 1869.

Route of administration

Buccal (Barnes 2007; BHP 1983)

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 the age category listed in this monograph and specified route of
administration are indicated 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 provide relief for the inflammation of nose and throat
mucosa (such as sore throat), gingivitis and (aphthous) ulcer/canker sore (BHC 2006; Mills and
Bone 2005; Wichtl 2004; Blumenthal et al. 2000; ESCOP 1996; BHP 1983; Culbreth 1927;
Felter 1922).

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

Dose(s)

Sub-population(s)

Adults 18 years and older

Quantity(ies)

Method of preparation: Fluid extract

3-12 grams of dried leaf, per day (BHP 1983)

Methods of preparation: Dry, Infusion

1-12 grams of dried leaf, per day (Mills and Bone 2005; BHP 1983).

Note: Dried leaves should be prepared as an infusion (see direction for use).

Direction(s) for use

Fluid extract

For gargle and/or mouthwash use, dilute each milliliter (1 ml) of fluid extract with 30 milliliters
of water. Rinse and/or gargle as needed (Blumenthal et al. 2000).
AND/OR

Sage – Salvia officinalis – Buccal Page 2 of 8

For local use in the mouth, apply the undiluted fluid extract to the affected area with a brush or
swab (Blumenthal et al. 2000)

Dried leaf

For each gram (1 g) of dried leaf, add 30 millilitres of boiling water and infuse (BHC 2006).
Rinse and/or gargle as needed.

Infusion

Rinse and/or gargle as needed.

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.

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

No statement required.

Sage – Salvia officinalis – Buccal Page 3 of 8

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.

References cited

Barnes J, Anderson LA, Philipson JD. Herbal Medicines.3rd edition. London (GB): The
Pharmaceutical Press; 2007.

BHC 2006: Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of
Scientific Information on Widely Used Plant Drugs – Companion to the British Herbal
Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.

BHP 1983: 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.

Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual
Patient. St. Louis (MI): Churchill Livingstone; 2003.

Cook WMH. The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica,

and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet]
Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com,
Boulder (CO). [Accessed 2018 August 14]. Available from:
http://www.henriettesherbal.com/eclectic/cook/index.html

Culbreth DMR. A Manual of Materia Medica and Pharmacology [Internet] 7th ed. Philadelphia
(PA): Lea & Febiger; 1927. Abridged and alphabetized by Michael Moore, director. The
Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2018 August 14]. Available
from: http://www.swsbm.com/ManualsOther/Culbreth.html

ESCOP 1996: European Scientific Cooperative of Phytotherapy. Monographs on the Medicinal

Uses of Plant Drugs. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 1996.

Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics [Internet]. Cincinnati
(OH): John K. Scudder; 1922. Reprint version by Michael Moore, The Southwest School of
Botanical Medicine, Bisbee (AZ). [Accessed 2018 August 14]. Available from:
http://www.swsbm.com/FelterMM/Felters.html
Sage – Salvia officinalis – Buccal Page 4 of 8
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition.
Silver Spring (MD): American Herbal Products Association; 2000.

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill
Livingstone; 2005.

USDA 2018: United States Department of Agriculture, Agricultural Research Service, National
Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet].
National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 August 14].
Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a

Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.

References reviewed

ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary

Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.

AU TGA 1999: Australian Therapeutic Goods Administration. TGA Approved Terminology for
Medicines, Section 3 – Herbal Substances. July 1999. [Internet]. Symonston (AU): Australian
Government Department of Health and Ageing, Therapeutic Goods Administration. [Accessed
2012 April 18]. Available from: http://www.tga.gov.au/pdf/medicines-approved-
terminologyherbal.pdf

Azevedo MF, Lima CF, Fernandes-Ferreira M, Almeida MJ, Wilson JM, Pereira-Wilson C.
Rosmarinic acid, major phenolic constituent of Greek sage herbal tea, modulates rat intestinal
SGLT1 levels with effects on blood glucose. Mol Nutr Food Res 2011; 55(Suppl 1): S15025.

Bartram T. Bartram’s Encyclopaedia of Herbal Medicine: The definitive guide to the herbal
treatment of diseases. New York: Marlowe & Company; 1998.

Blumenthal M, Brusse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS. The
Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin
(TX): American Botanical Council in Cooperation with Integrative Medicine Communications;
1998

Bommer S, Klein P, Suter A. First time proof of sage’s tolerability and efficacy in menopausal
women with hot flushes. Adv Ther 2011; 28(6): 490-500.

Brinker F. Herb Contraindications & Drug Interactions. 3rd edition. Sandy (OR): Eclectic
Medical Publications; 2001.

Sage – Salvia officinalis – Buccal Page 5 of 8

Brinker, F. Updates and Additions for Herb Contraindications and Drug Interactions, 3rd ed
including extensive Appendices addressing common problematic conditions, medications and
nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on
botanicals and complementary adjuncts with drugs. [Internet] Sandy (OR): Eclectic Medical
Publications. [Updated July 13, 2010; Accessed 2012 April 18]. Available from:
http://www.eclecticherb.com/emp/updatesHCDI.html

Canadian Nutrient File (CNF), 2012 [Internet]. Ottawa (ON): Food and Nutrition, Health
Canada. [Date Modified 2012-02-10; Accessed 2012 Apr 18]. Available from:
http://webprod3.hc-sc.gc.ca/cnf-fce/index-eng.jsp

Christensen KB, Jorgensen M, Kotowska D, Petersen RK, Kristiansen K, Christensen LP.

Activation of the nuclear receptor PPARγ by metabolities isolated from sage (Salvia officinalis
L.). J Ethnopharmacol. 2010; 132(1): 127-33.

Cook WMH. The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica,

and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet]
Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com,
Boulder (CO). [Accessed 2012 April 18]. Available from:
http://www.henriettesherbal.com/eclectic/cook/index.html

Duke JA, Bogenschutz-Godwin MJ, duCellier J, Duke P-AK. Handbook of Medicinal Herbs. 2nd
ed. Boca Raton (FL): CRC Press LLC; 2002.

European Medicines Agency. Public statement on Salvia officinalis L., aetheroleum. London
(GB): EMEA Committee on Herbal Medicinal Products (HMPC); 19 October 2010. [Accessed
2012 April 18] Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2010/10/WC500098
002.pdf

European Medicines Agency. Community Herbal Monograph on Salvia officinalis L., Folium.
London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 03 February 2010.
[Accessed 2012 April 18] Available from: http://www.ema.europa.eu/docs/

European Medicines Agency. Community Herbal Monograph on Salvia officinalis L., Folium.
London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 12 November 2009.
[Accessed 2012 April 18] Available from: http://www.ema.europa.eu/

Facciola S. Cornucopia II: A source book of edible plants. Vista (CA): Kampong Publications;
1998.

Felter HW, Lloyd JU. Kings American Dispensatory [Internet]. 18th ed, 3rd revision. Cincinnati
(OH): Ohio Valley Co.; 1898. Scanned version by Henriette Kress 1999-2011. [Accessed 2012
April 18]. Available from: http://www.henriettesherbal.com/eclectic/kings/index.html
Sage – Salvia officinalis – Buccal Page 6 of 8
Grieve, M. A Modern Herbal, Volume 1-2. New York (NY): Dover Publications, 1971 [Reprint
of 1931 Harcourt, Brace & Company publication].

Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines. 4th ed. Montvale (NJ):
Thomson Healthcare Inc; 2007.

Halicioglu O, Astarcioglu G, Yaprak I, Aydinlioglu H. Toxicity of Salvia officinalis in a

newborn and a child: an alarming report. Pediatr Neurol 2011; 45(4): 259-60

Health Canada. Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed
Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 18]. Available from:
http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp

Kennedy DO, Scholey AB. The psychopharmacology of European herbs with

cognitionenhancing properties. Curr Pharm Des 2006; 12(35): 4613-23

Lima CF, Andrade PB, Seabra RM, Fernandes-Ferreira M, Pereira-Wilson C. The drinking of a
Salvia officinalis infusion improves liver antioxidant status in mice and rats. J Ethnopharmacol
2005; 97(2): 383-9

Lima CF, Azevedo MF, Araujo R, Fernandes-Ferreira M, Pereira-Wilson C. Metform-like effect

of Salvia officinalis (common sage): is it useful in diabetes prevention? Br J Nutr 2006; 92(2):
326033

Martindale 2010: Sweetman SC, editor. Martindale: The Complete Drug Reference. 37th edition
[Internet]. London (GB): Pharmaceutical Press; 2012. [Sage: Salvia officinalis, Date of
monograph revision 20101127; Accessed 2012 August 1]. Available from:
http://ovidsp.tx.ovid.com/

McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association’s

Botanical Safety Handbook. Boca Raton (FL): CRC Press LLC; 1997

National Nutrient Database for Standard Reference. Spices, sage, ground. United States
Department of Agriculture, Agricultural Research Service; 2011 [Accessed 2012 April 18].
Available from: http://www.nal.usda.gov/fnic/foodcomp/cgi-bin/measure.pl

Natural Standard. Sage (Salvia officinalis, Salvia lavandulaefolia, Salvia lavandulifolia)

Copyright 2012 [Internet]. [Accessed 2012 April 18]. Available from:
http://www.naturalstandard.com.

Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health-care
Professionals. London (GB): Pharmaceutical Press; 1996

Sage – Salvia officinalis – Buccal Page 7 of 8

Perry NS, Bollen C, Perry EK, Ballard C. Salvia for dementia therapy: review of
pharmacological activity and pilot tolerability clinical trial. Pharmacol Biochem Behav 2003;
75(3): 651-9

Remington JP, Woods HC, editors. 1918. The Dispensatory of the United States of America
[Internet] 20th edition. Abridged; botanicals only. Scanned by Michael Moore, director, The
Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2011 April 18]. Available
from: http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf

Sá CM, Ramos AA, Azevedo MF, Lima CF, Fernandes-Derreira M, Pereira-Wilson C. Sage tea
drinking improves lipid profile and antioxidant defences in humans. Int J Mol Sci 2009; 10(9):
3937-50

Swanston-Flatt SK, Day C, Flatt PR, Gould BJ, Bailey CJ. Diabetes Res. 1989; 10(2): 69-73
Umezu T. Evaluation of the effects of plant-derived essential oils on central nervous system
function using discrete shuttle-type conditioned avoidance response in mice. Phytotherapy
Research 2012;26(6):884-891.

Weiss RF. Fintelmann VF. Herbal Medicine. Second edition, revised and expanded. Stuggart
(NY): Thieme; 2000.

World Health Organization. International Programme on Chemical Safety. Toxicological

Evaluation of Certain Food Additives: WHO Food Additives Series 16. [Internet]. Geneva (CH):
World Health Organization; 1981. [Accessed 2012 April 18]. Available from:
http://www.inchem.org/documents/jecfa/jecmono/v16je01.htm

World Health Organization. Summary of Evaluations Performed by the Joint FAO/WHO Expert
Committee on Food Additives. Thujone [Internet]. [Accessed 2012 April 18]. Available from:
http://www.inchem.org/documents/jecfa/jeceval/jec_2273.htm

World Health Organization. Summary of Evaluations Performed by the Joint FAO/WHO Expert
Committee on Food Additives. Isothujone [Internet]. [Accessed 2012 April 18]. Available from:
http://www.inchem.org/documents/jecfa/jeceval/jec_2273.htm

Sage – Salvia officinalis – Buccal Page 8 of 8