NATURAL HEALTH PRODUCT

GARLIC – ALLIUM SATIVUM

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 July 31, 2018

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

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

Source material(s)
Proper name(s) Common name(s)
Proper name(s) Part(s)
Allium sativum Garlic Allium sativum Bulb
References: Proper name: USDA 2018; Common name: McGuffin et al. 2000; Source material: ESCOP
2003, Bradley 1992.

Essential oil:

Table 2. Garlic essential oil: Proper name(s), Common name(s), Source material(s)
Source material(s)
Proper name(s) Common name(s)
Proper name(s) Part(s)
Allium sativum Garlic essential oil Allium sativum Bulb
References: Proper name: USDA 2018; Source material: ESCOP 2003, Bradley 1992.

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.

Garlic – Allium sativum Page 1 of 8

Acceptable dosage forms by age group:

Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/
liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/
suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The
acceptable dosage forms for this age category and specified route of administration are indicated
in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Traditionally used in Herbal Medicine to help relieve the symptoms associated with upper
respiratory tract infections and catarrhal conditions (such as nasal congestion/buildup of
excess mucuous) (Mills and Bone 2005; ESCOP 2003; Bradley 1992; Felter and Lloyd 1983).
Used in Herbal Medicine to help reduce elevated blood lipid levels (hyperlipidemia) in adults
(Kojuri et al. 2007; Macan et al. 2006; Mills and Bone 2005; ESCOP 2003; Kannar et al.
2001; Blumenthal et al. 2000; Bradley 1992).
Used in Herbal Medicine to help maintain cardiovascular health in adults (Kojuri et al. 2007;
Macan et al. 2006; Mills and Bone 2005; ESCOP 2003; Kannar et al. 2001; Blumenthal et al.
2000; Bradley 1992).

The following combined use(s) or purpose(s) is/are also acceptable:

Used in Herbal Medicine to help reduce elevated blood lipid levels (hyperlipidemia) and
maintain cardiovascular health in adults (Kojuri et al. 2007; Macan et al. 2006; Mills and
Bone 2005; ESCOP 2003; Kannar et al. 2001; Blumenthal et al. 2000; Bradley 1992).

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

Dose(s)

Subpopulation(s)

As specified below.

Garlic – Allium sativum Page 2 of 8

Quantity(ies)

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

Table 3. Dose information for garlic bulb presented as dose per day
Garlic bulb (g/day)
Subpopulation(s)1,2,3
Minimum Maximum
Children 2-4 years 0.08 2
5-9 years 0.1 3
10-11 years 0.2 6
Adolescents 12-14 years 0.2 6
15-17 years 0.5 12
Adults 18 years and older 0.5 12
1
Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of garlic in
children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.
2
Adult dose supported by the following references: Kojuri et al. 2007; Mills and Bone 2005; ESCOP 2003; Kannar
et al. 2001; Blumenthal et al. 2000; Bradley 1992.
3
Includes breastfeeding women

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction,
Infusion)

Table 4. Dose information for allicin and alliin presented as dose per day
Minimum (mg/day) Maximum (mg/day)
Subpopulation(s)1,2,3
Allicin Alliin Allicin Alliin
Children 2-4 years 0.17 0.3 2 4.5
5-9 years 0.25 0.5 3 7
10-11 years 0.5 1 6 14
Adolescents 12-14 years 0.5 1 6 14
15-17 years 1 2 12 27
Adults 18 years and older 1 2 12 27
1
Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of garlic in
children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.
2
Adult dose for allicin supported by the following references: Kojuri et al. 2007; Mills and Bone 2005; ESCOP
2003; Kannar et al. 2001; Bradley 1992. Adult dose for alliin calculated based on the conversion ratio of 0.45 mg
allicin: 1 mg alliin (ESCOP 2003).
3
Includes breastfeeding women

Garlic – Allium sativum Page 3 of 8

Methods of preparation: Oil, Essential (water steam distillation)

Table 5. Dose information for garlic essential oil presented as dose per day
Garlic essential oil (mg/day)
Subpopulation(s)
Minimum Maximum
1,2
Adults 18 years and older 2 5
1
Adult dose supported by the following reference: Bradley 1992.
2
Includes breastfeeding women

Direction(s) for use

No statement required.

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s)

For relief of upper respiratory tract infections and catarrhal (nasal congestion) conditions

Consult a health care practitioner/health care provider/health care professional/doctor/physician

if symptoms persist or worsen.

For all uses

Consult a health care practitioner/health care provider/health care professional/doctor/

physician prior to use if you are taking blood thinners or protease inhibitors (Brinker 2018;
Mills and Bone 2005).
Consult a health care practitioner/health care provider/health care professional/doctor/
physician prior to use if you are pregnant or have diabetes (Brinker 2018; Mills and Bone
2005).

Contraindication(s)

No statement required.

Garlic – Allium sativum Page 4 of 8

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Brinker 2018; Mills and Bone 2005).

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.

References cited

Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded

Commission E Monographs. Boston (MA): Integrative Medicine Communications.

Bove M. 2001. An Encyclopedia of Natural Healing for Children & Infants, 2nd edition. Toronto
(ON): McGraw-Hill.

Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on
Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association.

Brinker F. 2018. Online Updates and Additions to Herb Contraindications and Drug Interactions,
4thedition. Sandy (OR): Eclectic Medical Publications. [Accessed 2018 June 1]. Available from:
https://www.eclecticherb.com/herb-contraindications-drug-interactions/

EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines

for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper:
Formulations of choice for the paediatric population.[Accessed 2018 June 1]. Available from:

Garlic – Allium sativum Page 5 of 8

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500
003782.pdf

ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products,
2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme.

Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 1, 18th edition. Sandy
(OR): Eclectic Medical Publications [Reprint of 1898 original].

Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child
Health and Human Development Pediatric Formulation Initiative: selected reports from working
groups. Clinical Therapeutics 2008; 30(11):2097-2101.

JC 2008: Justice Canada. Food and Drug Regulations C.01.021. [online]. Ottawa (ON): Justice
Canada. [Accessed 2018 June 1]. Available from:
http://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-110.html#h-156

Kannar D, Wattanapenpaiboon N, Savige G, Wahlqvist M. 2001. Hypocholesterolemic effect of

an enteric-coated garlic supplement. Journal of the American College of Nutrition 20(3):225231.

Kojuri J, Vosoughi A, Akrami M. 2007. Effects of anethum graveolens and garlic on lipid profile
in hyperlipidemic patients. Lipids in Health and Disease 6(5):1476-1511.

Macan H, Uykimpang R, Alconel M, Takasu J, Razon R, Amagase H, Niihara Y. 2006.

Significance of garlic and its constituents in cancer and cardiovascular disease: aged garlic
extract may be safe for patients on warfarin therapy. Journal of Nutrition 136:793S-795S.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd
edition. Silver Spring (MD): American Herbal Products Association.

McIntyre A. 2005. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto
(ON): Elsevier Limited.

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

Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists.

Stuttgart (D): Medpharm Scientific Publishers.

USDA 2018: United States Department of Agriculture, Agricultural Research Service, National
Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online
database]. Allium sativum L. Beltsville (MD): National Germplasm Resources Laboratory.

Garlic – Allium sativum Page 6 of 8

[Accessed 2018 June 1]. Available from: http://www.ars-grin.gov/cgi-
bin/npgs/html/tax_search.pl

References reviewed

BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medicine
Association.

BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association.

Budoff M. 2006. Aged garlic extract retards progression of coronary artery calcification. The
Journal of Nutrition 136(3 Suppl):741S-744S.

CDC 2007: Centers for Disease Control and Prevention. Update: International Outbreak of
Restaurant-Associated Botulism -- Vancouver, British Columbia, Canada [online]. Morbidity
and Mortality Weekly Report (MMWR) October 18, 1985 / 34(41);643. Atlanta (GA): Centers
for Disease Control and Prevention (CDC), United States Department of Health and Human
Services. [Accessed 2008 May 9]. Available from:
http://www.cdc.gov/mmwr/preview/mmwrhtml/00000627.htm

Gardner CD, Lawson LD, Block E, Chatterjee LM, Kiazand A, Balise RR, Kraemer HC. 2007.
Effect of raw garlic vs commercial garlic supplements on plasma lipid concentrations in adults
with moderate hypercholesterolemia. Archives of Internal Medicine 167(4):346-353.
HC 2007: Health Canada. Natural Health Products Directorate Guidance Document for the
Evidence for Quality of Finished Natural Health Products, Version 2.0 [online]. Ottawa (ON):
Her Majesty the Queen in Right of Canada, represented by the Minister of Health. [Accessed
2008 May 9]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-
paq_e.html

HC 2006. Health Canada. Health Products and Food Branch (HPFB) Standards and Guidelines
for Microbiological Safety of Food - An Interpretive Summary [online]. Ottawa (ON): Food
Directorate Evaluation Division, Bureau of Microbial Hazards, Health Canada. [Accessed 2008
May 9]. Available from: http://www.hc-sc.gc.ca/fn-an/res-rech/analy-
meth/microbio/volume1/intsum-somexp_e.html

Lund B. 1993. Quantification of factors affecting the probability of development of pathogenic

bacteria, in particular Clostridium botulinum, in foods. Journal of Industrial Microbiology
12(35):144-155.

Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill
Livingstone.

Garlic – Allium sativum Page 7 of 8

NIH 2008a: National Institutes of Health. ChemIDplus advanced [online]. Alliin; RN: 556-27-4.
Bethesda (MD): Specialized Information Services, National Library of Medicine, National
Institutes of Health, US Department of Health & Human Services. [Accessed 2008 May 9].
Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp

NIH 2008b: National Institutes of Health. ChemIDplus advanced [online]. Allicin; RN: 539-866.
Bethesda (MD): Specialized Information Services, National Library of Medicine, National
Institutes of Health, US Department of Health & Human Services. [Accessed 2008 May 9].
Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp

NIH 2008c: National Institutes of Health. ChemIDplus advanced [online]. S-allylcysteine; RN:
21593-77-1. Bethesda (MD): Specialized Information Services, National Library of Medicine,
National Institutes of Health, US Department of Health & Human Services. [Accessed 2008 May
9]. Available from:
http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp

Ziaei S, Hantoshzadeh P, Rezasoltani P, Lamyian M. 2001. The effect of garlic tablet on plasma
lipids and platelet aggregation in nulliparous pregnants at high risk of preeclampsia. European
Journal of Obstetrics & Gynecology and Reproductive Biology 99(2):201-206.

Garlic – Allium sativum Page 8 of 8