Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Garlic

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

May 9, 2008

Proper name(s)

Allium sativum L. (Alliaceae) (USDA 2008)

Common name(s)

Garlic (McGuffin et al. 2000)

Source material(s)

Bulb or distilled oil from the bulb (ESCOP 2003; Bradley 1992)

Route(s) of administration

Oral

Dosage form(s)

  • Those suited to the allowable route(s) of administration.
  • This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

  • Traditionally used in Herbal Medicine to help relieve the symptoms associated with upper respiratory tract infections and catarrhal conditions (Mills and Bone 2005; ESCOP 2003; Bradley 1992; Felter and Lloyd 1983 [1898]).
  • Used in Herbal Medicine to help reduce elevated blood lipid levels/ hyperlipidaemia 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).

Dose(s)

Table 1: Dose information for garlic bulb presented as dose per day

Subpopulation Garlic bulb (g/day)
Minimum Maximum

Table 1 Footnotes

Table 1 Footnote 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; Schilcher 1997; Bove 2001.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Adult dose supported by the following references: Kojuri et al. 2006; Mills and Bone 2005; ESCOP 2003; Kannar et al. 2001; Blumenthal et al. 2000; Bradley 1992.

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

Includes breastfeeding women

Return to Table 1 footnote3 referrer

Children 1 2-4 y 0.08 2
Children and adolescents 1 5-9 y 0.1 3
Adolescents 1 10-14 y 0.2 6
Adolescents and adults 1,2,3 ≥ 14 y 0.5 12

Table 2: Dose information for distilled garlic oil presented as dose per day

Subpopulation Distilled garlic oil (mg/day)
Minimum Maximum

Table 2 Footnotes

Table 2 Footnote 1

Adult dose supported by the following reference: Bradley 1992.

Return to Table 2 footnote1 referrer

Table 2 Footnote 2

Includes breastfeeding women

Return to Table 2 footnote2 referrer

Adults 1,2 ≥ 19 y 2 5

Table 3: Dose information for allicin and alliin presented as dose per day.

Subpopulation Minimum (mg/day) Maximum (mg/day)
Allicin Alliin Allicin Allin

Table 3 Footnotes

Table 3 Footnote 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; Schilcher 1997; Bove 2001.

Return to Table 3 footnote1 referrer

Table 3 Footnote 2

Adult dose for allicin supported by the following references: Kojuri et al. 2006; 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).

Return to Table 3 footnote2 referrer

Table 3 Footnote 3

Includes breastfeeding women

Return to Table 3 footnote3 referrer

Children 1 2-4 y 0.17 0.3 2 4.5
Children and adolescents 1 5-9 y 0.25 0.5 3 7
Adolescents 1 10-14 y 0.5 1 6 14
Adolescents and adults 1,2,3 ≥ 14 y 1 2 12 27

Note: See Appendix 1 for examples of appropriate dosage preparations, frequencies of use and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement required.

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

For relief of upper respiratory tract infections and catarrhal conditions:
Consult a health care practitioner if symptoms persist or worsen.

For all uses:

  • Consult a health care practitioner prior to use if you are pregnant (Brinker 2008; Mills and Bone 2005).
  • Consult a health care practitioner prior to use if you have diabetes (Brinker 2008).
  • Consult a health care practitioner prior to use if you are taking blood thinners or protease inhibitors (Brinker 2008; Mills and Bone 2005).

Contraindication(s)

No statement required.

Known adverse reaction(s)

Hypersensitivity (e.g. allergy) has been known to occur; in which case discontinue use (Brinker 2008; Mills and Bone 2005).

Non-medicinal ingredients

Must be chosen from the current NNHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications

  • The finished product must comply with the minimum specifications outlined in the current NNHPD Compendium of Monographs.
  • The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 4 below.
  • For products containing fresh garlic in oil, the preparations must meet at least one of the following conditions in order to prevent the growth of the bacterial spores associated with botulism:
    1. Products are subjected to a validated treatment, such as heat treatment, with equivalent effect to the 12 D canning process (a thermal process designed to reduce the probability of survival of a single, heat-resistant spore of Clostridium botulinum by a factor of 1012) to inactivate spores of C. botulinum (FAO 1985), or
    2. The water activity of the garlic bulb is reduced to 0.94 or less before adding it to the oil, or
    3. Ensure that the pH of the plant material is adjusted to 4.6 or less before adding it to the oil (HC 2007).

Table 4: Garlic monographs published in British, European and US Pharmacopoeias

Pharmacopoeia Monograph
British Pharmacopoeia Garlic, Powdered Garlic, Powdered Garlic Extract, or Garlic Fluid Extract
European Pharmacopoeia Garlic Powder Monograph
US Pharmacopoeia Garlic Powder Monograph

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. 2008. Next link will take you to another Web site Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 09 May 2008].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme.
  • FAO 1985. Food and Agriculture Organization of the United Nations. Next link will take you to another Web site Planning and engineering data 2: Fish canning [online]. Myrseth A, editor. Fisheries Circular - C784; 1985. Rome (I): Food and Agriculture Organization of the United Nations Document Repository. [Accessed 09 May 2008].
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • HC 2007: Health Canada. Next link will take you to another Web site Natural Health Products Directorate Monthly Communiqué Volume 3, Issue 4, December 2007 [online]. Ottawa (ON): Natural Health Products Directorate, Health Canada. [Accessed 09 May 2008].
  • JC 2008: Justice Canada. Next link will take you to another Web site Food and Drug Regulations C.01.021. [online]. Ottawa (ON): Justice Canada. [Accessed 09 May 2008].
  • 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):225-231.
  • 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 2008: Next link will take you to another Web site 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. [Accessed 09 May 2008].

References reviewed

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Garlic bulb

Dried powder:

  • 0.8 g, per day (Kojuri et al. 2006)
  • 0.5-1 g, per day (Mills and Bone 2005; ESCOP 2003)
  • 0.88 g, per day (Kannar et al. 2001)
  • 4-12 g, per day (Bradley 1992)

Dried bulb:

  • 2-4 g, 3 times per day (ESCOP 2003)
  • 2-5 g fresh (air-dried) bulb, per day (Bradley 1992)

Infusion:

4 g garlic bulbs, per day

Directions for use: Pour 150 ml of boiling water on garlic bulb and infuse.

Fluidextract:

  • 6-11.5 g dried equivalent, per day
    (1:1, 6-11.5 ml) (Mills and Bone 2005)
  • 4 g dried equivalent, per day
    (1:1, 4 ml) (Blumenthal et al. 2000)

Tincture:

  • 1.2-2.4 g dried equivalent, per day
    (1:5, 6-12 ml) (Mills and Bone 2005)
  • 0.4-0.8 g dried equivalent, 3 times per day
    (1:5, 45% ethanol, 2-4 ml) (ESCOP 2003)
  • 4 g dried equivalent, per day
    (1:5, 20 ml) (Blumenthal et al. 2000)
Distilled garlic oil

2-5 mg, per day (Bradley 1992)

Preparations providing the following quantities of allicin:

  • 1 mg, per day (Kojuri et al. 2006)
  • 5-12 mg (or total thiosulphinates), per day (Mills and Bone 2005)
  • 9.6 mg, per day (Kannar et al. 2001)

Preparations providing the following quantities of alliin:

  • 6-10 mg (~3-5 mg of allicin), per day (ESCOP 2003)
  • 4-12 mg (~2-5 mg of allicin), per day (Bradley 1992)