Garlic - ALLIUM SATIVUM

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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

July 18, 2017

Proper name(s)

Allium sativum L. (Alliaceae) (USDA 2008)

Common name(s)

Garlic (McGuffin et al. 2000)

Essential oil:
Garlic essential oil

Source material(s)

Bulb (ESCOP 2003; Bradley 1992)

Route(s) of administration

Oral

Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

• Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
• Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
• Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

• 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	≥ 15 y	0.5	12

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

Subpopulation		Garlic essential 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	≥ 15 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

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 Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

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.
• 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, 2^nd 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.  Online Updates and Additions to Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 09 May 2008].
• EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web siteFormulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
• ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme.
• FAO 1985. Food and Agriculture Organization of the United Nations.  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, 18^th 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.
• HC 2007: Health Canada.  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.  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, 2^nd 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:  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

• 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 09 May 2008].
• 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 09 May 2008].
• 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 09 May 2008].
• 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(3-5):144-155.
• Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
•  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 09 May 2008].
•  NIH 2008b: National Institutes of Health. ChemIDplus advanced [online]. Allicin; RN: 539-86-6. Bethesda (MD): Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services. [Accessed 09 May 2008].
•  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 09 May 2008].
• 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.

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)

Garlic essential 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)