CARAWAY - CARUM CARVI
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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 statements are synonymous. Either term or statement may be selected by the applicant.
Date
August 5, 2019
Proper name(s), Common name(s), Source material(s)
Caraway dried seed
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation(s) | ||
Carum carvi |
Caraway |
Carum carvi |
Seed |
Dried |
References: Proper name: USDA 2019; Common name: McGuffin et al. 2000, Wiersema and Léon 1999; Source material: Bradley 2006, Blumenthal 1998.
Caraway essential oil
Proper name(s) | Common name(s) | Source material(s) | |
---|---|---|---|
Proper name(s) | Part(s) | ||
Carum carvi |
Caraway essential oil |
Carum carvi |
Seed |
References: Proper name: USDA 2019; Common name: NHPID 2019; Source material: Bradley 2006, Blumenthal 1998.
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 by age group:
Infants 6-12 months, and Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMA/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; EMA/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 aid digestion and to help stimulate appetite (stomachic) (Bradley 2006; Wichtl 2004; Hoffmann 2003; Ellingwood 1983; Felter and Lloyd 1983a; Grieve 1971).
- Traditionally used in Herbal Medicine to help relieve digestive spasms (anti-spasmodic) and indigestion/flatulent dyspepsia (carminative) (Bradley 2006; ESCOP 2003; Hoffmann 2003; Blumenthal 1998; Felter and Lloyd 1983a,b; Grieve 1971).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
As specified below.
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
Subpopulation(s)1,2 | Caraway dried seed (g/day) | ||
---|---|---|---|
Minimum | Maximum | ||
Infants |
6-12 months |
0.06 |
1 |
Children |
1-3 years |
0.3 |
2 |
4-9 years |
0.3 |
4 |
|
10-11 years |
0.3 |
15 |
|
Adolescents |
12-17 years |
0.3 |
15 |
Adults |
18 years and older |
0.3 |
15 |
1The use of caraway seed in infants, children and adolescents is supported by the following references: Bradley 2006, McIntyre 2005, ESCOP 2003, Schilcher 1997.
2Adult dose supported by the following references: Bradley 2006, Wichtl 2004, ESCOP 2003, Hoffmann 2003.
Methods of preparation: Oil, Essential (water steam distillation)
Subpopulation(s)1,2 | Caraway essential oil (μl/day) | ||
---|---|---|---|
Minimum | Maximum | ||
Infants |
6-12 months |
0.26 |
130 |
Children |
1-3 years |
18 |
260 |
4-11 years |
18 |
390 |
|
Adolescents |
12-17 years |
18 |
390 |
Adults |
18 years and older |
18 |
600 |
1The use of caraway essential oil in infants, children and adolescents is supported by the following references: Bradley 2006, McIntyre 2005, ESCOP 2003, Schilcher 1997.
2Adult dose supported by the following references: Bradley 2006, Blumenthal 1998.
Direction(s) for use
No statement required.
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 (ESCOP 2003).
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant, breastfeeding or experiencing acute abdominal pain (ESCOP 2003).
Contraindication(s)
No statement required.
Known adverse reaction(s)
Stop use if hypersensitivity/allergy occurs (Brinker 2010; ESCOP 2003).
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. The Complete German Commission E Monographs. Austin (TX): American Botanical Council; 1998.
- 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.
- Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1919 original]. EMA/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. Adopted September 2006. EMA/CHMP/PEG/194810/2005. [Accessed 2019 June 14]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_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; 1983a [Reprint of 1898 original].
- Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983b [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.
- Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
- Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
- NHPID 2019: Natural Health Products Ingredients Database. Drugs & Health Products, Health Canada. [Accessed 2019 June 20]. Available from: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do
- Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
- USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Carum carvi L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 June 13]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
- Wiersema J, Léon B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
References Reviewed
- BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
- McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
- Moerman DE. Native American Ethnobotany. Portland (OR): Timber Press; 1998.
- Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.