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

Date

August 5, 2019

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

Caraway dried seed

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

Table 2. Proper name(s), Common name(s), Source material(s)
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)

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)

Table 3. Dose information for caraway dried seed presented as dose (grams) per day
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)

Table 4. Dose information for caraway essential oil presented as dose (microliters) per day
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)

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

References Cited

References Reviewed