CARROT - DAUCUS CAROTA SUBSP. SATIVUS

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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)

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

Daucus carota subsp. sativus

Carrot

Daucus carota subsp. sativus

Root

Dried

References: Proper name: USDA 2019a, McGuffin et al. 2000; Common name: USDA 2019a, McGuffin et al. 2000; Source material: USDA 2019b, CNF 2015.

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:

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)

General

Specific

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

Note
1Vitamin A deficiency claim: Refer to Table 3 for the dose requirements.

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Methods of preparation: Standardized extracts

All uses/purposes except vitamin A deficiency

Table 2. Dose information of Beta-carotene (micrograms) presented as dose per day, based on subpopulations
Subpopulation(s) Beta-carotene (µg/day)1,2
Minimum Maximum

Children

1-3 years

180

3,600

4-8 years

180

5,400

Adolescents

9-13 years

180

10,200

14-18 years

390

16,800

Adults3

19 years and older

390

18,000

1Values were derived from the conversion factor of 6 µg of beta-carotene = 1 µg all-trans retinol; hence, a ratio of 6:1 beta-carotene: vitamin A, on a weight to weight basis (HC 1990; FAO/WHO 1967).

2Minimum doses based on approximately 5% of the highest AI or RDA for vitamin A, and the maximum doses based on the UL for vitamin A (IOM 2006).

3Includes pregnant and breastfeeding women.

Vitamin A deficiency

Table 3. Dose information of Beta-carotene (micrograms) presented as dose per day for Vitamin A deficiency claim, based on subpopulations
Subpopulation(s) Beta-carotene (µg/day)1
Minimum Maximum

Children

1-3 years

1,800

3,600

4-8 years

2,400

5,400

Adolescent males

9-13 years

3,600

10,200

14-18 years

5,400

16,800

Adult males

19 years and older

5,400

18,000

Adolescent females

9-13 years

3,600

10,200

14-18 years

4,200

16,800

Adult females

19 years and older

4,200

18,000

Pregnancy

14-18 years

4,500

16,800

19-50 years

4,620

18,000

Breastfeeding

14-18 years

7,200

16,800

19-50 years

7,800

18,000

1These values are based on the RDA and AI values for vitamin A based on subpopulations (IOM 2006) and were derived from the conversion factor of 6 µg of beta-carotene = 1 µg all-trans retinol; hence, a ratio of 6:1 beta-carotene:vitamin A, on a weight to weight basis (HC 1990; FAO/WHO 1967).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Products providing more than 6,000 µg of Beta-carotene, per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are a tobacco smoker (Touvier et al. 2005; Omenn et al. 1996; ATBC 1994).

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

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