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

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)

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

Provitamin A/Source of vitamin A for the maintenance of good health (IOM 2006).
Source of vitamin A.

Specific

Helps to prevent vitamin A deficiency¹ (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
Provitamin A/Source of vitamin A to help/helps in the development and maintenance of bones (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
Provitamin A/Source of vitamin A to help/helps in the development and maintenance of night vision (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
Provitamin A/Source of vitamin A to help/helps in the development and maintenance of teeth (Shils et al. 2006).
Provitamin A/Source of vitamin A to help/helps maintain eyesight, skin, membranes and immune function (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).

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

Provitamin A/Source of vitamin A to help/helps in the development and maintenance of bones and teeth (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
Provitamin A/Source of vitamin A to help/helps in the development and maintenance of night vision, bones and teeth (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
Provitamin A/Source of vitamin A to help/helps maintain eyesight, skin, membranes and immune function and helps in the development and maintenance of night vision, bones and teeth (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
Provitamin A/Source of vitamin A for the maintenance of good health and to prevent vitamin A deficiency¹ (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).

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
Subpopulation(s)		Minimum	Maximum
Children	1-3 years	180	3,600
Children	4-8 years	180	5,400
Adolescents	9-13 years	180	10,200
Adolescents	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
Subpopulation(s)		Minimum	Maximum
Children	1-3 years	1,800	3,600
Children	4-8 years	2,400	5,400
Adolescent males	9-13 years	3,600	10,200
Adolescent males	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
Adolescent females	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
Pregnancy	19-50 years	4,620	18,000
Breastfeeding	14-18 years	7,200	16,800
Breastfeeding	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

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

ATBC (Alpha-tocopherol, beta-carotene cancer prevention) study group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. The New England Journal of Medicine1994;330(15):1029-1035.
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 19]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf
CNF 2015: Canadian Nutrient File (CNF), 2015 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Accessed 2019 June 18]. Available from: https://food-nutrition.canada.ca/cnf-fce/index-eng.jsp
FAO/WHO 1967: Food and Agricultural Organization of the United Nations / World Health Organization. 1967. Requirements of vitamin A, thiamine, riboflavine and niacin: report of a joint FAO/WHO Expert Group. Geneva (CH): WHO Technical Report Series 362.
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.
Groff J, Gropper S. Advanced Nutrition and Human Metabolism. 3^rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
HC 1990: Nutrition Recommendations. The Report of the Scientific Review Committee. Ottawa: Minister of Supply and Services, Health Canada; 1990.
IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements.
Washington (DC): National Academies Press; 2006.
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2^nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, Glass A, Keogh JP, Meyskens FL, Valanis B, Williams JH, Barnhart S, Hammar S. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. New England Journal of Medicine 1996;334(18):1150-1155.
Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease. 10^th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
Touvier M, Kess E, Clavel-Chapelon F, and Boutron-Rualt MC. Dual association of beta- carotene with risk of tobacco-related cancers in a cohort of French women. Journal of the National Cancer Institute 2005;97(18):1338-1344.
USDA 2019a: USDA, ARS, National Genetic Resources Program. Germplasm Resources Information Network - (GRIN) [Internet]. Daucus carota L. subsp. Sativus. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 June 18]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
USDA 2019b: United States Department of Agriculture (USDA), Agricultural Research Service. Nutrient Data Laboratory, National Nutrient Database for Standard Reference; Carrots, raw NDB. No: 11124. Release 24 Software v. Release 1.0 3/30/12 2012. [Accessed 2019 June 19]. Available from: http://ndb.nal.usda.gov/ndb/search/list

References Reviewed

Burri BJ, Clifford AJ. Carotenoid and retinoid metabolism: insights from isotope studies. Archives of Biochemistry and Biophysics 2004;430(1):110-119.
Dueker SR, Lin Y, Buchholz BA, Schneider PD, Lame MW, Segall HJ, Vogel JS, Clifford AJ. Long-term kinetic study of β-carotene, using acceleratory mass spectrometry in an adult volunteer. Journal of Lipid Research 2000;41:1790-1800.
Expert Group on Vitamins and Minerals. 2003. Safe Upper Levels for Vitamins and Minerals. United Kingdom Food Standards Agency. [Internet]. [Accessed 2012 April 26]. Available from: http://cot.food.gov.uk/pdfs/vitmin2003.pdf
Food and Drug Regulations. (C.01.021). Ottawa (ON): Health Canada; 2008. [Accessed 2012 April 26] Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html
Furr HC, Green MH, Haskell M, Mokhtar N, Nestel P, Newton S, Ribaya-Mercado JD, Tang G, Tanumihardjo S, Wasantwisut E. Stable isotope dilution techniques for assessing vitamin A status and bioefficacy of provitamin A carotenoids in humans. Public Health Nutrition 2005;8(6):596-607.
Haskell MJ, Brown KH. Reply to M van Lieshout and S de Pee. American Journal of Clinical Nutrition 2005;81(4):945-946.
Hickenbottom SJ, Follett JR, Lin Y, Dueker SR, Burri BJ, Neidlinger TR, Clifford AJ. Variability in conversion of β-carotene to vitamin A in men as measured by using a double-tracer study design. American Journal of Clinical Nutrition 2002;75(5):900-907.
Hickenbottom SJ, Lemke SL, Dueker SR, Lin Y, Follett JR, Carkeet C, Buchholz BA, Vogel JS, Clifford AJ. Dual isotope test for assessing β-carotene cleavage to vitamin A in humans. European Journal of Nutrition 2002;41(4):141-147.
Institute of Medicine. Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academy Press; 2001.
Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press; 2003.
Lemke SL, Dueker SR, Follett JR, Lin Y, Carkeet C, Buchholz BA, Vogel JS, Clifford AJ. Absorption and retinol equivalence of β-carotene in humans is influenced by dietary vitamin A intake. Journal of Lipid Research 2003;44(8):1591-1600.
Lin Y, Dueker SR, Burri BJ, Neidlinger TR, Clifford AJ. Variability of the conversion of β- carotene to vitamin A in women measured by using a double-tracer study design. American Journal of Clinical Nutrition 2000;71(6):1545-1554.
Natural Health Products Regulations [Internet]. Ottawa (ON): Department of Justice Canada. [Accessed 2012 April 26]. Available from: http://laws.justice.gc.ca/en/ShowFullDoc/cr/SOR- 2003-196///en
Ribaya-Mercado JD, Solon FS, Solon MA, Cabal-Barza MA, Perfecto CS, Tang G, Solon JAA, Fjeld CR, Russell RM. Bioconversion of plant carotenoids to vitamin A in Filipino school-aged children varies inversely with vitamin A status. American Journal of Clinical Nutrition 2000;72(2):455-465.
Russell RM, Ross AC, Trumbo PR, West KP. Retinol equivalency ratio of β-carotene. Journal of Nutrition 2003;133(9):2915-2916.
Tang G, Qin J, Dolnikowski GG, Russell RM. Vitamin A equivalence of β-carotene in a woman as determined by a stable isotope reference method. European Journal of Nutrition 2000;39(1):7- 11.
Tang G, Qin J, Dolnikowski GG, Russell RM. Short-term (intestinal) and long-term (postintestinal) conversion of β-carotene to retinol in adults as assessed by a stable-isotope reference method. American Journal of Clinical Nutrition 2003;78(2):259-266.
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van Lieshout M, West CE, Muhilal, Permaesih D, Wang Y, Xu X, van Breemen RB, Creemers AFL, Verhoeven MA, Lugtenburg J. Bioefficacy of β-carotene dissolved in oil studied in children in Indonesia. American Journal of Clinical Nutrition 2001;73(5):949-958.
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Date modified:: 2019-03-01