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Drugs and Health Products

Carrot - Daucus carota L. ssp. 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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

March 22, 2013

Proper name(s)

Daucus carota L. ssp. sativus (Apiaceae) (USDA 2011; McGuffin et al. 2000)

Common name(s)

Carrot (USDA 2011; McGuffin et al. 2000)

Source material(s)

root (USDA 2012; CNF 2010)

Route(s) of administration

oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

General

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

Specific

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

Note

Refer to Appendix I for a background on claims.

Dose(s)

Statement(s) to the effect of:

Note

  • Both the potency, expressed as the quantity of beta-carotene, and the total quantity of carrot must be provided.
  • International Units (IU) may be provided as optional additional information on the PLA form in the "potency" field and on product labels. The following USP conversion factor is to be used:
    1 IU of beta-carotene = 0.6 μg of all-trans beta-carotene.

All uses/purposes except vitamin A deficiency:

Table 1 Daily dose for carrot and beta-carotene

Life stage group Beta-carotene (μg/day) Table 1 Footnote 1 Carrot (g/day) Table 1 Footnote 2

Table 1 Footnotes

Table 1 Footnote 1

Values 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).

Return to Table 1 footnote 1 referrer

Table 1 Footnote 2

Minimum 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). Refer to Appendix II for definitions.

Return to Table 1 footnote 2 referrer

Table 1 Footnote 3

Calculated dried carrot equivalencies for recommended beta-carotene intake using beta-carotene composition values in carrot from CNF 2010 and USDA 2012.

Return to Table 1 footnote 3 referrer

Table 1 Footnote 4

Includes pregnant and breastfeeding women.

Return to Table 1 footnote 4 referrer

Children 1-3 y 180-3,600 0.25-5.1
4-8 y 180-5,400 0.25-7.6
Adolescents 9-13 y 180-10,200 0.25-14.4
14-18 y 390-16,800 0.55-23.8
Adults Table 1 Footnote 3 Table 1 Footnote 4 ≥ 19 y 390-18,000 0.55-25.5

Vitamin A deficiency:

Table 2 Daily doses for carrot and beta-carotene for vitamin A deficiency

Life stage group Beta-carotene (μg/day) Table 2 Footnote 1 Carrot (g/day) Table 2 Footnote 2

Table 2 Footnotes

Table 2 Footnote 1

Values 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).

Return to Table 2 footnote 1 referrer

Table 2 Footnote 2

Minimum 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).

Return to Table 2 footnote 2 referrer

Table 2 Footnote 3

Calculated dried carrot equivalencies for recommended beta-carotene intake using beta-carotene composition values in carrot from CNF 2010 and USDA 2012.

Return to Table 2 footnote 3 referrer

Children 1-3 y 1,800-3,600 2.5-5.1
4-8 y 2,400-5,400 3.4-7.6
Adolescent males 9-13 y 3,600-10,200 5.1-14.4
14-18 y 5,400-16,800 7.6-23.8
Adult males ≥ 19 y 5,400-18,000 7.6-25.5
Adolescent females 9-13 y 3,600-10,200 5.1-14.4
14-18 y 4,200-16,800 5.9-23.8
Adult females ≥ 19 y 4,200-18,000 5.9-25.5
Pregnancy 14-18 y 4,500-16,800 6.4-23.8
19-50 y 4,620-18,000 6.5-25.5
Breastfeeding 14-18 y 7,200-16,800 10.2-23.8
19-50 y 7,800-18,000 11.0-25.5

Directions for use

No statement required

Duration of use

No statement required

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

Products containing greater than 6,000 µg beta-carotene:
If you are a tobacco smoker, consult a health care practitioner prior to use (Touvier et al. 2005; Omenn et al. 1996; ATBC 1994).

Contraindication(s)

No statement required

Known adverse reaction(s)

No statement required

Storage conditions

No statement required

Non-medicinal ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

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.
  • CNF 2010:Next link will take you to another Web site Canadian Nutrient File (CNF). 2010 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012-04-26; Accessed 2012 Apr 26].
  • 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.
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism. 3rd 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.
  • 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. 10th 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 2011:Next link will take you to another Web site USDA, ARS, National Genetic Resources Program. Germplasm Resources Information Network - (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Daucus carota L. subsp. sativus (Hoffm.) Schübl. & G. Martens: Last updated: 29-Nov-2011; Accessed 2012 August 15].
  • USDA 2012:United States Department of Agriculture (USDA), Agricultural Research Service. Nutrient Data Laboratory, National Nutrient Database for Standard Reference; Next link will take you to another Web site Carrots, raw NDB. No: 11124. Release 24 Software v. Release 1.0 3/30/12 2012. [Accessed 2012 April 26].

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.Next link will take you to another Web site Safe Upper Levels for Vitamins and Minerals. United Kingdom Food Standards Agency. [Internet]. [Accessed 2012 April 26].
  • Food and Drug Regulations.Next link will take you to another Web site (C.01.021). Ottawa (ON): Health Canada; 2008. [Accessed 2012 April 26].
  • 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.
  • Next link will take you to another Web site Natural Health Products Regulations.[Internet]. Ottawa (ON): Department of Justice Canada. [Accessed 2012 April 26].
  • 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.
  • van Lieshout M, de Pee S. Vitamin A equivalency estimates: understanding apparent differences. American Journal of Clinical Nutrition 2005;81(4):943-945.
  • 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.
  • Van Loo-Bouwman CA, West CE, van Breeman RB, Zhu D, Siebelink E, Versloot P, Hulshof PJM, van Lieshout M, Russel FGM, Schaafsma G, Naber THJ. Vitamin A equivalency of β-carotene in healthy adults: limitations of the extrinsic dual-isotope dilution technique to measure matrix effect. British Journal of Nutrition 2009;101(12):1837-1845.
  • Wang Z, Yin S, Zhao X, Russell RM, Tang G. β-Carotene - vitamin A equivalence in Chinese adults assessed by an isotope dilution technique. British Journal of Nutrition 2004;91(1):121-131.
  • West CE, Eilander A, van Lieshout M. Consequences of revised estimates of carotenoid bioefficacy for dietary control of vitamin A deficiency in developing countries. Journal of Nutrition 2002;132(9S):2920S-2926S.
  • West CE, Eilander A, van Lieshout M. Reply to Russel et al. Journal of Nutrition 2003;133(9):2917.
  • World Health Organization / Food and Agricultural Organization of the United Nations. 2004.Next link will take you to another Web site Vitamin and mineral requirements in human nutrition, 2nd edition. [online]. [Accessed 2012 April 26].

Appendix I Background on Claims

Although all of the claims for beta-carotene are associated with its vitamin A activity, it is not acceptable to cite beta-carotene as a source of vitamin A. This is because the rate of conversion of beta-carotene to vitamin A in the human body depends on numerous factors (e.g. vitamin A status, dietary factors such as vegetable consumption and fat intake, genetic factors, etc.). In other words, the consumption of supplemental beta-carotene does not always result in a consistent rate of conversion to vitamin A. Nevertheless, products providing beta-carotene do contribute to vitamin A requirements and therefore, all of the health claims associated with beta-carotene are linked to its vitamin A activity.

Appendix II Definitions

Adequate Intake (AI ):
The recommended average daily intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people that are assumed to be adequate. An AI is used when an RDA cannot be determined (IOM 2006).

Recommended Dietary Allowance (RDA):
The average daily dietary nutrient intake level sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group (IOM 2006).

Tolerable Upper Intake Level (UL):
The highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects may increase (IOM 2006).