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Monograph: Chromium (from Chromium picolinate)

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: (i) 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 are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) For Chromium sourced from non-picolinate sources, please refer to the monograph entitled `Chromium (from non-picolinate sources)'

Date: 2009-12-09

NHPID Name

Chromium (O'Neil et al. 2012)

Proper Name(s)

Chromium ( O'Neil et al. 2009 , Sweetman 2007 )

Common Name(s)

Chromium ( O'Neil et al. 2009 , Sweetman 2007 )

Source Material

Chromium (III) picolinate (EFSA 2009)

Route 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
A factor in the maintenance of good health  (IOM 2006)

Specific

Dose-specific
For products providing daily doses of Chromium at or above the Adequate Intake (AI):
Helps to prevent chromium deficiency  (IOM 2006, Shils et al. 2006, IOM 2001, Groff and Gropper 2000)

Dose(s)

Adults:

Dose(s): 2.2 - 500 Micrograms per day

  • Chromium deficiency is rare in North America (IOM 2006; Shils et al. 2006)
  • Does not include pregnant and breastfeeding women.
  • The maximum daily dose is supported by the following references: Anderson et al. 2001; Crawford et al. 1999; Roeback et al. 1991; Mossop et al. 1983.
  • The minimum daily doses are based on approximately 5% of the highest AI (IOM 2006). See Appendix 1 for definitions and Table 2 in Appendix 2 for AI values.
  • When chromium picolinate is used as source material for elemental chromium, the product should be indicated for adult subpopulation only

Duration of use

Consult a health care practitioner for use beyond 6 months  (Anton et al. 2008, Campbell et al. 2002, Campbell et al. 1999, Cefalu et al. 1999, Kato et al. 1998, Anderson et al. 1997, Pasman et al. 1997, Lee et al. 1994)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
For products providing 200 - 500 Micrograms per day:
Consult a health care practitioner prior to use if you have a kidney disorder and/or diabetes  (Wani et al. 2006, Cupp et al. 2003, Bunner and McGinnis 1998, Cerulli et al. 1998, McCarty et al. 1997, Wasser et al. 1997)

Contraindication(s):
Do not use if you are pregnant or breastfeeding  (EFSA 2009, Manygoats et al. 2002, IOM 2001, Sugden et al. 1992)

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

References cited

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  • Albion 1995: Chromium..has the public been mislead? Albion Research Notes 1995;4(3) [Accessed 2007-04-03]. Available at:http://www.albion-an.com/human/Newsletter/1995june.pdf
  • Albion 2000: Implications of the "other half" of a mineral compound. Albion Research Notes 2000;9(3) [Accessed 2007-05-18]. Available from: http://www.albion-an.com/human/Newsletter/2000October.pdf
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  • Bunner SP, McGinnis R. 1998. Chromium-induced hypoglycemia. Psychosomatics 39(3):298-299.
  • Campbell WW, Beard JL, Joseph LJ, Davey SL, Evans WJ. 1997. Chromium picolinate supplementation and resistive training by older men: effects on iron-status and hematologic indexes. The American Journal of Clinical Nutrition 66(4):944-949.
  • Campbell WW, Joseph LJO, Anderson RA, Davey SL, Hinton J, Evans WJ. 2002. Effects of resistive training and chromium picolinate on body composition and skeletal muscle size in older women. International Journal of Sport Nutrition and Exercise Metabolism 12(2):125-135.
  • Campbell WW, Joseph LJO, Davey SL, Cyr-Campbell D, Anderson RA, Evans WJ. 1999. Effects of resistance training and chromium picolinate on body composition and skeletal muscle in older men. Journal of Applied Physiology 86(1):29-39.
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Appendix 1: 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 a Recommended Dietary Allowance (RDA) cannot be determined (IOM 2006).

Recommended Dietary Allowances (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).

Appendix 2: Adequate intake (AI) values

AI values for chromium are provided below. For the purpose of this monograph, these values are intended to:

  • provide target values for setting appropriate supplement dosage levels
  • provide the minimum dose for the use of the dose-specific use or purpose: "Helps to prevent chromium deficiency";
  • facilitate the optional labelling of % AI values
Table 1: Adequate Intake values for chromium based on life stage group (IOM 2006)
Life stage group Chromium (µg/day)
Adult males 19-50 y 35
≥ 51 y 30
Adult females 19-50 y 25
≥ 51 y 20
Pregnancy 19-50 y 30
Breastfeeding 19-50 y 45