NATURAL HEALTH PRODUCT
SELENIUM
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:
February 9, 2016
Proper name(s):
Selenium (Sweetman 2015; O’Neil et al. 2001)
Common name(s):
Selenium (Sweetman 2015; O’Neil et al. 2001)
Source material(s):
Selenium acid (Sweetman 2015)
Selenium aspartate (NIH 2015)
Selenium citrate (NIH 2015)
Selenium dioxide, monohydrate (Sweetman 2015)
Selenium fumarate (Richards 2008)
Selenium glycinate (Richards 2008)
Selenium hydrolyzed animal protein (HAP) chelate (Albion 2015)
Selenium hydrolyzed vegetable protein (HVP) chelate (NIH 2015)
Selenium malate (Richards 2008)
Selenium succinate (Richards 2008)
Selenium-enriched yeast (EFSA 2008)
Selenocysteine (TGA 2007)
Selenomethionine (TGA 2007)
Sodium hydrogen selenite (EFSA 2008)
Sodium selenate (TGA 2007)
Sodium selenite (TGA 2007)
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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:
Source of selenium, a factor in the maintenance of good health (IOM 2006; IOM 2000).
Source of selenium, a factor in normal growth and development (CFIA 2015).
Source of selenium, to support biological functions which play a key role in the maintenance
of good health (IOM 2006; IOM 2000).
Mineral supplement (IOM 2006; IOM 2000).
Specific:
Source of/An antioxidant for the maintenance of good health (CFIA 2015; IOM 2006; Shils et
al. 2006; Groff and Gropper 2000; IOM 2000).
Source of/An antioxidant that helps protect against oxidative stress (CFIA 2015; IOM 2006;
Shils et al. 2006; Groff and Gropper 2000; IOM 2000).
Source of/An antioxidant that helps (to) a) fight/ b) protect (cells) against/ c) reduce (the
oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals
(CFIA 2015; IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 2000).
Helps to maintain normal function of the thyroid gland (EC 2015).
Dose-specific:
For products providing daily doses of selenium at or above the Recommended Dietary
Allowance (RDA) (adjusted for the life stage groups), the following use or purpose is acceptable:
Helps to prevent selenium deficiency (IOM 2006; Shils et al. 2006; Groff and Gropper 2000;
IOM 2000).
Notes:
See Appendix 1 for definitions and Table 2 in Appendix 2 for RDA values.
Selenium deficiency is rare in North America (Groff and Gropper 2000).
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Dose(s):
Table 1: Dose information for selenium presented as dose per day
Selenium (µg/day)
Life stage group
Minimum1
Maximum2
Adults3
≥ 19 y
3.5
200
1
Based on approximately 5% of the highest RDA (IOM 2006). See Appendix 1 for definitions and Table 2 in
Appendix 2 for RDA values.
2
Maximum dose based on the Tolerable Upper Intake Level (UL) which applies to total selenium intake from food
and supplements. Maximum dose was obtained by subtracting the average dietary intake of selenium from UL (IOM
2006).
3
Includes pregnant and breastfeeding women.
Duration of use:
No statement required.
Risk information:
Statement(s) to the effect of:
Caution(s) and warning(s):
For products providing doses of selenium at 200 µg, per day, the following statement is
required:
If you have a history of non-melanoma skin cancer, consult a health care practitioner prior to use
(Duffield-Lillico et al. 2003).
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.
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Specifications:
The finished product specifications must be established in accordance with the requirements
described in the Natural and Non-Prescription Health Products Directorate Quality of
Natural Health Products Guide.
The medicinal ingredient must comply with the requirements outlined in the NHPID.
References:
Albion 2015: Albion Advanced Nutrition. Minerals; Science; Chelates; Clearfield (UT): Albion
Advanced Nutrition, Inc. [Accessed 2015 May 6]. Available from: http://albionminerals.com/.
CFIA 2015: Canadian Food Inspection Agency. Guide to Food Labelling and Advertising Nutrient Function Claims. Ottawa (ON): Canadian Food Inspection Agency and Health Canada.
[Accessed 2015 May 7]. Available from: http://www.inspection.gc.ca/food/labelling/foodlabelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=8.
Duffield-Lillico AJ, Slate EH, Reid ME, Turnbull BW, Wilkins PA, Combs GF Jr, Park HK,
Gross EG, Graham GF, Stratton MS, Marshall JR, Clark LC; Nutritional Prevention of Cancer
Study Group. Selenium supplementation and secondary prevention of nonmelanoma skin cancer
in a randomized trial. Journal of the National Cancer Institute 2003;95(19):1477-1481.
EC 2015: European Commission. EU Register of nutrition and health claims made on foods.
[Accessed 2015 May 6]. Available from: http://ec.europa.eu/nuhclaims/.
EFSA 2008: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Seleniumenriched yeast as source for selenium added for nutritional purposes in foods for particular
nutritional uses and foods (including food supplements) for the general population. The EFSA
Journal 2008;766:1-42. [Accessed 2015 May 6]. Available from:
http://www.efsa.europa.eu/en/efsajournal/doc/766.pdf.
Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA):
Wadsworth/Thomson Learning; 2000.
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.
IOM 2000: Institute of Medicine. Panel on Dietary Antioxidants and Related Compounds,
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 C, Vitamin E, Selenium and Carotenoids. Washington (DC): National Academy
Press; 2000.
Selenium - Page 4 of 6
NIH 2015: National Institutes of Health. Dietary Supplement Label Database. [Accessed 2015
May 6]. Available from: http://www.dsld.nlm.nih.gov/dsld/index.jsp.
O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of
Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc;
2001.
Richards JD. 2008. Methods for determining the metal bioavailability of metal sources. United
States Patent Application 20080090297. [Accessed 2015 May 6]. Available from:
http://www.freepatentsonline.com/y2008/0090297.html.
Shils ME, Olson JA, Shike M, Ross AC, editors. Modern Nutrition in Health and Disease, 10th
edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2006.
Sweetman SC, editor. 2015. Martindale: The Complete Drug Reference. London (GB):
Pharmaceutical Press. [Accessed 2015 May 6]. Available from:
http://www.medicinescomplete.com.
TGA 2007: Therapeutic Goods Administration. Australian Government. Department of Health.
Substances that may be used in Listed medicines in Australia. [Accessed 2015 May 6]. Available
from: http://www.tga.gov.au/industry/cm-listed-substances.htm.
Selenium - Page 5 of 6
Appendix 1: Definitions
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).
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).
Appendix 2: RDA Values
The RDA values for selenium (provided below)for the purpose of this monograph are intended
to:
provide targets for setting appropriate supplement dosage levels;
provide the minimum dose for the use of the dose specific use or purpose: “Helps to prevent
selenium deficiency”;
facilitate the optional labelling of % RDA values.
Table 2: Recommended Dietary Allowance for selenium based on life stage group (IOM 2006)
Life stage group
Selenium (µg/day)
Adults
≥ 19 y
55
Pregnancy
19-50 y
60
Breastfeeding
19-50 y
70
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