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Drugs and Health Products

Monograph: Flaxseed oil

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) Vitamin E is an optional medicinal ingredient in flax oil products. However, no use or purpose statements may be associated with vitamin E. See Appendix 2 for vitamin E proper name, common name, source material, and dose information.

Date: 2010-04-13

NHPID Name

Flaxseed Oil (USDA 2008)

Proper Name(s)

Linum usitatissimum L. (Linaceae) ( USDA 2004 )

Common Name(s)

Source Material

Seed ( Sweetman 2007 )

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:

  • Source of essential fatty acids for the maintenance of good health  (IOM 2006)
  • Source of omega-3 fatty acids for the maintenance of good health  (IOM 2006)
  • Source of alpha-linolenic acid (ALA) for the maintenance of good health  (IOM 2006)
  • Source of omega-6 fatty acids for the maintenance of good health  (IOM 2006)
  • Source of linoleic acid (LA) for the maintenance of good health  (IOM 2006)

Dose(s)

Children 2 - 4 years:

essential fatty acids; omega-3 fatty acids; ALA
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 0.04 - 5.33 Grams per day, seed oil
Dose(s): 0.17 - 5.67 Millilitres per day, seed oil
omega-6 fatty acids; linoleic acid
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 1.28 - 5.33 Grams per day, seed oil
Dose(s): 1.33 - 5.67 Millilitres per day, seed oil

Children and adolescents 5 - 9 years:

essential fatty acids; omega-3 fatty acids; ALA
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 0.06 - 8 Grams per day, seed oil
Dose(s): 0.25 - 8.5 Millilitres per day, seed oil
omega-6 fatty acids; linoleic acid
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 1.93 - 8 Grams per day, seed oil
Dose(s): 2 - 8.5 Millilitres per day, seed oil

Adolescents 10 - 14 years:

essential fatty acids; omega-3 fatty acids; ALA
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 0.12 - 16 Grams per day, seed oil
Dose(s): 0.5 - 17 Millilitres per day, seed oil
omega-6 fatty acids; linoleic acid
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 3.85 - 16 Grams per day, seed oil
Dose(s): 4 - 17 Millilitres per day, seed oil

Adults and adolescents 15 and over:

essential fatty acids; omega-3 fatty acids; ALA
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 0.23 - 32 Grams per day, seed oil
Dose(s): 1 - 34 Millilitres per day, seed oil
omega-6 fatty acids; linoleic acid
Preparation: Oil Fixed & Oil Fixed Standardised

Dose(s): 7.7 - 32 Grams per day, seed oil
Dose(s): 8 - 34 Millilitres per day, seed oil

  • Adult dose supported by the following references: IOM 2006; Schwab et al. 2006; Nordström et al. 1995; Kelley et al. 1993; Fischer et al. 1984.
  • Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Flax oil in children and adolescents is supported by Bove 2001.
  • If potencies are declared, the only acceptable potencies are as follows: A) 35-65 % ALA (CGC 2008; HC 2008; Ph. Eur. 2008; Hoffmann 2003); B)11-24 % LA (HC 2008; Ph. Eur. 2008; Hoffmann 2003)
  • Includes pregnant and breastfeeding women (Mills et al. 2006).
  • See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.
  • The following potency is considered as additional information and can be included on the label: 11-35% oleic acid (Ph. Eur. 2008)

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
No statement is required

Contraindication(s):
No statement is required

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.
  • For products providing vitamin E at doses lower than the minima specified in Table 2 of Appendix 1, vitamin E must be declared as a non-medicinal ingredient.

Storage Conditions

  • For all products, except those encapsulated: Refrigerate after opening (Nykter et al. 2006
  • Lukaszewicz et al. 2004).

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).
  • For products indicating one or more of the optional potencies listed in the dose section, an assay must be performed in order to confirm the potency(ies).
  • The medicinal ingredient may comply with the specifications outlined in the Linseed or Linseed Oil, Virgin, monographs published in the European Pharmacopoeia, or the Linseed or Virgin Linseed Oil monographs published in the British Pharmacopoeia.

References cited

  • BHP 1996: The British Herbal Pharmacopoeia. Exeter (GB): British Herbal Medicine Association.
  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications
  • Boon H. 2000. Flax in: Herbs: Everyday Reference for Health Professionals. Chandler F, editor. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
  • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants, 2nd edition. Toronto (ON): McGraw-Hill.
  • BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (GB): The Stationary Office.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brouillet L, Hay SG, Goulet I, Marie-Victorin. Flore laurentienne, 3e édition. Boucherville (QC): Éditions Gaëtan Morin; 2002.
  • Bruneton J. Pharmacognosie, Phytochimie, Plantes Médicinales, 3rd edition. Paris (FR): Technique & Documentation; 1999.
  • CGC 2005: Canadian Grain Commission. The Quality of Flaxseed in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2006 July 20]. Available from: http://www.grainscanada.gc.ca/flax-lin/trend-tendance/qfc-qlc-eng.htm
  • CGC 2008: Canadian Grain Commission. Flaxseed quality in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2010 January 20]. Available from: http://www.grainscanada.gc.ca/flax-lin/trend-tendance/qfc-qlc-eng.htm
  • Cunnane SC, Ganguli S, Menard C, Liede AC, Hamadeh MJ, Chen ZY, Wolever TM, Jenkins DJ. 1993. High alpha-linolenic acid flaxseed (Linum usitatissimum): some nutritional properties in humans. British Journal of Nutrition 69(2):443-53.
  • Daun JK, Barthet VJ, Chornick TL, Diguid S. 2003. Structure, composition, and variety development of flaxseed. In: Thompson LU, Connane SC, editors. Flaxseed in Human Nutrition, 2nd edition. Champaign (IL): AOCS Press.
  • EMEA 2006. European Medicines Agency. Community Herbal Monograph on Linum usitatissimum L., Semen. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2008 July 23]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/lini_semen/34084905en.pdf
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
  • Fischer VS, Honigmann G, Hora C, Schimke E, Beitz J, Hanefeld M, Leonhardt W, Haller H, Förster W, Schliack V. 1984. Results of linseed oil and olive therapy in hyperlipoproteinemia patients. Deutsche Zaitschrift für Verdauungs - und Stoffwechselkrankheiten 44(5):245-251.
  • Gennaro AR, editor. 2000. Remington: The Science and Practice of Pharmacy, 20th edition. Baltimore (MD): Lippincott Williams & Wilkins
  • HC 2008: Health Canada. The Canadian Nutrient File [online]. Ottawa (ON): Health Canada. [Accessed 2009 July 22]. Available from: http://205.193.93.51/cnfonline/newSearch.do?applanguage=en_CA
  • Hendler S, Rorvik D, editors. 2001. PDR for Nutritional Supplements. Montvale (NJ): Thompson PDR.
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • IOM 2003: Institute of Medicine. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Washington (DC): National Academies Press.
  • IOM 2006: Institute of Medicine. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Washington (DC): National Academies Press.
  • JC 2008: Justice Canada. Food and Drug Regulations (C.01.021) [online]. Ottawa (ON): Justice Canada. [Accessed 2009 June 24] Available from: http://laws.justice.gc.ca/en/showdoc/cr/C.R.C.-c.870/bo-ga:l_C-gb:s_C_01_001/20090622/enanchorbo-ga:l_C-gb:s_C_01_001
  • Jenkins DJA, Kendall CWC, Vidgen E, Agarwal S, Rao AV, Rodenberg RS, Diamandis EP, Novokmet R, Mehling CC, Perera T, Griffin LC, Cunnane SC. 1999. Health aspects of partially defatted flaxseed, including effects on serum lipids, oxidative measures, and ex vivo androgen and progestin activity: A controlled crossover trial. The American Journal of Clinical Nutrition 69(3):395-402
  • Kelley DS, Nelson GJ, Love JE, Branch LB, Taylor PC, Schmidt PC, Mackey BE, Iacono JM. 1993. Dietary alpha-linolenic acid alters tissue fatty acid composition, but not blood lipids, lipoproteins or coagulation status in humans. Lipids 28(6):533-537.
  • Kinniry P, Amrani Y, Vachani A, Solomides CC, Arguiri E, Workman A, Carter J, Christofidou-Solomidou M. 2006. Dietary flaxseed supplementation ameliorates inflammation and oxidative tissue damage in experimental models of acute lung injury in mice. The Journal of Nutrition 136(6):1545-1551.
  • León F, Rodríguez M, Cuevas M. 2003. Anaphylaxis to Linum. Allergologia et immunopathologia 31(1):47-49.
  • Lucas EA, Wild RD, Hammond LJ, Khalil DA, Juma S, Daggy BP, Stoecker BJ, Arjmandi BH. 2002. Flaxseed improves lipid profile without altering biomarkers of bone metabolism in postmenopausal women. Journal of Clinical Endocrinology and Metabolism 87(4):1527-1532.
  • Lukaszewicz M, Szopa Jan, Krasowska A. 2003. Susceptibility of lipids from different flax cultivars to peroxidation and its lowering by added antioxidants. Food Chemistry 88(2004):225-231
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
  • Nordström DC, Honkanen VE, Nasu Y, Antila E, Friman C, Konttinen YT. 1995. Alpha-linolenic acid in the treatment of rheumatoid arthritis. A double-blind, placebo-controlled and randomized study: flaxseed vs. safflower seed. Rheumatology International 14(6):231-234.
  • Nykter M, Kymäläinen H-R, Gates F, Sjöberg A-M. 2006. Quality characteristics of edible linseed oil. Agricultural and Food Science 15(4):402-413.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2009. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals [Online]. Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 2010-01-26]. Available at: http://www.medicinescomplete.com/mc/merck/current/09495.htm
  • Patade A, Devareddy L, Lucas EA, Korlagunta K, Daggy BP, Arjmandi BH. 2008. Flaxseed reduces total and LDL cholesterol concentrations in Native American postmenopausal women. Journal of Women's Health 17(3):355-366.
  • Ph. Eur. 2008: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • Prasad K. 1997. Dietary flax seed in prevention of hypercholesterolemic atherosclerosis. Atherosclerosis 132(1):69-76.
  • Prasad K. 2005. Hypocholesterolemic and antiatherosclerotic effect of flax lignan complex isolated from flaxseed. Atherosclerosis 179(2):269-275
  • Pray WS. 2006. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins.
  • Rajesha J, Murthy KNC, Kumar MK, Madhusudhan B, Ravishankar GA. 2006. Antioxidant potentials of flaxseed by in vivo model. Journal of Agricultural and Food Chemistry 54(11):3794-3799.
  • Repchinsky 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association.
  • Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers.
  • Schwab US, Callaway JC, Erkkilä AT, Gynther J, Uusitupa MI, Järvinen T. 2006. Effects of hempseed and flaxseed oils on the profile of serum lipids, serum total and lipoprotein lipid concentrations and haemostatic factors. European Journal of Nutrition 45(8):470-477
  • Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press.
  • USDA 2004: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Linum usitatissimum. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2008 June 17]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, Anton R, éditeurs. Plantes thérapeutiques : Tradition, pratique officinale, sciences et thérapeutique, 2e édition. Paris (F) : Lavoisier; 2003

References reviewed

  • Alonso L, Marcos ML, Blanco JG, Navarro JA, Juste S, del Mar Garcés M, Pérez R, Carretero PJ. 1996. Anaphylaxis caused by linseed (flaxseed) intake. The Journal of Allergy and Clinical Immunology 98(2):469-470.
  • Arjmandi BH, Khan DA, Juma S, Drum ML, Venkatesh S, Sohn E, Wei L, Derman R. 1998. Whole flaxseed consumption lowers serum LDL-cholesterol and lipoprotein(a) concentrations in postmenopausal women. Nutritional Research; 18(7):1203-1214.
  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association.
  • Birch DG, Birch EE, Hoffman DR, Uauy RD. 1992. Retinal development in very-low-birth-weight infants fed diets differing in omega-3 fatty acids. Investigative Ophthalmology and Visual Science 33(8):2365-2376.
  • Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. 2008. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. Journal of the American College of Nutrition 27 (1):65-74.
  • Brinker 2008. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2008 July 23]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • CGC 2005: Canadian Grain Commission. The Quality of Flaxseed in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2006 July 20]. Available from: http://www.grainscanada.gc.ca/flax-lin/trend-tendance/qfc-qlc-eng.htm
  • Chevallier A.1996. The Encyclopedia of Medicinal Plants. London (GB): Dorling Kindersley Limited.
  • Finnegan YE, Howarth D, Minihane AM, Kew S, Miller GJ, Calder PC, Williams CM. 2003. Plant and marine derived (n-3) polyunsaturated fatty acids do not affect blood coagulation and fibrinolytic factors in moderately hyperlipidemic humans. Journal of Nutrition 133(7):2210-2213.
  • Freese R, Mutanen M. 1997. Alpha-linolenic acid and marine long-chain n-3 fatty acids differ only slightly in their effects on hemostatic factors in healthy subjects. American Journal of Clinical Nutrition 66(3):591-598.
  • Hallund J, Ravn-Haren G, Bugel S, Tholstrup T, Tetens I. 2006. A lignan complex isolated from flaxseed does not affect plasma lipid concentrations or antioxidant capacity in healthy postmenopausal women. The Journal of Nutrition 136(1):112-116.
  • HC 2005: Health Canada. Addition of Vitamins and Minerals to Foods, 2005. Health Canada's Proposed Policy and Implementation Plans [online]. Ottawa (ON): Health Canada. [Accessed 2008 June 16]. Available from: http://www.hc-sc.gc.ca/fn-an/nutrition/vitamin/fortification_final_doc_1-eng.php
  • Jenkins DJ, Kendall CW, Vuksan V, Augustin LS, Mehling C, Parker T, Vidgen E, Lee B, Faulkner D, Seyler H, Josse R, Leiter LA, Connelly PW, Fulgoni V 3rd. 1999b. Effect of wheat bran on serum lipids: influence of particle size and wheat protein. Journal of the American College of Nutrition 18(2):159-65.
  • Jenkins DJA, Wolever TMS, Leeds AR, Gassull MA, Haisman P, Dilawari J, Goff DV, Metz GL, Alberti KG. 1978. Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. British Medical Journal 1(6124):1392-1398.
  • Lemay A, Dodin S, Kadri N, Jacques H, Forest J-C. 2002. Flaxseed dietary supplement versus hormone replacement therapy in hypercholesterolemic menopausal women. The American Colege of Obstetricians and Gynecologists 100(3):495-504.
  • Lezaun A, Fraj J, Colás C, Duce F, Domínguez MA, Cuevas M, Eiras P. 1998. Anaphylaxis from linseed. Allergy 53(1):105-106.
  • Li D, Sinclair A, Wilson A, Nakkote S, Kelly F, Abedin L, Mann N, Turner A. 1999. Effect of dietary alpha-linolenic acid on thrombotic risk factors in vegetarian men. American Journal of Clinical Nutrition 69(5):872-882.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2001. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc.
  • Pagana CD, Pagana TJ. 2002. Mosby's Manual of Diagnostic and Laboratory Tests, 2nd edition. St. Louis (MO): Mosby, Inc.
  • Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. 2007. Effects of a flaxseed-derived lignan supplement in Type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS ONE 11:1-7.
  • Sanders TA, Lewis F, Slaughter S, Griffin BA, Griffin M, Davies I, Millward DJ, Cooper JA, Miller GJ. 2006. Effect of varying the ratio of n-6 to n-3 fatty acids by increasing the dietary intake of alpha-linolenic acid, eicosapentaenoic and docosahexaenoic acid or both on fibrinogen and clotting factors VII and XII in persons aged 45-70 y: the OPTILIP Study. American Journal of Clinical Nutrition 84(3):513-522.
  • Simmer K, Schulzke SM, Patole S. 2008. Longchain polyunsaturated fatty acid supplementation in preterm infants. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000375. Update of: Cochrane Database Syst Rev. 2004;(1):CD000375.
  • Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. 2008. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholestrolaemic subjects. British Journal of Nutrition 99(6):1301-1309.

Appendix 1: Examples of dosages

  • 230 mg (approx. 1 ml), per day (provides approximately 5% of the IOM's AI for alpha-linolenic acid) (IOM 2006)
  • 7.7 g (approx. 8 ml), per day (provides approximately 5% of the IOM's AI for linoleic acid) (IOM 2006)
  • 28 g (approx. 30 ml), per day (Schwab et al 2006)
  • 30 g (approx. 32 ml), per day (Nordström 1995; Fischer 1984)
  • 32 g (approx. 34 ml), per day (Kelley 1993)

 

Appendix 2: Vitamin E

Table 1: Vitamin E proper names, common names and source material
Proper name(s) Common name(s) Source material(s)
Vitamin E
(Sweetman 2007; IOM 2003; O'Neil et al. 2001)
(i) Alpha-Tocopherol
(Sweetman 2007; O'Neil et al. 2001);
(ii) Vitamin E
(Sweetman 2007; IOM 2003; O'Neil et al. 2001)
(i) All racemic-alpha-Tocopherol/all rac-alpha-Tocopherol/ dl-alpha-Tocopherol
(Sweetman 2007; IOM 2003);
(ii) All racemic alpha-Tocopheryl acetate/all-rac-alpha-Tocopheryl acetate/ dl-alpha-Tocopheryl acetate
(Sweetman 2007; IOM 2003);
(iii) All racemic-alpha-Tocopheryl succinate/all rac-alpha-Tocopheryl succinate/ dl-alpha-Tocopheryl acid succinate/ dl-alpha-Tocopheryl succinate
(Sweetman 2007);
(iv) RRR-alpha-Tocopherol/ d-alpha-Tocopherol
(Sweetman 2007; IOM 2003; O'Neil et al. 2001);
(v) RRR-alpha-Tocopheryl acetate/ d-alpha-Tocopheryl acetate
(Sweetman 2007; IOM 2003);
(vi) RRR-alpha-Tocopheryl succinate/ d-alpha-Tocopheryl acid succinate/ d-alpha-Tocopheryl succinate
(Sweetman 2007; IOM 2003)

Quantity:

The quantity of vitamin E must always be provided in terms of alpha-Tocopherol (AT) (i.e. mg RRR-alpha-Tocopherol), irrespective of the source material used.

IUs may be provided as optional additional information on the PLA form in the "potency" field and on product labels.

Table 2: Dose information for vitamin E presented as dose per day
Subpopulation Vitamin E Minimum (mg AT/day) Vitamin E Maximum (mg AT/day)
Children 1-8 yrs 2.2 179
Adolescents 9-13 yrs 4.5 179
> 14-18 yrs 4.5 179
Adults > 18 yrs 4.5 179

Conversion factors:

Table 3: Conversion of vitamin E source material quantity into vitamin E quantity in terms of alpha-tocopherol (AT) and vitamin E activity in terms of International Unit (IU) (IOM 2006)
Source material (1mg) Vitamin E quantity (mg AT/day) Vitamin E activity (IU)
RRR-alpha-Tocopherol 1.00 1.49
RRR-alpha-Tocopheryl acetate 0.91 1.36
RRR-alpha-Tocopheryl succinate 0.81 1.21
All rac-alpha-tocopherol 0.50 1.10
All rac-alpha-tocopheryl acetate 0.46 1.00
All rac-alpha-tocopheryl succinate 0.41 0.89

Table 4: Conversion of vitamin E source material activity into vitamin E quantity in terms of alpha-tocopherol (AT) (IOM 2006)
Source material (1 IU) Vitamin E quantity (mg AT)
RRR-alpha-Tocopherol 0.67
RRR-alpha-Tocopheryl acetate 0.67
RRR-alpha-Tocopheryl succinate 0.67
All rac-alpha-tocopherol 0.45
All rac-alpha-tocopheryl acetate 0.45
All rac-alpha-tocopheryl succinate 0.45

Examples using the vitamin E conversion factors:

a) Converting vitamin E activity into quantity of AT (mg)

Convert 400 IU of RRR-a-Tocopheryl succinate activity into mg AT:

= 400 IU x 0.67 mg AT/IU

= 268 mg AT

b) Converting vitamin E source material quantity into quantity of AT (mg)

Convert 200 mg of all rac-a-Tocopheryl acetate into mg AT:

= 200 mg x 0.46 mg AT/mg

= 92 mg AT