Seal Oil

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

---

Note: Vitamin E is an optional medicinal ingredient in seal oil products. However, no use or purpose statements may be associated with vitamin E. See Appendix 1 for vitamin E proper name, common name, source material, and dose information.

Archive: May not be cited for licence application purposes.

Date: January 11, 2008

Proper name(s): Seal oil (Brox et al. 2001; Østerud et al. 1995)

Common name(s): Seal oil (Brox et al. 2001; Østerud et al. 1995)

Source material(s): Oil from the blubber of one or more of the following species (MMR 1993):

• Bearded seal (Erignathus barbatus) (ITIS 2008)
• Gray seal (Halichoerus grypus) (ITIS 2008)
• Harbor seal (Phoca vitulina) (ITIS 2008)
• Harp seal (Pagophilus groenlandicus, synonym: Phoca groenlandica) (ITIS 2008)
• Hooded seal (Cystophora cristata) (ITIS 2008)
• Ringed seal (Phoca hispida) (ITIS 2008)
  (in its natural triglyceride (triacylglycerol) form).

Route(s) of administration: Oral

Dosage form(s): Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons, are acceptable. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s): Statement(s) to the effect of:

For all products:

• Source of omega-3 fatty acids (Simopoulos 2007; Oh 2005; IOM 2002; Brox et al. 2001; Simopoulos 1999) for the maintenance of good health
• Source of eicosapentaenoic acid (EPA), (and/or) docosahexaenoic acid (DHA), (and/or) docosapentaenoic acid (DPA) (Simopoulos 2007; Oh 2005; IOM 2002; Brox et al. 2001; Simopoulos 1999) for the maintenance of good health

For products providing 150-2,500 mg EPA + DHA including at least 150 mg DHA, per day (maximum doses of EPA + DHA in Table 1 below will apply):
Helps support the development of the brain, eyes and nerves in children and adolescents (Marszalek and Lodish 2005; Haag 2003; IOM 2002).

Dose(s): Potency must be expressed as the percent (%) EPA, DHA and/or DPA (quantity of EPA, DHA and/or DPA in total quantity of seal oil) (% w/w) and/or the quantity (mg) of EPA, DHA and/or DPA.

Table 1: Dose information for EPA + DHA in seal oil presented as dose per day

Subpopulation		EPA + DHA (mg/day)
		Minimum1	Maximum2
Children	1-8 y	100	1,500
Adolescents	9-13 y	100	2,000
	14-18 y	100	2,500
Adults3	≥ 19 y	100	3,000

¹ Restrictions to minimum dose may apply according to Use(s) or Purpose(s) section above.
² Adult maximum dose supported by the following reference: FDA 1997. Children and adolescent maximum doses calculated as a fraction of the adult dose, are relative to body weight and caloric intake.
³ Includes pregnant and breastfeeding women

Duration of use: No statement required.

Risk information:

Caution(s) and warning(s): No statement required.

Contraindication(s): No statement required.

Known adverse reaction(s): No statement required.

Storage conditions: Statement(s) to the effect of:

For all products, except those in capsules:

• Refrigerate after opening (Wille and Gonus 1989).

Non-medicinal ingredients:

• Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
• For products providing vitamin E at doses lower than the minima specified in Table 4 of Appendix 1, vitamin E must be declared as a non-medicinal ingredient.

Specifications:

• Must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
• Peroxide, anisidine, and totox values of seal oil or omega-3 fatty acids derived from seal oil must be in accordance with the methods set out by the Association of Analytical Community (AOAC) and/or Pharmacopoeial analytical methods. These specifications are necessary to ensure the oxidative stability of the seal oil/omega-3 fatty acids (NHPD 2007). See Table 2 below.

Table 2: Maximum values of oxidative stability parameters for seal oil (NHPD 2007)

Oxidative stability parameter	Maximum value
Peroxide value (PV)	5 mEq/kg
Anisidine value (AV)	20 mEq/kg
Totox value	26 (calculated as 2 x PV + AV) mEq/kg

References cited:

Brox J, Olaussen K, Østerud B, Elvevoll EO, Bjornstad E, Brattebog G, Iversen H. A long-term seal- and cod-liver-oil supplementation in hypercholesterolemic subjects. Lipids 2001;36(1):7-13.

FDA 1997: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR 184 Substances affirmed as generally regarded as safe: menhaden oil; 1997. [Accessed 2008-01-10]. Available from: http://www.cfsan.fda.gov/~lrd/fr970417.html

Haag M. Essential fatty acids and the brain. Canadian Journal of Psychiatry 2003; 48(3):195-203.

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 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5^th edition. Washington (DC): National Academies Press; 2003.

IOM 2002: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board, Institute of Medicine. Washington (DC): National Academy Press; 2002.

ITIS 2008: Integrated Taxonomic Information System, Canadian Biodiversity Information Facility, Government of Canada [Accessed 2008-01-10]. Available from: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif

Marszalek JR, Lodish HF. Docosahexaenoic acid, fatty acid-interacting proteins, and neuronal function: breastmilk and fish are good for you. Annual Review of Cell and Developmental Biology 2005;21:633-657.

MMR 1993: Marine Mammal Regulations. SOR/93-56. Fisheries Act. Ottawa (ON): Government of Canada; 1993. [Accessed 2008-01-10]. Available at: http://laws.justice.gc.ca/en/f-14/sor-93-56/text.html

NHPD 2007: Natural Health Products Directorate. Evidence for Quality of Finished Natural Health Products. Ottawa (ON): Natural Health Products Directorate, Health Canada; 2007. [Accessed 2007-11-21]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php

Oh R. Practical applications of fish oil (Ω-3 fatty acids) in primary care. Journal of the American Board of Family Practitioners 2005;18(1):28-36.

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, & Biologicals, 13^th edition. Whitehouse Station: Merck & Co., Inc; 2001.

Østerud B, Elvevoll EO, Barstad H, Brox J, Halvorsen H, Lia K, Olsen JO, Olsen RL, Sissener C, Rekdal Ø, Vognild E. Effect of marine oils supplementation on coagulation and cellular activation in whole blood. Lipids 1995;30(12):1111-1118.

Simopoulos AP. Essential fatty acids in health and chronic disease. The American Journal of Clinical Nutrition 1999;70(3):560S-569S.

Simopoulos AP. Omega-3 fatty acids and athletics. Current Sports Medicine Reports 2007;6(4):230-236.

Sweetman SC, editor. Martindale: The Complete Drug Reference, 35^th edition. London (UK): Pharmaceutical Press; 2007.

Wille HJ, Gonus P. Preparation of fish oil for dietary applications. In: Galli C, Simopolous AP, editors. Dietary ω3 and ω6 fatty acids. Biological Effects and Nutritional Essentiality. New York (NY): Plenum Press; 1989.

Appendix 1: Vitamin E

Proper name(s), common name(s), and source material(s):

Table 3: Vitamin E proper name(s), common name(s) and source material(s)

Proper name(s)	Common name(s)	Source material(s)
Vitamin E (Sweetman 2007; IOM 2003; O'Neil et al. 2001)	Alpha (α)-tocopherol (Sweetman 2007; O'Neil et al. 2001); Vitamin E (Sweetman 2007; IOM 2003; O'Neil et al. 2001)	All racemic (all rac)-α-tocopherol/ dl-α-tocopherol (Sweetman 2007; IOM 2003) All rac­-α-tocopheryl acetate/ dl-α-tocopheryl acetate (Sweetman 2007; IOM 2003) All rac­-α-tocopheryl succinate/ dl-α-tocopheryl acid succinate/ dl-α-tocopheryl succinate (Sweetman 2007) RRR-α-tocopherol/ d-α-tocopherol (Sweetman 2007; IOM 2003; O'Neil et al. 2001)RRR-α-tocopheryl acetate/ d-α-tocopheryl acetate (Sweetman 2007; IOM 2003) RRR-α-tocopheryl succinate/ d-α-tocopheryl acid succinate/ d-α-tocopheryl succinate (Sweetman 2007; IOM 2003)

Quantity:

The quantity of vitamin E must always be provided in terms of α-tocopherol (AT) (i.e. mg RRR-α-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 4: Dose information for vitamin E presented as dose per day (IOM 2006)

Subpopulation		Vitamin E (mg AT/day)
		Minimum	Maximum
Children	1-8 y	2.2	179
Adolescents	9-13 y	4.5	179
	14-18 y	4.5	179
Adults	≥ 19 y	4.5	179

Conversion factors:

Table 5: Conversion of vitamin E source material quantity into vitamin E quantity in terms of alpha-(α)-tocopherol (AT) and vitamin E activity in terms of International Units (IU) (IOM 2006)

Source material (1 mg)	Vitamin E quantity (mg AT)	Vitamin E activity (IU)
RRR-α-Tocopherol	1.00	1.49
RRR-α-Tocopheryl acetate	0.91	1.36
RRR-α-Tocopheryl succinate	0.81	1.21
All rac-α-tocopherol	0.50	1.10
All rac-α-tocopheryl acetate	0.46	1.00
All rac-α-tocopheryl succinate	0.41	0.89

Table 6: Conversion of vitamin E source material activity into vitamin E quantity in terms of alpha-(α)-tocopherol (AT) (IOM 2006)

Source material (1 IU)	Vitamin E quantity (mg AT)
RRR-α-Tocopherol	0.67
RRR-α-Tocopheryl acetate	0.67
RRR-α-Tocopheryl succinate	0.67
All rac-α-tocopherol	0.45
All rac-α-tocopheryl acetate	0.45
All rac-α-tocopheryl succinate	0.45

Examples using the vitamin E conversion factors:

1. Converting vitamin E activity into quantity of AT (mg)
   
   Convert 400 IU of RRR-α-tocopheryl succinate activity into mg AT:
   = 400 IU x 0.67 mg AT/IU
   = 268 mg AT
   
   
2. Converting vitamin E source material quantity into quantity of AT (mg)
   
   Convert 200 mg of all rac-α-tocopheryl acetate into mg AT:
   = 200 mg x 0.46 mg AT/mg
   = 92 mg AT