Seal Oil

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Archived Monograph - January 2008

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications 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.

Notes:

• Text in parentheses is additional optional information which can be included on the Product Licence Application and product labels at the applicants' 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.
• 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.

Date: June 22, 2009

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).

Note: The term "blubber", the organism's common name and its Latin binomial must be indicated on the PLA and label as source material information (e.g. harp seal (Pagophilus groenlandicus) blubber oil).

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 foods or food-like dosage forms such as bars, chewing gums or beverages.

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

For products providing 100-3,000 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), per day:

• 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 to support the development of the brain, eyes and nerves in children up to 12 years of age (Ryan and Nelson 2008; Marszalek and Lodish 2005; Haag 2003; IOM 2002; Giedd et al. 1999; Mills 1999).

Dose(s):

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

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 encapsulated:

• Refrigerate after opening (Wille and Gonus 1989).

Non-medicinal ingredients:

• Must be chosen from the current NHPD 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 4 of Appendix 1, vitamin E must be declared as a non-medicinal ingredient.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs. (See Table 2: Finished product specifications template for a product containing a non-human animal material and/or their extracts or isolates).
• 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 (HC 2009). See Table 2 below.
• Polychlorinated dibenzo-para-dioxins (PCDD), polychlorinated dibenzofurans (PCDF) and polychlorinated biphenyls (PCB) are contaminants in oils isolated from fish and marine mammals such as seal. Testing for PCDD, PCDF and PCB is required, and must be performed using appropriate analytical methods. Applicants are advised to consult the Evidence for Quality of Finished Natural Health Products Guidance Document (HC 2009). See Table 3 below.

Table 2: Maximum values of oxidative stability parameters for seal oil (HC 2009)

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

Table 3: Tolerance limits for specific contaminants in seal oil (HC 2009)

Contaminant	Tolerance limit
PCDD PCDF	Dioxin < 2 pg/kg b.w./day
PCB	PCB < 0.10 µg/kg b.w./day

Note: Information detailed in this section is not to be submitted with the compendial PLA, although it may be requested at the NHPD's discretion.

References cited:

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

FDA 1997: United States Food and Drug Administration. Substances affirmed as generally regarded as safe: menhaden oil [online]. Federal Register, Volume 62, Number 74, April 17, 1997, Proposed Rule. Docket Number 97N-0103. Rockville (MD): Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 February 6]. Available from: http://www.cfsan.fda.gov/~lrd/fr970417.html

Giedd JN, Blumenthal J, Jeffries NO, Castellanos FX, Liu H, Zijdenbos A, Paus T, Evans AC, Rapoport JL. 1999. Brain development during childhood and adolescence: a longitudinal MRI study. Nature Neuroscience 2(10):861-863.

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

HC 2009: Health Canada. 2009. Evidence for Quality of Finished Natural Health Products. Ottawa (ON): Natural Health Products Directorate, Health Canada.

IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. 2006. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press.

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

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

ITIS 2008: Integrated Taxonomic Information System. Taxon Based on Biological Information System [online]. Canadian Biodiversity Information Facility, Government of Canada. [Accessed 2009 February 6]. Available from: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif

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

Mills MD. 1999. The eye in childhood. American Family Physician 60(3):907-918.

MMR 1993: Marine Mammal Regulations. SOR/93-56. Fisheries Act [online]. Ottawa (ON): Government of Canada. [Accessed 2009 February 6]. Available from: http://laws.justice.gc.ca/en/f-14/sor-93-56/text.html

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

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

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

Ryan AS, Nelson EB. 2008. Assessing the effect of docosahexa acid on cognitive functions in heal preschool children: a randomized, controlled, double-blind study. Clinical Pediatrics 47(4):355-362.

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

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

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

Wille HJ, Gonus P. 1989. 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.

References reviewed:

Bonefeld-Jørgensen EC, Møller SM, Hansen JC. 2001. Modulation of atherosclerotic risk factors by seal oil: a preliminary assessment. International Journal of Circumpolar Health 60 (1): 25-33.

Conquer JA, Cheryk LA, Chan E, Gentry PA, Holub BJ. 1999. Effect of supplementation with dietary seal oil on selected cardiovascular risk factors and hemostatic variables in healthy male subjects. Thrombosis Research 96 (3): 239-250.

Ikeda I, Yoshida H, Tomooka M, Yosef A, Imaizumi K, Tsuji H, Seto A. 1998. Effects of long-term feeding of marine oils with different positional distribution of eicosapentaenoic and docosahexaenoic acids on lipid metabolism, eicosanoid production, and platelet aggregation in hypercholesterolemic rats. Lipids 33 (9): 897-904.

Murphy MG, Wright V, Ackman RG, Horackova M. 1997. Diets enriched in menhaden fish oil, seal oil, or shark liver oil have distinct effects on the lipid and fatty-acid composition of guinea pig heart. Molecular and Cellular Biochemistry 177 (1-2): 257-269.

Murphy MG, Wright V, Scott J, Timmins A, Ackman RG. 1999. Dietary menhaden, seal, and corn oils differentially affect lipid and ex vivo eicosanoid and thiobarbituric acid-reactive substances generation in the guinea pig. Lipids 34 (2): 115-124.

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/ d-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