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Drugs and Health Products

Seal Oil

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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.

There are many N-3 polyunsaturated fatty acids, popularly known as omega-3 acids/ω-3 fatty acids (Ph. Eur. 2012). This monograph is specific to eicosapentaenoic acid (C20:5 n-3; EPA), docosahexaenoic acid (C22:6 n-3; DHA) and docosapentaenoic acid (C22:5 n-3; DPA).

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

July 18, 2017

Proper name(s)

Seal oil (NHPID; 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 2011) in its natural triglyceride/triacylglycerol form and/or its concentrated esterified form:

  • Bearded seal (Erignathus barbatus) (ITIS 2012)
  • Gray seal (Halichoerus grypus) (ITIS 2012)
  • Harbor seal (Phoca vitulina) (ITIS 2012), except the Phoca vitulina mellonae of the Lac des Loups Marins population (EC 2011, 2008)
  • Harp seal (Pagophilus groenlandicus, synonym: Phoca groenlandica) (ITIS 2012)
  • Hooded seal (Cystophora cristata) (ITIS 2012)
  • Ringed seal (Pusa hispida, synonym:Phoca hispida) (ITIS 2012)
Notes:
  • The term “blubber” and the organism's Latin binomial must be indicated on the PLA and labelled as source material information, e.g.,“Pagophilus groenlandicus” blubber.
  • The seal population is not required to be identified on the label, but the population must be identified on the Animal Tissue Form when the source material is oil from seals from Quebec populations.

Route(s) of administration

Oral

Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

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

  • Source of omega-3 fatty acids for the maintenance of good health (Wu et al. 2012; Simopoulos 2007; Oh 2005; FCC 7; Brox et al. 2001; Simopoulos 1999).
  • Source of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA) for the maintenance of good health (Wu et al. 2012; Simopoulos 2007; Oh 2005; FCC 7; Brox et al. 2001; Simopoulos 1999).

For products providing 150-2,000 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) + docosapentaenoic acid (DPA) including at least 150 mg DHA, per day (maximum doses of EPA + DHA in Table 1 below 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; FCC 7; Giedd et al. 1999; Mills 1999).

For products providing 1000-3,000 mg eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA) including at least 340 mg EPA, per day and having a ratio of Eicosapentaenoic acid (EPA): Docosapentaenoic acid (DPA): Docosahexaenoic acid (DHA) between 1-1.5:1:1.5-2

Helps to reduce serum triglycerides/triacylglycerols (Mann et al. 2010; Meyer et al. 2009).

For products providing 200-3000 mg Eicosapentaenoic acid (EPA) + Docosapentaenoic acid (DPA) + Docosahexaenoic acid (DHA) and having a ratio of Eicosapentaenoic acid (EPA): Docosapentaenoic acid (DPA): Docosahexaenoic acid (DHA) between 1-1.5:1:1.5

Helps support cardiovascular health (Mann et al. 2010; Meyer et al. 2009, WHO/FAO 2003).

Dose(s)

Note

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

Table 1 Daily dose for eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) + docosapentaenoic acid (DPA) in seal oil
Subpopulation EPA + DHA + DPA (mg/day)
Minimum 1 Maximum 2

Table 1 Footnotes

Table 1 Footnote 1

Restrictions to minimum dose may apply according to Use(s) or Purpose(s) section above.

Return to Table 1 footnote 11 referrer

Table 1 Footnote 2

Adult maximum dose is supported by National Heart Foundation of Australia 2008. Children and adolescent maximum doses, calculated as a fraction of the adult dose, are relative to body weight and caloric intake.

Return to Table 1 footnote 22 referrer

Table 1 Footnote 3

Includes pregnant and breastfeeding women

Return to Table 1 footnote 33 referrer

Children 1-8 y 100 1,500
Adolescents 9-13 y 100 2,000
14-17 y 100 2,500
Adults 3 ≥ 18 y 100 3,000

Duration(s) 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

For all products
Store in airtight container, protected from light (Ph.Eur. 2012; USP 35).

For all products, except those encapsulated
Refrigerate after opening (Wille and Gonus 1989).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) 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 Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • 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 and the omega-3 fatty acids from seal oil (HC 2013b). Refer to Table 2 below.
  • The dioxins, polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs); the dioxin-like polychlorinated biphenyls (dioxin-like PCBs); and the polychlorinated biphenyls (PCBs) are contaminants in oils from marine sources. Testing for these contaminants are required and must be performed using either the  analytical method of the European Commission Regulation EU 252/2012 (EU 2012) or the U.S. Environmental Protection Agency’s method 1613B for PCDDs and PCDFs and method 1668A for PCBs (USP 35; US EPA 2010, 2008, 1994). Applicants are advised to consult the Council of the European Union document on these contaminants for further information (EU 2011). Refer to Table 3 below.
Table 2 Maximum values of oxidative stability parameters for seal oil (HC 2013)
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 Acceptable limits of dioxins and dioxin-like polychlorinated biphenyls in oils from marine sources
Dioxin and dioxin-like polychlorinated biphenyl contaminants Maximum value 1

Table 3 Footnotes

Table 3 Footnote 1

Expressed in World Health Organization (WHO) toxic equivalents using WHO-toxic equivalent factors (TEFs). Analytical results relating to 17 individual dioxin congeners of toxicological concern are expressed in a single quantifiable unit: 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) toxic equivalent concentration or TEQ (EU 2006).

Return to Table 3 footnote 11 referrer

Table 1 Footnote 2

The dioxin-like PCBs that can be determined by Method 1668B are the 12 PCBs designated as toxic by WHO: congeners 77, 81, 126, 169, 105, 114, 118, 123, 156, 157, 167, and 189 (EPA 2008; EU 2006).

Return to Table 3 footnote 22 referrer

Sum of PCDDs + PCDFs 2.0 pg TEQ TEF/g oil
Sum of dioxins and dioxin-like PCBs 2 10.0 pg TEQ TEF/g oil

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.
  • EC 2011: Next link will take you to another Web siteSpecies at Risk Public Registry. Ottawa (ON): Environment Canada; 2011. [Accessed 2012 March 2].
  • EC 2008: Next link will take you to another Web siteCOSEWIC assessment and update status report on the Harbour Seal Atlantic and Eastern Arctic subspecies and Lacs des Loups Marins subspecies in Canada. Ottawa (ON): Environment Canada, Canadian Wildlife Service, Committee on the Status of Endangered Wildlife in Canada (COSEWIC); 2008. [Accessed 2012 March 23].
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Le lien suivant vous amène à un autre site Web Formulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • EU 2012: Next link will take you to another Web siteEuropean Commission. Commission Regulation (EU) No 252/2012 of 21 March 2012 laying down the methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EC) No 1883/2006. Official Journal of the European Union L 84/1 23.3.2012. [Accessed 2012 June 29].
  • EU 2011: Next link will take you to another Web siteEuropean Commission. Commission Regulation (EU) No 1259/2011 of 2 December 2011 amending Regulation (EC) No 1881/2006 as regards maximum levels for dioxins, dioxin-like PCBs and non dioxin-like PCBs in foodstuffs. Official Journal of the European Union L 320/18 3.12.2011. [Accessed 2012 March 23].
  • FCC 8: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
  • Next link will take you to another Web siteGiedd JN, Next link will take you to another Web siteBlumenthal J, Next link will take you to another Web siteJeffries NO, Next link will take you to another Web siteCastellanos FX, Next link will take you to another Web siteLiu H, Next link will take you to another Web siteZijdenbos A, Next link will take you to another Web sitePaus T, Next link will take you to another Web siteEvans AC, Next link will take you to another Web siteRapoport JL. 1999. Brain development during childhood and adolescence: a longitudinal MRI study. Nature Neuroscience 2(10):861-863.
  • Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
  • Haag M. 2003. Essential fatty acids and the brain. The Canadian Journal of Psychiatry 48(3):195-203.
  • HC 2014: Health Canada. 2014. Natural Health Products Ingredients Database.. Ottawa (ON): Natural Health Products Directorate, Health Canada. [Accessed 2014-05-01].
  • HC 2013: Health Canada. 2013b. Quality of Natural Health Prodcts Guide Version 3.0. Ottawa (ON): Natural Health Products Directorate, Health Canada. [Accessed 2014 May 9]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php
  • ITIS 2012: Next link will take you to another Web siteIntegrated Taxonomic Information System. Taxon Based on Biological Information System. Canadian Biodiversity Information Facility, Government of Canada. [Accessed 2014 May 9].
  • 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 2011: Next link will take you to another Web siteMarine Mammal Regulations. SOR/93-56. Fisheries Act. Ottawa (ON): Government of Canada. [Last amended 2011 February 10; Accessed 2012 January 12].
  • National Heart Foundation of Australia 2008. Next link will take you to another Web sitePosition statement Fish, fish oils, n-3 polyunsaturated fatty acids and cardiovascular health.[Accessed 2014 May 9].
  • 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.
  • 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.
  • Ph.Eur. 2012: European Pharmacopoeia, 8th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2012.
  • Ryan AS, Nelson EB. 2008. Assessing the effect of docosahexaenoic acid on cognitive functions in healthy, 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.
  • US EPA 2010: United States Environmental Protection Agency. April 2010. Next link will take you to another Web siteMethod 1668C: Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS. Washington (DC): Engineering and Analysis Division, Office of Science and Technology, Office of Water, U.S. Environmental Protection Agency. [Accessed 2012 March 23].
  • US EPA 2008: United States Environmental Protection Agency. November 2008. Next link will take you to another Web siteMethod 1668B: Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS. Washington (DC): Engineering and Analysis Division, Office of Science and Technology, Office of Water, U.S. Environmental Protection Agency. [Accessed 2012 March 23].
  • US EPA 1994: United States Environmental Protection Agency. October 1994. Next link will take you to another Web siteMethod 1613, Revision B: Tetra- through Octa-Chlorinated Dioxins and Furans by Isotope Dilution HRGC/HRMS. Washington (DC): Engineering and Analysis Division, Office of Water, U.S. Environmental Protection Agency. [Accessed 2012 March 23].
  • USP 35: United States Pharmacopeial Convention. United States Pharmacopeia and the National Formulary (USP 35 - NF 30). Rockville (MD): The United States Pharmacopeial Convention; 2012.
  • WHO/FAO (World Health Organization/Food and Agriculture Organization), Expert Report: Diet, nutrition and prevention of chronic diseases. Report of a Joint WHO/FAO Expert Consultation. WHO Technical Report Series (916, 160 pp) 2003.
  • 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.
  • Wu JHY, Lemaitre RN, King IB, Song X, Sacks FM, Rimm EB, Heckbert SR, Siscovick DS, Mozaffarian D. 2012. Association of Plasma Phospholipid Long-Chain Omega-3 Fatty Acids with Incident Atrial Fibrillation in Older Adults: The Cardiovascular Health Study. Circulation. Published online before print January 26, 2012, doi: 10.1161/ CIRCULATIONAHA.111.062653

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.
  • Next link will take you to another Web site Commission of the European Communities. Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down the methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs. Official Journal of the European Union L 364/32 20.12.2006. [Accessed 2012 March 23].
  • Next link will take you to another Web site Commission of the European Communities. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. Official Journal of the European Union L 364/5 20.12.2006. [Accessed 2012 March 23].
  • 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.
  • Kaur G, Cameron-Smith D, Garg M, Sinclair AJ. 2011. Docosapentaenoic acid (22:5n-3): a review of its biological effects. Progress in Lipid Research 50(1):28-34.
  • Mann NJ, O'Connell SL, Baldwin KM, Singh I, Meyer BJ. 2010. Effects of seal oil and tuna-fish oil on platelet parameters and plasma lipid levels in healthy subjects. Lipids 45(8):669-81.
  • 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.
  • US FDA 1997: United States Food and Drug Administration. Next link will take you to another Web siteSubstances affirmed as generally regarded as safe: menhaden oil. Federal Register Notice - the GRAS Proposal,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 2012 March 23].