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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/-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 statements are synonymous. Either term or statement may be selected by the applicant.

Date

September 25, 2018

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)

Seal oil

Seal oil

  • Cystophora cristata
  • Erignathus barbatus
  • Halichoerus grypus
  • Pagophilus groenlandicus
  • Phoca vitulina
  • Pusa hispida

Blubber

References: Proper name: NHPID, Brox et al. 2001,Østerud et al. 1995; Common name: Brox et al. 2001, Østerud et al. 1995; Source materials: ITIS 2012, MMR 2011, EC 2011, 2008.

The seal population is not required to be identified on the label, but the population must be identified on the Animal Tissue Form (ATF) when the source material is oil from seals from Quebec populations.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms by age group:

Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Products providing 100-3000 milligrams of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA), per day

  • Source of omega-3 fatty acids for the maintenance of good health (FCC 8 2012; Wu et al. 2012; Simopoulos 2007; Oh 2005; Brox et al. 2001; Simopoulos 1999).
  • Source of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA) for the maintenance of good health (FCC 8 2012; Wu et al. 2012; Simopoulos 2007; Oh 2005; Brox et al. 2001; Simopoulos 1999).

Products providing 150-2000 milligrams of EPA, DHA and DPA; including 150 milligrams or more DHA, per day (maximum doses of EPA + DHA in Table 1 below apply)

Helps support (healthy) development of the brain/(and), eyes/(and) nerves in children up to 12 years of age (FCC 8 2012; Ryan and Nelson 2008; Marszalek and Lodish 2005; Haag 2003; Giedd et al. 1999; Mills 1999).

Products providing 1000-3000 milligrams of EPA, DPA and DHA; including 340 milligrams or more EPA, per day and having a ratio of EPA: DPA: DHA between 1-1.5:1:1.5-2

  • Helps to reduce serum triglycerides/triacylglycerols (Mann et al. 2010; Meyer et al. 2009).
  • Helps reduce serum triglycerides and support cardiovascular health (Mann et al. 2010; Meyer et al. 2009; WHO/FAO 2003).

Products providing 200-3000 milligrams of EPA, DPA and DHA and having a ratio of EPA: DPA: 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)

Subpopulation(s)

As specified below.

Quantity(ies)

Method of preparation: Standardized fixed oil

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 2.Daily doses for eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA) in seal oil.
Subpopulation(s) EPA + DHA + DPA (mg/day)
Minimum1 Maximum2

Children

1-8 years

9-11 years

100

100

1500

2000

Adolescents

12-13 years

14-17 years

100

100

2000

2500

Adults3

18 years and older

100

3000

1Restrictions to minimum dose may apply according to Use(s) or Purpose(s) section above.

2Adult 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.

3Includes pregnant and breastfeeding women.

Direction(s) for use

No statement required.

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.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

All products

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

All products, except those encapsulated

Refrigerate after opening (Wille and Gonus 1989).

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). The maximum peroxide value (PV) must be 5 mEq/kg, the maximum anisidine value (AV) must be 20 while the maximum Totox value must be 26 (calculated as 2 X PV + AV).
  • 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 is required. Testing should be performed using appropriate analytical methods, such as method No. 1613 revision B of the Environmental Protection Agency for PCDDs and PCDFs and method No. 1668B of the Environmental Protection Agency for chlorinated biphenyl congeners (Ph. Eur: EPA 2008; EPA 1994). Licence holders are advised to consult the Commission of the European Communities documents on dioxins and dioxin-like PCB contaminants in marine oil for further information (EU 2006a.b; EU 2001). Refer to Section 3.3.8 of the Quality of Natural Health Products Guide for more information on the acceptable limits of dioxins and dioxin-like PCBs.

References Cited

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

EC 2008: COSEWIC assessment and update status report on the Harbour Seal Atlantic and Eastern Arctic subspecies and Lacs des Loups Marins subspecies in Canada. [Internet]. Ottawa (ON): Environment Canada, Canadian Wildlife Service, Committee on the Status of Endangered Wildlife in Canada (COSEWIC); 2008. [Accessed 2018 July 12]. Available at: http://www.sararegistry.gc.ca/

EC 2011: Species at Risk Public Registry. [Internet]. Ottawa (ON): Environment Canada; 2011. [Accessed 2018 July 12]. Available at: http://www.sararegistry.gc.ca/

EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. [Accessed 2018 July 12]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf

FCC 8 2012: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.

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.

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 2013: Health Canada. 2013b. Quality of Natural Health Products Guide Version 3.0 [Internet]. Ottawa (ON): Natural Health Products Directorate, Health Canada. [Accessed 2018 July 12]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php

ITIS 2012: Integrated Taxonomic Information System. Taxon Based on Biological Information System [Internet]. Canadian Biodiversity Information Facility, Government of Canada. [Accessed 2018 July 12]. Available from: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif

Mann NJ, O'Connell SL, Baldwin KM, Singh I, Meyer BJ. Effects of seal oil and tuna-fish oil on platelet parameters and plasma lipid levels in healthy subjects. Lipids. 2010 Aug;45(8):669-81. doi: 10.1007/s11745-010-3450-z. Epub 2010 Jul 23.

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.

Meyer BJ, Lane AE, Mann NJ. Comparison of seal oil to tuna oil on plasma lipid levels and blood pressure in hypertriglyceridaemic subjects. Lipids. 2009 Sep;44(9):827-35. doi: 10.1007/s11745-009-3333-3.

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

MMR 2011: Marine Mammal Regulations. SOR/93-56. Fisheries Act [Internet]. Ottawa (ON): Government of Canada. [Last amended 2011 February 10; Accessed 2018 July 12]. Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-93-56/index.html

National Heart Foundation of Australia 2008. Position statement Fish, fish oils, n-3 polyunsaturated fatty acids and cardiovascular health [Accessed 2018 July 12]. Available from: https://www.heartfoundation.org.au/images/uploads/main/For_professionals/Fish-FishOils-revie-of-evidence.pdf

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

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

US EPA 2008: United States Environmental Protection Agency. November 2008. Method 1668B: Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS [Internet]. Washington (DC): Engineering and Analysis Division, Office of Science and Technology, Office of Water, U.S. Environmental Protection Agency. [Accessed 2018 July 12]. Available from:

http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/2009_01_07_methods_method_1 668.pdf

USP 35 2012: 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 3 and 6 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.

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 [Internet]. [Accessed 2012 March 23]. Available from: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:364:0032:0043:EN:PDF

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 [Internet]. [Accessed 2012 March 23]. Available from: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:364:0005:0024:EN:PDF

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 longterm 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. Substances affirmed as generally regarded as safe: menhaden oil [Internet]. 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]. Available from:http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/ucm083 058.htm