FISH OIL

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Monograph: FISH OIL (PDF Version - 260 KB)

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) and docosahexaenoic acid (C22:6 n-3; DHA).

Notes

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)
Organism group(s) Part(s)

Fish oil

Fish oil
  • Ammodytidae
  • Carangidae
  • Clupeidae
  • Engraulidae
  • Osmeridae
  • Salmonidae
  • Scombridae

Whole

References: Proper name: BP 2012, Ph.Eur. 2012; Common name: BP 2012, Ph.Eur. 2012; Source materials: Froese and Pauly 2018, BP 2012, Ph.Eur. 2012, Froese and Pauly 2011, Martindale 2011.

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 100-5,000 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), per day

Products providing 100-5,000 mg EPA and DHA including at least 100 mg DHA, per day

Helps support cognitive health and/or brain function (EFSA 2012; van de Rest et al. 2008; Freund-Levi et al. 2006; Fontani et al. 2005a,b; Haag 2003; Morris et al. 2003; IOM 2002).

Products providing 150-2,000 mg EPA and DHA including at least 150 mg DHA, per day (maximum doses of EPA + DHA in Table 2 below will apply)

Helps support (healthy) development of brain/(and), eyes/(and) nerves in children up to 12 years of age (Marszalek and Lodish 2005; Haag 2003; IOM 2002; Giedd et al. 1999; Mills 1999).

Products providing 200-5,000 mg EPA and DHA, per day and containing a ratio of EPA:DHA between 0.5:1 and 2:1

Helps maintain/support cardiovascular health (EFSA 2012; Oh 2005; Wang et al. 2004; Leaf et al. 2003; Kris-Etherton et al. 2002).

Products providing 1,000-5,000 mg EPA and DHA, per day and containing a ratio of EPA:DHA between 0.5:1 and 2:1

Products providing 2,800-5,000 mg EPA and DHA, per day and containing a ratio of EPA:DHA between 0.5:1 and 2:1

In conjunction with conventional therapy, helps to reduce the pain of rheumatoid arthritis in adults (EFSA 2012; Volker et al. 2000; Sköldstam et al. 1992).

Products providing 1,500-5,000 mg EPA and DHA including at least 1000 mg EPA, per day and a ratio of EPA:DHA between 1.75:1 and 2:1

Helps to promote healthy mood balance (EFSA 2012; Nemets et al. 2006; Sontrop and Campbell 2006; Fontani et al. 2005a,b; Zanarini and Frankenburg 2003; Peet and Horrobin 2002; Stoll et al. 1999).

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Method of preparation: Standardized fixed oil

Potency must be expressed as the quantity (milligrams) and/or percent (%) of EPA and DHA (% w/w) relative to the total quantity of fish oil.

Table 2. Daily dose for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in fish oil.
Subpopulation(s)
EPA+DHA (mg/day)
Minimum1
Maximum2

Children

1-8 years

100

1,500

9-11 years

100

2,000

Adolescents

12-13 years

100

2,000

14-17 years

100

2,500

Adults3

18 years

100

2,500

19 years and older

100

5,000

Table 2 Footnotes

Table 2 Footnote 1

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

Return to Table 2 footnote1 referrer

Table 2 Footnote 2

Adult maximum dose is supported by US FDA 1997. Children and adolescent maximum doses are calculated as a fraction of the adult dose, are relative to body weight and caloric intake.

Return to Table 2 footnote2 referrer

Table 2 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 2 footnote3 referrer

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

References Cited

References Reviewed