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Drugs and Health Products

Kelp Products

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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.

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.
  • When "Fruit" is indicated as source material, it only includes the parts of the fruit that are used historically as human food.

Date

March 31, 2015

Medicinal Ingredients

Table 1 Medicinal ingredients. Footnote 1
Proper name(s) Common name(s) Source material(s)

Table 1 Footnotes

Table 1 Footnote 1

The following reference has been consulted :
Gardner and McGuffin 2013; Guiry and Guiry 2013a,b; The Biodiversity Committee of Chinese Academy of Science 2013; Guiry and Guiry 2012a,b; Seeley and Schlesinger 2012; Brinker 2010; Barnes et al. 2007; Sweetman 2007; TGA 1999.

Return to Table 1 footnote 1 referrer

Ascophyllum nodosum Norwegian Kelp
  • Thallus
  • Whole
Fucus vesiculosus
  • Bladder fucus
  • Kelpware
  • Seawrack
Laminaria digitata Kelp
Laminaria japonica
  • Japanese kelp
  • Makombu

Route(s) of administration

Oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • 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

All products

  • Source of/Provides antioxidants (CNF 2012; Kang et al. 2012; Zhang et al. 2007; Jin et al. 2004; Veena et al. 2007; Veena et al. 2008; Murphya et al. 2013).
  • Source of antioxidant(s)/Provides antioxidant(s) that help(s) fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals (CNF 2012; Kang et al. 2012; Zhang et al. 2007; Jin et al. 2004; Veena et al. 2007; Veena et al. 2008; Murphya et al. 2013).

All products standardized to iodine

As per the Natural and Non-Prescription Health Products Directorate (NNHPD) Iodine monograph.

Products containing ≥ 0.8 g of Fucus vesiculosus

  • Traditionally used in Herbal Medicine as an alternative for the glandular system (Hoffman 2003; Duke 2002; Grieve 1931a,b; Felter and Lloyd 1898).
  • Used in Herbal Medicine to support normal thyroid function (Bradley 1992; Grieve 1931a,b; Ellingwood 1919).

Dose(s)

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 18 years)

Quantity(ies)

Table 2 Acceptable Method of Preparation and Dosing. Footnote 1
Medicinal Ingredient(s) Method(s) of Preparation Dose(s))

Table 2 Footnotes

Table 2 Footnote 1

The following reference has been consulted :
Barnes et al 2007; Mills and Bone 2005; Kolb et al 2004; Duke 2002; BHP 1996; Bradley 1992.

Return to Table 2 footnote 1 referrer

Ascophyllum nodosum Dry, Powder, Non-standardized ethanolic extracts (fluid extract, tincture) Up to 1 gram per day
Fucus vesiculosus Up to 1 gram per day
Laminaria digitata Up to 1 gram per day
Laminaria japonica Up to 1 gram per day
Additional notes

Iodine

The total amount of iodine provided by the product must not exceed 800 mcg iodine per day (IOM 2006).

For iodine monograph claims

Medicinal ingredient(s) must provide the minimum amount of Iodine outlined on the NNHPD Iodine monograph.

Directions for use

No statement required.

Duration of use

No statement required.

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

All products

  • If you are taking blood thinners, consult a health care practitioner prior to use (Gardner and McGuffin 2013; Ren et al 2013; Zhao et al 2012; Brinker 2010; Gruenwald et al 2007; Duke 2002).
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use (Brinker 2010; Barnes 2002).

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.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide..
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

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  • Guiry MD, Guiry GM. 2013a. Next link will take you to another Web siteAscophyllum nodosum (Linnaeus) AlgaeBase - World-wide electronic publication. National University of Ireland, Galway. [Accessed 2015 February 20].
  • Guiry MD, Guiry GM. 2013b. Next link will take you to another Web siteLaminaria digitata (Hudson) J.V. Lamouroux. AlgaeBase - World-wide electronic publication. National University of Ireland, Galway. [Accessed 2015 February 20].
  • Guiry MD, Guiry GM. 2012a. Next link will take you to another Web siteFucus vesiculosus Linnaeus. AlgaeBase - World-wide electronic publication. National University of Ireland, Galway. [Accessed 2015 February 20].
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  • 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.
  • Jin DQ, Li G, Kim JS, Yong CS, Kim JA, Huh K. Preventive Effects of Laminaria japonica Aqueous Extract on the Oxidative Stress and Xanthine Oxidase Activity in Streptozotocin-induced diabetic rat liver. Biological and Pharmaceutical Bulletin 2004;27(7):1037-1040.
  • Kang YM, Lee BJ, Kim JI, Nam BH, Cha JY, Kim YM, Ahn CB, Choi JS, Choi IS, Je JY. Antioxidant effects of fermented sea tangle (Laminaria japonica) by Lactobacillus brevis BJ20 in individuals with high level of gamma-GT: A randomized double-blind and placebo controlled clinical study. Food and Chemical Toxicology 2012;50:1166-1169.
  • Kolb N, Vallorani L, Milanovic N, Stocchi. Evaluation of marine algae Wakame (Undaria pinnatifida) and Kombu (Laminaria digitata japonica) as food supplements. Food Technology and Biotechnology 2004;42:57-61.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Murphya P, Dal Bello F, O'Doherty J, Arendt EK, Sweeney T, Coffey A. The effects of liquid versus spray-dried Laminaria digitata extract on selected bacterial groups in the piglet gastrointestinal tract (GIT) microbiota. Anaerobe 2013;21:1-8.
  • Ren R, Azuma Y, Ojima T, Hashimoto T, Mizuno M, Nishitani Y, Yoshida M, Azuma T, Kanazawa K. Modulation of platelet aggregation-related eicosanoid production by dietary F-fucoidan from brown alga Laminaria japonica in human subjects. British Journal of Nutrition 2013;110:880-890.
  • Seeley RH, Schlesinger WH. Sustainable seaweed cutting? The rockweed (Ascophyllum nodosum) industry of Maine and the Maritime Provinces. Annals of the New York Academy of Science 2012:1249(1):84-103.
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  • Veena CK, Josephine A, Preetha SP, Varalakshmi P. Effect of sulphated polysaccharides on erythrocyte changes due to oxidative and nitrosative stress in experimental hyperoxaluria. Human & Experimental Toxicology 2007;26:923-932.
  • Veena CK, Josephine A, Preetha SP, Rajesh NG, Varalakshimi P. Mitochondrial dysfunction in an animal model of hyperoxaluria: a prophylactic approach with fucoidan. European Journal of Pharmacology 2008;579(1-3):330-336.
  • Zhang J, Tiller C, Shen J, Wang C, Girouard GS, Dennis D, Barrow CJ, Miao M, Ewart HS. Antidiabetic properties of polysaccharide- and polyphenolic-enriched fractions from the brown seaweed Ascophyllum nodosum. Canadian Journal of Physiology and Pharmacology 2007;85(11):1116-1123.
  • Zhao X, Dong S, Wang J, Li F, Chen A, Li B. A comparative study of antithrombotic and antiplatelet activities of different fucoidans from Laminaria japonica. Thrombosis Research 2012;129(6):771-778.

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