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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 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)

Ascophyllum nodosum

  • Kuppetang
  • Norwegian kelp

Ascophyllum nodosum

  • Thallus
  • Whole

Fucus vesiculosus

  • Black tang
  • Bladder fucus
  • Kelpware
  • Seawrack

Fucus vesiculosus

  • Thallus
  • Whole

Laminaria digitata

  • Horsetail kelp
  • Kelp
  • Silketare
Laminaria digitata
  • Thallus
  • Whole
Laminaria japonica
  • Hai dai
  • Japanese kelp
  • Makombu
  • Sea tangle
Laminaria japonica
  • Thallus
  • Whole

References: Proper name: Guiry and Guiry 2018a,b; Common names: TGA 2016, The Biodiversity Committee of Chinese Academy of Science 2013; Source materials: Guiry and Guiry 2018a,b.

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 for any age category listed in this monograph for the specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

All products

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

Products providing 0.8 g or more of Fucus vesiculosus per day

  • Traditionally used in Herbal Medicine as an alterative 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).

Products standardised to iodine

As per the Natural and Non-prescription Health Products Directorate (NNHPD) Multi-vitamin/mineral Supplements monograph.

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidants

Methods of preparation: Dry, Powder, Non-standardised ethanolic extracts (fluid extract, tincture)

Not to exceed 1 gram of kelp per day (Barnes et al 2007; Mills and Bone 2005; Kolb et al 2004; Duke 2002; BHP 1996; Bradley 1992).

Fucus vesiculosus: alterative, support normal thyroid function

0.8 - 1 gram of Fucus vesiculosus per day (Mills and Bone 2005; Bradley 1992).

Iodine claims (Multi-vitamin/mineral Supplements monograph)

Methods of preparation: Standardized preparations

Medicinal ingredient(s) must provide the minimum amount of iodine outlined on the NNHPD Multi-vitamin/mineral Supplements monograph. Iodine should be indicated on the Product License Application form as a potency constituent.

Note

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

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

All products

  • Consult a health care practitioner/health care provider/ health care professional/doctor/ physician prior to use if you are taking blood thinners (Gardner and McGuffin 2013; Ren et al 2013; Zhao et al 2012; Brinker 2010; Gruenwald et al 2007; Duke 2002).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding (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.

Storage conditions

No statement required.

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.

References Cited

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  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines. 3rd edition. London (GB): The Pharmaceutical Press; 2007.
  • BHP 1996: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1996.
  • Bradley P. British Herbal Compendium Vol 1; Companion to Volume 1 of the British Herbal Pharmacopoeia; 1992.
  • Brinker F. Herbal Contraindications and Drug Interactions: Plus Herbal Adjuncts with Medicines, expanded 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
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  • Duke JA, Bogenschutz-Godwin MJ, duCellier J, Duke PK. Handbook of Medicinal Herbs. 2nd edition. Boca Raton (FL): CRC Press; 2002.
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1998 [Reprint of 1919 original].
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. Second Edition. Boca Raton (FL): Taylor and Francis Group; 2013.
  • Grieve M. A Modern Herbal. Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931a. Harcourt, Brace & Company publication].
  • Grieve M. A Modern Herbal. Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931b. Harcourt, Brace & Company publication].
  • Gruenwald J, Brendler T, Jaenicke C. PDR for Herbal Medicines. Fourth Edition. Montvale (NJ): Thomspon Healthcare Inc.; 2007.
  • Guiry MD, Guiry GM. 20183a. Ascophyllum nodosum (Linnaeus). AlgaeBase - World-wide electronic publication. National University of Ireland, Galway. [Accessed 2018 July 23]. Available from: http://www.algaebase.org.
  • Guiry MD, Guiry GM. 2018b. Laminaria digitata (Hudson) J.V. Lamouroux. AlgaeBase - World-wide electronic publication. National University of Ireland, Galway. [Accessed 2018 July 23]. Available from: http://www.algaebase.org.
  • Hoffman D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • 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.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press; 2007.
  • TGA 2016: Australian Therapeutic Goods Administration TGA Approved Terminology for Medicines, Section 3 - Herbal Substances. June 2016. Symonston (AU): Australian Government Department of Health and Ageing, Therapeutic Goods Administration. [Accessed 2018 July 23]. Available from: https://www.tga.gov.au/sites/default/files/tga-approved-terminology-medicines.pdf
  • The Biodiversity Committee of Chinese Academy of Science 2013. Catalogue of Life China, 2013 Annual Checklist. [Accessed 2018 July 23]. Available from: https://www.gbif.org/dataset/3772da2f-daa1-4f07-a438-15a881a2142c
  • 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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