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Drugs and Health Products

Mushrooms

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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.

Date

December 8 2015

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

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

Table 1 Footnotes

Table 1 Footnote *

Agaricus blazei should be agaritine free. See specification section for details.

Return to Table 1 footnote * referrer

Table 1 Footnote 1

The following references have been consulted :

CABI 2014; De Sà-Nakanishi et al. 2014; Zhao 2013; Dai et al. 2012; PPRC 2010; NLM 2009; Youn et al. 2009; Nakajima et al. 2007; USDA 2006; Bensky et al. 2004; Chang and Miles 2004; Hobbs 2003; Chu et al. 2002; Wasser 2002; Bisby et al. 2000; McGuffin et al. 2000; TGA 1999; Lonvah and Deosthale 1998; MHPRC 1998; Saar 1991; Ying 1987.

Return to Table 1 footnote 1 referrer

Agaricus blazei Footnote * Himematsutake
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Auricularia auricula-judae Jelly Ear
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Ganoderma applanatum
  • Artist's conk
  • Polypore aplani
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Ganoderma lucidum As per NNHPD Reishi monograph As per NNHPD Reishi monograph
Grifola frondosa As per NNHPD Maitake monograph As per NNHPD Maitake monograph
Hericium erinaceus Lion's Mane
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Inonotus obliquus Chaga
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Lentinula edodes Shiitake
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Ophiocordyceps sinensis
  • Dong chong xia cao
  • Cordyceps
  • Chinese Caterpillar Fungus
  • Cordyceps sinensis
Stroma
Paecilomyces hepali
  • Fa xiao chong cao jun fen
  • Cordyceps
  • Cultured Chinese Caterpillar Fungus Powder
Cultured Mycelia
Schizophyllum commune Split Gill fungus
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Trametes versicolor
  • Kawaratake
  • Turkey Tail
  • Yunzhi
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Tremella fuciformis
  • Silver ear
  • White Mushroom
  • Fruiting body
  • Mycelia
  • Cultured Mycelia
Wolfiporia extensa As per NNHPD Poria monograph As per NNHPD Poria monograph

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 fungal polysaccharides with immunomodulating properties (Xu et al. 2014; Mizuno and Nishitani 2013; Dai et al. 2012; Jung et al. 2012; Won et al. 2011; Wang et al. 2009; Chang and Miles 2004; Bensky et al. 2004; Hobbs 2003; Li et al. 2002; MHPRC 1998; Wasser 2002; Bin and Yang 1991).

Products containing Lentinula edodes fruiting body and/or (cultured) mycelia, the decocted fruiting body of Agaricus blazei, the decocted fruiting body of Hericium erinaceus and/or the decocted stroma of Ophiocordyceps sinensis
  • Source of antioxidants/Provides antioxidants (De Sà -Nakanishi et al. 2014; Zheng et al. 2014; Han et al. 2013; Qi et al. 2013; Wang et al. 2011; Bisen et al. 2010; Xu et al. 2010).
  • Source of antioxidants/Provides antioxidants that help fight/protect (cell) against/reduce (the oxidative effects of/the oxidative damage caused by/cell damage caused by) free radicals (De Są-Nakanishi et al. 2014; Zheng et al. 2014; Han et al. 2013; Qi et al. 2013; Wang et al. 2011; Bisen et al. 2010; Xu et al. 2010).
Products containing Ganoderma lucidum, Grifola frondosa and/or Wolfiporia extensa

As per respective NNHPD monographs.

Products containing Ophiocordyceps sinensis stroma

Used in Traditional Chinese Medicine to help tonify and replenish the lungs and kidneys, and resolve phlegm (PPRC 2010; Liu et al. 2005; Bensky et al. 2004).

For products containing Paecilomyces hepiali cultured mycelia

Used in Traditional Chinese Medicine to help tonify and replenish the lungs and kidneys, tonify essence, and replenish qi (PPRC 2010).

Products containing decocted fruiting body of Trametes versicolor

Used in Traditional Chinese Medicine to fortify the spleen to drain dampness and clear toxic heat (PPRC 2010).

Products containing decocted fruiting body of Tremella fuciformis

Used in Traditional Chinese Medicine to nourish the stomach yin, moisten the lungs and generate fluids; for yin deficiency with ascendant yang (Bensky et al. 2004).

Products containing fruiting body or (cultured) mycelium of Lentinula edodes

Used in Herbal Medicine to support the immune system (Hobbs 2003; Wasser 2002).

Dose(s)

Subpopulation(s)

Adults (≥ 18 years)

Quantity(ies)

Table 2: Acceptable Method of Preparation and Dosing Footnote 1
Proper name(s) Method of Preparation Dose(s)

Table 2 Footnotes

Table 2 Footnote 1

The following references have been consulted :

PPRC 2010; Mori et al. 2009; Liu et al. 2008; Liu et al. 2005; Bensky et al. 2004; Hobbs 2003; Levy et al. 1998; MHPRC 1998; Ying 1987.

Return to Table 2 footnote 1 referrer

Agaricus blazei Decoction
  • Up to 9 grams of dried mushroom per day
Auricularia auricula-judae Decoction
  • Up to 15 grams of dried mushroom per day
Powder, tincture, fluid extract
  • Up to 3.6 grams of dried mushroom per day
Ganoderma applanatum Decoction
  • Up to 30 grams of dried mushroom per day
Powder, tincture, fluid extract
  • Up to 3.6 grams of dried mushroom per day
Ganoderma lucidum As per NNHPD Reishi monograph
Grifola frondosa As per NNHPD Maitake monograph
Hericium erinaceus Decoction
  • Up to 12 grams of dried mushroom per day
Powder, tincture, fluid extract
  • Up to 2.8 grams of dried mushroom per day
Inonotus obliquus Powder, tincture, fluid extract, decoction
  • Up to 3.6 grams of dried mushroom per day
Lentinula edodes Decoction
  • Up to 16 grams of dried mushroom per day
  • Minimum 6 grams of dried mushroom per day for Herbal Medicine claim
Powder, tincture, fluid extract
  • Up to 6 grams of dried mushroom per day
  • Minimum 1.6 grams of dried mushroom per day for Herbal Medicine claim
Ophiocordyceps sinensis Decoction
  • Up to 9 grams of dried mushroom per day
  • Minimum 3 grams of dried mushroom per day for Traditional Chinese Medicine (TCM) claim
Powder, tincture, fluid extract
  • Up to 3 grams of dried mushroom per day
  • Minimum 1.5 grams of dried mushroom per day for TCM claim
Paecilomyces hepali Decoction
  • Up to 9 grams of dried mushroom per day
  • Minimum 3 grams of dried mushroom per day for TCM claim
Powder, tincture, fluid extract
  • Up to 3 grams of dried mushroom per day
  • Minimum 1.5 grams of dried mushroom per day for TCM claim
Schizophyllum commune Decoction
  • Up to 16 grams of dried mushroom per day
Powder, tincture, fluid extract
  • Up to 3.6 grams of dried mushroom per day
Trametes versicolor Decoction
  • Up to 27 grams of dried mushroom per day
  • Minimum 9 grams of dried mushroom per day for TCM claim
Powder, tincture, fluid extract
  • Up to 5 grams of dried mushroom per day
Tremella fuciformis Decoction
  • Up to 9 grams of dried mushroom per day
  • Minimum 3 grams of dried mushroom per day
Powder, tincture, fluid extract
  • Up to 3.6 grams of dried mushroom per day
Wolfiporia extensa As per NNHPD Poria monograph As per NNHPD Poria monograph

Note

Potency (Optional) for each medicinal ingredient: up to 40% polysaccharides.

Directions for use

No statement required

Duration of use:

Statement(s) to the effect of:
For Products containing Wolfiporia extensa

As per NNHPD Poria monograph

Risk information:

Statement(s) to the effect of:

Consult Table 3 to determine the required risk statements for each medicinal ingredient. The medicinal ingredients of Table 3 are associated with the numbered statements below. For products containing Auricularia auricula-judae, the caution and warning statement "If you are pregnant or breastfeeding, consult a health care practitioner prior to use" will not be needed as it will be covered by a contraindication for that subpopulation (statement #8).

Caution(s) and warning(s)
  1. If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
  2. If claims related to reductions of symptoms are made: If symptoms persist or worsen, consult a health care practitioner.
  3. Products providing ≥ 150 mg of dried Grifola frondosa, used as powder, tincture or fluid extract and/or ≥ 300 mg of dried Grifola frondosa, used as decoction, and/or ≥ 300 mg of dried Agaricus blazei: If you have diabetes, consult a healthcare practitioner prior to use (Brinker 2010; Firenzuoli et al. 2008; Hsu et al. 2007; Konno 2003, 2001).
  4. If you are taking blood thinners (anti-coagulants), consult a health care practitioner prior to use (Bisen et al. 2010; Wasser 2005).
  5. Products making TCM claims based on Ophiocordyceps sinensis or Paecilomyces hepali: If you have exterior pathogens/conditions, consult a health care practitioner prior to use (Bensky et al. 2004).
  6. Products making TCM claims based on Tremella fuciformis: If you have cough from wind-cold, consult a health care practitioner prior to use (Bensky et al. 2004).
  7. Products making TCM claims based on Wolfiporia extensa: If you have a yin deficiency, sunken Spleen qi, or cold from deficiency with spermatorrhea, consult a health care practitioner prior to use (Bensky et al. 2004; Chen and Chen 2004).
Contraindication(s)
  1. If you are pregnant or breastfeeding, do not use this product.
Known adverse reaction(s)
  1. Hypersensitivity/allergy can occur; in which case, discontinue use (derMarderosian and Beutler 2008; Bensky et al. 2004; Gao et al. 2003, 2002; Levy et al. 1998).
  2. Diuretic effect may occur (PPRC 2010).
Table 3: Risk information
Medicinal Ingredient Risk Information
Agaricus blazei 1, 3
Auricularia auricula-judae 8
Ganoderma applanatum 1
Ganoderma lucidum 2, 9
Grifola frondosa 3
Hericium erinaceus 1
Inonotus obliquus 1
Lentinula edodes 4, 9
Ophiocordyceps sinensis 1, 2, 5
Paecilomyces hepali 1, 2, 5
Schizophyllum commune 1, 2
Trametes versicolor 1, 2
Tremella fuciformis 1, 2, 6
Wolfiporia extensa 7, 9, 10

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 Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • This product must not contain any traces of agaritine.

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