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

Date

March 25, 2019

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) Preparation(s)

Agaricus blazei

Himematsutake

Agaricus blazei

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Auricularia auricula- judae

Jelly ear

Auricularia auricula- judae

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Ganoderma applanatum

Artist's conk

Ganoderma applanatum

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Ganoderma lucidum

  • Ganoderma
  • Ling zhi
  • Reishi

Ganoderma lucidum

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Grifola frondosa

Maitake

Grifola frondosa

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Hericium erinaceus

Lion's Mane

Hericium erinaceus

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Inonotus obliquus

Chaga

Inonotus obliquus

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Lentinula edodes

Shiitake

Lentinula edodes

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Ophiocordyceps sinensis

  • Chinese caterpillar fungus
  • Cordyceps
  • Cordyceps sinensis
  • Dong chong xia cao

Ophiocordyceps sinensis

Stroma

Dried

Paecilomyces hepiali

  • Cordyceps
  • Cultured Chinese caterpillar fungus
  • Fa jiao chong cao jun

Paecilomyces hepiali

Cultured mycelium

Dried

Schizophyllum commune

Split Gill fungus

Schizophyllum commune

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Trametes versicolor

  • Kawaratake
  • Turkey Tail
  • Yunzhi

Trametes versicolor

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Tremella fuciformis

  • Silver ear
  • White mushroom

Tremella fuciformis

  • Cultured mycelium
  • Fruiting body
  • Mycelium

Dried

Wolfiporia extensa

  • Fu ling
  • Hoelen
  • Indian bread
  • Poria
  • Sclerotium of tuckahoe

Wolfiporia extensa

  • Cultured mycelium
  • Sclerotium/mycelium

Dried

References: 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.

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 listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

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; Wasser 2002; MHPRC 1998; Bin and Yang 1991).

Products containing Lentinula edodes fruiting body and/or (cultured) mycelium, a decocted fruiting body of Agaricus blazei, a decocted fruiting body of Hericium erinaceus, a decocted cultured mycelium of Paecilomyces hepiali and/or a decocted stroma of Ophiocordyceps sinensis

Products containing Ganoderma lucidum

Fruiting Body

Fruiting Body; Cultured Mycelium; Mycelium

Products containing Grifola frondosa

Used in Herbal Medicine to support the immune system (Godfrey et al. 2010; Hobbs 2003; Hoffmann 2003; derMarderosian and Beutler 2002).

Products containing Wolfiporia extensa

Products containing Ophiocordyceps sinensis stroma

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

Products containing Paecilomyces hepiali cultured mycelium

Used in Traditional Chinese Medicine (TCM) 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 (TCM) 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 (TCM) to nourish the stomach yin, moisten the lungs and generate fluids and 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).

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)

Refer to Table 2 below.

Table 2.Uses or purposes and associated daily doses
Medicinal Ingredients Uses or purposes Methods of Preparation Dose(s (grams))/day

Agaricus blazei

Source of fungal polysaccharides

Decoction

Up to Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Source of antioxidants

Decoction

Not to exceed 9 g of dried fruiting body per day

Decoction standardized

Not to exceed 9 g of dried fruiting body per day and 40 % polysaccharides

Auricularia auricula- judae

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Ganoderma applanatum

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 30 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 30 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Ganoderma lucidum

Source of antioxidants/fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Herbal Medicine Immune Support claim

Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

1.5-6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-6 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Decoction

3-15 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

3-15 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Other Herbal Medicine claims/TCM claims

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-6 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Decoction

3-15 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

3-15 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Grifola frondosa

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Extract (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Extract (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Herbal Medicine Immune Support claim

Dry, Powder, Non-Standardized Ethanolic Extract (Dry extract, Tincture, Fluid extract)

1.6-7 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extract (Dry extract, Tincture, Fluid extract)

1.6-7 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Decoction

3-7 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

3-7 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Hericium erinaceus

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

Not to exceed 2.8 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Extract (Dry extract, Tincture, Fluid extract)

Not to exceed 2.8 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 12 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 12 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Source of antioxidants

Decoction

Not to exceed 12 g of dried fruiting body per day

Decoction standardized

Not to exceed 12 g of dried fruiting body per day and 40 % polysaccharides

Inonotus obliquus

Source of fungal polysaccharides

Dry, Powder, Non- Standardized Extracts (Dry extract, Tincture, Fluid Extract, Decoction)

Not to exceed Up to 3.6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Extracts (Dry extract, Tincture, Fluid Extract, Decoction)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Lentinula edodes

Source of antioxidants/fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Herbal Medicine Immune Support claim

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.6-6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.6-6 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Decoction

6-16 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

6-16 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40 % polysaccharides

Ophiocordyceps sinensis

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3 g of dried stroma per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3 g of dried stroma per day and 40 % polysaccharides

Source of antioxidants/fungal polysaccharides

Decoction

Not to exceed 9 g of dried stroma per day

Decoction standardized

Not to exceed 9 g of dried stroma per day and 40 % polysaccharides

TCM claim

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-3 g of dried stroma per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-3 g of dried stroma per day and not to exceed 40 % polysaccharides

Decoction

3-9 g of dried stroma per day

Decoction standardized

3-9 g of dried stroma per day and not to exceed 40 % polysaccharides

Paecilomyces hepiali

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3 g of dried cultured mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3 g of dried cultured mycelium per day and 40 % polysaccharides

Source of antioxidants/fungal polysaccharides

Decoction

Not to exceed 9 g of dried cultured mycelium per day

Decoction standardized

Not to exceed 9 g of dried cultured mycelium per day and 40 % polysaccharides

TCM claim

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-3 g of dried cultured mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.5-3 g of dried cultured mycelium per day and not to exceed 40 % polysaccharides

Decoction

3-9 g of dried cultured mycelium per day

Decoction standardized

3-9 g of dried cultured mycelium per day and not to exceed 40 % polysaccharides

Schizophyllum commune

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Trametes versicolor

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 5 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 5 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 27 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 27 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

TCM claim

Decoction

9-27 g of dried fruiting body per day

Decoction standardized

9-27 g of dried fruiting body per day and not to exceed 40 % polysaccharides

Tremella fuciformis

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day

Decoction standardized

Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day and 40 % polysaccharides

TCM claim

Decoction

3-9 g of dried fruiting body per day

Decoction standardized

3-9 g of dried fruiting body per day and not to exceed 40 % polysaccharides

Wolfiporia extensa

Source of fungal polysaccharides

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/sclerotium/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 g of dried cultured mycelium/sclerotium/mycelium per day and 40 % polysaccharides

Decoction

Not to exceed 18 g of dried cultured mycelium/sclerotium/mycelium per day

Decoction standardized

Not to exceed 18 g of dried cultured mycelium/sclerotium/mycelium per day and 40 % polysaccharides

Herbal Medicine Immune Support claim

Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.6-3.6 g of dried cultured mycelium/sclerotium/mycelium per day

Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.6-3.6 g of dried cultured mycelium/sclerotium/mycelium per day and not to exceed 40 % polysaccharides

Herbal Medicine Immune Support claim/TCM claims

Decoction

9-18 g of dried cultured mycelium/sclerotium/mycelium per day

Decoction standardized

9-18 g of dried cultured mycelium/sclerotium/mycelium per day and not to exceed 40 % polysaccharides

References: Wachtel-Galor et al. 2011; Godfrey et al. 2010; PPRC 2010; Mori et al. 2009; Liu et al. 2008; Liu et al. 2005; Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003; derMarderosian and Beutler 2002; Upton 2000; Huang 1999; Levy et al. 1998; MHPRC 1998; Ying 1987.

Notes:

Direction(s) for use

Products containing Ganoderma lucidum

Take with food/meal to avoid digestive upset (Flynn and Roest 1995).

Duration(s) of Use

Products containing Wolfiporia extensa

Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Risk Information

Caution(s) and warning(s)

  1. Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.
  2. For claims related to reductions of symptoms: Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
  3. Products providing 150 mg or more of dried Grifola frondosa, per day, prepared as dry, powder, dry ethanolic extract, tincture or fluid extract and/or 300 mg or more of dried Grifola frondosa, per day, prepared as decoction, and/or 300 mg or more of dried Agaricus blazei per day: Consult a healthcare practitioner/health care provider/health care professional/doctor/physician prior to use if you have diabetes (Brinker 2010; Firenzuoli et al. 2008; Hsu et al. 2007; Konno 2003, 2001).
  4. Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood thinners (anti-coagulants) (Bisen et al. 2010; Wasser 2005).
  5. Products making TCM claims based on Ophiocordyceps sinensis or Paecilomyces hepiali: Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have exterior pathogens/conditions (Bensky et al. 2004).
  6. Products making TCM claims based on Tremella fuciformis: Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have cough from wind-cold (Bensky et al. 2004).
  7. Products making TCM claims based on Wolfiporia extensa: Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a yin deficiency, sunken Spleen qi, or cold from deficiency with spermatorrhea (Bensky et al. 2004; Chen and Chen 2004).
  8. Contraindication(s)

  9. Do not use this product if you are pregnant or breastfeeding.
  10. Known adverse reaction(s)

  11. Stop use if hypersensitivity/allergy occurs (derMarderosian and Beutler 2008; Bensky et al. 2004; Gao et al. 2003, 2002; Levy et al. 1998).
  12. Diuretic effect may occur (PPRC 2010).
Table 3. Risk information
Medicinal Ingredients 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 hepiali

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

References Cited

References Reviewed