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

Due to poor alcohol solubility of immunomodulatory polysaccharides, ethanolic preparations of the medicinal ingredients are not permitted for the claims “Source of fungal polysaccharides with immunomodulating properties” and “Used in Herbal Medicine to support the immune system” (Huang et al. 2022).
Liquid and dry extracts prepared using only water as an extraction solvent (including decoctions and infusions) contain water soluble immunomodulatory polysaccharides and support the claim “Source of fungal properties with immunomodulatory properties”. Polysaccharides may be purified from these extract using ethanol to cause polysaccharide precipitation, after which the polysaccharides are separated from the water an ethanol mixture (Huang et al. 2022). The polysaccharide precipitate should be represented as an “extract dry” with the extraction solvent specified as “water” on the PLA form.
Products making any Traditional Chinese Medicine (TCM) claim must contain the TCM ingredient(s) prepared according to the current version of the Chinese pharmacopoeia or a comparable reference text.
Text in parentheses is additional optional information which can be included on the 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 on the label.
This monograph may be used to support single ingredient or multi-ingredient products containing any medicinal ingredient from Table 1.

Date

October 25, 2024

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s)	Common name(s)	Source information
Proper name(s)	Common name(s)	Source material(s)	Part(s)	Preparation(s)
Agaricus blazei	Himematsutake	Agaricus blazei	Cultured mycelium Fruiting body Mycelium	Dry
Auricularia auricula- judae	Jelly ear	Auricularia auricula- judae	Cultured mycelium Fruiting body Mycelium	Dry
Cordyceps militaris	Chinese caterpillar fungus Cordyceps Cordyceps fungus Cordyceps militaris Trooping cordyceps	Cordyceps militaris	Cultured fruiting body Cultured mycelium Stroma	Dry
Ganoderma applanatum	Artist's conk	Ganoderma applanatum	Cultured mycelium Fruiting body Mycelium	Dry
Ganoderma lucidum	Ganoderma Ling zhi Reishi	Ganoderma lucidum	Cultured mycelium Fruiting body Mycelium	Dry
Grifola frondosa	Maitake	Grifola frondosa	Cultured mycelium Fruiting body Mycelium	Dry
Hericium erinaceus	Lion's Mane	Hericium erinaceus	Cultured mycelium Fruiting body Mycelium	Dry
Inonotus obliquus	Chaga	Inonotus obliquus	Cultured mycelium Fruiting body Mycelium	Dry
Lentinula edodes	Shiitake	Lentinula edodes	Cultured mycelium Fruiting body Mycelium	Dry
Ophiocordyceps sinensis	Chinese caterpillar fungus Cordyceps Cordyceps sinensis Dong chong xia cao	Ophiocordyceps sinensis	Stroma	Dry
Paecilomyces hepiali	Cordyceps Cultured Chinese caterpillar fungus Fa jiao chong cao jun	Paecilomyces hepiali	Cultured mycelium	Dry
Schizophyllum commune	Split Gill fungus	Schizophyllum commune	Cultured mycelium Fruiting body Mycelium	Dry
Trametes versicolor	Kawaratake Turkey Tail Yunzhi	Trametes versicolor	Cultured mycelium Fruiting body Mycelium	Dry
Tremella fuciformis	Silver ear White mushroom	Tremella fuciformis	Cultured mycelium Fruiting body Mycelium	Dry
Wolfiporia extensa	Fu ling Hoelen Indian bread Poria Sclerotium of tuckahoe	Wolfiporia extensa	Cultured mycelium Mycelium Sclerotium	Dry

References: CABI 2023; USDA 2023; PPRC 2020; Schoch 2020; De Sà-Nakanishi et al. 2014; Gardner and McGuffin 2013; Zhao 2013; Dai et al. 2012; Youn et al. 2009; Nakajima et al. 2007; Bensky et al. 2004; Chang and Miles 2004; Hobbs 2003; Chu et al. 2002; Wasser 2002; Bisby et al. 2000; TGA 1999; Lonvah and Deosthale 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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Appropriate methods of preparations and mushroom parts associated with each claims are specified in Table 2.

All mushrooms

Source of antioxidants/Provides antioxidants
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

References: Ern et al. 2024; Qiu et al. 2024; Razak et al. 2024; Rijia et al. 2024; Al-Azad and Ping 2022; Dai et al. 2022; Ji et al. 2022; Kolniak-Ostek et al. 2022; Tachabenjarong et al. 2022; Nie et al. 2020; Hou et al. 2021; Ma et al. 2021; Mapoung et al. 2021; Gebreyohannes et al. 2019; He et al. 2019; Panthong et al. 2016; Xu et al. 2016; Friedman 2015; De Sà-Nakanishi et al. 2014; Dong et al. 2014; Li et al. 2014; Zheng et al. 2014; Han et al. 2013; Qi et al. 2013; Kozarski et al. 2012; Da Silva and Jorge 2011; Wachtel-Galor et al. 2011; Wang et al. 2011; Yeh et al. 2011; Bisen et al. 2010; Godfrey et al. 2010; Xu et al. 2010; Tsai et al. 2007; Wicks et al. 2007; Cui et al. 2005.

All mushrooms (except ethanolic extracts*)

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; Bin and Yang 1991).

*Note: Extracts made with any quantity of ethanol.

Products containing Cordyceps militaris

Used in Traditional Chinese Medicine (TCM) to help tonify and replenish the lungs and kidneys, and resolve phlegm (Zhonghua Ben Cao 1999).

Products containing Ganoderma lucidum

Fruiting Body

Used in Traditional Chinese Medicine (TCM) to dispel phlegm, stop cough and arrest wheezing (PPRC 2020; Bensky et al. 2004; Chen and Chen 2004).
Used in Traditional Chinese Medicine (TCM) to nourish the Heart and strengthen qi and blood to treat Heart and Spleen deficiencies that manifest in insomnia, forgetfulness, fatigue, listlessness and poor appetite (PPRC 2020; Bensky et al. 2004; Chen and Chen 2004).
Used in Traditional Chinese Medicine (TCM) to strengthen the body and tonify qi (PPRC 2020; Bensky et al. 2004; Chen and Chen 2004).

Fruiting Body; Cultured Mycelium; Mycelium

Used in Herbal Medicine as a liver tonic (Godfrey et al. 2010; Yarnell et al. 2003; Saunders 2000; Huang 1999; Peirce 1999; Belanger 1997; Hsu et al. 1986).
Used in Herbal Medicine to support the immune system (Wachtel-Galor et al. 2011; Godfrey et al. 2010; Ko and Leung 2007; Lin 2005; Chen and Chen 2004; Wachtel-Galor et al. 2004; Hoffmann 2003; Yarnell et al. 2003; Wasser 2002; Peirce 1999; Belanger 1997; Hsu et al. 1986).
Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (in case of mental and physical fatigue related to stress) (Godfrey et al. 2010; Hobbs 2003; Hoffmann 2003; Leung and Foster 2003).

Products containing Grifola frondosa

Used in Herbal Medicine to support the immune system (Godfrey et al. 2010; derMarderosian and Beutler 2008; Hobbs 2003; Hoffmann 2003).

Products containing Lentinula edodes

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

Products containing Ophiocordyceps sinensis

Used in Traditional Chinese Medicine (TCM) to help tonify and replenish the lungs and kidneys, and resolve phlegm (PPRC 2020; Liu et al. 2005; Bensky et al. 2004).

Products containing Paecilomyces hepiali

Used in Traditional Chinese Medicine (TCM) to help tonify and replenish the lungs and kidneys, tonify essence, and replenish qi (PPRC 2020).

Products containing Trametes versicolor

Used in Traditional Chinese Medicine (TCM) to fortify the spleen to drain dampness and clear toxic heat (PPRC 2020).

Products containing 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 Wolfiporia extensa

Used in Herbal Medicine to support the immune system (Rios 2011; Hobbs 2003; Hoffmann 2003).
Used in Traditional Chinese Medicine (TCM) for small quantity of urination, dizziness caused by phlegm-fluid retention, spleen deficiency, reduced food intake, sloppy stool, diarrhea, disquietude of heart spirit, and insomnia (PPRC 2020).
Used in Traditional Chinese Medicine (TCM) to promote urination and leach out dampness (for urinary difficulty and cases of scanty urine due to damp-heat) (Bensky et al. 2004).
Used in Traditional Chinese Medicine (TCM) to promote urination to drain dampness, fortify the spleen, and calm the heart (PPRC 2020).
Used in Traditional Chinese Medicine (TCM) to strengthen the spleen and harmonize the middle burner: for spleen deficiency compounded by dampness with symptoms such as loss of appetite, diarrhea, and epigastric distention (Bensky et al. 2004).
Used in Traditional Chinese Medicine (TCM) to strengthen the spleen and transform phlegm: for spleen deficiency with thin mucous in which phlegm moves upward with symptoms such as headache, dizziness, and thick, greasy tongue coating (Bensky et al. 2004).

Notes

The above claims can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g. Used in Traditional Chinese medicine (TCM) to strengthen the spleen and harmonize the middle burner: for spleen deficiency compounded by dampness with symptoms such as loss of appetite, diarrhoea, and epigastric distention and to help tonify and replenish the lungs and kidneys, tonify essence, and replenish qi).
For multi-ingredient products:
- To prevent the product from being represented as a "traditional medicine", any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Reishi is used in Traditional Chinese Medicine (TCM) to strengthen the body and tonify qi).
- When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

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 Preparation¹	Dose(s (grams))/day
Agaricus blazei	Source of fungal polysaccharides/Source of antioxidants	Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day
Agaricus blazei	Source of fungal polysaccharides/Source of antioxidants	Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
Auricularia auricula- judae	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
Cordyceps militaris	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3 g of dried cultured fruiting body/cultured mycelium/ stroma per day
		Dry standardized, Powdered* standardized	Not to exceed 3 g of dried cultured fruiting body/cultured mycelium/ stroma per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured fruiting body/cultured mycelium/ stroma per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured fruiting body/cultured mycelium/ stroma per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3 g of dried cultured fruiting body/cultured mycelium/ stroma per day
	TCM claim	Dry, Powdered*, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	1.5-3 g of dried cultured fruiting body/cultured mycelium/ stroma per day
	TCM claim	Decoction	3-9 g of dried cultured fruiting body/cultured mycelium/ stroma per day
Ganoderma applanatum	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 30 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 30 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
Ganoderma lucidum	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 15 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day
	Herbal Medicine Immune Support claim	Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	3-15 g of dried cultured mycelium/fruiting body/mycelium per day
	Herbal Medicine Immune Support claim	Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	3-15 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
	Herbal Medicine Adaptogen or liver tonic claims	Dry, Powdered*, Non- Standardized Ethanolic Extract (Dry extract, Tincture, Fluid extract)	1.5-6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	1.5-6 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	3-15 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	3-15 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
	TCM claims	Dry, Powdered*, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	1.5-6 g of dried fruiting body per day
	TCM claims	Decoction	3-15 g of dried fruiting body per day
Grifola frondosa	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 7 g of dried cultured mycelium/fruiting body/mycelium per day
	Herbal Medicine Immune Support claim	Dry, Powdered*	1.6-7 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	1.6-7 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	3-7 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	3-7 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
Hericium erinaceus	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 2.8 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 2.8 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 12 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 12 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 2.8 g of dried cultured mycelium/fruiting body/mycelium per day
Inonotus obliquus	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
Lentinula edodes	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 6 g of dried cultured mycelium/fruiting body/mycelium per day
	Herbal Medicine Immune Support claim	Dry, Powdered*	1.6-6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	1.6-6 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	6-16 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	6-16 g of dried cultured mycelium/fruiting body/mycelium per day and not to exceed 40% polysaccharides
Ophiocordyceps sinensis	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3 g of dried stroma per day
		Dry standardized, Powdered* standardized	Not to exceed 3 g of dried stroma per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried stroma per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried stroma per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3 g of dried stroma per day
	TCM claim	Dry, Powdered*, Non- Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)	1.5-3 g of dried stroma per day
	TCM claim	Decoction	3-9 g of dried stroma per day
Paecilomyces hepiali	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3 g of dried cultured mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 3 g of dried cultured mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3 g of dried cultured mycelium per day
	TCM claim	Dry, Powdered*, Non- Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)	1.5-3 g of dried cultured mycelium per day
	TCM claim	Decoction	3-9 g of dried cultured mycelium per day
Schizophyllum commune	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 16 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
Trametes versicolor	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 5 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 5 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 27 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 27 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 5 g of dried cultured mycelium/fruiting body/mycelium per day
	TCM claim	Decoction	9-27 g of dried fruiting body per day
Tremella fuciformis	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
		Dry standardized, Powdered* standardized	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 9 g of dried cultured mycelium/fruiting body/mycelium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3.6 g of dried cultured mycelium/fruiting body/mycelium per day
	TCM claim	Decoction	3-9 g of dried fruiting body per day
Wolfiporia extensa	Source of fungal polysaccharides/Source of antioxidants	Dry, Powdered*	Not to exceed 3.6 g of dried cultured mycelium/mycelium/ sclerotium per day
		Dry standardized, Powdered* standardized	Not to exceed 3.6 g of dried cultured mycelium/mycelium/ sclerotium per day and 40% polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 18 g of dried cultured mycelium/mycelium/ sclerotium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	Not to exceed 18 g of dried cultured mycelium/mycelium/ sclerotium per day and 40% polysaccharides
	Source of antioxidants	Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)	Not to exceed 3.6 g of dried cultured mycelium/mycelium/ sclerotium per day
	Herbal Medicine Immune Support claim	Dry, Powdered*	1.6-3.6 g of dried cultured mycelium/mycelium/sclerotium per day
		Dry standardized, Powdered* standardized	1.6-3.6 g of dried cultured mycelium/mycelium/sclerotium per day and not to exceed 40% Polysaccharides
		Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	9-18 g of dried cultured mycelium/mycelium/sclerotium per day
		Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)	9-18 g of dried cultured mycelium/mycelium/sclerotium per day and not to exceed 40% polysaccharides
	TCM claims	Decoction	9-18 g of dried cultured mycelium/mycelium/sclerotium per day

References: PPRC 2020; Wachtel-Galor et al. 2011; Godfrey et al. 2010; Mori et al. 2009; derMarderosian and Beutler 2008; Liu et al. 2008; Liu et al. 2005; Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003; Upton 2000; Huang 1999; Levy et al. 1998; Ying 1987.

¹When the method of preparation 'decoction' or 'infusion' is listed as part of the acceptable methods of preparation in Table 2, the method of preparation 'decoction concentrate' or 'infusion concentrate' is also applicable. This would also apply to standardized extracts.

Notes

For standardized extracts, as evidence mainly supports the quantity crude equivalent, both the quantity crude equivalent and the maximum concentration of the potency constituent must be met.
*The method of preparation 'powdered' is defined as a dried and ground preparation (= unextracted). No fungal fragments remain identifiable by visual inspection.
The maximal quantity of total polysaccharides provided by the product should not exceed 180 g per day and 45 g per single dose.

Direction(s) for use

Products containing Ganoderma lucidum

Take with food (Flynn and Roest 1995).

Duration(s) of Use

Products containing Wolfiporia extensa

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

Risk Information

Caution(s) and warning(s)

Products making TCM claims

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have serious or major conditions, any type of acute infection, deficiency or excess.

Consult Table 3 to determine the required risk statements for each medicinal ingredient.

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding.
Products providing 150 mg or more of dry or unextracted powdered Grifola frondosa, per day and/or 300 mg or more of dried Grifola frondosa, per day, prepared as an aqueous extract, and/or 300 mg or more of dried Agaricus blazei per day, prepared as an aqueous extract
Ask a healthcare practitioner/health care provider/health care professional/doctor/physician before use if you have diabetes (Brinker 2010; Firenzuoli et al. 2008; Hsu et al. 2007; Konno 2003, 2001).
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking blood thinners (Bisen et al. 2010; Wasser 2005).

Contraindication(s)

Do not use if you are pregnant or breastfeeding.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (derMarderosian and Beutler 2008; Bensky et al. 2004; Gao et al. 2003, 2002; Levy et al. 1998).
When using this product you may experience diuretic effects (PPRC 2020).

Table 3. Risk information
Medicinal Ingredients	Risk Information
Agaricus blazei	1,2
Auricularia auricula-judae	4
Cordyceps militaris	1
Ganoderma applanatum	1
Ganoderma lucidum	5
Grifola frondosa	2
Hericium erinaceus	1
Inonotus obliquus	1
Lentinula edodes	3,5
Ophiocordyceps sinensis	1
Paecilomyces hepiali	1
Schizophyllum commune	1
Trametes versicolor	1
Tremella fuciformis	1
Wolfiporia extensa	5,6

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

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.
The product must not contain any traces of agaritine.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

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