How Products were Selected:
Products were selected to represent those commonly sold and/or available nationally in the U.S. and Canada. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers or direct sales companies. Products were not accepted directly from manufacturers.Testing Methods:
- Quantification of beta-glucans (Beta-D-(1,3)(1,6)-glucan and alpha-glucans (Alpha-D-(1,4)(1,6)-glucan (AOAC 995.16 modified, Megazyme mushroom and yeast beta-glucan assay K-YBGL).
- Quantitative analyses of all products for lead, cadmium, arsenic and mercury by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS).
- Disintegration of tablets (excluding chewable, sublingual and time-release formulations) utilizing the United States Pharmacopeial (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score:*
To be "Approved" by Consumerlab.com, a product must meet the following requirements:- Any type of lion's mane or chaga product claiming to include mushroom or fruiting body must contain a detectable amount of beta-glucan and a minimum of 100% of its labeled amount of beta-glucan. Products claiming to contain mycelium must contain a detectable amount of alpha-glucan to avoid the potential to mislead consumers. Products that contain a mixture of fruiting body and mycelium, in that order, must contain more beta-glucan than alpha-glucan, and those claiming mycelium and fruiting body, in that order, must contain more alpha-glucan than beta-glucan. The term "mushroom" in a product name must refer to use of fruiting body in the product ingredients.
- Heavy Metals. All products must not exceed the following limits:
Lead:- Products marketed for use by children may not exceed the State of California's Prop 65 limits for lead in dietary supplements of 0.5 mcg per recommended daily serving with an additional allowance of 0.8 mcg if the product contains more than 1,000 mg/day of calcium.
- Products with single serving weights of less than 5 grams that are not marketed for use by children, may not exceed 0.5 mcg of lead per recommended daily serving (based on the State of California's Prop 65 limit for lead in dietary supplements, above which a warning is required regarding reproductive harm, birth defects, and cancer risks) with an additional allowance of 0.4 mcg if containing 250-999 mg/day of any combination of elemental calcium, magnesium and potassium or 0.8 mcg if containing more than 1,000 mg/day of any combination of these minerals. An additional allowance of 0.5 mcg is provided if containing 250-999 mg/day of whole herb (not extract) or 1.0 mcg if containing 1,000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg.
- Products with single serving weights of 5 grams or more which are not marketed for children may not exceed 2.5 mcg per serving nor 4.0 mcg per daily serving.
- If marketed for use by children, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit for a child weighing 75 lbs.). If not marketed for use by children, may not exceed 4.1 micrograms of cadmium per recommended daily serving (above which California's Prop 65 law requires a "reproductive harm" warning due to developmental toxicity and male reproductive harm).
- Contain less than 10 micrograms of total arsenic (EPA limit and state of New Jersey limits - based on 1 liter of water) and no more than 2.1 micrograms of inorganic arsenic per daily serving (Canada's limit in natural health products).
- May not exceed 2 micrograms of mercury per daily serving (based on EPA limit for mercury in 1 liter of water).
- Meet recommended USP <2040> parameters for disintegration of dietary supplement tablets (excluding chewable, sublingual and time-release products).
- Meet all FDA labeling requirements.
* Passing scores allow for specific margins of technical error associated with each analysis. ConsumerLab.com reserves the right to disqualify a product at any time from passing it's testing if it considers such product to display unacceptable variation in quality, present a safety risk or provide misleading or inaccurate information in its labeling.
