How Products were Selected:
Products were selected to represent those commonly sold and/or available nationally in the U.S. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, and direct sales or multi-level marketing companies. Products were not accepted directly from manufacturers.
- Analysis of Nattokinase activity fibrinolytic units (FU). Enzyme activity is measured using an industry standard method from Japan Biosciences Labs (JBSL) or J. Agric Food Chem 2000, 48, 3210-3216.
- Analyses for lead, arsenic, and cadmium performed using an ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Disintegration of non-chewable, non-capsulated, non-time-release formulations was analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations.
Any product that did not pass the testing was sent to a second independent laboratory for repeat analysis using similar methodologies.
The identities of the products were not disclosed to the laboratories performing the testing.
To pass, a product must:
- Contain at least 100% and no more than 135% of the claimed activity for Nattokinase unless product contains protease, then no upper limit.
Heavy Metal Contamination:
Products containing whole herbs and/or more than 250 mg of minerals per daily dose must not exceed the following limits:
- 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 a single serving weights of less than 5 grams which are not 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 0.4 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 1000 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.
Arsenic: Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic arsenic per daily serving (EPA limit - based on 1 liter of water).
- If applicable to the product, it must meet recommended USP <2040> parameters for disintegration for dietary supplements (excluding capsule, chewable 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 its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
** If available for sale in California, a product that exceeds the State of California's Prop 65 lead limit requires a warning label. However, with or without this warning label, a product cannot pass ConsumerLab.com testing if it exceeds the levels described in this paragraph.