HOW PRODUCTS WERE EVALUATED:
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, and direct sales or multi-level marketing companies. Products were not accepted directly from manufacturers.
Ginseng products were tested in one or more independent laboratories for the following:
- Total ginsenosides by High Performance Liquid Chromatography (HPLC) based on the Ginseng Evaluation Program (GEP) methods established by the American Botanical Council (ABC). This analysis specifically tests for the presence and amount of the eight major ginsenosides including Rg3 in red Panax ginseng. Based on the scientific literature, the weight of these eight ginsenosides is assumed to represent approximately 90% of the total ginsenosides in a product and is, therefore, used to calculate the total ginsenoside content in products with an additional 10% added to the value to reflect the total amount of ginsenosides.
- Analyses for lead, cadmium and arsenic were performed using ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy).
- Analysis for the pesticides quintozene (pentachloronitrobenzene), lindane (hexachlorocyclohexane), hexachlorobenzene and related compounds (pentachloroaniline, pentachlorothioanisol, alpha-benzenehexachloride, beta-benzenehexachloride, delta-benzenehexachloride, and tetrachloroanaline) was performed using by High Resolution Gas Chromatography (HRGC) with an electron capture detector (ECD) and mass spectrometer (MS) detectors described in the U.S. FDA Pesticide Analytical Manual (PAM) and a modification of the PAM method (presented at the Sept. 1999 AOAC, Houston, TX entitled "Trace Contaminants in Dietary Supplements: Pesticide Analysis in Ginseng").
- Non-chewable, non-capsule, non-enteric coated and non-time-release formulations were analyzed for disintegration utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing any initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies.
Identities of products were not disclosed to laboratories performing the testing.
To achieve a "Pass" in the testing, a product had to:
- Meet its label claims for ginsenoside content and, at a minimum, contain the following total ginsenosides, respective of the type of ginseng labeled: 1.5% for Asian root powder (German Commission E recommendation), 3.0% for Asian root extract (USP recommendations), 2.0% for American root powder, and 4.0% for American root extract (common industry standard).
- Not exceed the following limits for elemental 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 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 or 4.0 mcg per daily serving.
- 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).
- Contain less than 0.3 micrograms of cadmium per gram (World Health Organization/ADI proposed in dried plant materials).
- Contain less than 0.1 part per million of hexachlorobenzene, 1 part per million of quintozene (total of pentachloronitrobenzene (PCNB), pentachloroaniline and pentachlorothioanisol), and less than 0.6 part per million of lindane (United States Pharmacopeia/European Pharmacopeia).
- If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
- Be in compliance with 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.