HOW PRODUCTS WERE EVALUATED:
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.
- Quantification of caftaric acid, cichoric acid, chlorogenic Acid, dicaffeoylquinic acid and echinacoside by High Performance Liquid Chromatography (HPLC).
- 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.
- Analyses for microbial contaminants in products containing whole herb or root powder were made using methods from the FDA's Bacteriological Analytical Manual (BAM) or other appropriate methods determined by CL.
- 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:
- Meet 100% and not more than 150% of the claimed or minimum expected amount of individual marker compounds and/or total phenolic compounds (TPCs) stated. TPCs consist of the sum of the individual percentages of the following compounds; caftaric acid, cichoric acid, chlorogenic Acid, dicaffeoylquinic acid and echinacoside (USP 36). Powdered root/rhizome of E. angustifolia, pallida and purpurea are expected to contain a minimum of 0.5% TPCs (wt./wt.) (USP 36,Expanded Commission E monographs. Powdered aerial E. purpurea is expected to contain a minimum of 1% TPCs (USP 36, Expanded Commission E monographs). E. angustifolia extract (root) is expected to contain a minimum of 4% TPCs. E. purpurea extract (aerial or root) is expected to contain a minimum of 4% TPCs (USP 36) unless otherwise publicly known to contain a lower percentage. The minimums will be applied if the product does not state amounts of phenolic compounds in an Echinacea based ingredient or if the claimed amount is lower than the expected minimum.
- 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).
- Microbial Contamination: Test negative for Escherichia coli, Salmonella spp., Staphylococcus aureus and Pseudomonas aeruginosa (as required by the FDA). In addition, contain less than the following levels of microbes per gram (as specified by the World Health Organization, Quality Control Methods for Medicinal Plant Material, 1998):
a. 100,000 aerobic bacteria
b. 1,000 yeast and mold
c. 1,000 other coliform bacteria
- 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.