How Products were Selected:
Products tested 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 companies. Products were not accepted directly from manufacturers.Testing Methods:
- Quantification of caftaric acid, chicoric acid, chlorogenic Acid, dicaffeoylquinic acid and echinacoside by High Performance Liquid Chromatography (HPLC).
- Analyses for lead, arsenic, and cadmium by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) 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 tablets (excluding chewable, sublingual and time-release formulations) using United States Pharmacopeia (USP) <2040> methodology.
The identities of the products were not disclosed to the laboratories performing the testing.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Passing Score:*
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, chicoric acid, chlorogenic Acid, dicaffeoylquinic acid and echinacoside (USP-36, USP-40). Powdered root/rhizome of E. angustifolia, pallida and purpurea are expected to contain a minimum of 0.5% TPCs (wt./wt.) (USP-36, USP-40, Expanded Commission E monographs). Powdered aerial E. purpurea is expected to contain a minimum of 1% TPCs (USP-36, USP-40, Expanded Commission E monographs) and 0.25% for fresh aerial parts and roots of E. purpurea (Zagumennikov, Pharm Chem 2013; Kabganian, Dry Technol 2002), respectively. 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, USP-40) 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:
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 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 75lbs). If not marketed for use by children, may not exceed 4.1 micrograms of cadmium per recommended daily serving (based on the State of California's Prop 65 limit).
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 and, Salmonella spp., In addition not more than 1000 cfu yeast and mold per gram (as specified by USP-40 <2023>).
- Meets recommended USP <2040> parameters for disintegration for dietary supplement tablets (excluding chewable, sublingual and time-release products).
- Meet all FDA labeling requirements.
** The State of California's Prop 65 limit. California requires supplements exceeding this limit to bear a warning label.
