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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.
Testing Method:
Echinacea products were tested for their potential contamination with arsenic, cadmium, lead, chlorinated pesticides, and microbes and for their ability to disintegrate (break apart) properly.
Analyses for the heavy metals arsenic, cadmium and lead were made using Inductively Coupled Plasma/Mass Spectroscopy (ICP/MS).
Analyses for microbial contaminants were made using methods from the FDA's Bacteriological Analytical Manual (BAM) and included testing for Escherichia coli, Salmonella spp. Staphylococcus aureus, Pseudomonas aeruginosa and other enteric bacteria including Klebsiella, Enterobacter, Proteus, Citrobacter, Aerobacter, Providencia, and Serratia. Testing also included analyses for total yeast and mold.
Analysis for chlorinated pesticides listed in Appendix A (General Pesticides) was performed using a modified FDA-PAM method with GPC clean up prior to analysis with High Resolution Gas Chromatography (HRGC) with an electron capture detector (ECD) and High Resolution Gas Chromatography (HRGC) with mass spectroscopy/mass spectroscopy (MS/MS) detection.
Disintegration of non-chewable, non-capsule, non-enteric coated and non-time-release formulations was analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations.
Any product that did not pass the testing was sent to another independent laboratory to repeat testing for at least one of the criteria on which it did not pass. The identities of the products were not disclosed to the laboratories performing the testing.
Quality Criteria: *
To meet ConsumerLab.com quality criteria, a product had to:
- Heavy Metal Contamination
- Lead – Meet the State of California's Prop 65 limits for lead in supplements: 0.5 mcg of lead per daily serving with an additional allowance of 1.0 mcg for supplements containing 1,000 mg/day or more of elemental calcium and 0.5 mcg for supplements containing specific other minerals. For supplements not marketed for use by children, ConsumerLab.com provides an additional allowance of 0.5 mcg if containing 250 to 499 mg/day of elemental calcium or 1.0 mcg if containing 500 to 999 mg/day of elemental calcium and an allowance of 0.5 mcg for if containing one whole herb (not extract) ingredient or 1.0 mcg for two or more whole herb ingredients. If a maximum recommended daily serving is not defined, a daily serving size will be determined and applied by CL.
- Cadmium – Contain less than 0.3 parts per million (or micrograms per gram) of cadmium for dried raw herb (World Health Organization, Quality Control Methods for Medicinal Plant Material, proposed guidelines, 1998) or less than 0.1 parts per million for extracts. The lower concentration standard for extracts reflects the ability to remove heavy metals such as cadmium during the extraction process.
- Arsenic – Contain less than 10 micrograms of arsenic per daily serving (State of California).
- 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
- Pesticide Contamination: Concentration of any detectable chlorinated pesticide residue(s) must be less than the individual limit(s) listed in Appendix A. (United States Pharmacopeia/European Pharmacopeia)
- Meet recommended USP parameters for disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
- Meet all FDA labeling requirements.
A "Pass" was based on passing each criterion in any one of the analyses.
* The analytical methods 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.
Appendix A: Pesticides
Substance Limit (mg/kg, ppm)
Alachlor 0.02
Aldrin and Dieldrin (sum of) 0.05
Azinphos-methyl 1.0
Bromopropylate 3.0
Chlordane (sum of "technical" cis- and trans- isomers
and oxychlordane) 0.05
Chlorfenvinphos 0.5
Chlorpyrifos 0.2
Chlorpyrifos-methyl 0.1
Cypermethrin (and isomers) 1.0
DDT (sum of p,p’-DDT, o,p’-DDT, p,p’-DDE and p,p’-TDE) 1.0
Deltamethrin 0.5
Diazinon 0.5
Dichlorvos 1.0
Dithiocarbamates (as CS2) 2.0
Endosulfan (sum of endosulfan isomers and endosulfan sulfate) 3.0
Endrin 0.05
Ethion 2.0
Fenithrothion 0.5
Fenvalerate 1.5
Fonofos 0.05
Heptachlor (sum of heptachlor and heptachlor epoxide) 0.05
Hexachlorobenzene 0.1
Hexachlorocyclohexane isomers (other than gamma) 0.3
Lindane (gamma-hexachlorocyclohexane) 0.6
Malathion 1.0
Methidathion 0.2
Parathion 0.5
Parathion-methyl 0.2
Permethrin 1.0
Phosalone 0.1
Piperonyl butoxide 3.0
Pirimiphos-methyl 4.0
Pyrethrins (sum of) 3.0
Quintozene (sum of quintozene, pentachloroanaline
and methylpentachlorophenyl sulfide) 1.0
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