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Product Review: Echinacea |
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How Products were Selected:
Products selected 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, catalogues, or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Methods:
Echinacea products were tested for their phenolic content (specifically caftaric acid, chlorogenic acid, echinacoside and cichoric acid), potential contamination with microbes, lead, and cadmium, and their ability to disintegrate ("break apart") properly.
All products were first analyzed in an independent laboratory for the phenolic constituents utilizing a HPLC (High Performance Liquid Chromatography) assay developed by the Institute for Nutraceutical Advancement's (INA) Method Validation Program (MVP) to specifically test for the presence and amount of caftaric acid, chlorogenic acid, echinacoside and cichoric acid. Products not passing this initial assay were tested in a second independent laboratory using the same HPLC method.
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 aerobic bacteria, yeast, and mold. Any product that did not pass the microbial testing was sent to another independent laboratory to repeat testing for any of the microbial criteria for which it did not pass.
Analyses for the heavy metals cadmium and lead were made using Inductively Coupled Plasma/Mass Spectroscopy (ICP/MS) or Atomic Absorption/Graphite Furnace.
Disintegration of non-chewable, non-capsule, non-enteric coated and non-time-release formulations was analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
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.
Passing Score: *
To achieve a "Pass" in the testing, a product had to:
- Provide all of the following information in its labeling (as required by the FDA):
- The species of echinacea (i.e., E. purpurea, E. angustifolia, or E. pallida);
- The part of the plant used, such as root or the aerial (above-ground) portions which include the stem, leaves, and flowers and is also generally referred to as the "herb;"
- The form of echinacea used (e.g., whole herb or root, extract, or tincture);
- The amount of echinacea per pill or dose in grams (g) or milligrams (mg) [1 gram = 1,000 milligrams]
- Meet its label claims for total phenolic content, with a minimum of 1.0% total phenols based on whole herb or root, or proportionally higher for extracts or tinctures depending on their level of concentration. Total phenols were calculated as the sum of caftaric acid, chlorogenic acid, echinacoside and cichoric acid;
- Products labeled as containing the roots of E. angustifolia and/or E. pallida were required to contain the specific marker compound echinacoside and low levels of cichoric acid; products labeled to contain roots or herb of E. purpurea were required to contain cichoric, caftaric, and chlorogenic acids but, if they were E. purpurea-only products, could not have more than trace levels of echinacoside.
- 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):
- 100,000 aerobic bacteria
- 1,000 yeast and mold
- 1,000 other coliform bacteria
- Not exceed California Prop 65 levels for lead contamination in a recommended daily serving and, in no event, exceed 2 mcg of lead in a recommended daily serving.
- 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.
- Meet recommended USP parameters for disintegration for vitamin supplements (excluding capsule, enteric coated, chewable and time-release products).
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
* 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.
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