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, catalogues, or direct distributors. Products were not accepted directly from manufacturers.
Testing Methods: St. John's wort products were tested for their amount of total hypericin, total hyperforin (if claimed) and potential contamination with lead and cadmium and their ability to disintegrate ("break apart") properly. All products were analyzed for total hypericin using both the Deutscher Arzneimittel-Codex method (DAC '86 Rev. '91) and a separate high performance liquid chromatography (HPLC) method for hyperforin (Institute for Nutraceutical Advancement (INA)).
Analyses for lead and cadmium were made using Inductively Coupled Plasma/Mass Spectroscopy (ICP/MS).
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.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Passing Score: * To achieve a "Pass" in the testing, a product had to:
Meet its label claims for total hypericin and total hyperforin, with a minimum of 0.3% total hypericins for extracts and 0.1% total hypericins for herb (common industry standard).
Not exceed the State of California's Prop 65 limits for lead in supplements in a recommended daily serving: 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.
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 dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
Product must meet all FDA labeling requirements.
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.
