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Product Review:Valerian Supplements
HOW PRODUCTS WERE EVALUATED:
How Products were Selected: Products were selected to represent those commonly available in the U.S. and Canada. 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: Valerian products were tested for their total valerenic acid content (specifically acetoxyvalerenic acid, hydroxyvalerenic acid, and valerenic acid) and valernal. All products were first analyzed in an independent laboratory for the valerenic acid constituents using an HPLC (High Performance Liquid Chromatography) assay. This HPLC method was developed by the Institute for Nutraceutical Advancement's (INA) Method Validation Program (MVP) to specifically test for the presence for these substances. Products not passing this initial assay were tested in a second independent laboratory utilizing a similar HPLC assay.
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.
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:
Meet its label claim for total valerenic acid content, with a minimum of 0.17% total valerenic acids for root powder (dried herb) preparations. Extracts or tinctures of 3:1 to 6:1 ratios were expected to have minimum total valerenic acids of 0.4% - 0.8%, respectively — with 0.4% the minimum if a concentration was not stated on the label. Total valerenic acids were calculated as the sum of acetoxyvalerenic acid, hydroxyvalerenic acid and valerenic acid. (Note hydroxyvalerenic acid may be a degradation product rather than an inherent marker compound).
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.
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).
Meet all FDA 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.
