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Product Review: Valerian Supplements |
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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. For each product, the sample was composed of one or more purchased samples from a lot having an expiration date (if labeled) later than the date of testing.
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) 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."
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 all FDA requirements, including listing the following information in its labeling:
- Proper plant name (Valerian; Valeriana officinalis L.);
- Part of the plant used (root/rhizome);
- Form of valerian used (e.g., root powder, extract, or tincture);
- Amount of valerian per pill or dose in grams (g) or milligrams (mg) [1 gram = 1,000 milligrams]
- 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).
- Not exceed California's 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 herb or extract. This is based on the World Health Organization, Quality Control Methods for Medicinal Plant Material, proposed guidelines, 1998). Although this guideline was developed for dried herb, the same standard is applied here to extracts because heavy metals should be removed 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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