How Products were Selected:
Products tested represent those commonly sold and/or available nationally 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 Methods:
Valerian products were tested in one or more independent laboratories for the following:
- Total valerenic acid content (including valerenic acid, acetoxyvalerenic acid and hydroxyvalerenic acid) by High Performance Liquid Chromatography (HPLC).
- Quantitative analyses for lead, arsenic and cadmium levels by Inductively Coupled Plasma-Mass Spectroscopy. (ICP-MS) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Non-chewable, non-capsule and non-time-release formulations were analyzed for disintegration utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing testing was sent to another independent laboratory to repeat testing for the criterion on which it did not pass.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Identities of products were not disclosed to laboratories performing the testing.
Passing Score:*
To achieve a "Pass" in testing, a product had to meet the following criteria:
- Contain 100% and no more than 200% of claimed total valerenic acids, with total valerenic acids calculated as the sum of valerenic acid, acetoxyvalerenic acid and hydroxyvalerenic acid. Products having no label claim for total valerenic acid content must contain a minimum of 0.1% total valerenic acids form dried root powder (CL minimum), 0.4% for powdered extracts (USP-40) and 0.015% for Tinctures (USP-40). (Note hydroxyvalerenic acid may be a degradation product rather than an inherent marker compound.)
- Heavy Metals: Products containing whole herbs and/or more than 250 mg of mineral per daily dose must not exceed the following limits:
Lead**:- Products marketed for use by children may not exceed the State of California's Prop 65 limits for lead in dietary supplements: 0.5 mcg of lead per daily serving with an additional allowance of 0.8 mcg for supplements containing more than 1,000 mg/day of calcium.
- Products with a single serving weight of less than 5 grams which are not marketed for use by children, may not exceed the State of California's Prop 65 limits for lead in dietary supplements of 0.5 mcg per recommended daily serving with an additional allowance of 0.4 mcg if containing 250-999 mg/day of elemental calcium, magnesium and potassium, 0.8 mcg if containing 1,000 mg/day or more of any combination of these minerals. An additional 0.5 mcg is provided if containing 250-999 mg/day of whole herb (not extract) ingredient or 1.0 mcg for products containing 1000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg per daily serving.
- Products with single serving weights of 5 grams or more which are not marketed for children may not exceed 2.5 mcg per serving nor 4.0 mcg per daily serving.
- If marketed for use by children, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit for a child weighing 75 lbs.). If not marketed for use by children, may not exceed 4.1 micrograms of cadmium per recommended daily serving (based on the state of California's Prop 65 limit).
- Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic arsenic per daily serving (EPA and state of New Jersey limits - based on 1 liter of water).
- If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
- Be in compliance with FDA labeling requirements
** Based on State of California's Prop 65 limits. California requires supplements exceeding this limit to bear a warning label.
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.
