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:
- Products containing black cohosh analyzed for triterpene glycoside content and the presence of cimifugin by High Performance Liquid Chromatography (HPLC) or other appropriate methods determined by CL.
- Products containing soy or red clover analyzed for their total isoflavone content using HPLC assay or other appropriate methods determined by CL.
- Analysis for arsenic, cadmium and lead using ICP/MS for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Progesterone cream products analyzed for their progesterone content using HPLC.
- Disintegration of non-chewable, non-capsule, non-enteric coated, and non-time release formulations was analyzed by ConsumerLab.com using USP (United States Pharmacopeia) <2040>.
Products failing to meet any Passing Score (below) were re-tested in a second independent laboratory using similar methods and instrumentation.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Passing Score:*
To achieve a "Pass" in testing, a product had to meet the following applicable criteria:
- Black cohosh products must meet 100%, and not more than 130%, of label claim for total triterpene glycosides (USP-36). If not claimed, or if amount found is outside the acceptable range, total triterpene glycoside content will be reported. Root/rhizome powders are expected to provide a minimum of 0.4% (% wt/wt) total triterpene glycosides (USP 36). The minimum was applied if the powdered root product did not state an amount of triterpene glycosides or if the claimed amount was lower than the expected minimum. A formulation out of compliance with this minimum requirement may "pass" if there is clinical evidence deemed significant by ConsumerLab.com supporting its efficacy in preventing or treating menopausal symptoms. Cimifugin must not be present at above100 ng (0.1 mcg) per gram), as its presence signifies adulteration with incorrect species of Actaea (American Botanical Council Botanical Adulteration Program (proposed)).
- Soy and red clover products must meet 100% and not more than 130% of label claim for total isoflavone content (USP-36) and, if declared, for specific glycosidic or aglycone isoflavones. Total isoflavones is calculated as the sum of the glycosidic and aglycone forms.
- Progesterone products must meet 100% of label claim for progesterone, and not more than 125% of the claim.
- Heavy Metals: Products containing whole herb and/or 250 mg of minerals per daily dose must not exceed the following limits:
Lead: Not exceed the following limits for elemental lead:- Products 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 0.8 mcg if the product contains more than 1,000 mg/day of calcium.
- Products with a single serving weights 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 any combination of elemental calcium, magnesium and potassium or 0.8 mcg if containing more than 1,000 mg/day of any combination of these minerals. An additional allowance of 0.5 mcg is provided if containing 250-999 mg/day of whole herb (not extract) or 1.0 mcg if containing 1000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg.
- 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.
Arsenic: Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic arsenic per daily serving (EPA limit - 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.
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.
** If available for sale in California, a product that exceeds the State of California's Prop 65 lead limit requires a warning label. However, with or without this warning label, a product cannot pass ConsumerLab.com testing if it exceeds the levels described in this paragraph.
