HOW PRODUCTS WERE EVALUATED:
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, and direct sales or multi-level marketing companies. Products were not accepted directly from manufacturers.
- Quantitative analysis of saw palmetto fatty acids by Gas Chromatography (GC) using AOCS (American Oil Chemists Society) or comparable analytical methodology.
- Quantitative analysis of phytosterols by GC using AOCS or comparable analytical methodology.
- Analyses for lead, arsenic, and cadmium were performed using an ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Disintegration of non-chewable, non-capsule, non-enteric coated and non-time release formulations was analyzed by ConsumerLab.com utilizing USP (United States Pharmacopeia) <2040> methodology.
Products failing to meet any Passing Score 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.
To achieve a "Pass" in the testing, a product had to:
* Passing scores allow for specific margins of technical error associated with each analysis.
- Products containing phytosterols must contain at least 100% and not more than 150%, of the claimed amounts of beta-sitosterol and/or individual claimed sterols.
- Products containing saw palmetto berry powder or extract must contain at least 100%, and not more than 150% of the minimum expected or claimed amounts of total or individual fatty acids and total or individual sterols. For products containing berry powder the minimum total fatty acid content will be 9% (wt./wt.) (USP 36). For products containing liquid extract the minimum total fatty acid content will be 80% (wt./wt.) and 0.2% for sterols (wt./wt.) (DSC 2015). For products containing powdered extract the minimum total fatty acid content will be 25% (wt./wt.) (industry standard) based on the sum of the following fatty acids; Capric acid, caproic acid, caprylic acid, lauric acid, linoleic acid, linolenic acid, myristic acid, oleic acid, palmitic acid, palmitoleic acid and stearic acid. Total phytosterols content is based on the sum of campesterol, stigmasterol, stigmastanol and beta-sitosterol.
- Heavy Metals: Products containing whole herbs and/or more than 250 mg of minerals per daily dose must not exceed the following limits:
Cadmium: 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).
- 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).
- Meet recommended USP parameters for disintegration for vitamin-mineral supplements
(excluding capsule, enteric coated, chewable and time-release products).
- Meet FDA labeling requirements.
** 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.
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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