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HOW PRODUCTS WERE EVALUATED:
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:
Saw palmetto products were tested for their total fatty acid and sterol content, while beta-sitosterol products were tested for their sterol content. All products were tested for lead. The products were analyzed for their respective constituents using a Gas Chromatography (GC) assay in an independent laboratory. Products not passing this initial assay were tested in a second independent laboratory utilizing a similar GC assay.
Disintegration of non-chewable and non-time release formulations was analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Analyses for lead were performed using an atomic absorption/graphite furnace method or ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy).
All testing was conducted in independent laboratories which the identities of the products were not disclosed.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Passing Score:*
To pass testing, a product must meet the following criteria:
Saw Palmetto
Must contain a minimum of 100%, and not more than 150%, of the expected amounts of total or individual fatty acids and total or individual sterols from the berry extract based on the claimed amount of Saw Palmetto berry extract and the ratios defined below.1
| Total Fatty Acids: 85 - 95%1 (%wt/wt.)(Sum of fatty acids below) |
| Individual Fatty Acids:2 |
Formula |
Percentage |
| Caproic Acid |
C6H12O2 |
1.0-3.0 |
| Caprylic Acid |
C8H16O2 |
1.0-3.0 |
| Capric Acid |
C10H20O2 |
1.0-3.0 |
| Lauric Acid |
C12H24O2 |
25.0-32.0 |
| Myristic Acid |
C14H28O2 |
10.0-15.0 |
| Palmitic Acid |
C16H32O2 |
7.0-11.0 |
| Stearic Acid |
C18H36O2 |
1.0-2.0 |
| Oleic Acid |
C18H34O2 |
26.0-35.0 |
| cis-Linoleic Acid |
C18H32O2 |
3.0-5.0 |
| Linolenic Acid |
C18H30O2 |
0.5-1.5 |
|
| Total Sterols: 0.15% (%wt/wt)(sum of campesterol, stigmasterol and beta-sitosterol)1 |
| Individual Sterols:2 |
| Campesterol |
C28H48O |
0.01-0.1 |
| Stigmasterol |
C29H48O |
0.01-0.1 |
| Beta-sitosterol |
C29H50O |
0.1-0.4 |
1 For products containing berry powder only and no extract, the total and individual constituents were calculated as 10% (w/w) of the extract values. For products containing 45% dried extract, the total and individual constituents were calculated on a proportional basis of the 85% extract values.
2 Based on industry specification standards. |
Beta-sitosterol:
Must contain a minimum of 100%, and not more than 150%, of the claimed amounts of beta-sitosterol and individual claimed sterols.
All Products:
- 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.
- Meet recommended USP parameters for disintegration for nutritional supplements (excluding capsule, enteric coated, chewable and time-release products).
- The level of any ingredient in the Product must not pose a significant health risk when used as recommended on an acute or chronic basis. Additionally, if Product exceeds the most recent UL (Tolerable Upper Intake Level established by the Institute of Medicine of the National Academies) for any ingredient claimed or contained, CL may indicate this fact in its listing(s) of the Product. This will be determined based on the Product’s suggested daily unit dose for routine use multiplied by the greater of (i) the claimed amount of the ingredient per unit or (ii) the amount of ingredient per unit as measured in Testing.
- Must meet all FDA labeling requirements.
For a product to fail testing, confirmation of a failing result was required on at least one of the criteria through repeat testing in a second independent laboratory.
*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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