Product Review:Prostate Supplements (Saw Palmetto and Beta-Sitosterol)
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 both their total fatty acid and sterol content and beta-sitosterol products were tested for their sterol content. Products were analyzed for their respective fatty acid and sterol constituents by gas chromatography (GC). Products not passing this initial assay were tested in a second independent laboratory utilizing a similar GC assay.
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.
Analyses for lead were performed using ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy).
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.
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 recommended USP parameters for disintegration for vitamin supplements (excluding capsule, enteric coated, chewable and time-release products).
Not exceed California Prop 65 levels for lead contamination in a recommended daily serving of a dietary supplement, i.e., contain less than 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 if containing one whole herb (not extract) ingredient or 1.0 mcg for two or more whole herb ingredients. If a maximum recommended daily serving is not defined, a daily serving size will be determined and applied by CL.
Must meet FDA labeling requirements.
* 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.
** Based on State of California's Prop 65 lead limit. California requires supplements exceeding this limit to bear a warning label regarding lead.
