Prostate Supplements Review (Saw Palmetto and Beta-Sitosterol)

Testing Methods:

1. Quantitative analysis of saw palmetto fatty acids by Gas Chromatography (GC) using AOCS (American Oil Chemists Society) or comparable analytical methodology.
2. Quantitative analysis of phytosterols by GC using AOCS or comparable analytical methodology.
3. Analyses for lead, arsenic, and cadmium by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
4. Disintegration of tablets (excluding chewable, sublingual, and time release formulations) using United States Pharmacopeia (USP) <2040> methodology.

Passing Score:*

1. 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.
2. 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 is 9% (wt./wt.) (USP 40). For products containing liquid extract and no sterol containing ingredients, the minimum total fatty acid content is 80% (wt./wt.) and 0.2% for sterols (wt./wt.) (USP 40). For products containing powdered extract the minimum total fatty acid content is 25% (wt./wt.) (industry standard). Total fatty acid content is defined as the sum of the following: 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 defined as the sum of the following: campesterol, stigmasterol, stigmastanol and beta-sitosterol (USP 40).
3. Heavy Metal Contamination: Products containing whole herbs and/or more than 250 mg of minerals 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 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.
   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 75lbs). 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).
   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).
4. Meet recommended USP <2040> parameters for disintegration of dietary supplement tablets (excluding chewable, sublingual and time-release products).
5. Meet FDA labeling requirements.