Cholesterol-Lowering Supplements Review (Sterols and Policosanol)
HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products were selected to represent those commonly sold and/or available 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.
Products containing policosanol, and Sterol products were tested in one or more independent laboratories for the following:
- Quantitative analysis of policosanol components by Gas Chromatography (GC) utilizing Flame Ionization Detection (FID) analytical method.
- Quantitative Analysis of Phytosterols by Gas Chromatography (GC) using a Flame Ionization Detector (FID) analytical method.
- Quantitative analyses for lead, cadmium and arsenic by 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 and non-time released formulations utilizing USP (United States Pharmacopeia) <2040> methods.
Any product not passing initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies.
Identities of the products were not disclosed to the laboratories performing the testing.
To achieve a "Pass" in the testing, a product had to:
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
- Contain no less than 100% and no more than 150%, of its claimed amount of total policosanol and other specified individual fatty alcohols. The total policosanol from sources other than rice or spinach must contain no less than 60% (wt/wt) octacosanol or the percentage specified on the label (which may not be less than 50%). In addition, the sum of octacosanol, tetracosanol, hexacosanol, heptacosanol, triacosanol and nonacosanol should represent no less than 85% (wt/wt). Total policosanol from rice or spinach must contain no less than 30% octacosanol. In addition, the sum of octacosanol, tetracosanol, hexacosanol, heptacosanol, triacosanol and nonacosanol should represent no less than 70% (wt/wt).
- Contain no less than 100% and no more than 150% of its claimed amount of total plant sterol esters or free sterols. The sum of free beta-sitosterol, campesterol and stigmasterol must be not less than 62.5% of the total claimed amount. If a health claim is made, product must provide a minimum of 1.3g total plant sterol esters divided over two or more servings per day (equivalent to a minimum of 0.813g free sterols).
- Heavy Metals: Products containing 250mg or more of herbs and/or minerals per daily dose must not exceed the following limits:
Lead**: Not exceed the following limits for elemental lead:
Cadmium: Contain less than 0.3 micrograms of cadmium per gram (World Health Organization /ADI proposed in dried plant materials).
- 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 or 4.0 mcg per daily serving.
Arsenic: Contain less than 10 micrograms of arsenic per daily serving (EPA limit - based on 1
liter of water).
- Contain less than 0.3 micrograms of cadmium per gram (World Health Organization/ADI proposed in dried plant materials).
- Contain less than 10 micrograms of 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.
* 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.
** 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.
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