Cholesterol-Lowering Supplements Review (Sterols/Stanols 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/or multi-level marketing companies. Products were not accepted directly from manufacturers.
Products containing sterols, stanols and/or policosanol were tested in one or more independent laboratories for the following:
Any product not passing testing was sent to another independent laboratory to repeat testing for the criterion on which it did not pass.
- Quantitative analysis of policosanol components by Gas Chromatography (GC) utilizing Flame Ionization Detection (FID) analytical method.
- Quantitative Analysis of sterols and stanols 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.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Identities of the products were not disclosed to the laboratories performing the testing.
To be "Approved" by ConsumerLab.com, a product had to meet the following requirements:
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 sterol and stanol 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 per day divided over two or more servings (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:
- 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 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.
- 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).
- Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic per daily serving (EPA limit and state of New Jersey limits- based on 1 liter of water).
- If applicable to the product, it must meet recommended USP <2040> parameters for disintegration of dietary supplements (excluding capsule, enteric coated, chewable, sublingual 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 if it considers such product to display unacceptable variation in quality, present a safety risk or to provide misleading or inaccurate information in its labeling.
** Based on State of California's Prop 65 limits. Requires a warning label. California requires supplements exceeding this limit to bear a warning label regarding lead.
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