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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. For each product, the sample was composed of one or more purchased samples from a lot having an expiration date (if labeled) later than the date of testing.
Testing Method:
Policosanol, and Sterol products were subjected to the analyses listed below:
Policosanol:
Quantitative Analysis of Policosanol by Gas Chromatography (GC) using a Flame Ionization Detector (FID) analytical method.
Sterols:
Quantitative Analysis of Phytosterols by Gas Chromatography (GC) using a Flame Ionization Detector (FID) analytical method.
Disintegration of non-chewable, non-capsule, non-enteric coated and non-time-release formulations was analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
All products were analyzed for for lead by ICP-MS.
Any product that did not pass the testing was sent to another independent laboratory to repeat testing for at least one of the criteria on which it did not pass. The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score: *
To pass testing, a product must meet the following criteria:
Policosanol:
- Must contain at least 100%, and not more than 150%, of its claimed amount of total policosanol and other specified individual fatty alcohols.
- The total policosanol must contain no less than 55 (%wt/wt) octacosanol. In addition, the sum of octacosanol, tetracosanol, hexacosanol, heptacosanol, triacosanol and nonacosanol should represent no less than 85% (%wt/wt).
Sterols:
- Contain at least 100%, and not more than 150%, of its claimed amount of total plant sterol esters or free sterols.
- If 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).
- If product contains plant sterol esters, the sum of free beta-sitosterol, campesterol and stigmasterol shall not be less than 62.5% of the total claimed amount.
All Products:
- Not exceed the State of California's Prop 65 limits for lead in supplements in a recommended daily serving: 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. If a maximum recommended daily serving is not defined, a daily serving size will be determined and applied by CL.
- Meet recommended USP parameters for disintegration for nutritional supplements (excluding capsule, chewable and time-release products).
- Meet all FDA labeling requirements.
A product passed if it passed each criterion in any one of the analyses.
* 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.
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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