| |
Product Review: Cholesterol-Lowering Supplements (Sterols, Policosanol, Guggulsterones) |
|
|
 |
HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products were selected to represent those commonly available in the U.S. and Canada. 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:
Guggulsterone, Policosanol, and Sterol products were subjected to the analyses listed below:
Guggulsterones:
- Quantitative Analysis of E and Z forms of guggulsterones performed by High Performance Liquid Chromatography HPLC with UV detection.
- Analyses for lead and arsenic were performed using an ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy) in an independent laboratory.
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."
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: All Products tested:
- Meet recommended USP parameters for disintegration for vitamin supplements (excluding capsule, enteric coated, chewable and time-release products).
- Meet all FDA labeling requirements.
Guggulsterones:
- Must contain at least 100%, and not more than 150% of the claimed amount of total and specific guggulsterones.
- The E and Z forms of guggulsterones must account for at least 2.5% and not more than 6.0% of the resin (extract) content if resin content is claimed.
- Must not exceed CA Prop 65 levels for lead contamination in a recommended daily serving and, in no event, exceed 2 mcg of lead in a recommended daily serving and must not exceed 10 mcg of arsenic per suggested daily serving.
Policosanol:
- Must contain at least 100%, and not more than 150%, of its claimed amount of total policosanol.
- The total policosanol must contain no less than 60% (%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.
A product passed testing if it met each applicable criterion in any one of the analyses.
* Minimum standards allow for specific margins of technical error associated with each analysis and are based on meeting the above criteria in either the first or second rounds of testing.
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.
Back to review
|
|
|
|
|
