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HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products were selected to represent those commonly sold and/or available nationally 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.
Testing Methods:
Each product was tested for its amount of chromium. Analysis included identification of potential contamination with hexavalent chromium. The products were also tested for their amounts of bitter orange (sour orange, Citrus aurantium L.)(if claimed) and caffeine (if claimed). Products were also tested for their ability to disintegrate in solution (excluding capsules, chewable and time-releaseproducts).
The following testing methods were employed:
- Bitter orange products were quantitatively analyzed for synephrine-type alkaloids (synephrine, hordenine, N-methyl Tyramine, octopamine, tyramine) by High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis (CE), and screened by Gas Chromatography with Mass Spectral Detection (GC-MS).
- Chromium products were analyzed using an Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) for total chromium and Ion Chromatography (EPA method 3060A/7199) for hexavalent chromium (chromium VI).
Other tests:
- Any product claiming to contain bitter orange or a stimulant blend was also screened for stimulants and related compounds by Gas Chromatography. Confirmation of any detected banned substances was made by GC-mass spectroscopy. Products were quantitatively analyzed for xanthine alkaloids (caffeine, theophylline and theobromine) by HPLC.
- Disintegration of non-capsule, non-chewable and non-time release formulations was analyzed utilizing USP (United States Pharmacopeia) 2040 recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
- Lead was analyzed by ICP-MS.
Products not having passing levels of key ingredients or contaminants were then re-tested in a second independent laboratory using similar methods and instrumentation. The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score: *
To achieve a "Pass" in the testing, a product had to meet the following criteria:
Bitter Orange/Stimulant Blend Products
- Contain a minimum 100% and no more than 135% of label claim for synephrine and contain other bitter orange alkaloids (hordenine, N-methyl tyramine, octopamine, tyramine) in appropriate levels 4:1. Dry extracts without label claim should have no less than 1% synephrine and no more than 6% (%wt/wt of peel extract) and contain other bitter orange alkaloids (hordenine, N-methyl tyramine, octopamine, tyramine) in appropriate levels 4:1.
- Contain 100% and no more than 120% of label claim for xanthine alkaloids (as caffeine, theophylline and theobromine).
- Contain no detectable amounts of stimulants may be present in products not claiming to contain caffeine, stimulants or related ingredients.
Chromium Products
- Contain a minimum of 100% and no more than 120% of label claim for total chromium.
- Contain less than 0.1% of hexavalent chromium (chromium VI) by %wt/wt of total chromium.
All Products
- Must not exceed California 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. (The State of California has established its own strict standards for lead, including 0.5 micrograms of lead per serving per day for foods and most supplements. Products sold in California that exceed these levels are required to bear warning labels).
- 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.
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