How Products were Selected:
Products selected represent those popular among readers of ConsumerLab.com and 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 companies. Products were not accepted directly from manufacturers.Testing Methods:
- Quantification of coumarin by High Performance Liquid Chromatography (HPLC).
- Identification and quantification of procyanidins (PACs) as a predefined molecular degree of polymerization (DP) of 1-7 (which includes the soluble flavanol monomers catechin and epicatechin that are DP1) by high performance liquid chromatography (HPLC) methodology. (Robbins, JAOACI 2012) (modified).
- Quantitative analyses for lead, arsenic, cadmium and mercury by ICP-MS or other appropriate methods determined by CL.
- Disintegration time of tablets (excluding chewable, sublingual and time-release formulations) using United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
- Disintegration time of enteric coated, time-release, and sustained release tablet, caplet and softgel formulations utilizing USP <2040> methodology for delayed-release (enteric-coated) tablets.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
The Identities of products were not disclosed to laboratories performing the testing.
Passing Score:*
To be "Approved", a product must meet the following requirements. (Note: For ground cinnamon spices, a daily serving is based on 0.5 grams (approximately 1/4 teaspoon):- Meet 100% of its label claim and no more than 120% for the amount of soluble PAC's DP 1-7. The amount of soluble PACs DP 1-7 is reported for each product and spice.
- Coumarin: A cassia cinnamon product may not contain more than 7 mg of coumarin per daily serving (or 3.5 mg if specifically marketed for children) (Based on Tolerable Daily Intake, EFSA Journal 2008). A Ceylon cinnamon (Cinnamonum verum) product may not contain more than 1 mg of coumarin per daily serving (as Ceylon should contain only trace levels of coumarin (Blahova, Sci World J 2012Blahova, Sci World J 2012) and exceeding this level would suggest adulteration).
- Heavy Metals: Products containing whole herbs and/or more than 250 mg of minerals per daily serving must not exceed specific limits for lead, arsenic, cadmium and mercury.
Lead:
- Products marketed for use by children under 12 years of age or by pregnant or nursing women 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 weight of less than 5 grams that are not marketed for use by children under 12 years of age, may not exceed the State of California's Prop 65 limits for lead in dietary supplements of 0.5 mcg per recommended daily serving (above which a warning regarding reproductive harm, birth defects, or cancer risks is required in California) 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 must not exceed 2 mcg per daily serving.
- Products with single serving weights of 5 grams or more that are not marketed for children under 12 years of age may not exceed 2.5 mcg per serving nor 4.0 mcg per daily serving.
- Contain less than 10 micrograms of total arsenic per daily serving (based on Canada’s limit per daily serving of a natural health product, and U.S. EPA and state of New Jersey limit in 1 liter of water). Products found to exceed this amount were tested for inorganic arsenic and must not contain more than 2.1 micrograms of inorganic arsenic per daily serving (Canada's additional limit in natural health products).
- If marketed for use by children under 12 years of age, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit for a child weighing 75lbs). If not marketed for use by children under 12 years of age, may not exceed 4.1 micrograms of cadmium per recommended daily serving (above which California's Prop 65 law requires a "reproductive harm" warning due to developmental toxicity and male reproductive harm.
- May not exceed 2 micrograms of inorganic mercury per daily serving (based on EPA limit for mercury in 1 liter of water).
- If applicable to the product, must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, chewable, sublingual and time-release products).
- Enteric coated, time-release, and sustained release tablet, caplet and softgel formulations must meet recommended USP <2040> parameters for delayed-release (enteric-coated) tablets, caplets and softgels by visual inspection.
- Be in compliance with all 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 display an unacceptable variation in quality, present a safety risk or to provide misleading or inaccurate information in its labeling.
