How Products Were Selected:
Products tested represent those popular among members 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:
Products were tested in one or more independent laboratories for the following:- Nutrients: Nutrient analysis using Association of Official Analytical Chemists (AOAC) International methods including total fat (AOAC 954.02), protein (AOAC 992.15), total dietary fiber (AOAC 991.43), total carbohydrates and calories (by calculation).
- Microbial contamination: Analysis of microbial contaminants using the FDA's Bacteriological Analytical Manual (BAM) and AOAC methodologies with application to USP <2023> for E.coli, Staphylococcus aureus, Salmonella, Listeria yeast and mold.
- Analyses for lead, cadmium, arcenic, mercury, magnesium and iron by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS).
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Identities of products were not disclosed to the laboratories performing the testing.
Passing Score:*
To be "Approved" by ConsumerLab.com, a product must meet the following requirements:
- Values for nutritional analysis which includes protein, fat, carbohydrates, calories and total dietary fiber. Products must meet label claims within a specified range for each nutritional component as indicated below:
- Calories (within ±20% of claim);
- Total Fat (within 1 gram or ±20% of claim, whichever is greater; or, if claiming zero total fat, no more than 0.5 gram/serving);
- Total Carbohydrates (within 1 gram/serving or ±20% of claim, whichever is greater; or, if claiming zero within 1g of claim);
- Protein (within 1 gram/serving or ±20% of claim, whichever is greater);
- Total dietary fiber (within 2.5 grams or ±25% of claim, whichever is greater);
- Magnesium and Iron 80 – 130% of claimed amount. Levels cannot exceed the %DV listed per serving.
- Test negative for Escherichia coli, Salmonella spp., and Listeria. Total combined yeasts and molds count NMT 1000 cfu/g USP <2023>, CHTA 2026.
- Heavy Metals: Products must not exceed the following limits:
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.
- 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).
- 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).
- 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, it must meet recommended USP <2040> parameters of disintegration for dietary supplements "Disintegration and Dissolution of Nutritional Supplements." (excluding capsule, chewable and timed-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 its testing 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.
