How Products Were Selected:
Selected products 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, or 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, Salmonella, Listeria, yeast and mold.
- Heavy metals: Analyses for lead, cadmium and arsenic using 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:
- Report 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 ±25% 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).
- Test negative for Escherichia coli, Salmonella spp., and Listeria. Total combined yeasts and molds count NMT 1000 cfu/g USP <2023>.
- Heavy Metals: Products must not exceed the following limits:
Lead: Not exceed the following limits for elemental lead:
- Products marketed for use by children 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 weights of less than 5 grams which are not marketed for use by children, 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 0.4 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 will not exceed 2 mcg. 1000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg.
- Products with single serving weights of 5 grams or more which are not marketed for children may not exceed 2.5 mcg per serving nor 4.0 mcg per daily serving.
- If marketed for use by children, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit in a natural health product for a child weighing 75 lbs. - although, technically, flaxseed is not considered a natural health product in Canada, but a food, for which there is no limit). If not marketed for use by children, may not exceed 4.1 micrograms of cadmium per recommended daily serving (based on the California's Prop 65 limit).
- Contain less than 10 micrograms of total arsenic per daily serving (EPA and state of New Jersey limits - based on 1 liter of water). Products found to exceed this amount are tested for inorganic arsenic and must contain no more than 2.1 micrograms of inorganic arsenic per daily serving (Canada's limit in natural health 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, present a safety risk or to provide misleading or inaccurate information in its labeling.
