How Products were Selected:Products tested 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. Products were not accepted directly from manufacturers.
Testing Methods:B Vitamin products were tested in one or more independent laboratories for the following:
- B vitamins: Total B-1, (thiamine HCL, mononitrate and derivative), total vitamin B-2 (riboflavin and derivatives), total B3 (niacin (nicotinic acid), niacinamide and inositol hexanicotinate), total B5 (pantothenic acid and derivative), total B6 (pyridoxine HCL and derivatives), B-9 (total folic acid and/or folate), folate derivatives including methylfolate, B-7 (biotin) and total B12 (cyanocobalamin and methylcobalamin); as well as benfotiamine . Analyses of B vitamins and benfotiamine were performed in independent laboratories using United States Pharmacopoeia(USP) and/or AOAC methodologies.
- Quantitative analyses for lead, cadmium and arsenic by ICP/MS (Inductively Coupled Plasma-Mass Spectroscopy) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Disintegration of tablets (excluding chewable, sublingual and time-release formulations) utilizing the United States Pharmacopeial (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Identities of products were not disclosed to laboratories performing the testing.
Passing Score:*To be "Approved" by Consumerlab.com, a product must meet the following requirements:
- A product must contain at least 100% and no more than 150% of the claimed amount of the B vitamins tested in a B complex (USP-DSC 2020) or single ingredient B vitamin (or benfotiamine) product; although vitamin B-3 (Niacin), B-6 (pyridoxine) and B-9 (folic acid/folate) single ingredient products must contain at least 100% and no more than 125% of the claimed amount. However, an overage must not cause the product to exceed any Tolerable Upper Intake Levels (UL).
- Heavy Metals: Products containing whole herbs and/or 250 mg minerals per daily dose must not exceed the following limits:
- Products marketed for use by children may not exceed 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 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 elemental calcium, magnesium and potassium, 0.8 mcg if containing 1,000 mg/day of any combination of these minerals. An additional 0.5 mcg is provided if containing 250-999 mg/day of whole herb (not extract) ingredient 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 per recommended daily serving.
- 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 for a child weighing 75 lbs.). If not marketed for use by children, 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 (EPA limit and state of New Jersey limits - based on 1 liter of water) and no more than 2.1 micrograms of inorganic arsenic per daily serving (Canada's limit in natural health products).
- Clearly and accurately state the amount of minerals and vitamins (oil-and water-soluble) expected to be in the product.
- Meet recommended USP <2040> parameters for disintegration of dietary supplement tablets (excluding chewable, sublingual and time-release products).
- Meet 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 unacceptable variation in quality, present a safety risk or to provide misleading or inaccurate information in its labeling.