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.
- Analysis of vitamin A in supplements and fish liver oil products by HPLC (High Performance Liquid Chromatography) or other appropriate methods determined by CL.
- Heavy metals:
- SUPPLEMENTS: Quantitative analyses of lead in supplements containing whole herbs and/or more than 250 mg of minerals per daily dose by ICP/MS.
- FISH LIVER OIL PRODUCTS: Quantitative analysis of lead, cadmium, total and inorganic arsenic in fish liver products by ICP/MS or other appropriate methods determined by CL.
- Determination of Peroxide (PV), anisidine (AN) and calculation of TOTOX values by AOCS method (CD 8-53 & 18-90 respectively) or other methods as appropriate in fish liver oil products.
- Determination of PCBs in fish liver oil products by HRGC/HRMS or similar method.
- Non-chewable, non-capsule, non-enteric coated supplements, enteric coated fish liver oil products and non-time-release formulations analyzed for disintegration utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies.
The identities of the products were not disclosed to the laboratories performing the testing.
To achieve a "Pass" in the testing, a product had to:
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.
- Contain at least 100% and no more than 150% of its claimed amount of total vitamin A (beta-carotene and retinol combined) as well as meet any claimed ratio of beta-carotene to total vitamin A. However, an overage must not cause the product to exceed any Tolerable Upper Intake Levels (UL).
- Heavy Metals: Supplements
Lead**: Not exceed the following limits for elemental lead:
Fish Liver Oil products:
- 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.
- Products with single serving weights of 5 grams or more which are not marketed for children may not exceed 2.5 mcg per serving or 4.0 mcg per daily serving.
- Contain less than 0.1 ppm of lead, cadmium and mercury (GOED 2012).
- Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic arsenic per daily serving (EPA limit - based on 1 liter of water).
- Have a peroxide value (PV) of no more than 20 meq/kg, an anisidine value (AV) of no more than 60 and a TOTOX value of no more than 60 (calculated as (2 x PV) + AV) (GOED 2012)
- Total PCBs and Dioxin-like PCBs; PCBs include total polychlorinated biphenyls (all 209 PCB congeners) less than 0.09 mg/kg (GOED 2012). Dioxin-like PCBs include the sum of 4 individual non-ortho PCBs and 8 mono-ortho PCBs. For non-concentrated fish body oils (<80% EPA & DHA (%wt/wt)) a limit of 3pg/g (GOED 2012). For fish body oil concentrates (> 80%), fish liver oil and oil from other marine organisms a limit of 6 pg/g (proposed EU).
- If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
- Be in compliance with FDA labeling requirements.
** If available for sale in California, a product that exceeds the State of California's Prop 65 lead limit requires a warning label. However, with or without this warning label, a product cannot pass ConsumerLab.com testing if it exceeds the levels described in this paragraph.
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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