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:- Quantification of lutein and zeaxanthin by High Performance Liquid Chromatography (HPLC) methodology or other appropriate methodology as determined by CL. Form of lutein (esterified or non-esterified) will also be reported.
- Analyses for lead, arsenic, cadmium and mercury performed using Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) 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 United States Pharmacopeia (USP) <2040> methodology For the disintegration of dietary 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:- Lutein: Contain at least 100% and no more than 130% of its claimed amount of lutein (USP-DSC 2022). Zeaxanthin: Contain at least 100% and no more than the greater of 50% or 1 mg more than its claimed amount of zeaxanthin.
- Heavy Metals: Products containing whole herbs and/or more than 250 mg of minerals per daily dose 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 weight of less than 5 grams which are not marketed for use by children, may not exceed the 0.5 mcg per recommended daily serving (based on the state of California's Prop 65 limit for lead in dietary supplements, above which a warning is required regarding reproductive harm, birth defects, and cancer risks) with an additional allowance of 0.4 mcg if containing 250 to 999 mg/day of any combination of elemental calcium, potassium and magnesium, 0.8 mcg if containing 1000 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 for products containing 1000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg per 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 arsenic per daily serving (EPA limit 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).
- May not exceed 2 micrograms of 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 (excluding capsule, chewable and time-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 if it considers such product to display unacceptable variation, present a safety risk or to provide misleading or inaccurate label information.
