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, online 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:- 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, cadmium, arsenic, mercury and zinc 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 orodispersible tablets (ODTs), chewable, sublingual, and time-release formulations) using United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
- Disintegration time of enteric-coated, time-release, and sustained-release tablet, caplet and softgel formulations utilizing USP <2040> methodology for delayed-release (enteric-coated) tablets.
- Disintegration of ODTs analyzed utilizing European Pharmacopoeia recommendations (European Pharmacopoeia 7th edition 2010).
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 and Zeaxanthin: Contain at least 100% and no more than the greater of 150% or 3 mg over the claimed amount.
- Products containing 25 mg or more of zinc per daily dose must contain not more than 120% of claim.
- Heavy Metals: Products containing whole plant materials, rice bran, cacao and/or more than 250 mg of minerals per daily dose 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 nutritional supplements (excluding ODTs, sublingual, chewable and time-release products).
- Enteric coated, time-release, and sustained release tablet, caplet and softgel formulations must meet recommended USP <2040> parameters for delayed-release (enteric-coated) tablets, caplets and softgels by visual inspection.
- ODTs must meet recommendations of European Pharmacopoeia 7th edition, 2010 (Brniak et.al, SPS 2015).
- A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
* 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 provide misleading or inaccurate label information.
