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:
- Analyses of L-theanine by capillary electrophoresis (CE), and/or high performance liquid chromatography (HPLC) or other methodology deemed appropriate by CL.
- Quantitative analysis of lead, cadmium, arsenic and mercury by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) or other appropriate methods determined by CL.
- 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.
The identities of the 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:- L-theanine: Meet 100% of its label claim and contain no more than 150% of claimed amount of L-theanine.
- 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 that 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 250-999 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 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 0.3 micrograms of cadmium per gram (World Health Organization/ADI proposed in dried plant materials).
- ontain 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).
- Meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, chewable and time-release products).
- Be in compliance with FDA labeling requirements.
