How Products Were Selected:
Products were selected to represent those popular among readers of ConsumerLab.com and commonly available nationally in the U.S. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, and direct sales companies. Products were not accepted directly from manufacturers.Testing Methods:
- Analyses for melatonin by High Performance Liquid Chromatography (HPLC) or other appropriate method as determined by CL.
- Analyses for lead, arsenic, cadmium and mercury performed by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) for products containing whole herbs and/or 250 mg or more of minerals per daily dose.
- Disintegration time of tablets (excluding chewable, sublingual and time-release formulations) utilizing United States Pharmacopeia (USP) <2040> methodology for the disintegration of Dietary 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, based on gastric fluid phase only.
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:- Products containing more than 0.5 mg per unit must meet 100% of label claim and contain no more than 135% of claimed amount of melatonin. Products containing 0.5 mg per unit or less must meet 100% of label claim and contain no more than 175% of claimed amount of melatonine, e.g., a supplement claiming 0.3 mg must not contain more than 0.525 mg.
- Heavy Metals: Products containing whole herbs and/or 250 mg or more of minerals per daily dose must not exceed the following limits:
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 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 (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, 0.8 mcg if containing 1000 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) 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.
- 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).
- 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).
- 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 tableted product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding chewable, sublingual 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 by visual inspection, based on gastric fluid phase only.
- 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 in quality, present a safety risk or to provide misleading or inaccurate information in its labeling.
