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, catalogues, or direct distributors. Products were not accepted directly from manufacturers.
Any product not passing any initial testing criteria was sent to a second independent laboratory for repeat analysis using a similar methodology.
- Quantification of hypericin, pseudohypericin and hyperforin by high performance liquid chromatography (HPLC) (AOAC, modified DSC-2015)
- Analyses for lead, arsenic and cadmium by inductively Coupled Plasma Mass Spectroscopy (ICP-MS) (only for products containing whole herbs and/or more than 250 mg of minerals per daily dose).
- Tablet disintegration of non-chewable, non-capsule and non-time-release formulations using United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
The identities of the products were not disclosed to the laboratories performing the testing.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
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 or minimum expected percentages of hypericin (calculated as total hypericin and pseudohypericin) and hyperforin. For dried, powdered flowers/ tops or aerial parts, the minimums are 0.04% (wt/wt) hypericin and 0.6% hyperforin (USP 36, DSC 2015). For extracts, the minimum is 0.3% total hypericin (industry standard by UV-VIS method which equates to approximately 0.2% by HPLC method required in USP 36 due to greater specificity of HPLC). The minimums will apply when amounts of these compounds are not listed or the listed amounts are lower than the minimums, except when the product contains other amounts of hypericin and hyperforin supported, in ConsumerLab.com's opinion, by published clinical evidence of efficacy.
- Heavy Metals: Products containing whole herbs and/or more than 250 mg of minerals per daily dose must not exceed the following limits:
- 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 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 (based on the State of California's Prop 65 limit).If marketed for use by children, may not exceed 3.0 micrograms 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 (based on the State of California's Prop 65 limit).
- 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).
- If applicable to the product, must meet recommended USP parameters for disintegration of dietary supplements (excluding capsule, chewable and time-release products).
- Product must meet 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.
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