Milk Thistle and Liver Formula Supplements Review
HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products tested 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 multi-level marketing companies. Products were not accepted from manufacturers.
Milk thistle products were analyzed in one or more independent laboratories for the following:
Any product not passing any initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies.
- Total silymarin content (specifically the sum of dehydrosilybinin, isosilybinin A and B, silybinin A and B, silychristin and silydianin) by High Performance Liquid Chromatography(HPLC) methodology (USP-36, DSC 2015).
- Analyses for lead, cadmium and arsenic were made using Inductively Coupled Plasma/Mass Spectroscopy (ICP/MS) (only for products containing whole herbs and/or more than 250 mg of minerals per daily dose).
- Non-chewable, non-capsule and non-time-release formulations were analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
The identities of the products were not disclosed to the laboratories performing the testing.
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 100% of its minimum expected or claimed amount of for total silymarin content, with a minimum of 1.5% silymarin (% wt./wt.) for powdered seed product and a minimum of 70% silymarin (wt./wt.) for dry powdered extracts. Total silymarin is calculated as the sum of dehydrosilybinin, isosilybinin A and B, silybinin A and B, silychristin and silydianin.
- Heavy Metals: Products containing whole herbs and/or more than 250 mg of minerals per daily dose must not exceed the following limits:
Cadmium**: 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).
- 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 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 to 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.
Arsenic: 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 <2040> parameters for disintegration for dietary supplements (excluding capsule, chewable and time-release products).
- Be in compliance with FDA labeling requirements including listing the following information on its label: Proper plant name (Milk thistle; Silybum marianum; or Silybum marianum (L.) Gaertn.); Part of the plant used (seed/fruit); Form of milk thistle used (e.g., seed powder, extract, or tincture);A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
** 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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