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, and direct sales or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Methods:
Whole herb preparations (including gelatinized preparations):
- Determination of fill weight of products in capsule form.
- Identity of maca (Lepidium meyenii, Walpers) by DNA analysis.
If DNA present, then semi-quantitative, gross determination of product contents by polarized light microscopy. If DNA not present, then High Performance Thin Layer Chromatography (HPTLC).
- Determination of fill weight of products in capsule form.
- Identity of maca extract (Lepidium meyenii, Walpers) by High Performance Thin Layer Chromatography (HPTLC).
- If HPTLC profile does not match then DNA analysis.
- Analyses for lead, arsenic, and cadmium performed using an ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Non-chewable, non-capsule, non-enteric coated and non-time-release formulations analyzed for disintegration utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies.
The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score:*
To achieve a "Pass" in the testing, a product had to:
Whole herb maca product (including gelatinized preparation):
- Fill weight of product in capsule must be equal to or greater than listed amount of maca.
- Contain maca Lepidium meyenii (Walpers), (Herbs of Commerce) by DNA based analysis.
- Microscopy must show approximate expected amount of material to be maca.
Note: Whole herb products not containing maca root by DNA analysis will be re-assayed by HPTLC. If positive by HPTLC analysis product status will be listed as NA.
- Fill weight of product in capsule must be equal to or greater than listed amount of maca extract.
- HPTLC analysis must yield correct profile of key maca compounds.
Note: Maca extracts negative by HPTLC but positive on DNA analysis for Lepidium meyenii will be listed as NA.
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 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.
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, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
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 its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
** 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.
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.
