How Products Were Selected:
Products were selected to represent those commonly sold and/or available in the U.S. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, or direct sales. Products were not accepted directly from manufacturers.Testing Methods:
Products were tested in one or more independent laboratories for the following:
- Quantitative analysis of triterpenes, calculated as the sum of oleanolic acid and ursolic acid using the United States Pharmacopeia methodology (USP 40).
- Quantitative analyses of lead, cadmium and arsenic by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) for all products.
- Disintegration of non-chewable, non-capsule and non-time released formulations utilizing United States Pharmacopeia (USP) <2040> methods.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Identities of the products were not disclosed to the laboratories performing the testing.
Passing Score:*
To be "Approved" by ConsumerLab.com, a product had to meet the following requirements:
- Holy Basil leaf powder is expected to contain a minimum of 0.5% of triterpenes (wt./wt. dried basis), calculated as the sum of oleanolic acid and ursolic acid (USP-40). For holy basil leaf extract, not less than 100% and not more than 125% of the labeled amount of triterpenes, calculated as the sum of oleanolic acid and ursolic acid. The minimum for leaf powder will be applied if the product does claim an amount of triterpenes or if the claimed amount is lower than the expected minimum.
- Heavy metals: Products must not exceed the following limits:
Lead**: Not exceed the following limits for elemental lead:- Products marketed for use by children 12 years of age or younger 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 single serving weights of less than 5 grams which are not marketed for use by children 12 years of age or younger, 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 12 years of age or younger 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).
- Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic per daily serving (EPA limit and state of New Jersey limits- based on 1 liter of water).
- If applicable to the product, it must meet recommended USP <2040> parameters for disintegration of dietary supplements (excluding capsule, chewable, sublingual 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 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.
** Based on State of California's Prop 65 limits. California requires supplements exceeding this limit to bear a warning label regarding lead.
