How Products were Selected:
Selected products represent those commonly sold and/or available nationally in the U.S. and generally popular among ConsumerLab members. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, or direct sales companies. Products were not accepted directly from manufacturers.Testing Methods:
Products were tested in one or more independent laboratories for the following:- Microbial contamination:Analysis of microbial contaminants using the FDA's Bacteriological Analytical Manual (BAM) and AOAC methodologies with application to USP <2023> for E. coli, Salmonella, Listeria, yeast and mold.
- Mycotoxins: Aflatoxin B1, B2, G1, G2, Fumonisin B1, B2, Ochratoxin A, Deoxynivalenol and Zearalenone in products not approved for yeast and mold by liquid chromatography-tandem mass spectroscopy (LC-MS/MS).
- Heavy Metals: Lead, arsenic, cadmium and mercury by Inductively Coupled Plasma/Mass Spectroscopy (ICP-MS).
- Gluten: All products that wre labeled as "gluten-free" were analyzed for gluten by Enzyme Linked Immunosorbent Assay (ELISA).
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" for quality, a product had to meet the following requirements:- Microbial contamination: Product must test negative for E. coli, Salmonella and Listeria. Total combined yeast and mold NMT 1,000 cfu/g USP <2023>.
- Mycotoxins: Product must not exceed the following limits based on EU limits mcg/kg: Aflatoxins (including B1, B2, G1, G2) unprocessed grains 10, processed cereals 4.DON (deoxynivalenol) unprocessed grains 1750, processed cereals 750. Fumonisins (B1, B2) unprocessed grains 4000, processed cereals 1000 (maize), ZEA (zearalenone) unprocessed grains 100, processed cereals 75. OTA (ochratoxin A) unprocessed grains 5, processed cereals 3, (EU Commission Regulations 2023).
- Heavy Metals: Products must not exceed the following limits:
Lead:- Products marketed for use by children under 12 years of age 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 that are not marketed for use by children under 12 years of age, 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 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 must not exceed 2 mcg per daily serving.
- Products with single serving weights of 5 grams or more that are not marketed for children under 12 years of age 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 under 12 years of age, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit for a child weighing 75lbs). If not marketed for use by children under 12 years of age, 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).
- Gluten: Products labeled "Gluten-free" must contain no more than 20 ppm of gluten per serving (FDA). Products containing no more than 5 ppm of gluten will be specially noted in the Review as ultra gluten-free if also labeled as gluten-free.
* 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 display unacceptable variation, present a safety risk, or to provide misleading or inaccurate information in its labeling.
