HOW PRODUCTS WERE EVALUATED:
How Products Were Selected:
Products tested represent those commonly sold and/or available nationally in the U.S. and Canada. 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.
Probiotic products were tested in one or more independent laboratories for the following
- Amount of viable anaerobic microorganisms including species of the genus Lactobacillus and Bifidobacterium and facultative anaerobic microorganisms including species of the genus Bacillus, Streptococcus and Saccharomyces. Enumeration methods used are outlined in Standard Methods for the Examination of Dairy Products 17th Edition and including a modified De Man Rogosa and Sharpe agar to which L-cysteine HCl (MRS+C) was added and a Reinforced Clostridia agar (RCA) for Lactobacillus and Bifidobacterium. Enumeration of Bacillus, Streptococcus and Saccharomyces were performed using DTA, M-17 and a glucose yeast extract agar (GYEA) under aerobic conditions.
- Analyses for microbial contaminants were performed using methods from the FDA's Bacteriological Analytical Manual (BAM) and included testing for Escherichia coli, Salmonella spp. Staphylococcus aureus, Pseudomonas aeruginosa, and mold.
- 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.
- Products claiming to Gluten Free will be analyzed by Enzyme Linked Immunosorbent Assay (ELISA).
- Lactose: Analysis by High Performance Liquid Chromatography (HPLC) (AOAC or AACC).
- Non-chewable, non-capsule, non-enteric coated and non-time-release formulations were analyzed for disintegration utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing any initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies. ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
Identities of products were not disclosed to laboratories performing the testing.
To achieve a "Pass" in the testing, a product had to:
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
- Have a minimum of 100% of its labeled amount of microorganisms as viable anaerobic microorganisms and, for a product for people, yield at least 1 billion anaerobic microorganisms per maximum recommended daily serving or a lower amount clinically proven to be effective.
- Test negative for Escherichia coli, Salmonella spp., Staphylococcus aureus and Pseudomonas aeruginosa (as required by the FDA). In addition, contain less than 1,000 CFU per gram of mold (USP <2023>).
- All products containing whole herb 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 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 or 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).
- Gluten: To be "Gluten-free" solid and powdered supplements and products with a serving size of less than five grams or liquid supplements and products with a serving size of less than five mL must contain less than 20 ppm of gluten per serving (FDA). Products with serving sizes greater than five grams or five mL must contain less than 5 ppm of gluten per serving.
- Lactose: Must meet label claim for amount of lactose. To be "Lactose Free" must contain less than 0.5 grams of lactose per serving. Based on USDA Sugar Free guidelines.
- If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, 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.
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