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 companies. Products were not accepted directly from manufacturers.
Testing Methods: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.
- Quantitative analyses of lead, arsenic, and cadmium by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) for products containing whole herbs and/or more than 250 mg of minerals per daily dose.
- Disintegration of tablets (excluding chewable, sublingual and time release formulations) using United States Pharmacopeia (USP) <2040> methodology for the disintegration of dietary supplement tablets.
Testing was performed by one or more independent laboratories. Any product that did not initially Pass (below) a test was sent to another independent laboratory to repeat testing for the criterion on which it did not pass.
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 be "Approved" by ConsumerLab.com, a product had to meet the following requirements:
- Contain 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>).
- 3. Heavy Metals: Products containing whole herbs and/or more than 250 mg of minerals and/or plant based mineral material per daily dose must not exceed the following limits:
- 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 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 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 arsenic per daily serving (EPA and state of New Jersey limits - based on 1 liter of water).
- Meet recommended USP <2040> parameters of disintegration of dietary supplement tablets (excluding chewable, sublingual and time-release products).
- Meet FDA labeling requirements.