How Products Were Selected:
Products selected to represent those popular among readers of ConsumerLab.com and commonly sold and/or available nationally 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 (in CFUs — colony forming units) 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., and Staphylococcus aureus and mold.
- Quantitative analyses of lead, arsenic, cadmium and mercury 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 time of tablets (excluding chewable, sublingual and time release formulations) using United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
- Disintegration time of enteric coated, time-release, and sustained release tablet, caplet and softgel formulations utilizing USP <2040> methodology for delayed-release (enteric-coated) tablets.
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.
Passing Score:*
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 (based on CFUs found, even if product lists amount in AFUs — active fluorescent units — or lists amount only as of time of manufacture) and, products for human consumption must 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., and Staphylococcus aureus (as required by the FDA). In addition, contain less than 1,000 CFU per gram of mold (USP <2023>).
- 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:
Lead:- Products marketed for use by children under 12 years of age or by pregnant or nursing women 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 weight 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).
- If applicable to the product, Meet recommended USP <2040> parameters of disintegration of dietary supplement tablets (excluding chewable, sublingual and time-release products).
- Enteric coated, time-release, and sustained release tablet, caplet and softgel formulations must meet recommended USP <2040> parameters for delayed-release (enteric-coated) tablets, caplets and softgels by visual inspection.
- Meet FDA labeling requirements.
