How Products were Selected:
Products selected 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:
- Analysis of alpha-amylase activity from nonbacterial (DU) and bacterial (BAU) sources (USP Dietary supplement Compendium) and animal or fungal pancreatin (USP) (USP-36).
- Analysis of lipase activity from microbial (LU or FIP) and animal sources (LU) (USP Dietary supplement Compendium) as well as animal or fungal pancreatin (USP) (USP-36) in products not containing Ox bile or betaine.
- Analysis of protease activity from bromelain and papain (PU), bacterial sources (PC), fungal sources (HUT, SAP) as well as animal or fungal pancreatin (USP) (USP-36). Values may be converted from other industry standard units if needed.
- Quantitative analysis for lead, cadmium and arsenic using 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) utilizing United States Pharmacopeia (USP) <2040> methodology for the disintegration of dietary supplements.
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" by ConsumerLab.com, a product had to meet the following requirements:- Contain at least 100% of the claimed activity for amylase, lipase and protease from bacterial, fungal or animal sources as well as amylase, lipase and protease from fungal or animal pancreatic sources.
- Heavy Metals: Products containing whole herbs and/or 250 mg minerals per daily dose must not exceed the following limits:
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 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 (EPA limit and state of New Jersey limits - based on 1 liter of water) and no more than 2.1 micrograms of inorganic arsenic per daily serving (Canada's limit in natural health products).
- Meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, chewable, sublingual and time-release products).
- Meet 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, present a safety risk or to provide misleading or inaccurate information in its labeling.
