Digestive Enzyme Supplements Review
HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products selected 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, catalogues, or multi-level marketing companies. Products were not accepted directly from manufacturers.
- 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) 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.
- Non-chewable, non-capsule and non-time-release formulations analyzed for disintegration utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing initial testing criteria was sent to a second independent laboratory for repeat analysis using similar methodologies.
The identities of the products were not disclosed to the laboratories performing the testing.
To achieve a "Pass" in the testing, a product had to achieve the following:
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
- 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:
Cadmium: Contain less than 0.3 micrograms of cadmium per gram (World Health Organization/ADI proposed in dried plant materials).
- 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 arsenic per daily serving (EPA limit - based on 1 liter of water).
- If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, enteric coated, 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.
** If available for sale in California, a product that exceeds the State of California's Prop 65 lead limit requires a warning label. However, with or without this warning label, a product cannot pass ConsumerLab.com testing if it exceeds the levels described in this paragraph.
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