Product Review:
Review of Products for Lactose Intolerance (Lactase Enzymes and Lactose-Free Milks)


How Products were Selected:
Products selected represent those commonly sold and/or available nationally in the U.S. and Canada. 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.

Testing Methods:
Lactase enzyme products were tested for their claimed amount of lactase activity and possible contamination with lead. Lactase enzyme activity was analyzed using the Food Chemical Codex (FCC) methodology (FCC IV or VI assay). Analyses for lead were performed using ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy).

Disintegration of non-chewable, non-capsule, non-enteric coated and non-time release formulations was analyzed by utilizing USP (United States Pharmacopeia) <2040>.

Lactose-free milk products were analyzed for their lactose content using an AOAC (Association of Official Analytical Chemists, International) HPLC method in an independent laboratory.

Products failing to meet any Passing Score were re-tested in a second independent laboratory using similar methods and instrumentation. may modify or use other appropriate test methods if necessary to test special product formulations.

Passing Score: *
To pass testing, a product must meet the following criteria:
  1. Contain at least 100% of its claimed amount of lactase activity.
  2. Not exceed California Prop 65 levels for lead contamination in a recommended daily serving of a dietary supplement, i.e., contain less than 0.5 mcg of lead per daily serving with an additional allowance of 1.0 mcg for supplements containing 1,000 mg/day or more of elemental calcium and 0.5 mcg for supplements containing specific other minerals.** For supplements not marketed for use by children, provides an additional allowance of 0.5 mcg if containing 250 to 499 mg/day of elemental calcium, or 1.0 mcg if containing 500 to 999 mg/day of elemental calcium, and an allowance of 0.5 mcg if containing one whole herb (not extract) ingredient or 1.0 mcg for two or more whole herb ingredients. If a maximum recommended daily serving is not defined, a daily serving size will be determined and applied by CL.
  3. Meet recommended USP parameters for disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products). If enteric-coated, must meet recommended USP parameters for disintegration for enteric-coated tablets and dietary supplements (excluding capsule and chewable products).
  4. Not contain any detectable amount of lactose if claimed to be lactose-free.
  5. Meet FDA labeling requirements.
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.

* Passing scores allow for specific margins of technical error associated with each analysis. 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.

** Based on State of California's Prop 65 lead limit. California requires supplements exceeding this limit to bear a warning label regarding lead.

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