Dietary supplements are regulated inCanadaas natural health products. Prior to being sold each product must have a product license, which may be granted after evaluation of the safety, efficacy and quality by the Natural Health Product Directorate (NHPD). Product licensing requires submission of detailed product information including ingredients, source, dose, potency, and recommended use. Manufacturing, packaging, labeling and import facilities must also have site licenses which require compliance with appropriate cGMPs.
NHPD has defined “pre-cleared” information which can be referenced in the registration process to speed evaluation. This information is published as single ingredient monographs, product monographs, or abbreviated labeling standards (AbLS). For most digestive enzymes, NHPD has published pre-cleared information in the form of AbLS monographs. Use of non-monographed enzymes and/or source organisms as well as formulation outside the monographed parameters may necessitate a Class II evaluation. The AbLS monographs define dosage, labeling standards, source organisms, claims and other relevant aspects of use. The existing monographs detail the use of enzymes as digestive aids by adults. The complete monographs can be found on the Health Canada website: