Canada takes risk-based approach to food-drug borderline

Health Canada has received hundreds of Product License Applications from food makers that under Canadian food and drug law as it stands, could be considered as either foods or drugs. The guidance has been issued as part of its desire to clear the backlog.

Such borderline products are known in Canada as natural health products (NHPs) and fall either under the Natural Health Products Regulations​​(NHPR)​or Parts A, B and D of the​Food and Drug Regulations​​(FDR). Or both.

“There have been regulatory challenges in classifying these products,”​ Health Canada said. “In the past, proposals have been explored to exclude these products as a class of products from the application of the NHPR through a regulatory amendment.”​

As part of this ongoing regulatory review, the latest guidance seeks to “increase regulatory certainty for applicants”​ around the case-by-case risk-based approach employing four criteria:

· Product Composition

· Product Representations

• Product Format
• Public Perception and History of use

Health Canada said the rule review process was ongoing and would produce a Q&A, glossary of terms as well as a template to help industry apply the criteria.

A workshop/brainstorming session with industry and consumer stakeholders will also be held in April 2009 that will look into “risk mitigation strategies for NHPs in food formats.”​

The risk-based approach will break products into two classes – low and high risk. Low-risk products will be backed by “readily available, authoritative and high-quality sources of evidence”​ that relate the “efficacy, safety and quality of products and/or claims.”​

Assessment of such products would be minimal, Health Canada said. High-risk products, on the other hand, would require “a thorough assessment.”​

Strong evidence, or “pre-cleared information (PCI)” could be made up of:

• widely recognized reference sources, such as pharmacopeias, monographs and labelling standards
• expert opinion reports
• international standards
• information from other regulatory bodies, such as market authorization /licensing decisions

A Health Canada fact sheet on its risk analysis can be found here​.

Further details can be found here​.

The NHPR classifies NHPs as those that are used in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
• restoring or correcting organic functions in humans
• modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health