Health Canada has received several hundred Product Licence Applications for products in food format which have characteristics of both natural health products (NHPs) and foods. There have been regulatory challenges in classifying these products (commonly referred to as "food-like NHPs", or "NHPs in food format") since they could fall under either the Natural Health Products Regulations (NHPR) and/or Parts A, B and D of the Food and Drug Regulations (FDR).
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. This proposal was presented as part of the Natural Health Products Regulatory Review paper "Charting a Course" in May 2006. In a notice to stakeholders issued on October 9, 2007 (Update - Assessment of Product Licence Applications for Natural Health Products in Food Formats), Health Canada announced that food-like NHPs would be reviewed by the Food Directorate in accordance with the NHPR and reiterated that a regulatory amendment was being explored to place these products under the appropriate regime.
To address the regulatory challenges associated with this approach, it is important to clarify which products most appropriately fall under the NHPR versus the FDR through clear classification guidance. Such guidance will both increase regulatory certainty for applicants and assist with the application of requirements of the appropriate regulatory regime.
New Guidance Document
The Classification of Products at the Food-Natural Health Product Interface: Product in Food Formats is intended to facilitate decision-making for the classification of products by basing decisions on the following four criteria:
- Product Composition;
- Product Representations;
- Product Format; and
- Public Perception and History of use.
Individual applicants for product licenses who are affected by classification decisions where products are foods and not NHPs will be sent letters as decisions are made on their Product License Application.
In those cases where products are classified as foods and are subject to the requirements of the food regulatory framework, any required compliance and enforcement action would be under the jurisdiction of the Canadian Food Inspection Agency (CFIA).
In cases where products continue to be NHPs and subject to the requirements of the NHPR, Product Licence Applications will continue to be processed in accordance with Natural Health Product Directorate (NHPD) procedures. Any compliance and enforcement action as necessary would be taken by the Health Products and Food Branch Inspectorate (HPFBI).
This guidance document represents only the first tool in addressing the challenges of classifying and regulating these types of products and will be modified based on relevant feedback received during its implementation. Health Canada will be proceeding with the development of a series of questions and answers, a glossary of terms, and a template to help industry apply the criteria. These documents will be posted separately following the publication of this guidance document.
A workshop/brainstorming session with stakeholders (both industry and consumers) is being organized for April 2009 on risk mitigation strategies for NHPs in food formats. The input from this session will help to determine the best way to manage the health and safety issues associated with these products.
Should you have any questions or concerns regarding this guidance document, please do not hesitate to contact the undersigned.
Natural Health Products Directorate
Acting Director General