New Draft Guidance Document – Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats

May 12, 2014 By

Health Canada releases draft food-natural health product classification guidance document with additional classification information.

When marketing and selling a food or natural health product in Canada it is important to be in compliance with the Regulations. This can be particularly challenging when your product does not meet the clear cut definition of a food or a natural health product. To assist the industry with product classification Health Canada has just released a new Draft guidance document on the Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats.

Since the creation of the Natural Health Products Directorate (NHPD) in 2004, many applications for Natural Product Numbers (NPNs) have been submitted for products in formats widely viewed as foods, with the consumer perception that these products can be consumed ad libitum. Juices, waters, energy drinks, and gummy products are being supplemented with vitamin and mineral ingredients outside the permitted fortification in the Food and Drug Act and Regulations or may make claims that force the product to be considered a natural health product.

In May 2010, an initiative was started to safely transition these food-like natural health products into the food regulatory framework, through either reformulation or the issuance of a Temporary Marketing Authorization Letter (TMAL). The primary goal was to ensure that these products that looked like foods and could be consumed as foods were regulated as Food products, allowing less regulatory hurdles and more incentive for innovative product development.

The purpose of this new guidance document is to help companies to determine if a product considered in a food format would be considered an natural health product or a food, on both a category and a case-by-case basis. This new guidance document is an update to the original guidance document released in 2010, and is open for consultation until May 28th, 2014. It expands the main criteria that will be reviewed when determining the classification of a product at the food-natural health product interface:

  • Product Composition
  • Product Representation
  • Product format
  • Public perception and history of use

An appendix to the existing Guidance Document has been included, which contains further details of the main criteria as it relates to specific classifications of food products. The following categories of food products are addressed in this guidance document:

  • Pre-packaged, Ready-to-Consume Drink Products
  • Products with Conventional Food Formats
  • Products with Conventional Food Formats – Confectionary Products
  • Granulated and Powdered Products
  • Granulated and Powdered Products and Other Formats – Beverage Mix Products
  • Granulated and Powdered Products and Other Formats – Natural Health Products in Powder, Granulated, or Gel Forms
  • Tea Products and Herbal Tea Products at the Food- natural health product Interface

When launching a product in Canada dicentra can assist you with determining whether your product meets the definition of a food or an natural health product and advise of the requirements and timelines for each category. dicentra can help ensure you have a clearcut path to market and avoid costly reformulation or border issues before a non-compliant product is launched.

Dicentra can assist you with reviewing and classifying your food or natural health product to ensure they are compliant with respect to their formulation and labelling and advise if a TMA or natural health product application is required. natural health product Consultant and FDA Consultant dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at or at 1-866-647-3279.