Natural Health Product Raw Material Policy: Overview

On this page

• Disclaimer
• Introduction
• Purpose
• Scope
• Background

Disclaimer

This document does not constitute part of the Food and Drugs Act (the Act) or the Natural Health Products Regulations (the Regulations) and in the event of any inconsistency or conflict between the Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Introduction

The Regulations do not specify whether raw materials are or are not included in the definition of a natural health product (NHP). The NHP definition does not clearly differentiate between:

• raw material (for example: ginger root that has just been harvested) or
• finished product (for example: encapsulated ginger that is packaged and labelled for the consumer).

The intent of the Natural Health Product Raw Material Policy is to clarify at which point a substance is considered a finished NHP, and when product and site licensing requirements are applicable, as per the Regulations.

The Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada recognizes the need to distinguish between the terms raw material and finished NHP in order to help stakeholders determine whether or not a site licence is required for a particular activity associated with the product and whether a product licence is required for the substance.

Purpose

The purpose of this document is to:

1. Provide guidance on when a substance is considered a raw material or a finished NHP based primarily on the intended use and representation and whether product and site licensing requirements apply.
2. Provide a policy framework to assist in distinguishing between activities that are licensable (manufacture, package, label and/or import) for NHPs versus those that are not.

Scope

The NHP Raw Material Policy clarifies at which point a substance:

• becomes a finished NHP and therefore needs to comply with product and site licensing requirements as per the Regulations, or
• remains a raw material, for which these requirements do not apply.

The primary way to distinguish between the two is based on the intended purpose of use of the substance.

This policy applies to:

• substances listed under Schedule 1 of the Regulations (Included Natural Health Products Substances)

This policy does not apply to:

• substances listed under Schedule 2 of the Regulations (Excluded Natural Health Product Substances)

Background

The Regulations set out the requirements for NHPs in Canada for the:

• Sale
• Manufacturing
• Packaging
• Labelling
• Importation
• Distribution
• Storage

Additional clarification is needed to distinguish between when a substance meets the definition of an NHP, as defined in the Regulations, when it is considered a finished NHP or raw material, or when it would fall outside the scope of the Regulations.

In 2006, NNHPD released the first iteration of the Natural Health Product Raw Material Policy following consultation with a broad range of practitioners, including pharmacists, Traditional Chinese Medicine practitioners, herbalists and naturopathic doctors.

In 2025, NNHPD gathered input from practitioners and provincial licensing bodies to more clearly distinguish raw materials and finished NHPs. This updated policy offers clearer guidance to support compliance and addresses longstanding questions in the field. This revised version replaces the 2006 policy.