Proposed fees for natural health products: Overview

Organization: Health Canada

Date published: May 2023

Cat.: H164-350/2023E-PDF

ISBN: 978-0-660-41531-4

Pub.: 230061

On this page

• Introduction
• Background

Introduction

Health Canada is the federal department responsible for helping people in Canada maintain and improve their health. One of the roles we play in carrying out this mandate is that of a regulator. As a regulator, we evaluate products before they are authorized for sale, monitor these products once they are on the market, and oversee compliance and enforcement.

These regulatory activities incur costs to the federal government and provide benefits to the regulated industry. Health Canada charges industry fees to cover a portion of these costs. This practice of establishing fees is referred to as cost recovery and has been in place for certain health product lines since the 1990s. By pursuing cost recovery, we make sure that our activities do not rely solely on public funding (taxpayers).

Health Canada's authority to set and charge health product fees comes from the Food and Drugs Act (FDA). Currently, we have cost recovery in place for various regulatory programs, including those related to human and veterinary drugs, and medical devices.

To promote transparency and accountability when setting fees, we consult and engage with industry stakeholders. When proposing a new set of fees, we establish a fee proposal for their review and comment.

To accurately set fees and develop a robust cost-recovery program, Health Canada:

• calculates the costs of regulated activities
• establishes corresponding fee amounts and performance standards
• for example, the time for us to evaluate a new product application
• puts in place appropriate fee mitigation and remission measures

Once fees are implemented, industry stakeholders will pay to receive specified regulatory services, regulatory oversight and maintain access to the Canadian market.

Background

Natural health products

Health Canada defines natural health products (NHPs) as naturally occurring substances that are used to restore or maintain good health. They are often made from ingredients such as plants, animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.

NHPs include:

• vitamins and minerals
• herbal remedies
• homeopathic medicines
• traditional medicines like Chinese and Ayurvedic (East Indian) medicines
• probiotics
• other products like amino acids and essential fatty acids

Many everyday products used by consumers, such as certain toothpastes, antiperspirants, shampoos, facial products and sunscreens, are also classified as NHPs in Canada.

In Canada, oversight of NHPs falls under the Natural Health Products Regulations (NHPR) of the FDA. These regulations came into effect on January 1, 2004, after we consulted extensively with stakeholders and the public to determine an appropriate regulatory framework for NHPs. The regulations help people in Canada access a wide range of NHPs that are safe, effective and of high quality.

To be legally sold in Canada, NHPs must have a product licence and the Canadian sites that manufacture, package, label and import these products must have a site licence (SL). To obtain product and site licences, labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.

According to the 2011 Functional Foods and Natural Health Products Survey, the NHP industry in Canada had annual sales of $5 billion CAD. While a similar survey has not been conducted since 2011, there is further indication that the industry continues to grow. As of 2022, Health Canada had licensed over 120,000 NHPs (although about half of these do not appear on the Canadian market). Every year, we receive an average of 10,000 applications for product licences.