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In Canada, natural health products (also known as complementary medicines or traditional remedies) are subject to the Food and Drugs Act and Regulations.
Internationally, the regulation of natural health products varies. Generally they are regulated as drugs in European Union countries. Australia has classified many of these products as "complementary medicines" and has made legislative and regulatory changes to regulate these products as a subclass of "therapeutic goods." In the United States, many natural health products are regulated as "dietary supplements," which means they do not require pre-market review or proof of safety by the manufacturer before marketing, and they cannot make treatment/cure claims.
Interest in natural health products continues to grow. Studies show that over 70% of Canadians use some form of natural health products regularly. As the use of natural health products has become more widespread, it became apparent that a review of the current Canadian regulatory framework was needed.
Many Canadians began expressing concerns about the regulation, safety and accessibility of herbal remedies. Health Canada responded by creating the Advisory Panel on Natural Health Products. The Panel provided the Department with direction and advice.
The Minister of Health announced a full public review of the legal regime governing natural health products by the House of Commons Standing Committee on Health. The objective of the review was to strike a balance between Canadians' freedom of choice with respect to natural health products and consumer safety. The review also looked at what would be an appropriate regulatory framework for natural health products in Canada.
The House of Commons Standing Committee on Health consulted a wide range of interested parties both at home and abroad. It heard from over 150 individuals, associations and coalitions representing many Canadians, including: health care providers, industry, consumer groups, herbalists, and the Advisory Panel on Natural Health Products. The Committee prepared recommendations for a distinct regulatory framework for natural health products.
Health Canada's Advisory Panel on Natural Health Products presented its final report, Regulatory Framework for Natural Health Products, to the House of Commons Standing Committee on Health.
The Standing Committee on Health tabled its report, Natural Health Products: A New Vision, in the House of Commons. At that time, the then Minister of Health, Allan Rock, announced he would move quickly to address their recommendations.
The Minister of Health tabled the Government Response to the Standing Committee on Health's Report, Natural Health Products: A New Vision, in the House of Commons. The Government accepted all 53 of the Standing Committee's recommendations and said that these would form the basis of the broad policy framework for natural health products. The Minister of Health also announced the creation of the Office of Natural Health Products (now the Natural Health Products Directorate), which would give Canadians the assurance of safe products while continuing to provide access to a full range of health products.
On May 19, 1999, the Minister of Health announced the appointment of a 17-member Transition Team to help set up the new Directorate and its regulatory framework. The Standing Committee on Health recommended the creation of the Transition Team in its report so that a new regulatory framework could be created quickly. The Team included 14 members from the natural health private sector, as well as representatives from Health Canada.
Health Canada, in co-operation with Dalhousie University, held a Natural Health Products Research Priority-Setting Conference in Halifax, Nova Scotia from November 6-8, 1999. Over 60 representatives from the scientific, government, academic, industry and community sectors took part in this unique opportunity to determine a direction for research activities in the area of natural health products.
The Assistant Deputy Minister, Health Protection Branch, announced the appointment of Philip Waddington, Doctor of Naturopathy, as the new Director General of the Natural Health Products Directorate.
The Transition Team worked diligently throughout ten months to find ways for the Directorate to implement the 53 recommendations made by the Standing Committee on Health. The team produced six reports that highlight their progress during this period.
The Transition Team submitted to the Minister of Health their final report, called Final Report: A Fresh Start. The report summarized the discussions and recommendations of the Transition Team meetings and outlined broad policy directions toward a regulatory regime for natural health products. An Expert Advisory Committee was also formed to advise the Director General of the Directorate on issues related to the safety, use and regulation of natural health products.
The Natural Health Products Directorate conducted open consultation meetings with interested Canadians across the country on the proposed regulatory framework for natural health products. Over 2,100 participants in 11 cities (Ottawa, Kingston, Halifax, Fredericton, Montréal, Québec, Vancouver, Calgary, Regina, Winnipeg and Toronto) took part in the meetings. The Natural Health Products Directorate heard from industry representatives and associations, consumer associations, professional associations, academics, consumers and various government bodies.
A second version of the proposed regulatory framework was drafted and released at the end of March 2001. Phase II of the consultation process was held between March and May 2001. Feedback was accepted on the proposal, and targeted stakeholder consultation sessions were held at the request of stakeholders.
On September 28, 2001, a working draft of the proposed regulatory framework was shared with stakeholders through the Natural Health Products Directorate's website. Updates on outstanding issues were also communicated on the website.
As the Natural Health Products Directorate moved toward the regulation of natural health products, an industry working group was formed to allow the Directorate to continue communicating with and consulting industry. This group, in addition to other stakeholders, provided the Natural Health Products Directorate with timely advice about the planning and implementation of the proposed regulatory framework for natural health products.
On December 22, 2001 the proposed Natural Health Products Regulations were pre-published in the Canada Gazette, Part I. A public comment period began on this day and ended on March 22, 2002. The Directorate received over 600 submissions during this comment period and undertook an in-depth analysis of them.
The Directorate completed a cross-country consultation on its Good Manufacturing Practices for Natural Health Products Guidance Document. Information workshops were held in six cities (Halifax, Montréal, Toronto, Winnipeg, Edmonton and Vancouver).
The Directorate proceeded with cross-country information and town hall consultations on the proposed Standards of Evidence (SOE) for the evaluation of safety and claims of natural health products in five cities (Halifax, Saskatoon, Toronto, Vancouver and Montréal).
To better understand the financial impact of the proposed Regulations on the natural health product industry, the Natural Health Products Directorate undertook a Business Impact Test from December 6, 2002 to January 22, 2003. A total of 108 responses were received and reviewed, a robust sample representing all business activities, sizes, product types and provinces.
The Natural Health Products Directorate published the Natural Health Products Regulations in the Canada Gazette, Part II, followed by a short period to come into force.
The Natural Health Products Regulations came into force on January 1, 2004, with a transitional period: two years for site licensing and six years for licensing products with Drug Identification Numbers (DIN).
A regulatory review was launched to meet the Government's commitment to review and refine the Natural Health Products Regulations within 3-5 years of their implementation.
Because of a backlog in product licence applications, Health Canada published the Natural Health Products (Unprocessed Product Licence Applications) Regulations. These new regulations allow for the legal sale of "exempted" products which do not yet have a product licence, but which passed an initial assessment for information and safety criteria, giving Health Canada more time to evaluate them fully.
For more information, see About Natural Health Product Regulation in Canada.
Many stakeholders have invested significant time and effort in participating in this consultation process. The Natural Health Products Directorate would like to take this opportunity to thank our stakeholders for their valuable contribution.