Natural Health Products - Over 43,000 Products authorized for sale and growing
The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.
Thank you for your patience and understanding.
The Government of Canada is committed to oversight for natural health products that protects consumers' health and safety while enabling them to choose from a wide range of alternative products that have been assessed for safety, effectiveness and quality.
The regulations define a clear timeline for assessing applications and timely access for Canadians to a wide range of NHPs.
As of December 31st, 2010:
- 25,919 product licences issued (representing over 34,900 products).
- 1,120 site licences issued.
- 6,795 Exemption Numbers (ENs) granted (representing over 8300 products).
Product Licence Applications and Amendments Approved per Year
Bar chart titled "product licence applications and amendments completed per year." The chart consists of seven bars each representing the total number of product licence applications and amendments approved by Health Canada for a specific year, beginning with the year 2004 and ending with the year 2010. The chart indicates a consistent increase in approvals since 2004. The figures are as follow: 191 product licence applications and amendments approved in 2004; 940 product licence applications and amendments approved in 2005; 1260 product licence applications and amendments approved in 2006; 2869 product licence applications and amendments approved in 2007; 5415 product licence applications and amendments approved in 2008; 8420 product licence applications and amendments approved in 2009, and 8819 product licence applications and amendments approved in 2010.
What is an NHP?
NHPs range from low risk products that consumers can choose for themselves at a store - for example, a vitamin supplement, to higher risk products that may require some sort of health care practitioner intervention - for example, fluoride rinses used only by dentists. NHPs cannot contain ingredients or amounts of ingredients that require a prescription at the federal level in order to be sold. These ingredients are ones that are listed on Schedule F to the Food and Drug Regulations. The presence of such an ingredient or amount of in a health product makes that product a drug.
The Regulations define NHPs as: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as Traditional Chinese Medicines, probiotics, and other products like amino acids and essential fatty acids. Other health products, such as certain toothpastes, shampoos, facial products and mouthwashes are also regulated as NHPs.
Since 2004, natural health products (or NHPs) have been regulated under the Natural Health Products Regulations, a unique regulatory framework that provides oversight for a separate and distinct category of products. NHPs are not regulated as foods or drugs, but rather have their own set of regulations which govern such things as the definition of what an NHP is, product labelling, manufacturing and evidence standards to support product safety, quality and health claims.
The Government of Canada is committed to ensuring that the ongoing regulation of natural health products continues to balance the protection of consumers' health and safety with the freedom to choose health products that have been assessed for their safety, efficacy and quality.
Learn more about the Natural Health Product Regulation :
Natural Health Products - The Evolution of Regulations
October 1997 to May 1998: The House of Commons Standing Committee on Health engages in broad consultations and ultimately recommends a distinct regulatory framework for natural health products. Its report " Natural Health Products: A New Vision" is tabled in the House of Commons.
March 1999: The Government of Canada accepts all 53 recommendations from the Standing Committee's report and the Minister of Health announces the creation of the Office of Natural Health Products within Health Canada, which is now the Natural Health Products Directorate (NHPD).
December 2001-June 2003: Draft regulations fornatural health product are created, pre-published via Canada Gazette for public comments, and finalized - with an understanding that they will come into force with a transitional period of two years for site licensing and six years for the Drug Identification Numbers (DINs).
January 1, 2004: The Natural Health Product Regulations (NHPR) come into effect. For the first time in Canada, NHPs have their own unique regulatory system designed specifically for this diverse category of products.
January 1, 2006: As of this date, Health Canada had approved 1,131 product licences and amendments and issued 145 site licences.
October 2006: Consumer Advertising Guidelines are issued to help advertisers meet all the relevant provisions of the Food and Drugs Act and Regulations, the Natural Health Products Regulations and other related Health Canada Policies and Guidelines. The publication of these guidelines provides increased assurance that natural health products sold in Canada are advertised and labelled appropriately to enable Canadians to make informed choices.
January 1, 2007: As of this date, Health Canada had approved 2,391 product licences and amendments and issued 473 site licences.
March 12, 2007: The Natural Health Products Regulatory Review (NHPRR) initiative is launched. Entitled, Charting a Course: Refining Canada's Approach to Regulating Natural Health Products, its purpose is to give stakeholders an opportunity to share their experiences with the Natural Health Products Regulations and to propose areas where the Regulations may be modified or strengthened. A total of 77 comments were received over a 60 day consultation period. The vast majority of respondents support the need for appropriate regulation for NHPs. A summary of the comments received is available in Health Canada's Final Report - Online Consultation: Natural Health Products Regulatory Review.
January 1, 2008: As of this date, Health Canada had approved 5,260 product licences and amendments and issued 619 site licences.
January 2009: Health Canada issues its Reconsideration Process for Natural Health Products to assist in resolving licensing disputes in a fair, transparent and timely manner, enabling companies to formally ask Health Canada to reconsider decisions that resulted in a natural health product being denied authorization for sale in Canada or a site being refused a licence to manufacture, package, label or import products for sale.
January 1, 2009: As of this date, Health Canada had issued 10,675 product licences and amendments and issued 828 site licences.
February 26, 2009: Health Canada officially launches the Natural Health Products Online Solution, a state-of-the-art electronic system to facilitate the completion and submission of licence applications. Since its implementation, the NHP Online Solution has enabled Health Canada to assess applications in a much timelier and efficient manner.
May 2009: Heath Canada publishes its Fact Sheet - The New Risk-Based Approach for Natural Health Products describing how Health Canada will further refine and improve its regulatory framework for natural health products, while assuring that Canadians have continued access to natural health products that are safe, effective and of high quality.
August 2009: Health Canada convenes the first meeting of its new Natural Health Products Program Advisory Committee (NHP-PAC). Consisting of members from the NHP industry, practitioners, researchers, and consumer and patient groups, the goal of the NHP-PAC is to provide Health Canada with advice and guidance on a number of topics relating to the regulation of NHPs, such as standards for evidence (SOEs), good manufacturing practices (GMPs), and compliance and enforcement. The NHP-PAC provides a fresh and comprehensive perspective on issues of interest which help inform and guide decisions that impact the manner in which NHPs are made available to Canadians.
January 1, 2010: As of this date, Health Canada had issued 19,096 product licences and amendments and issued 969 site licences.
August 2010: The new Compliance and Enforcement Policy for Natural Health Products is introduced to facilitate compliance with the Food and Drugs Act, the Regulations and the applicable administrative policies.
August 2010: The Natural Health Products (Unprocessed Product Licence Application) Regulations (NHP UPLAR) come into effect to help addresschallenges faced by consumers, health professionals and retailers due the presence of a number of unlicensed products on store shelves. The NHP UPLARallow for the legal sale of certain NHPs while their product licence applications are being fully assessed. Products exempted under the NHP UPLAR are granted exemption numbers (ENs) that must appear on the label. A database of exempted NHPs.
September 9, 2010: Health Canada publishes its Final Response to the Natural Health Products Program Advisory Committee: Report 1 - Standards of Evidence for Non-Traditional Natural Health Products describing how it will implement the 33 recommendations made by the NHP-PAC regarding the evidence standards for NHPs.
December 31, 2010: As of this date, Health Canada has approved 27,914 product licences and amendments and granted 6,795 exemption numbers (EN). This represents over 43,000 products that can be legally sold in Canada. In addition, 1,120 site licences have been issued.
Learn more about the Natural Health Product Regulation
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