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January 7, 2002
OTTAWA, Ontario--The Canadian government published proposed regulations for the country's dietary supplement industry that would stop regulating the products as food or drugs but instead as health products. Published in the Dec. 22 Canada Gazette (http://canada.gc.ca/gazette/part1/ascII/g1-13551_e.txt), the document details the steps to create a new set of regulations specific to natural health products (NHPs).
These regulations would fall under the Food and Drugs Act and would be overseen by Health Canada's Natural Health Products Directorate (NHPD), which reports to the Assistant Deputy Minister of the Health Products and Food Branch. "[NHP] Regulations would provide Canadians with ready access to NHPs that are safe, effective and of high quality, while respecting philosophical and cultural diversity," the report's authors wrote.
The report was presented by the Advisory Panel on Natural Health Products, the House of Commons Standing Committee on Health and the Transition Team (appointed by the Standing Committee). The proposed rule process began in 2000, when the committees met with more than 2,100 consumers, stakeholders and industry members. Over the past two years, NHPD regularly asked for comment from the public in regard to the regulatory framework. Via these communications, the Standing Committee found that product users want assurances of safety, quality and efficacy, as well as evidence that supports health claims through a system of pre-market product review.
Currently regulated under the Food and Drugs Act and the Food and Drug Regulations, the panel and committees came to their decision after weighing what other world governments were doing around the world. In their report, they state, "Countries such as Australia and those of the European Union consider these products to be drugs. The United States exists as an anomaly, having classified many natural health products as `dietary supplements' . [and which permit] only limited health claims that are not assessed by the regulatory authority and allows marketing without proof of safety."
In terms of costs, the NHP industry would bear most of the expenses in implementing these rules. The report's authors noted that those NHP manufacturers that also produced pharmaceuticals would not be significantly impacted by the costs. However, those companies specializing in NHPs, without the benefit of pharmaceutical revenues, "would probably incur some substantial costs." The government will be paying for certain areas, such as administration, product licensing, site licensing, inspections, compliance and enforcement.
The regulations cite that a "natural health product" is a substance or combination of substances that include homeopathic remedies and traditional medicine. These NHPs may be "manufactured, sold or represented for use" in the diagnosis, treatment, mitigation or prevention of a disease, disorder or physical state; in restoring or correcting organic functions; and in maintaining or promoting health or otherwise modifying organic functions. Highlights from the proposed regulations include:
* Ingredients with Latin names must be labeled on a product with their genus and species.
* Products must be labeled with suggested duration of use.
* Products must have risk information involved with usage.
* Recommended product usage must be in accordance with previous applications in humans and/or clinical trials.
* The Minister will have 60 days to review NHP applications before giving a license to sale the product.
* Those who sell NHPs will prepare an annual report of adverse events reported in Canada, which will be submitted to the Minister.
* Those who sell NHPs must manufacture, package, label, import, distribute and store products according to Canada's Good Manufacturing Practices (GMPs).
Any comments in respect to these regulations may be directed to NHPD at [email protected]. The comment period is open until March 23, 2002.
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