The Natural Health Products Directorate (NHPD) is tasked with the important responsibilities of framing legislative proposals to help ensure the safety, quality, and efficacy (effectiveness) of natural health products for sale in Canada, and assessing product regulatory license applications for safety, quality, and efficacy, under federal and Health Canada mandates. Natural health products that have completed NHPD/Health Canada assessment for safety, quality, and efficacy are granted Natural Product Numbers (NPNs).
Cautions and durations of use recommendations that go on NHPD/Health Canada approved labels of natural health products are based on the available literature and other available information (e.g., international expert committee reports and international regulatory body decisions) provided by license applicants to NHPD/Health Canada and/or available to NHPD/Health Canada, and NHPD/Health Canada assessment of the literature/information. A guiding principle of the mandates of NHPD and Health Canada is to minimize health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products, and balancing that with the potential health benefits of health products. Their highest priority in determining the health risk-health benefit balance is public safety.
The statements “consult your health care practitioner …” if you suffer from certain health conditions or beyond the use of x months are sometimes required to appear on labels for certain ingredients, based on literature and information. Unless it is clear-cut that certain cautions or recommended durations of use are not required, the statements appear on the label precautionarily and conservatively. For example, vegetarian sourced, oral hyaluronic acid has been clinically studied in Japan and North America with ample evidence supporting its safety. However, due to logistics of the study designs themselves, the longest published study of intake of vegetarian sourced, oral hyaluronic acid has been three months. This is not to say that hyaluronic acid is unsafe after three months of long-term use, just that there is no clinical evidence to support long-term use beyond three months, and that it is in the best interest of patient safety that patients choosing to taking hyaluronic acid long-term beyond three months also consult with their health care practitioner. The cautions are recommended by NHPD/Health Canada for consumer education and information, in order to help guide you in making your own informed decisions about your health.
Since the Natural Health Products Regulations were introduced in 2004, a process has been ongoing to license and regulate natural health products in Canada, a large number of which were already on the market. Since its implementation, AOR has been supportive of federal legislative efforts to modernize the NHP regulatory framework. AOR currently has over 221 NPNs, and remains committed to supporting Health Canada’s NHP licensing process, and its principles of ensuring safety, quality, and efficacy of NHPs for the Canadian public.
However, natural health products range from simple to complex formulations, and many new license applications are received daily by Health Canada. To help address the backlog of product license applications, and to implement improved assessment time standards, the Natural Health Products Regulations allow for the legal sale of a category of NHPs for which Health Canada has not yet issued a regulatory product license (within six months of application submission acknowledgment), but are in process of assessment for safety, quality, and efficacy. This allows certain natural health products to continue to be sold in Canada while they complete the full licensing process. Such products are granted an exemption number (EN) in the interim.
Dr. Mary Chou is Senior Scientist and Head of Clinical Research & Regulatory Affairs of AOR. She also holds an appointment on Health Canada’s advisory committee on federal regulation of natural health products (Natural Health Products Program Advisory Committee, NHP-PAC). Dr. Chou holds a BSc in Cellular, Molecular, & Microbial Biology, and an MSc and a PhD in Medical Biochemistry & Molecular Biology specializing in cancer research, from the University of Calgary. She has presented her doctoral research at several international conferences, and has published many peer-reviewed studies and articles."The opinions of those who submit comments on this page are not necessarily those of AOR or Dr. Nibber".Share