October 3, 2016
389 Regulating Natural Health Products [3 Oct 2016]
Canada is a global leader in the regulation of natural health products (NHPs). The current system is based on 53 recommendations made by the Standing Committee on Health (SCOH) in 1998. The SCOH considered hundreds of submissions by consumer groups, Health Canada, the Canadian Food Inspection Agency, and international regulators over 6 months of consultation. Based on this consultation process, an appropriate framework was developed for the regulation of natural health products.
The Natural Health Product Regulations came into effect in 2004 with the Natural Health Products Directorate, a branch of Health Canada, established to oversee the regulations. The NHPD is responsible for licensing natural health products, approving labels, reviewing evidence for health claims, licensing manufacturing sites, compiling reported adverse reactions, and ensuring that Good Manufacturing Practices are in place. When satisfied, the product is approved for sale and an NPN number is issued. All this information is archived in a public database on Health Canada’s website.
Over the next 9 years the NHPD reviewed submissions for 70,000 natural health products, finally getting caught up in 2013. Since then all natural health products are pre-approved before allowed on the Canadian market (over 109,000 to date). The level of evidence required for approval depends on the risk of the product and the claims being made. The natural health product industry worked with the NHPD spending much effort, time and money in the process. There were some products lost, others (like tryptophan) gained that were unavailable before.
The NHP regulation process is running smoothly. Consumers can shop in Canadian health food stores with confidence in the quality, safety and effectiveness of our natural health products. Now Health Canada wants to change the system.
Based on a small survey and only six weeks of consultation (currently underway) Health Canada wants to implement a completely different system where natural health products and drugs are regulated together based on risk assessment. While there may be some advantages to this system (whatever it will be) you can be sure that it will mean the loss of many safe, effective products and a sharp price increase on the rest, with no obvious benefit to the public. If this concerns you, write to your local M.P. Visit chfa.ca for more information.
For more information on this or other natural health topics, stop in and talk to Stan; for medical advice consult your licensed health practitioner.