Regulations Squeezing Natural Health Products Industry
by HANS staff
Source: Health Action, Winter 2009/2010
A new national campaign by Canada's largest trade group for natural health products (NHPs) highlights the immediate problems facing items in the natural health aisle.
"Save Our Natural Health Supplements," launched in October 2009 by the Canadian Health Food Association (CHFA), urges the federal government to revisit the regulations governing the NHP industry.
"The availability of new naturalhealth products will be significantly reduced unless immediate improvements are made to the product licensing process. Without significant changes, the industry's revenues, profitability and viability in Canada will be at risk," stated
a recent CHFA media release.
Since 2004, the NHP industry has been implementing regulations governed by the Natural Health Product Directorate of Health Canada.
During the past five years, more than 41,000 product license applications have been filed-a process involving considerable expense and effort by manufacturers and suppliers wishing to continue selling products in Canada.
In five years, only 16,000 applications have been approved. More than 10,000 applications currently wait to be evaluated in a backlog of political making-a backlog that seems to have gotten worse not better, despite political promise (read previous analyses at www.hans.org).
Health Canada's deadline of April 2010 is rapidly approaching and many natural health products now sold are stuck in a regulatory quagmire without a natural product number (NPN) and thus are at risk of being removed from the market.
Regular readers of Health Action magazine will be aware of this issue as we have been reporting on it since 2007.
License applications for almost 10 percent of the 41,000 products that millions of Canadians rely on to support their health have been refused or withdrawn after sometimes impossible requests for more information.
The bulk of natural health products are of safe, high quality yet do not conform to the scientific requirements of the current regulatory process, which is better suited to high-risk pharmaceuticals than low-risk supplements.
AOR, for instance, is a Calgary-based supplements company with a reputation for high-quality, effective products. However, of the approximately 170 product license applications that they have filed, only 41 have been approved.
Preferred Nutrition is another example. The distributor for Lorna Vanderhaeghe, Brad King and Julian Whitaker health products, they have received only 21 licenses for the hundreds of products once in queue.
Here are the results for a few other popular supplement brands:
New Chapter: 21 licenses.
New Roots Herbal: 22 licenses.
Enerex: 25 licenses.
To determine whether your favourite products have been approved, search the Licensed Natural Health Products Database at Health Canada.
The situation is at a worrisome stage. According to the CHFA, "A revised standards of evidence proposal was developed by the industry with input from a broad cross-section of NHP suppliers. Essentially, it provides for softer benefit claims (eg: promotes prostate health) based on appropriate evidence while, at the same time, preserves stringent requirements for more serious, therapeutic claims. The complete proposal was presented to Health Canada in concept form in January 2009 with a more complete proposal presented in June. Still there is no change in NHPD's review strategy and Health Canada's 2010 deadline to enforcement continues to draw closer."
The bulk of the industry agrees that current requirements for licensing are unrealistic and inappropriate.
Another faction of the industry goes further than the CHFA's campaign by urging the government to suspend the regulatory process until appropriate amendments to the regulations are made. This faction is headed by the Natural Health Products Protection Association.
Health Canada says concerns are unwarranted, that product licensing is an ongoing task, and that they are working towards the 2010 deadline.
For more information, visit www.chfa.ca and www.nhppa.org.
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