Unless a person is completely immersed in the business of
natural health product (NHP) licensing, the status of NHP regulation in Canada is difficult to keep up to date on, understand or fully appreciate. To be sure, though, we are in the midst of a regulatory crisis. Anyone who says differently is trying to sell you something.

NHPs have been subject to government scrutiny under new regulations from the Natural Health Products Directorate (NHPD) of  Health Canada since 2004. The next seven months, however, will be the most crucial time in determining the future availability of NHPs.

The NHP industry has been struggling to meet the evidence requirements for the last five years. A "transition period" intended to allow the industry to get accustomed to the regulations ends March 31, 2010.

Meanwhile, Health Canada is nowhere close to meeting any reasonable performance standard in licensing NHPs. The issue at hand isn't that NHP manufacturers haven't made the effort to comply with regulations; it's that they have a regulator incompetent in understanding complex products.

As the transition period ends, products are expected to have licences. If they don't, they could be removed from
the market, despite the enormous licence application failure rates and an escalating backlog in the approval process at Health Canada. Still, the deadline continues to
be March 31, 2010, with no commitment from Health Canada to cooperate with the NHP industry.

Vitamins on the political stage In the 1990s, the Canadian public was outraged when Health Canada began banning their favourite NHPs. Products suc as melatonin were physically removed from shelves by the Therapeutic Product Inspectorate and, occasionally, with the help of the RCMP. The products were available in the US, but the high-handed Canadian Directorate was running their own show. Canadians were furious.

In 1997, a very powerful lobbying effort on Parliament Hill had a tremendous impact-the Minister of Health provided for Parliament to make a formal study of NHPs. A few years later, it was unequivocally mandated by the Minister of Health that NHPs should not be subject to pharmaceutical standards because they are (for the vast majority) inherently safe products, and that new expertise was needed to regulate these products. The NHPD was born.

The NHPD was mandated to create regulations governing NHPs. Five years later, in 2004, the NHPD opened its doors
to evaluate the safety, efficacy and quality of NHPs, but the process has gotten off track. While it's true that the simple, popular products (like MSM, melatonin and fish oil) now experience little difficulty getting a licence, complex (multi-ingredient) combination products have an incredibly high failure rate. Today, the failure rate of licence applications for innovative, complex products is around 82 per cent.

Unless a product has only one or two ingredients, the NHPD is incapable of processing an NHP application in accordance with their own regulations. They are almost always asking for randomized clinical trials when analyzing these innovative products but, for the most part, such strictly scientific studies simply are not appropriate and do not exist. When such studies do exist, they do not show exactly what the NHPD would like them to. In other words, the NHPD is applying a biopharmaceutical model of academic analysis to the NHP industry, which just doesn't fit (as the formal study of NHPs back in 1997 concluded).

No patents on nature
The biopharmaceutical model only works well for very simple chemical entities, such as a synthetic drug. A drug can be analyzed, measured, absorbed and quantified. But this so-called "reductionist" model is useless for most NHP products. NHPs are too complex, as is nature itself-they are more holistic in both their composition and effectiveness. Tomatoes, for example, contain thousands of known nutrients that are thought to promote health; how can each nutrient be quantified, measured and examined? And who would pay for this research? NHPs cannot be patented, and pharmaceutical companies (who sponsor a hefty amount of the health research today) have no protected interest in studying NHPs.

NHPs are natural substances (many people would call them medicines) with a high safety profile, no intellectual property privileges, little research incentives and thousands of years of safe, traditional use, but Health Canada is trying to judge and regulate them like drugs.

In addition to inappropriate means of approving NHPs, the NHPD has an escalating backlog that grows every day. Their rate of incoming applications is remarkably constant; however, their licensing rates have not improved. The
NHPD is "committed" to clearing the backlog by March 31, 2010.

However, the NHPD appears prone to over-optimism. They have been singing the same song since 2005. In reality, it is taking the NHPD approximately two years to review
an application- and each day processes fewer
applications than they receive.

A step ahead of enforcement
In late June 2009, the Canadian Health Food Association (CHFA) and several of its members met with the NHPD to discuss standards of evidence and quality testing and enforcement, among other issues.

The NHPD has acknowledged that the standards of evidence for product licensing may not be appropriate to the generally low-risk nature of NHPs. This has been the most encouraging step forward in a long time for the NHP industry, which has been working for years to make themselves heard while they struggle to comply.

The NHPD is also acknowledging that quality testing is too onerous for the NHP industry and does not reflect the intent of the NHP regulations.

The fact remains, however, that Health Canada will soon launch its NHP regulation enforcement campaign, stating that products without a licence will be removed from the shelves. This threat is very real, and, despite a twoyear backlog, Health Canada is making no provision for its own potential failure in the process.

Canadian consumers are not without recourse. Everyone who cares about NHPs should write to their Member of Parliament and/or ask for an appointment. Speaking up can make a difference. Meeting with your MP is your democratic right, and this industry needs your help. Health Canada is not the enemy, but they need to know they're off course. Tell them. Tell your MP. Participate in the democratic process and make sure your voice is heard.


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Brian Wagner is the president of NHP Consulting Inc, a natural health regulatory consultant in the manufacturing and scientific industry, and is a member of the CHFA and Industry Roundtable.

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