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Compliance and Enforcement of Natural Health Products in Canada, the New Landscape

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There were many times when I had left Health Canada Natural Health Products Advisory Committee (NHP-PAC) meetings more frustrated than confident that full regulation of pre-market Alternative Medicine.approval, and compliance and enforcement, of natural health products (NHPs) in Canada would ever take ground. In one corner, we had pharmaceutical stakeholders pushing for stricter standards of evidence for safety, efficacy, and quality.  In another corner, we had the passionate consumer/patient stakeholders digging their heels in and lobbying (almost stalking) their MPs and Health Canada Senior officials to not over regulate, and to not limit their choices of natural health products and their rights to tailor their own personalized health regimens (barring any high safety risk).  Understandably, when it comes to consumer protection, and the safety, efficacy, and quality of natural health products, nothing should be glossed over. Although the process was arduous, slow, and bumpy, Health Canada ultimately kept its resolve. It was never a matter of if there would be full regulation of natural health products, it was always a matter of when.

In the thick of it, however, even as there was progress being made towards framing our current-day NHP regulations with each conference call and meeting, pushback from every angle threw doubt on whether the regulations would ever be fully enacted. There were long months (and years!) of confidential discussions between stakeholders, lobbyists, MPs, and senior Health Canada officials, details of which were often not publically disclosed at every turn. Indeed, there were many factors that led to Canada’s ten year progression to our current-day natural product regulations mandating pre-market approval, enforcement and compliance. But it definitely didn’t help to cloak the resolution of competing interests and bureaucratic procedures on such a hot button issue, even for the sake of confidential discussion and productivity. To top it all off, in the world of legislation, nothing is ever guaranteed until the last draft of regulatory guidelines.  As an industry stakeholder, AOR was supportive of regulation of NHPs from day one, as we believe that there should be regulation in any industry, but not overregulation so as to put up barricades to R&D, innovation, growth, and international competitiveness. As industry is subject to supply chain and market timing, we did, however, require clarity on the final regulatory guidelines and certainty on the timelines for enactment, compliance and enforcement. 

Finally, the date for enactment of regulations for pre-market approval for natural health products was announced: December 1st, 2013 was the date past which manufacturers/packagers and labelers could only sell NHPs that have regulatory market authorization (i.e. NPNs and DIN-HMs).  And September 1st, 2014 will mark the end of the transition period for distributors/retailers, after which distributors/retailers can only sell NHPs that have regulatory market authorization. In short, September 1st, 2014 is when the NHP Regulations and Compliance and Enforcement Policies come into full effect.  

No more excuses. Although the period was fraught with uncertainty, the time leading up to enactment of the NHP Regulations was plenty for stakeholders. And the transition period for the coming into full effect of the NHP Regulations and Compliance and Enforcement has been ample, giving manufacturers and distributors/retailers enough time and opportunity to transition into compliance.

Health claims on nutraceuticals/natural health products/functional foods have become an increasingly important policy issue. The growing burden of health care costs remains a concern in Canada and other countries with publically funded health care systems. Around the world, governments are seeking effective ways of minimizing health care costs and maximizing citizens’ health. This is exacerbated by the rise of diet- and lifestyle-related diseases. The relationship between diet and health is becoming increasingly important in the context of ageing populations globally. Healthier diets today may lead to fewer diseases tomorrow – and the consumption of nutraceuticals/natural health products/functional foods provides an avenue for improving citizens’ health. So, the potential effects on public health care costs of increasing the consumption of nutraceuticals/functional/healthier foods is of major policy relevance. The pre-existing and continuing challenge, in Canada and internationally, remains balancing consumer protection from misleading health claims with a regulatory environment that encourages investment in R&D in products with positive health benefits for consumers. 

Regulations on nutraceuticals/natural health products vary from country to country. Some countries treat natural health products in a similar manner as food. Japan and China are prime examples of this, making little or no legal or regulatory distinction between food and pill form. The United States does distinguish between food and natural health products (dietary supplements), but does not impose significantly different regulations (the same claims are available to food and to dietary supplements).  New Zealand treats natural health products (dietary supplements) like food, but does not permit certain claims (including disease risk reduction claims) on supplements. The EU treats food supplements as a food, but significantly limits food supplements to only approved vitamins and minerals. Then there are countries that treat natural health products in a crossover zone between food and drugs. Canada, Australia, and Brazil all regulate natural health products differently than food by using a product-specific system, with a more substantial level of evidence required. South Korea extends the example of this type of regulatory system, categorizing functional foods as natural health products, and requiring licenses even for vendors of the products, not just the producers. 

Currently, the global framework for nutraceutical/natural health product regulation is national regulation, with regulations varying from country to country. However, one can envision that there may be untapped benefits in international regulation and harmonizing regulations across borders. There is movement among regulators to support this; by recognizing the benefits of international regulation for boosting more international trade, academic/business collaboration, and innovation.  It would make it easier for firms to export and import goods, and also provide firms with access to larger markets.  For, example, with the FDA New Dietary Ingredient (NDI) draft guidance (at least for new ingredients) the US and Canadian regulatory systems begin to look more similar. In the reality of implementation though, it will be difficult to change entrenched regulatory systems, especially where some countries have relatively more stringent regulations and the other countries have relatively more lax regulations.

As the Canadian regulatory system for NHPs continues to evolve, insights from other regulatory jurisdictions can provide useful lessons. The relatively smaller size of the Canadian domestic market means that substantial differences between Canadian regulations and those of major export markets could inhibit investment in nutraceutical/natural health product/functional food development in the Canadian market. As always in health product regulation, the challenge remains to balance consumer protection from misleading health claims with a regulatory environment that encourages investment in R&D in products, both providing positive benefits for population health. NHP regulation is a work in progress nationally and globally, and there is still a lot to merge in the landscape. Balancing, sustaining, and improving population health with scientific progress/innovation, consumer interests/demands, stakeholder interests, interest group lobbying, and political factors are a few of these mergers. At the crux of this all, we need to take ownership of our regulatory policies and our health care system in Canada!  The way to continue to shape policies into ones that best meets our needs is to voice our thoughts to our MPs and stakeholder groups, whether supportive or critical of the current framework. This is the only way to ensure continued evolution of our health regulatory and health care systems to benefit our best interests and the health of our population overall.

Who are the Natural Health Products Directorates (NHPD)? Click here for more information.

Image by © 2013 gitusik via DollarPhotoClub

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