In 2016 Health Canada began a consultation on an innovative and progressive concept to regulate cosmetics, OTC drugs and Natural Health Products. If brought to life, the idea would regulate these three categories on a continuum of risk, as opposed to three separate categories as they currently are regulated. This concept makes sense, and is consistent with how governments regulate everything from consumer products to serious prescription drugs. The consultation has however ignited a firestorm of controversy and underscores the challenge for a government agency to bring in sweeping change.
So far, the most forceful opposition to the Consumer Product Framework has come from the natural health community. While they have several concerns with this proposal, an important one is that Canada’s current Natural Health regulations are working just fine. When Canada’s rules for this new category came into force in 2004, they were completely unworkable. Companies were forced to apply for approval for their Natural Health remedies, only to find their applications languish in file boxes in Ottawa for years. To their credit, Health Canada has made enormous improvements to the system and it now works extremely well. Natural remedies are classified into three groups based on complexity and risk. The simplest ones can be approved in 10 days, and the most complex in 180 days with higher proof requirements. This is a great system.
So what’s not working in Canada’s regulatory scheme for these three categories today? The answer is easy. Simple OTC drugs like sunscreens still have regulations that bear too many similarities to prescription drugs. If a company wants to import their sunscreens into Canada, it can take years and hundreds of thousands of dollars to bring their systems up to pharmaceutical standards. This is just wrong and wastes both public and private sector resources at a time when these are so precious.
We are hopeful that Health Canada will be able to find a compromise solution that satisfies all sectors. If the proposed framework proves too ambitious and gets bogged down in stakeholder opposition, there a reform that could be easily implemented. Simple OTC drugs like sunscreens should be moved to the same process that is followed by natural health remedies. These require a simple Health Canada approval and some importation oversight but not nearly as extensive as with drugs. This is by no means a stretch and is not a significant risk. Some sunscreens such as those that use zinc or titanium as sun filters already are regulated as Natural Health Products. A simple administrative change like this would be a revolution for the industries involved and would save enormous resources for both the government and the companies trying to remain competitive.
If you need assistance determining how the proposed regulatory framework may affect your consumer products, please do not hesitate to contact Focal Point Research Inc. We are leading Canadian regulatory consultants for natural health products, OTC drugs, cosmetics, and other personal care products.