Regulatory Barriers to Trade for Consumer Health Products

May 28, 2012 By

By Dr. John Harrison, PhD, MSc, BSc
Senior Government Relations Advisor

So you want to import a consumer health product from the U.S.A. to Canada. Good luck! There are many regulatory inconsistencies, even for low risk health products, that become barriers to trade when a consumer health product company wants to import into Canada. Canadian consumer health product regulations under the Canadian Food and Drug Act are not all harmonized with similar U.S. products and, depending on the type of product you want your company to import to Canada, there are numerous barriers. Non-harmonized regulations create barriers to trade between countries such as the U.S. and Canada. Consumers are denied product choices and industry is denied the opportunity to offer these choices to the Canadian public.

Mutual recognition agreements (MRAs) are just that—agreements between countries to facilitate trade. Ideally you would think that MRAs would assist the Canadian importer and the U.S. manufacturer. Think again. MRAs don’t always exist to help the flow of goods such as health or self-care products between Canada and other countries. In fact, there is no MRA between Canada and the U.S. for consumer health products such as sunscreen products and most natural health products. Why is this?

Let’s talk about health risks for a moment. One of the guiding principles that Health Canada uses when considering the regulation of health products and foods under the Canadian Food and Drug Act is a risk-based approach to protecting health and safety. Low risk products would not require as much regulatory requirements as high risk products. The consumer health products, such as sunscreen products that require a Drug Identification number under the Canadian Food and Drug Act, are low risk from a health point of view. Excessive regulatory barriers such as items required by Canadian authorities but not required in the U.S. create barriers to getting a low health risk product like a sunscreen product imported into Canada. Why does this happen when there are options that Health Canada has to try to solve these challenges?

The U.S. regulatory authorities are apparently reluctant to move to an MRA and Canada does not appear to be making this a regulatory priority, despite the fact that this is a multi-billion dollar industry. Having participated in MRA discussions with the European Union on the topic of medical devices fifteen years ago, I know these discussions are lengthy but, if there is no movement or attempts by one side, things do not go anywhere as in the case of consumer health products. New approaches have to be developed by governments.

If Health Canada was to initially survey the consumer health product industry or at least conduct a stakeholder meeting to get an idea of how consumers and industry could be assisted by getting low health risk products to market, this would be a big step forward. Health Canada could ask the opinions of industry regarding what they think the main regulatory irritants of trade were and then develop a prioritized list of challenges that could be addressed to reduce these regulatory irritants. They could create a work plan with a time table and be proactive.

Canadian regulatory authorities in Health Canada responsible for the Food and Drug Act do have options. They can reinitiate MRA discussions and if the timetable for this looks to be too forward focussed, they can initiate discussions and pilot projects through the Trilateral Meetings (held among the U.S., Canada and Mexico). The priorities developed from stakeholder meetings can provide ideas of where to start. I know this can be done because I sat at the table of Trilateral Meetings a dozen years ago working in the area of foods, drugs and natural health and self-care products and watched pilot projects being raised by proactive officials from Health Canada. Applying risk related regulatory principles that are grounded in international norms for consumer health products should be the Health Canada goal to facilitate international trade. Those willing will find a way!

With this prioritized list of challenges and a plan to address them, Health Canada could begin to reduce the barriers to trade caused by un-harmonized regulations between Canada and the U.S. By listening to consumers and industry and facilitating trade, Health Canada will be able to focus on its mission of being responsible for helping the people of Canada maintain and improve their health and, additionally assist consumers by removing these regulatory barriers so people will have a wider choice of health products. You, as the owner or manager of a consumer health product company, would be able to import products into Canada without waiting years and expending the huge financial costs that are now required on this unequal regulatory playing field. Many of these low risk health products are now being sold in the U.S. Why should not Canadians have the option and freedom of choice to purchase the health and self-care products in Canada?

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at