In Canada, sunscreens are sold as either Drugs or Natural Health Products (NHPs). Sunscreens are considered NHPs if their active ingredients are either titanium or zinc oxide. All other sunscreens are drugs.
The drug classification brings with it extremely onerous requirements, almost impossible for small to medium size companies to meet. It is in fact more difficult to import an SPF 15 foundation classified as a drug, than to import a multivitamin tablet. This is an unacceptable historical construct that must end. Compared to Natural Health Products, drug importers face mandatory and challenging Health Canada inspections, extremely high standards of scientific assessment and quality assurance, and documentation that chokes innovation and the basic conduct of business. In analysis performed by our company, we estimated that for an importer to bring one simple SPF drug into Canada for the first time, their cost would be in the range of $170,000 strictly for regulatory and quality assurance oversight.
Health Canada is reconsidering the regulation of all Consumer Health Products. This is an extremely complex process with uncertain timelines. In our view, all sunscreen products should be immediately moved to Natural Health Product status. There is ample precedent for Health Canada to make such a move. Antiperspirants were once classified as drugs, and overnight were reclassified as NHPs. They have since become classified as cosmetics unless they make extraordinary claims, at which time they remain NHPs. Remarkably and conveniently, drugs and NHPs are now reviewed by the same department at Health Canada.
While most jurisdictions in the world classify sunscreens as cosmetics, if Health Canada is not ready to make that leap, their classification as NHPs makes enormous sense. This regulatory classification would enable regulatory greater oversight than cosmetics, but importantly significantly reduce the burden on both Health Canada and the private sector. The time to act on this change is now.