Health Canada is considering sweeping changes to how they regulate cosmetics, OTC drugs and Natural Health Products. It is a revolutionary approach which would regulate all products in these categories under one set of rules for “Consumer Health Products”. Lower risk products like most cosmetics would have the least regulatory burden, with increasing regulatory oversight for higher risk products such as therapeutic OTC drugs.
This is a very thoughtful approach, and there are good reasons to do it. There are many products that sit on the borderline of our current product classifications. For example sunscreens which are common in many lines of cosmetics are regulated as either OTC drugs or Natural Health Products. Based on a regulatory loophole, sunscreen active ingredients can be present in products classified as cosmetics as long as the SPF claim isn’t made. This mishmash of rules creates massive inconsistencies in the approvals and importation of OTC drugs and Natural Health Products, which seems wrong to many stakeholders.
It is a thoughtful plan, and also very ambitious. The Natural Health community is voicing strong opposition to these changes after fighting for years for improved regulations. It’s also expected that the new regulatory approach would involve user fees for Natural Health Products to be paid to Health Canada. This is always been required for OTC drugs but never for Natural Health Products. This is a bone of contention.
While there is optimism that this new approach will proceed, fingers are crossed it doesn’t get bogged down in dissenting opposition. As a veteran of the three categories of products, what’s broken are the regulations for OTC drugs. Canada’s rules for cosmetics and Natural Health Products work well. Cosmetic regulations are constantly updated, for example through the constantly evolving Cosmetic Ingredients Hotlist. Canada’s rules for Natural Health Products are only 13 years old and have undergone significant changes to improve them since inception. What’s wrong is the OTC drug category. It’s not the fact that they require preapproval by Health Canada but the onerous and costly importation requirements. The importation of OTC drugs requires the dreaded Drug Establishment License. Under this license, a manufacturer is required to test their products shelf life to ICH stability requirements. It requires validation in manufacturing and testing just like serious prescription drugs. These requirements far exceed the risk posed by these products, and act as barriers to trade and innovation.
Over the course of the last 13 years that the Natural Health Product regulations have been in place, Health Canada has made several administrative changes, for example to reclassify antiperspirants. Originally they were drugs, then they became Natural Health Products, and today most are classified as cosmetics. It would make infinite sense to immediately classify all sunscreens and acne products as Natural Health Products in a similar fashion. This would eliminate importation under a Drug Establishment License and solve many of the problems that the cosmetics and OTC drug industries face. This type of administrative change would free up tremendous resources in both the public and private sectors while details of the Consumer Health Product regulations are hammered out.
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.