Why Pharmacovigilance Is Needed for Cosmetics- Our View

Cosmetics- Cosmetovigilance

Drug products go through extensive review before approval by Health Canada and the US FDA. However, the oversight by these regulators does not end there. Drug companies are obliged to monitor adverse reactions to their products after sale and have strict reporting responsibilities should anything go wrong. In technical language, this process is called pharmacovigilance, and it is a powerful tool for companies and regulators to find out the real-world advantages and risks of drugs once they get into mass distribution.

Historically, cosmetics have not followed this practice, the thinking being they do not pose sufficient risk to warrant such a practice. In the past this did make sense, with the ingredients and processing techniques that were in widespread use. However, in recent years the concept of Cosmetovigilance has begun in Europe and has uncovered some important cases of allergic reactions caused by cosmetics. There are two very compelling reasons why this should be expanded globally and made mandatory by government agencies just as pharmacovigilance is for drug products.

The first reason is the expanded use of natural ingredients in cosmetics. While most consumers perceive natural to be better than synthetic, natural ingredients tend to have a greater propensity to cause allergy because of their complex mixtures of natural compounds. By comparison, today’s science can produce synthetic ingredients that are extremely pure and have very little batch to batch variation. Natural ingredients such as plant extracts can vary from field to field and season to season and contain tens of thousands of individual components. For scientists formulating with these products they are far more challenging to deal with. When we clinically test cosmetic products for allergy and irritation, we typically use 200 subjects. What happens when the number of users becomes 2000 or 20,000 or 200,000 once the products appear on store shelves?

The other reason cosmetovigilance is important has to do with the fast-evolving science of cosmetic active ingredients. Historically, cosmetics such as antiaging creams were not all that different from each other, and any special ingredients were added mostly for marketing purposes and included at very low levels. That has all changed. The frontier of anti-aging is altering the biochemical processes in skin, and the innovation by both ingredient companies and finished product manufacturers is racing ahead at a pace we’ve never seen before. These provide exciting and innovative possibilities for consumers who could see real change from their products. However, if cosmetics can actually change the structure or function of the skin, how do we distinguish them from drug products? Our view is the practice of cosmetovigilance should be embraced around the world and that today’s ingredient and brand owners should monitor and analyse these data with the same vigilance as drug companies.

If you have any questions, please feel free to contact Focal Point Research Inc.  We are industry leading Cosmetic Regulatory Consultants that you can trust to help guide your company in the right direction.