FDA Crackdown on ‘Cosmeceuticals’

It is no secret that new technologies and discoveries in biology are paving the steps for more effective and innovative cosmetics. However, the fine line between a cosmetic and a pharmaceutical product still exists for regulators. It is important to note that it is not only the physical function performed by the product that classifies it, but also the specific claims made in marketing the product. The US FDA has recently been keeping an eye out for cosmetics companies that are selling products with drug-like claims on the labels. A California company recently received an FDA warning letter, prompting them to edit the claims of their product, or submit a “New Drug Application”. It is important to remember that cosmetic products are not drugs in the eyes of regulators, and that fine line must always be respected to avoid consequences. The term “Cosmeceutical”, although well known in pop culture, is not a term that is currently legally defined by regulators.

With the advent of innovation, does this mean it is time to perhaps draw a finer line between drugs and cosmetics? Should there perhaps be changes to regulations to accommodate for new innovative cosmetics that are drifting on the boundary of being a drug product? Health Canada has recently released a new framework for what they call “Consumer Health Products”. Consumer Health Products consist of low-risk drugs, cosmetics, natural health products and disinfectants. The purpose of the framework is to standardize product regulation based on the risks associated. The first step is to update regulations for low-risk drugs, which are currently regulated almost to the same level as high-risk prescription drugs. Many more changes to regulations, such as a revamp to sunscreen regulations in Canada, will be announced by Health Canada in the coming months. Perhaps other world regulators should take Health Canada’s actions as an example, and encourage manufacturers to be innovative and provide the appropriate regulatory framework to encourage this.