The State of US Regulatory

By Karen Yarussi-King, President at Global Regulatory Associates Inc.

As the world was enjoying the Christmas season last year, the US Congress quietly passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), its first major update to the US cosmetics regulations in nearly a century. While some people feel it was overdue, it is quite clear to many US industry insiders that the authors of the Act know very little about the US beauty industry, and this is clearly reflected in the short comings of MoCRA. Those of us who have been in the industry for a few decades believe that this regulation will end up having several unintended, negative consequences that will leave the US with some of the same issues that existed in the European Union (EU) pre-2009 and were the impetus for the passing of EC No. 1223/2009. It also disproportionately impacts small and medium-sized brands while favoring large brands, multinationals, and the Environmental Working Group (EWG). More on this to follow. Ultimately, it will negatively impact the consumer, particularly those who are lower income.

To make matters worse, there are many myths swirling around this regulation creating fear in the global cosmetic industry. One of the primary reasons for so many misconceptions is that the US Food and Drug Administration (FDA) has not yet published the final regulations and the actual details are unknown. Just to provide perspective, in the US, Congress passes laws and acts that are then given to the federal agencies to write the regulations. To date, we only have MoCRA which is the Act and FDA, the agency, is developing the regulations. There are many consulting companies claiming to know the FDA’s thinking behind the regulations and therefore are propagating these myths with the goal of profiting from MoCRA.
There is one myth that will be debunked throughout this article and that is that MoCRA is inspired by the EU regulations and is very similar to EC No. 1223/2009. I will provide examples of how MoCRA is very different than the European regulations. I will also debunk additional myths as I address the deficiencies of MoCRA.
So where has this Act fallen short and what are the untended, negative consequences? While there are three primary areas, preemption, raw material and product safety and regulatory definitions, they are all intricately intertwined.


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