The State of US Regulatory

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

august 2023

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.

Preemption and State’s Rights

previous versions of this bill, some industry experts were able to get a federal preemption clause included to ensure one single federal cosmetics regulation that would sunset any existing state regulations. However, this was rewritten in MoCRA’s final draft, with input from EWG, allowing states to establish any new law or regulation related to cosmetics so long as it is not in conflict with the requirements of MoCRA related to registration and product listing, good manufacturing practice, record retention, recalls, adverse event reporting or safety substantiation. What that means is that if every US state put a reporting requirement in place like the FDA’s, a brand would have to register all their products 51 times. Someone who may be questioning how it is possible to have a patchwork of cosmetic laws in a single country when there is federal regulation is asking an important question. The US’ founding fathers, to get the original 13 colonies to buy into a centralized, federal government, created the concept of federalism providing for state rights. Federalism gives the states the right to address policy areas under the First Amendment that are not addressed by the national government. This miss in the drafting of MoCRA will make compliance in the US potentially much more difficult. As an industry, our only hope is to try to influence the regulations both at the state and federal levels. Now, to further illustrate the first potential unintended, negative consequence, state regulation proliferation, let’s look at California more closely.
As anyone who has sold products in the US knows, not only do brands need to comply with the FDA, but also with California’s many onerous regulations. Despite having several federal regulations, the state of California has passed mirror image regulations but with different requirements from the US (federal) regulations.
Currently cosmetics are regulated under FDA’s Food, Drug and Cosmetics Act (FD&C Act) because MoCRA has not been fully enacted. Over the last few decades, California has passed three Acts, The Food, Drug, and Cosmetic Law (Sherman Act) which regulates the packaging, labeling, and advertising of cosmetics, drugs and devices; The California Safe Cosmetics Act which established the requirement to report cosmetic products containing “hazardous” ingredients through an on-line portal; and The Cosmetic Fragrance and Flavor Ingredient Right to Know Act which requires the disclosure to the state of fragrance or flavor ingredients in cosmetics and professional salon products.
In addition, despite the existence of the US Environmental Protection Agency’s (EPA) Clean Air Act, which California has never been able to fully meet, the California Air Resources Board (CARB) has passed the Consumer Products Regulation to limit the amount of volatile organic compounds in consumer goods, including beauty products. The EPA also administers the Toxic Substances Control Act (TSCA) which requires reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures and bans substances accordingly. Again, California has its own scheme –Proposition 65 (Prop 65), officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which identifies chemicals known to the state of California to cause cancer, birth defects or other reproductive harm, and requires warnings on products containing these chemicals.



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