Delaney Szwed 

Associate Editor 

Loyola University Chicago School of Law, JD 2024

The cosmetic industry is vast and new products are constantly being manufactured and marketed to consumers. The majority of Americans, both men and women, use cosmetic products in their daily routines. On average, consumers use between six and twelve cosmetic products per day. Because these cosmetics contain new and existing chemicals that may be potentially harmful for human use, consumers are regularly exposing themselves to tens of thousands of chemicals. In an effort to keep up with the regulation of cosmetics, Congress enacted the Modernization of Cosmetic Regulation Act of 2022 which tasked the Food and Drug Administration with the regulation of cosmetic products in order to ensure consumer health and safety.

History of cosmetic regulation

Prior to 1938, there was no prevalent law granting any authority to the FDA to regulate cosmetics before or after they hit the market. However, this changed in 1938 with the passage of the Food, Drug, and Cosmetic Act (FDCA). This act gave the FDA power to regulate cosmetics and their ingredients, take enforcement action against adulterated or misbranded cosmetics, inspect cosmetic manufacturers, and prohibit imports of cosmetics that violated the act. While the FDCA introduced the idea of FDA regulation of cosmetics, it left some gray area that prompted for further regulation. 

Further, in 1966, the Fair Packaging and Labeling Act mandated cosmetic manufacturers to exhibit accurate and unambiguous information on cosmetic packaging and labels. The intent of this act was to prevent manufacturers from deceiving consumers about what they are purchasing and using. Following this, Congress enacted the Microbead-Free Waters Act of 2015, which prohibited against any sale or distribution of rinse-off cosmetics containing plastic microbeads. Plastic microbeads are small beads in products that are intended to cleanse and exfoliate. Congress’s concern was that after the microbeads were washed down the drain, they would make their way into bodies of water and be mistaken by fish as food. 

Most recently, the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) has expanded the FDA’s authority to regulated cosmetics more than any other act has in the past. 

What is MoCRA?

While MoCRA has granted the FDA regulatory power over cosmetics, it also enforces stricter policing over industries. Some authorities granted to the FDA under MoCRA include the ability to access copies of records related to a cosmetic products and the ability to order a mandatory recall of adulterated or misbranded cosmetics. 

On the contrary, new requirements for industry include adverse event reporting, facility registration and renewal, product listing, and safety substantiation. If a person experiences or has knowledge of an adverse event following the use of a cosmetic product, they are required to report it to the FDA so they can take administrative and preventative measures. Moreover, facility registration guidelines are implemented to give notice to the agency of manufacturing locations and performances. Specifically, for cosmetic companies and manufactures to comply with new FDA regulations, they must be proactive in applying these new rules to their practices and prepare for new legislation in the coming months. However, some small businesses are exempt from facility registration and product listing requirements. 

Finally MoCRA requires that industry comply with regulations the FDA will establish in the future regarding testing methods for detecting asbestos in cosmetic products containing talc, fragrance allergen labeling requirements, and Good Manufacturing Practice requirements. MoCRA’s fragrance allergen labeling requirement, which will be enacted on June 29, 2024, requires products containing fragrance allergens to display the ingredients on the label. Additionally, Good Manufacturing Practice Requirements refers to a system that assures proper and compliant design, monitoring, and control of manufacturing processes and facilities. 

The future of cosmetic regulations

While MoCRA enables the FDA to regulate cosmetics in a manner that protects public health and safety like never before, there is still room for growth and improvement in this area. Primarily, MoCRA does not force the agency to review or restrict harmful chemicals. Unlike countries across the world that have banned or restricted over 1,600 chemicals from cosmetic products, the FDA has banned or restricted only nine chemicals.  

However, states are not waiting on the FDA to catch up to other nations through enactment of legislation restricting the use harmful chemicals in cosmetics. In October of 2023, the state of California passed the Toxic-Free Cosmetic Act banning over 24 potentially toxic chemicals from fragrances, cosmetics, and other personal care items. Similarly, Washington passed its own Toxic-Free Cosmetic Act, prohibiting the use of eight chemicals from being used in cosmetics. While California and Washington have covered significant ground in protecting consumers from potentially unsafe chemicals, it is the hope that this will serve as a model for other states to enact similar legislation. 

Overall, while Congress and the FDA have made significant regulatory progress through the implementation of MoCRA, consumer health and safety are always at risk and the regulation of cosmetics must continue to advance in order to ensure consumer well-being.

ile Congress and the FDA have made significant regulatory progress through the implementation of MoCRA, consumer health and safety are always at risk and the regulation of cosmetics must continue to advance in order to ensure consumer well-being.