The Modernization of Cosmetics Regulation Act of 2022 is the most significant change to U.S. personal care product policy in decades. Such a comprehensive renewal of the regulations has created concern for the sector as to whether they will be able to manage the entire compliance process on their own.

MoCRA was adopted in December last year, providing new powers to the FDA. The aim of the law is to ensure the safety of cosmetic products on the market at the highest level. Before MoCRA, the government had not made compelling changes to the way it regulates cosmetic products since the passage of the Food Drug and Cosmetic Act (FDCA) in 1938 and the Fair Packaging and Labeling Act in 1966.

As we have mentioned in our previous articles, the FDA has required all facilities that manufacture or process cosmetic products intended for sale in the United States – regardless of whether the facility is located in the United States – to register with the FDA and list product and ingredient information for any cosmetics intended for US distribution. MoCRA also required the FDA to enact regulations addressing good manufacturing practices and give the administration greater enforcement authority over cosmetics that potentially contain additives.

Under the FDA, companies had a legal duty to ensure that their products were not adulterated and were safe when used as intended. With MoCRA, FDA has expanded its enforcement authority, including facility inspection and record access rights, and its mandatory recall authority over cosmetics that it believes are misbranded and will cause serious adverse health consequences.

MoCRA has also introduced greater record keeping obligations regarding product safety and the reporting, documentation and tracking of serious undesirable effects.

MoCRA announced new obligations for personal care product manufacturers, setting deadlines for when companies must be ready to meet these obligations. The first of these deadlines is December 29, 2023. By the applicable date, anyone who owns or operates a facility must register the facility with the FDA and submit cosmetic product listings for all marketed products.

Last month, the FDA released Draft Guidance on facility registration and product listing requirements and announced that it expects its portal to go live in October.

Leading cosmetics industry associations have stated that the US personal care industry is at the beginning of a years-long process to fundamentally change cosmetics regulations in the US, and that companies should proceed with caution and seek as much advice as possible rather than trying to manage these changes alone.

Macro Professional USA, offers you high-quality U.S. Agent and consultancy services and evaluations on compliance with the MoCRA law and FDA regulations for your products that you will market in the USA. For your questions and requests, you can contact us at