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Feb 24th, 2023

Modernization of Cosmetics Regulation Act of 2022 : Preparing for mandatory adverse event reporting and cosmetovigilance

The Modernization of Cosmetics Regulation Act( MoCRA) of 2022 brings significant changes to chapter VI of the Federal Food, Drug, and Cosmetics Act (FDCA), which has not been updated since its enactment in 1938. The MoCRA, legislated on December 29th, 2022, replaces Chapter VI of the Federal Food, Drug, and Cosmetic Act and provides the civil government with increased oversight over the cosmetic industry through the Food and Drug Administration (FDA).

Following are the crucial factors of the Act that will affect operations of cosmetic companies after its enactment: 

Adverse Events Reporting, Recordkeeping & Safety Substantiation –  

The Act requires the responsible person, which includes the manufacturer, packer, or distributor of cosmetic product whose name appears on the label of similar cosmetic product, to submit to the FDA any report entered of a serious adverse event associated with the use of a cosmetic product manufactured, packed, or distributed by such person in the United States. The report must be accompanied by a copy of the label on or within the retail packaging of the product not more than 15 business days after the report is entered by the responsible person. Companies must maintain records supporting acceptable validation of the safety of their products, including tests or studies, exploration, analyses, or other substantiation by a person or company with scientific training and experience.  

Talc and Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Regulations –  

Proposed regulations will be established and communicated within one year of the enactment of this Act to bear standardized testing styles for detecting and relating asbestos in talc- containing ornamental products. Within three years from the enactment date the FDA needs to assess the use, safety, and pitfalls associated with PFAS in cosmetics.  

Good Manufacturing Practices-  

The FDA will propose a ruling on good manufacturing practices (GMPs) between December 29, 2024 to December 29, 2025, in order to ensure the safety and quality of cosmetic products. 

Registration and Product Listing-  

Existing companies and contract manufacturers must register their facilities with the FDA, renew them biennially, and provide a cosmetic product listing within one year of the enactment. In the cosmetic product listing, each ingredient must be identified by name and the product listing number, including fragrances, flavors, and colors which needs to be updated on an annual basis. 


Consumers should be given a domestic address, phone number, or email address on labels so that they can report adverse events. Products used by professionals, such as cosmetologists, nail technicians, barbers, or aestheticians, should clearly state “for licensed professionals only.” The requirement takes effect two years after the legislation is passed.

Mandatory Recall and Facility Suspension –  

Companies can recall or no longer sell or distribute a product that has a reasonable probability that it’s adulterated or misbranded and can cause serious adverse effect or death. However, the FDA will issue the immediate recall of the product, and the public must be made apprehensive of this recall, if a voluntary recall isn’t done. This requirement will take effect one year after the date of enactment of this Act. FDA is also authorized to suspend a facility registration if the Agency determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences and believes other products may be similarly affected. 

All cosmetics companies will be affected by the regulation. By the end of this year, US manufacturers, packers and distributors of cosmetics will be required to comply with new legal requirements under the Modernization of Cosmetics Regulation Act (MoCRA) and they will face unique challenges and implications.  

At Datafoundry, we help companies address the impacts following these regulatory changes. For more information on how Datafoundry can support your company’s cosmetovigilance, please reach out to us at  


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