The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant expansion of FDA’s authority to regulate cosmetics to help ensure the safety of cosmetic products. This requirement became mandatory on July 1st, 2024.
This expansion will include the registration of any facility that manufactures or processes cosmetic products distributed in the United States. This registration must occur every two (2) years and gives the FDA authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences.
The FDA has now opened the Cosmetics Facility Registration site to allow companies to register prior to the deadline. There are tutorials and webinar links on the registration site to assist in the process. They have also provided an update with new tools and forms for registration.
Additionally, Registrar Corp has created a free tool, MoCRA Wizard, to help importers and exporters to determine which requirements apply to your company.
The Food, Drug and Cosmetic Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].” Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
Additionally, this will allow the FDA to access certain records related to a cosmetic product, including safety records, and exercise recall authority in some circumstances.
The FDA has issued Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products.
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