As per US FDA’s new regulation for regulating cosmetic industry – MoCRA (Modernization of Cosmetics Regulation Act of 2022), FDA now requires cosmetic companies to register their facility and list the cosmetic products with FDA.
The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Some examples are listed here.
MoCRA defines a Responsible Person as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Under MoCRA, the Responsible Person will have following responsibilities:
- To obtain the relevant facility registration number or where small business exemption applies, the facility name & address, for each facility where its cosmetic products are manufactured or processed
- Submit product listing for each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
- Reporting serious adverse events associated with the use of cosmetic products in the US to FDA within 15 business days. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.
- To ensure and maintain records supporting adequate safety substantiation of their cosmetic products.
Liberty Management Group Ltd. provides assistance with Cosmetic Facility Registration and Cosmetic Product Listing.
Namrata
Regulatory Consultant
support@libertymanagement.us