The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, is an important update to US cosmetic regulations. It gives the FDA broader authority over cosmetic facility registration, product listing, adverse event reporting, safety substantiation, and GMP requirements.
Earlier, cosmetics were regulated less aggressively than drugs and medical devices. MoCRA ensures that cosmetic companies follow a more formal regulatory system that covers their product from manufacturing to post market monitoring. The FDA now has stronger tools to inspect, request records, and enforce compliance when safety concerns arise.
MoCRA requires cosmetic manufacturers and processors to register their facilities with FDA and renew that registration every two years. It also requires product listing, which means submitting product and ingredient information to FDA. Label Compliance, Adverse event reporting and safety substantiation are also important compliance requirements.
MoCRA generally applies to cosmetics manufactured or processed for sale in the US, including products made outside the country. That means foreign manufacturers, importers, and responsible persons may all have compliance obligations if their products enter the US market.
There are some small-business exemptions, but those exemptions do not cover every product type.
Liberty Management Group Ltd can help with Cosmetic Facility Registration, Cosmetic Product Listings and label compliance.
Namrata
Regulatory Consultant
support@libertymanagement.us