Section 607 of MoCRA requires all companies, both within the US and internationally, that manufacture or process cosmetic products sold in the US to register their facilities and list their products.
Facilities that only produce over-the-counter (OTC) drug products, such as acne treatments, dandruff shampoos, and SPF care, do not need to register under MoCRA. However, if a facility makes both OTC drug products and cosmetic products, it must comply with the registration requirement.
Facility Registration Timelines, Renewals, and Updates
– Facilities Operational Before December 29, 2022: Must register with the FDA by December 29, 2023.
– Facilities That Began Operations in 2023: Must register by February 27, 2024.
– New Facilities: Must register within 60 days of starting operations.
– Renewals and Updates: Registration must be renewed or updated whenever there are changes to the facility, or at least every two years. Updates must be made within 60 days of changes such as contact information, product types, or brands produced.
How to Register Facilities
– Electronic Submission: The FDA will launch its electronic portal, FDA Direct (Cosmetics Direct), in October 2023. Electronic submission is preferred, but paper forms are also accepted.
– Where to Access: Both the electronic portal and paper forms are available at [FDA’s website](https://www.fda.gov).
– Cost: Cosmetic facility registration with the FDA is free.
Required Information for Registration
– Facility Name
– FEI Number (obtained via FDA’s FEI Search Portal)
– Physical Address
– Email Address
– Phone Number
– Owner/Operator Name
– US-based Agent Information (if the facility is outside the US)
– All Brands and Responsible Persons for Each Brand
– Product Category Codes
Cosmetic Product Listing Requirements
– Current Products: Must be listed with the FDA by December 29, 2023.
– New Products: Must be listed within 120 days of their commercial introduction in the US.
– Annual Updates: Product listings must be renewed or updated annually, including for discontinued products.
How to List Products
– Electronic Submission: The FDA will launch its electronic portal, FDA Direct (Cosmetics Direct), in October 2023. Electronic submission is preferred, but paper forms are also accepted.
– Where to Access: Both the electronic portal and paper forms are available at [FDA’s website](https://www.fda.gov).
– Lost: Cosmetic product listing with the FDA is free.
Required Information for Product Listing
– Facility Name(s) and FEI Number(s)
– Product Name and Responsible Person’s Contact Information
– Product Category Codes
– Complete Ingredient List with UNII (Unique Ingredient Identifier)
Exemptions
– Small Businesses: Those with average gross annual sales below $1,000,000 USD over the past three years are exempt from facility registration and product listing.
– Loss of Exemption: Applies if the company makes products that:
– Contact the mucous membrane of the eye
– Are injectable
– Are intended for internal consumption
– Modify appearance for more than 24 hours
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