Upcoming Deadlines
July 1, 2024
Product listings and facility registrations for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) must be completed by July 1, 2024. These filings can be made online in the FDA Cosmetics Direct portal. FDA has released a user guide to assist responsible parties in signing up and using the online portal.

The official MoCRA deadline for these filings was December 29, 2023, however, due to delays in releasing the Cosmetics Direct portal, FDA allowed a 6-month grace period during which no enforcement action would be taken. The U.S. FDA has stated enforcement for products and facilities that are not properly registered will begin following the July 1st deadline.

The SRC team is trained and ready to assist you with all of your MoCRA compliance needs and has completed many product listings and facility registrations to date. Please contact our team as soon as possible for assistance with your product listings and facility registrations prior to the end of the grace period.

December 29, 2024
By December 29th, all cosmetic product labels must include a U.S. address, phone number, or email address for consumers to file adverse event reports.  SRC recommends updating your label now in preparation for this rule.

Additionally, by December 29th, FDA will publish a Notice of Proposed Rulemaking for Cosmetic Good Manufacturing Practices, which will outline the required process to manufacture cosmetic products for sale in the U.S.

Previous Deadlines
Though facility registrations and product listings are due in July, the deadline for product safety substantiation, adverse event reporting, and the professional cosmetics label language requirement was December 29, 2023. If you were unaware of these deadlines and do not have these processes and documentation in place, please contact our team as soon as possible so we can help you with the MOCRA compliance. 

Ongoing Requirements
Facility Registrations
Registered cosmetic facilities must notify FDA of any changes to their name, contact information, brand names produced, product categories, or U.S. agent within 60 days of the change. Facilities that start producing cosmetics after the deadline will have 60 days to complete their facility registration.
All facilities must be reregistered every two years.

Product listings
Product listings must by renewed annually in the Cosmetics Direct portal. New cosmetics must be registered within 120 days of the initial marketing of the product.

Our experts are available to assist you in all aspects of MoCRA and would be happy to complete your initial product listings and facility registrations, as well as manage your ongoing compliance requirements.  Please contact David Swain at David.swain@srcconsultants.com regarding cosmetic products and MOCRA requirements.


David Swain 

VP, Regulatory Services 

Posted on: 06/05/24