Navigating US Cosmetic Regulations: MoCRA and Beyond
Enacted on December 29, 2022, the Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) is the first major overhaul of the Federal Food, Drug and Cosmetic Act for cosmetics regulation since its passage in 1938, modernizing the country’s cosmetic regulatory framework to meet current needs. This milestone legislation, driven by a primary objective to fortify product safety assurances from cosmetic manufacturers, introduces a set of new obligations for the cosmetics industry and extends the enforcement authority of the U.S. Food and Drug Administration (FDA) over cosmetics in the region.
MoCRA Spotlight
VIEW MORE
RESOURCES
Permitted Freckle-removing and Whitening Ingredients in Cosmetics in Major Countries/Regions Worldwide
Permitted Freckle-removing and Whitening Ingredients in Cosmetics in Major Countries/Regions Worldwide
Apr 24, 2024
This article is an overview of the current regulatory status of freckle-removing and whitening cosmetics, as well as their active ingredients, in major cosmetics markets worldwide.
Washington State to Ban Animal Testing for Cosmetics
Washington State to Ban Animal Testing for Cosmetics
Apr 10, 2024
On March 15, 2024, the Governor of Washington State signed HB 1097 into law, prohibiting the sale of cosmetics developed or manufactured using animal testing within the state...
Monthly Recap: Global Cosmetic Regulatory Updates | January 2024
Monthly Recap: Global Cosmetic Regulatory Updates | January 2024
Feb 06, 2024
ChemLinked rounded up the global regulatory updates on cosmetic products in January...
Monthly Recap: Global Cosmetic Regulatory Updates | December 2023
Monthly Recap: Global Cosmetic Regulatory Updates | December 2023
Jan 11, 2024
ChemLinked rounded up the global regulatory updates on cosmetic products in December...
MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing
MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing
Jan 10, 2024
Beyond the existing electronic submission portal, Cosmetic Direct, the U.S. Food and Drug Administration (FDA) introduced additional submission tools on January 8, 2024, providing...
VIEW MORE
United States 
In force
Release Date: 2023-12-18
Guidance on Registration and Listing of Cosmetic Product Facilities and Products
Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
United States 
In force
Release Date: 2023-12-18
User's Guide to FDA Direct (Cosmetics Direct)
CDER Direct User's Guide
United States 
In force
Release Date: 2023-11-14
Structured Product Labeling (SPL) Implementation Guide with Validation Procedures
Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (Version 1 Revision 202311100937)
United States 
In force
Release Date: 2023-11-08
Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
United States 
In force
Release Date: 2022-12-29
Modernization of Cosmetics Regulations Act of 2022 (MoCRA)
Modernization of Cosmetics Regulations Act of 2022
VIEW MORE
VIEW MORE
Timeline
2023.12.29
MoCRA will come into force.
The requirements including facility registration, product listing, safety substantiation, adverse event recordkeeping and SAE reporting, professional-use cosmetics labeling, and FDA’s mandatory recall authority will take effect.
Cosmetic manufacturers and distributors capable of meeting this deadline are encouraged to proceed with facility registration and product listing with the FDA. If not, companies can be subject to an additional six-month grace period to ensure compliance with these requirements.
The rule for testing method for asbestos determination in talc-containing cosmetics will be proposed by the FDA.
2024.06.29
The rule for labelling of fragrance allergens will be proposed by the FDA.
The rule for testing method for asbestos determination in talc-containing cosmetics will be finalized by the FDA.
2024.07.01
The FDA enforces the requirement for facility registration and product listing.
Owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022 shall complete the facility registration with the FDA.
Cosmetic product that first marketed after December 29, 2022 shall complete the product listing with the FDA.
2024.12.29
The requirements for labeling U.S. contact details will be enforced.
The rule for labelling of fragrance allergens will be finalized by the FDA.
The GMPs regulation will be proposed by the FDA.
2025.12.29
The GMPs regulation will be finalized by the FDA.
The PFAS report will be published on the FDA website.
State Legislations
WHY REACH24H?
With a group of highly capable and professional regulatory experts, REACH24H is dedicated to offering customized US market access consultations and regulatory compliance guidance for global cosmetic companies, facilitating efficient and cost-effective access to the marketplace for your products. Get in touch to discuss the optimal solution for your business.
©2012-2024 REACH24H Consulting Group
MoCRA Spotlight Resources Timeline State Legislations Why Reach24h