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
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RESOURCES
Monthly Recap: Global Cosmetic Regulatory Updates | February 2025
Monthly Recap: Global Cosmetic Regulatory Updates | February 2025
Mar 06, 2025
ChemLinked rounded up the global regulatory updates on cosmetic products in February...
2024 Review: U.S. FDA Rejects 1,300 Batches of Imported Cosmetics
2024 Review: U.S. FDA Rejects 1,300 Batches of Imported Cosmetics
Feb 24, 2025
In 2024, the FDA rejected a total of 1,300 batches of imported cosmetics from 42 countries...
Top 10 Global Cosmetic Regulation Highlights in 2024
Top 10 Global Cosmetic Regulation Highlights in 2024
Feb 19, 2025
In 2024, the global cosmetic industry made significant strides in regulations and enforcement aimed at enhancing the safety, quality, and transparency of cosmetics. Governments around the world introduced new policies and regulations to support these objectives, including the release of the MoCRA rules, updates to safety standards, and revisions to ingredient usage requirements. In this article, ChemLinked highlights the top 10 key updates from major regions worldwide.
U.S. FDA Report (January 2025): 89 Batches of Imported Cosmetics Rejected
U.S. FDA Report (January 2025): 89 Batches of Imported Cosmetics Rejected
Feb 19, 2025
In January 2025, the U.S. Food and Drug Administration (FDA), under the Food, Drug, and Cosmetic Act (FD&C Act), refused entry to 89 batches of imported cosmetics from 24 countries due to regulatory non-compliance...
Monthly Recap: Global Cosmetic Regulatory Updates | January 2025
Monthly Recap: Global Cosmetic Regulatory Updates | January 2025
Feb 12, 2025
ChemLinked rounded up the global regulatory updates on cosmetic products in January...
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United States 
In force
Release Date: 2024-12-11
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 
To be enforced
Release Date: 2023-10-08
California State: Updates to 2020 Toxic-Free Cosmetics Act
Assembly Bill No. 496
United States 
In force
Release Date: 2023-07-26
California State: Listing Nail Products Containing Toluene as a Priority Product
Safer Consumer Products Regulations – Listing Nail Products Containing Toluene as a Priority Product
United States 
In force
Release Date: 2023-03-03
New York State: An Act to Amend the Environmental Conservation Law, in Relation to the Sale of Cosmetic Products Containing Trace Amounts Of Mercury
Assembly Bill A619 / Senate Bill S1340
United States 
In force
Release Date: 2022-12-29
Modernization of Cosmetics Regulations Act of 2022 (MoCRA)
Modernization of Cosmetics Regulations Act of 2022
United States 
In force
Release Date: 2022-12-23
New York State: An Act to Amend the Environmental Conservation Law, in Relation to Prohibiting Cosmetic Products and Personal Care Products that Contain Mercury
Assembly Bill A8630A / Senate Bill S8291A
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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
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MoCRA Spotlight Resources Timeline State Legislations Why Reach24h