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
U.S. FDA Report (July 2024): 72 Batches of Imported Cosmetics Rejected
U.S. FDA Report (July 2024): 72 Batches of Imported Cosmetics Rejected
Aug 22, 2024
In July 2024, the U.S. Food and Drug Administration (FDA) exercised its authority under the Food, Drug, and Cosmetic Act (FD&C Act)..
Monthly Recap: Global Cosmetic Regulatory Updates | July 2024
Monthly Recap: Global Cosmetic Regulatory Updates | July 2024
Aug 12, 2024
ChemLinked rounded up the global regulatory updates on cosmetic products in July...
H1 2024 Review: U.S. FDA Rejects 697 Batches of Imported Cosmetics
H1 2024 Review: U.S. FDA Rejects 697 Batches of Imported Cosmetics
Aug 09, 2024
In the first half of 2024, the FDA refused entry to 697 batches of imported cosmetics from 36 countries. Côte d'Ivoire led the list, followed by...
U.S. FDA Delays Rulemaking on Fragrance Allergens and Asbestos Testing Methods Under MoCRA
U.S. FDA Delays Rulemaking on Fragrance Allergens and Asbestos Testing Methods Under MoCRA
Aug 02, 2024
On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) released the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions" (the Unified Agenda), which includes updates on several proposed rules concerning cosmetics...
U.S. FDA Launches New Features in Cosmetics Direct for Improved Product Management
U.S. FDA Launches New Features in Cosmetics Direct for Improved Product Management
Aug 02, 2024
On July 29, 2024, the U.S. Food and Drug Administration (FDA) announced the addition of two new features to Cosmetics Direct...
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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 
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