The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) Brings Significant Changes
In a landmark move to ensure consumer safety, the Modernization of Cosmetic Regulations Act of 2022 (MoCRA) has introduced pivotal changes to the cosmetic industry’s regulatory framework. These modifications, effective from December 29, are a result of amendments to Chapter VI of the Federal Food Drug and Cosmetic Act (FDA).
Key Changes Under MoCRA
The Act outlines several critical updates, which include:
- Facility Registration: Required to be updated biennially.
- Product Listing: Mandatory annual updates.
- Safety Substantiation and Record Keeping: Enhanced safety measures and detailed record-keeping.
- Labeling Revisions: Special focus on cosmetics for professional use, fragrance allergens, and US contact information.
- Adverse Event Reporting: Mandatory reporting of adverse events to the FDA.
- Compliance with Good Manufacturing Practices.
- New Regulations: Specific focus on talc asbestos and PFAS, with guidelines to be published by the FDA.
The FDA has granted a 6-month extension, until July 1, 2024, for companies to comply with facility registration and product listing requirements.
Structured Product Labeling (SPL) Implementation Guide Update
The FDA has also released an updated Structured Product Labeling (SPL) Implementation Guide for cosmetics in line with these changes. This guide includes:
- Cosmetics Integration into SPL: Aligning facility registrations and product listings with MoCRA.
- Enhanced SPL Tools: Facilitating efficient SPL-formatted submissions.
- Simplified Submission Process: Future SPL-formatted submissions will be accepted through channels like the Electronic Submissions Gateway (ESG) and SPL authoring software.
- Cosmetics Direct Portal: A user-friendly electronic submission portal (https://direct.fda.gov/) streamlining the submission process.
Understanding SPL
Structured Product Labeling (SPL) is a standardized document format endorsed by Health Level Seven (HL7) for exchanging product and facility information. It enhances product labeling standards for safety and usability. The FDA’s commitment to SPL adoption since 2005 underscores its dedication to modernizing regulations and safeguarding consumers and industry stakeholders.
For more details, stay tuned as we explore the evolving cosmetics regulatory landscape, and feel free to visit the FDA’s website or contact our regulatory experts at https://ceway.eu/contact/.
