The U.S. Food and Drug Administration (FDA) has set a deadline of July 1, 2024, for cosmetic product manufacturers and processors to comply with new registration and listing requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This compliance is essential for shipping cosmetics to the USA.
Key Points of MoCRA for Cosmetic Products
MoCRA grants the FDA new authorities and sets forth specific requirements for the industry:
Facility Registration
Cosmetic product manufacturers and processors must:
- Register their facilities with the FDA.
- Update their registration within 60 days of any changes.
- Renew their registration every two years.
Product Listing
A responsible person must:
- List each marketed cosmetic product with the FDA, including product ingredients.
- Provide updates annually.
Who is the Responsible Person?
The responsible person is defined as the manufacturer, packer, or distributor whose name appears on the product label according to section 609(a) of the Federal Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.
Exemptions to the Registration Requirements
Certain small businesses are exempt from facility registration and product listing requirements. However, exemptions do not apply to facilities or responsible persons for the following cosmetic products:
- Products that regularly come into contact with the mucus membrane of the eye.
- Products that are injected.
- Products intended for internal use.
- Products that alter appearance for more than 24 hours and cannot be easily removed by the consumer.
Delayed Enforcement for Compliance
To ensure adequate time for the industry to comply, the FDA has delayed enforcement of these requirements until July 1, 2024.
Resources and Tools Provided by FDA
The FDA offers several resources to help with compliance:
Structured Product Labeling (SPL) Implementation Guide
Published in October 2023 and updated in December 2023, this guide assists in developing SPL authoring tools for submitting SPL-formatted submissions via the FDA’s Electronic Submissions Gateway (ESG).
Cosmetics Direct Electronic Submission Portal
Launched in December 2023, this portal allows for the registration and listing of cosmetic product facilities and products. Tutorials and user guides are available to facilitate the process.
Xforms and Paper Forms
In January 2024, the FDA introduced Xforms, an SPL authoring tool, along with Forms FDA 5066 and FDA 5067 for additional submission options. These resources are available on the Registration & Listing of Cosmetic Product Facilities and Products webpage.
How ASLG Can Help with Your Cosmetic Shipping Needs
Shipping cosmetics to the USA involves navigating complex regulatory requirements. ASLG specializes in international logistics and offers comprehensive support to ensure your products meet FDA regulations.
Our Services Include:
- Regulatory Compliance Assistance: We help you understand and comply with FDA registration and listing requirements.
- Document Preparation and Submission: Our experts guide you through the documentation process, ensuring accurate and timely submissions.
- Seamless Shipping Solutions: We provide end-to-end shipping services tailored to the unique needs of the cosmetic industry.
By partnering with ASLG, you can focus on your business while we handle the logistics and regulatory complexities.
