Today, we bring crucial information regarding changes from the Federal Drug Administration (FDA) that impact cosmetic product facility registration and cosmetic product listing in the United States. These changes, outlined in the Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing Guidance for Industry released by the FDA in November 2023, signify a shift in deadlines and compliance requirements

Background

On December 29, 2023, the FDA implemented specific deadlines for cosmetic product listings based on the market date of the product. Here’s a breakdown:

1. Products Marketed Before December 29, 2022:
   • Deadline: Submit a cosmetic product listing no later than December 29, 2023.
2. Products Marketed After December 29, 2022:
   • Deadline: Submit a cosmetic product listing within 120 days of distributing the product in interstate commerce.
3. Exceptions for Small Businesses:
   • Small businesses, as defined in section 612 of the FD&C Act, are exempt from registering facilities and listing cosmetic products.

Revised Compliance Date Change

In a recent update from the FDA, a significant “delay in enforcement” has been granted, offering businesses more time to align with regulatory requirements:

1. For Existing Facilities/Product Listing:
   • Previous Deadline: December 29, 2023
   • New Deadline: July 1, 2024
2. For Facilities Engaging in Manufacturing/Processing after Dec. 29, 2022, or Product Listing for Products Marketed After Dec. 29, 2022:
   • Deadline: July 1, 2024

How Can I Be Prepared

To ensure a seamless compliance process, consider the following steps:

1. Review Product Market Date:
   • Determine whether your cosmetic product was marketed before or after December 29, 2022.
2. Compliance Check:
   • If your product falls under the December 29, 2023, deadline or the 120-day window, ensure timely submission of cosmetic product listings.
3. Small Business Exemption:
   • If applicable, confirm your eligibility for the small business exemption as defined in section 612 of the FD&C Act.
4. Update Internal Processes:
   • Adjust internal processes to align with the revised compliance dates and educate relevant stakeholders.

By staying informed and taking proactive measures, your company can navigate these regulatory changes effectively and maintain a strong standing within the industry.

We understand that compliance can be a complex process, and we are here to support you in any way possible.