FDA Releases New Guidance on Cosmetic Facility and Product Registration

On August 7, FDA issued a new draft guidance on the registration and listing of cosmetic product facilities and products, which is mandated by the Modernization of Cosmetic Regulations Act of 2022 (MoCRA).

This guidance is not legally enforceable, but it provides recommendations and instructions that can help businesses comply with the new registration and listing requirements.

The guidance covers the following topics:

• The statutory requirement to submit cosmetic product facility registrations and product listings.
• Definitions
• Who is responsible for making the submissions.
• What information to include in the submissions.
• How to make the submissions.
• When to make the submissions.

Here are the key takeaways from the guidance:

• All facilities that manufacture or process cosmetic products for distribution in the United States must register with the FDA, unless they are exempt as a small business or are manufacturing or processing cosmetic products that are also drugs, unless it also manufactures or processes cosmetic products that are not also drugs.
• A facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States on December 29, 2022, must register no later than December 29, 2023. A facility that first engages in manufacturing or processing of a cosmetic product for distribution in the United States after December 29, 2022, must register within 60 days of first engaging in such activity or by February 27, 2024, whichever is later. Registration must be updated within 60 days of any changes to the information required for registration.
• With respect to any foreign facility, the contact for the United States agent of the facility (name, phone number, and email) is required as part of facility registration and product Listing.
• Facility registration must be renewed every two years.
• The responsible person of a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce or within 120 days of December 29, 2023, whichever is later.
• The responsible person must provide any updates to product listing annually.
• To streamline the process, the FDA cosmetic product facility registration and product listing will be available using the same electronic submission process available to register an establishment and list a drug with FDA.
• The FDA encourages electronic submission of registration and product listing through the FDA’s new submission portal and is developing a paper form as an alternative submission tool. The portal is expected to be available in October 2023.

Here’s what you should do next:

• Review the draft guidance to understand the new registration and listing requirements.
• If you have any input on the draft guidance, submit electronic comments to gov. FDA will consider all comments received on the guidance by September 7, 2023.
• Determine if your facility is required to register with the FDA.
• If your facility is required to register, gather the required information and submit your registration through the FDA’s new submission portal once it’s available.
• Reach out to Victoria Pankovich, EAS Consulting Group Regulatory Services Manager, vpankovich@easconsultinggroup.com, for help with facility registration and product listing.
• Continue to monitor the FDA’s website for updates on the new registration and listing requirements and sign up for EAS updates.

Please reach out to us if you have questions or need help.