FDA Announces Availability of Decision Tool and SPL Xforms For MoCRA Facility Registration and Product Listings

On January 8, 2024, the U.S. Food and Drug Administration (FDA) announced that SPL Xforms, a Structured Product Labeling authoring tool, is now available as an additional option for completing facility registration and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As a result, companies may submit their facility registration(s) and product listing(s) in one of four ways:

1. 1. FDA Direct;
   2. Electronic Submissions Gateway;
   3. SPL Xforms; and
   4. Paper Submissions via FDA Form 5066 (Facility Registration) and FDA Form 5067 (Product Listing).

Completed paper submissions can be emailed to RLC-PaperSubmissions@fda.hhs.gov or mailed to the following address:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
Office of Cosmetics and Colors
Registration and Listing of Cosmetic Product Facilities and Products Program
5001 Campus Drive, CPK1, Room 1B-046
College Park, MD 20740-3835.

The FDA indicated that it does not intend to enforce the facility registration and product listing requirements until July 1, 2024. Nevertheless, companies are now able to submit this information and are encouraged to do so in advance of the July 1, 2024 enforcement deadline.

The FDA’s Decision Tool should also be of help to cosmetics companies who are still trying to determine whether to register one or more facility.