Today, FDA announced that it is effectively pushing back its anticipated October launch date for electronically submitting cosmetic product facility registration and product listing information required by the Modernization of Cosmetics Regulation Act (MoCRA).
MoCRA requires any facility that manufactures or processes cosmetic products intended for sale in the United States—irrespective of whether the facility is located in the United States—to register with FDA, and further requires manufacturers, packers, and distributors of cosmetics intended for sale in the United States to submit to FDA lists of products and ingredient information. The statutory deadline for facility registration and product listing is December 29, 2023.
FDA has previously stated that it expected its newly developed draft electronic submission portal–Cosmetics Direct–to begin accepting submissions in October 2023, in advance of the year-end deadline.
Today, however, FDA advised that it will provide more information on the launch date for electronic submission and paper submission forms “in the coming weeks.”
FDA advised that “[i]ndustry can continue to prepare for registration and listing by reviewing the documents FDA has provided and being proactive in collecting the information required to complete their facility registrations and product listings.”
FDA’s announcement comes after its issuance of draft guidance in August 2023, which, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.
FDA also solicited comments on Cosmetics Direct in its draft form, as well as the proposed paper forms (Forms FDA 5066 and 5067). The comment period is now closed, and FDA is in the process of obtaining approval from the Office of Management and Budget (OMB) in the Executive Office of the President, under the Paperwork Reduction Act for the proposed collection of registration and listing information, as well as concluding beta-testing of Cosmetics Direct.
In October 2023, FDA also announced publication of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, which can be used to develop SPL authoring tools and generating SPL-formatted submissions for cosmetic product facility registrations and product listings.
FDA will continue to provide updates on its MoCRA rollout, and until then, stay tuned for additional MoCRA updates.