Register, List, Report, Repeat: FDA Clarifies MoCRA Cosmetics Requirements

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final guidance and a newly launched registration and listing portal, provide additional clarity as to what the agency’s approach to implementing MoCRA requirements will be in 2024.

As we have previously discussed, MoCRA added biennial registration requirements for establishments (including establishments of importers) that manufacture or process cosmetics for distribution in the United States. Facilities that conduct only labeling, packaging, holding, or distribution activities are excluded. Product listings must also be submitted to FDA by “responsible persons” whose name appears on the product labels.

EXTENSION OF DEADLINE FOR FACILITY REGISTRATION AND PRODUCT LISTING

In December 2023, FDA announced the launch of its electronic registration and listing portal, Cosmetics Direct, for cosmetic product facilities and products and issued final guidance on registration and listing requirements. The agency also announced that it has prepared alternative paper submission forms (Forms 6055 and 5067) for use “as an alternative submission tool.” Companies may also transmit submissions through FDA’s Electronic Submissions Gateway using the Structured Product Labeling (SPL) framework.

The registration and listing website’s launch follows FDA’s announcement that it will postpone enforcement of the cosmetic product facility registration and product listing requirements. This delay, which extends the original deadline of December 29, 2023 by an additional six months to July 1, 2024, is intended to provide the industry with ample time to comply.

For entities that engage in manufacturing or processing of cosmetic products marketed as of December 29, 2022, the listing must now be submitted by July 1, 2024. Further, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022 if they register within 60 days of first engaging in such activity or by July 1, 2024, whichever is later.

For cosmetic products that are first marketed after December 29, 2022, the listing must be filed within 120 days of introducing the product in interstate commerce or by July 1, 2024, whichever is later.

CLARIFYING SERIOUS ADVERSE EVENT REPORTING REQUIREMENTS

On December 14, 2023, FDA issued a constituent update providing instructions for serious adverse event (SAE) reporting for cosmetic products under MoCRA. As we have discussed, MoCRA requires cosmetics companies to keep records of health-related adverse events for six years (three years for small businesses) and to report SAEs to FDA.

Effective as of December 29, 2023, responsible persons (defined as the “manufacturer, packer, or distributor of a cosmetic whose name appears on the label of that product”) are now required to report to FDA the occurrence of an SAE within 15 business days after receiving the information.

In the constituent update, FDA noted that it has updated the instructions for MedWatch Form 3500A to simplify the submission process for cosmetic product SAE reports. Since the form is used for numerous types of FDA-regulated products, FDA explained that any fields that are not applicable to cosmetics should be left blank. The form and supporting information, including label scans and pictures of the SAE, if available, can be sent to FDA by email or regular mail.

FDA is still in the process of creating an electronic submissions portal for reporting SAEs and will provide more information regarding the electronic portal launch date “in the coming months.”

KEY TAKEAWAYS

• Registration and Listing: While FDA has provided an extension for the registration and listing obligations, cosmetics companies should familiarize themselves with FDA’s listing and registration portal and prepare the necessary information for all affected products. For example, the portal requests details on product ingredients, brand names, health and beauty categories, manufacturer/processor addresses, and FEI, DUNS, and UNII numbers. Companies should begin making facility and product submissions in early 2024 to ensure that any questions can be worked through long before July 1, 2024, since FDA may not offer another deadline extension.
• SAE Reporting: Cosmetic companies should have standard operating procedures (SOPs) in place for the collection, recordkeeping, and reporting of SAEs to FDA and begin training employees on those requirements while having medical and legal experts available for inevitable questions. Employees should be aware of their obligations to collect and report information regarding SAEs through the appropriate channels. Companies should also consider their supply chains and vendors and prepare SOPs for the qualification of suppliers and vendors as well as the allocation of regulatory compliance duties.
• Multiple FDA Regulatory Regimes: While cosmetics are subject to unique statutory definitions and requirements, FDA is using both new and retrofitted forms and portals to implement the MoCRA submissions. Companies that also manufacture and distribute drugs, medical devices, foods, and dietary supplements should implement new, separate SOPs and workstream instructions that apply to their cosmetic products to achieve compliance with MoCRA and avoid internal confusion.