On September 15, 2023, the U.S. Food and Drug Administration (FDA) made the announcement that they are seeking comments on their newly developed draft electronic submission portal, known as ‘Cosmetics Direct’, as well as paper forms, specifically Forms FDA 5066 and 5067. These elements are part of the FDA’s ongoing implementation of the new registration and listing requirements. These requirements were mandated in accordance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This announcement is the next key step in the process of modernizing the way cosmetics are regulated in the United States, reflecting a commitment on the part of the FDA to engaging with all relevant stakeholders and ensuring all voices are heard in the process of development and implementation. This move allows for insight into the FDA’s drafts before they are finalized, thus practitioners and interested parties have the opportunity to provide their feedback.
The JDSupra report noted that, along with the announcement, the FDA shared screenshots of the draft electronic system and the draft Form FDA 5066. This can serve as a guide for those gathering their comments on the draft submission portal and paper forms. It is a important step towards increasing transparency in the mechanisms for regulation and control of cosmetics in conformity with the MoCRA.
The regulatory changes outlined in MoCRA aim to provide greater clarity and standardization for the cosmetics industry. Ensuring that industry professionals have opportunities to share their views and perspectives on these new systems and forms is central to the modernization process.
This call for comments is an important deadline on the calendar for all involved in the cosmetics industry, from manufacturers and importers, practitioners to legal professionals specializing in the regulation of cosmetic products. The FDA has reaffirmed its commitment to consultation and collaboration in pursuit of an effective and efficiently regulated cosmetics sector.