On August 7, 2023, the Food and Drug Administration (FDA) published a draft guidance document, dubbed Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (informally known as “The Draft Guidance”). This move reflects an intent by the agency to define its current perspectives on facility and product registration requirements, as per the provisions of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”).
The Draft Guidance actively invites comments from industry players regarding the FDA’s interpretation of MoCRA’s registration and listing stipulations. Although the specifics of the document are not yet widely available, it is clear that the FDA is seeking open dialogue with industries that will be impacted by these proposed changes.
The implications of this Draft Guidance are considerable for the cosmetics industry, on a global scale, particularly for the key industry stakeholders. This is reflective of recent trends within regulatory bodies to keep pace with evolutions and innovations in various industry sectors, in this case, the cosmetics industry. The Draft Guidance, by soliciting industry feedback, seeks to ensure better regulation by aligning the law with the realities and challenges of the industry it governs.
Legal professionals interested in cosmetics regulation specifically, or regulatory law as a whole, would do well to keep an eye on developments surrounding this Draft Guidance, as it is likely to impact both domestic and international operations of cosmetics companies and, by extension, the job of legal teams serving these organizations.