Proposed FDA Reorganization Would Move Cosmetics Regulation Function Out of CFSAN

The US Food & Drug Administration’s proposed restructuring of the Human Foods Program and Office of Regulatory Affairs (ORA) will reportedly include moving cosmetics regulation and color certification functions out of the Center for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist.

The move, according to FDA, will “better align the expertise of the agency’s cosmetics subject matter experts with the chief scientist who is focused on research, science, and innovation that underpins the agency’s regulatory mission, and recognize the evolution and innovation in this product space.”

The agency says this shift will leverage FDA's areas of expertise across the agency as it works to implement the Modernization of Cosmetics Regulation Act of 2022. According to FDA, the office will closely collaborate with the FDA’s Human Foods Program, Center for Drug Evaluation and Research, Office of Minority Health and Health Equity and Office of Women’s Health.

“Our proposal specifically tackles issues identified in two independent evaluations of our food programs, one conducted by the Reagan-Udall FoundationExternal Link Disclaimer and an internal evaluation of the agency’s infant formula response. We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication. We intend to fix this and strengthen both the regulatory programs and field force,” Commissioner Robert M. Califf said in a statement. “Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

The FDA is seeking to finalize its proposal this Fall. The process includes the development of a reorganization package that contains the newly designed structure, an established budget, and a detailed mapping and crosswalk of staff from the current to new organization, the Agency said. The package will have thorough review before advancing to Congress for a 30-day notification period where members may raise any concerns that the FDA may need to address. Afterwards, the FDA will issue a Federal Register Notice, provide notification to and engage, as needed, in negotiations with the Unions for impacted staff, prior to initiation of the new proposal. The FDA will continue to engage with stakeholders throughout this process.

The FDA chief scientist is Namandjé Bumpus, Ph.D.

PCPC Statement

The Personal Care Products Council (PCPC) issued the following statement from Lezlee Westine, president and CEO:

“The Personal Care Products Council (PCPC) is committed to working with the US Food and Drug Administration (FDA) to support its mission to protect consumer health and to understand better how the FDA's proposed reorganization could impact cosmetics and personal care products regulation. As we have in the past, we stand ready to collaborate with the Agency and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe and effective products while maintaining consumer trust.

“PCPC's current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. This historic legislation gives the FDA additional tools to ensure cosmetics' safety and to protect public health, reinforcing consumer confidence in the products they trust and use every day. MoCRA also brings the FDA's oversight of the beauty and personal care sector more in line with other categories the agency regulates and helps contribute to global regulatory alignment. We look forward to working with FDA Chief Scientist Namandjé Bumpus, Ph.D., who will be leading the effort on MoCRA's implementation as cosmetics and personal care products will now reside in the Office of the Chief Scientist within the Office of the Commissioner. We believe the Commissioner's decision is the right one.

“Our industry will work with the FDA as it moves forward with the proposed reorganization, and contribute our expertise to support appropriate cosmetics and personal care products regulation. We recognize the importance of transparency in regulatory decision-making and will continue to advocate for a transparent, science-based and risk-based approach to regulation.”

The Role of FDA's Chief Scientist

According to the FDA, the Office of the Chief Scientist supports the research foundation, science, and innovation that underpins the FDA’s regulatory mission. It does this through a broad framework that encompasses scientific collaborations, laboratory safety, the transfer of FDA inventions to the private sector, scientific integrity in FDA policy- and decision-making, the professional development of regulatory scientists, and its core research component—the FDA’s National Center for Toxicological Research—which generates the data that the FDA requires for its regulatory decision-making and development of sound regulatory policy.

Bumpus was named FDA chief scientist in June 2022.

Before joining the FDA, Dr. Bumpus was the E.K. Marshall and Thomas H. Maren Professor and chair of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. She served previously as associate dean for basic research in the Johns Hopkins University School of Medicine. Her research has focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology. Dr. Bumpus joined the faculty at Johns Hopkins in 2010 as an assistant professor. She earned a bachelor’s degree in biology at Occidental College in 2003, a doctorate in pharmacology at the University of Michigan in 2007 and completed a postdoctoral fellowship in molecular and experimental medicine at The Scripps Research Institute in La Jolla, CA in 2010.