Overview
Congress overhauled FDA’s regulatory framework for cosmetics as part of the Consolidated Appropriations Act of 2023. The Modernization of Cosmetics Regulation Act (MoCRA) gave new regulatory authorities to FDA under Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In this webinar, speakers will discuss the new regulatory framework for cosmetics and key provisions for the cosmetics industry, such as facility registration, product listing, mandatory adverse reporting, safety substantiation, mandatory allergen labeling, mandatory recall authority, and current good manufacturing practices (CGMPs) for cosmetics.
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Speakers
Linda M. Katz, Director, Office of Cosmetics and Color, FDA-CFSAN
Surya Kundu, Associate, Steptoe & Johnson LLP
Anand Natarajan, Associate Counsel, Estee Lauder Companies
Moderated by Jessica O’ Connell, Partner, Covington & Burling LLP
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LINDA M. KATZ is the Director of the Office of Cosmetics and Colors (OCAC) at the Center for Food Safety and Applied Nutrition (CFSAN), which regulates cosmetics and certifies colors used in foods, cosmetics, drugs, and devices. Dr. Katz joined FDA in 1989 in the Center for Drug Evaluation and Research (CDER) first as a primary medical officer and later as Team Leader and Acting Director of the Pilot Drug Evaluation Staff which reviewed anti-rheumatic drugs, anesthetic agents, and drugs of abuse. Her subsequent appointments in CDER included: Deputy Director of the Division of Dermatologic and Dental Drug Products and Deputy Director of the Division of Over-the-Counter Drug Products. In 2002, Dr. Katz joined CFSAN in her present position and additionally served 10 years as the Acting Chief Medical Officer. In her current role as OCAC Office Director, Dr. Katz is responsible for establishing the strategic plans for OCAC and directing regulatory and research activities. She also is responsible for liaising with industry, nongovernmental organizations, consumers, stakeholder groups, and national and international regulators on policy and research related issues. She is recognized nationally and internationally for cosmetic initiatives involving harmonization, safety, and legislative activities. Dr. Katz received her MD from the University of Connecticut School of Medicine, her MPH in Epidemiology from the University of Michigan School of Public Health, and her BA in Biology from the University of Pennsylvania. She did her internship and residency in Internal Medicine and fellowship in Rheumatology at the George Washington Medical Center. Dr. Katz is an elected Fellow in the American College of Physicians as well as a Fellow in the American College of Rheumatology. In addition, Dr. Katz has taught at Walter Reed Army Medical Center and the Uniformed Services University of the Health Sciences, and has numerous publications in the scientific and medical literature.
SURYA KUNDU balances litigation with counseling to serve a diverse range of clients within the consumer products and retail industry, including leading and emerging brands, retailers and e-commerce businesses, and related suppliers, manufacturers, trade associations, and advertising/publishing entities. As a litigator, she focuses on false advertising, unfair competition, products liability, consumer protection, fraud, contract, and tort claims and has defended her clients in state and federal court, as well as in arbitration and against threatened NAD challenges, pre-suit demands, and government investigations. Surya also provides strategic advice and risk management counseling related to a variety of issues, including: labeling and claims accuracy and substantiation; sustainability initiatives, green claims, and other ESG issues; endorsements and reviews; auto-renewal, subscription, and other pricing issues; in-store and online accessibility; and keeping ahead of new legal and policy developments.




























































































































































