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This webinar will cover laws and regulations for successful marketing and compliance of cosmetics in the U.S. It will help clarify what claims and product labeling are appropriate for cosmetics to market them successfully and avoid regulatory issues and problems with FDA compliance and competitive challenges. Current FDA Warning letters to cosmetic firms will be reviewed. Adverse Event Reporting requirements for cosmetics will be discussed with focus on how these requirements will change under newly proposed legislation for cosmetics: The Personal Care Products Safety Act.
Key Learning Objectives of Topic :
- Key regulatory requirements for marketing cosmetics in the U.S.
- FDA labeling requirements for cosmetics.
- What cosmetic claims are appropriate for cosmetics vs. those to avoid.
- FDA’s changing views on cosmetic enforcement.
- Newly proposed legislation: The Personal Care Products Safety Act and how it will impact cosmetic regulatory requirements.
- Serious Adverse Event reporting for cosmetics and how this will change.
Instructor Profile :
Norma Skolnik has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry. She was Associate Director of Regulatory Affairs at Lederle Laboratories in Pearl River, N.Y. and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum and Caltrate dietary supplements. When Lederle was acquired by Wyeth, she became Associate Director of Regulatory Affairs there, acquiring more experience in the Dietary Supplement and OTC drug fields. She joined Warner-Lambert Consumer Health division in 1998 and became Assistant Director of Adams Regulatory Affairs. In 2002 after Pfizer’s takeover of Warner-Lambert, she was promoted to Director of Regulatory Affairs for the Adams division. Adams was acquired by Cadbury-Schweppes in 2003 and she served as Cadbury Adams’ Director of Regulatory Affairs for the Americas from 2003 until her retirement in 2008.
Norma earned a Bachelor’s degree in Biology from the University of Cincinnati and holds a Master’s degree from Pratt Institute in Brooklyn, New York. She's also done graduate work at Columbia University and Montclair State University. Today Norma works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A