This interactive workshop will set the stage for the two-day main conference by providing you with a comprehensive overview of the laws and regulations affecting cosmetics and personal care products. Points of discussion will include:

• Understanding the role and authority of FDA in the cosmetics and personal care products market
• Regulatory classification: Is it a cosmetic, a drug or something else?
• Definitions: Identifying the difference between a cosmetic product and a drug under the Food, Drug & Cosmetics Act
• Exploring circumstances in which a product can be considered a drug, medical device, dietary supplement, or consumer product
• Explaining structure/function claims
• Analyzing how a personal care product comes to market: Cosmetics vs. OTC drugs
• Notification vs. Listing
• Labeling
• cGMPs
• OTC Monographs
• Identifying FDA requirements governing
• Ingredients, including color additives
• Reviewing FDA versus FTC jurisdiction for advertising and promotion of cosmetics and personal care products
• Comprehending pre and post market responsibilities
• Complaint monitoring and investigation
• Adverse event reporting
• Best practices for cosmetic recalls and product reintroduction
• Other “regulators”
• Retailers
• Consumers
• The States
• CPSC, EPA, other federal agencies