Workshop A – The Foundation of Beauty: An Introduction to Cosmetics and Personal Care Products Law and Regulation
Riëtte van Laack
Director
Hyman, Phelps & McNamara
Cynthia Meyer
Partner
Kleinfeld, Kaplan & Becker LLP
Registration to begin at 8:30 am (BREAK 10:30-11:00)
This informative and engaging workshop will pave the way for the two-day main conference by offering a thorough overview of the laws and regulations governing the cosmetics and personal care products industry. Whether you are a newcomer on the market or wish to stay up to date with the latest legal developments, join our workshop leaders for an in-depth resource and training session.
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