PRE-CONFERENCE WORKSHOPS

Wednesday, September 27th, 2023

A9:00 am–12:30 pm – Registration to begin at 8:30 am (BREAK 10:30 am–11:00 am)

The Foundation of Beauty: An Introduction to Cosmetics and Personal Care Products Law and Regulation

Microphone-alt Riëtte van Laack, Director, Hyman, Phelps & McNamara

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

12:30 pm–1:00 pm

B1:30 pm–5:00 pm – Registration to begins at 12:30 pm (BREAK at 2:30 pm)

• 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

MoCRA Compliance Working Group: A Practical and Tactical Guide to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

With more than six months since MoCRA 2022 was introduced as law, companies are now turning to FDA and industry for guidance and support on complying with new federal standards in the cosmetics industry for registration, adverse event reporting product listing, recordkeeping, recalls, safety substantiation and more.

Join our workshop leaders for a deep dive into the MoCRA framework, which will provide you with essential knowledge to help your company ensure compliance with current guidelines and prepare for upcoming changes and requirements. Points of discussion will include:

• Examining how MoCRA changed the way cosmetics are regulated by the FDA

• Analyzing the latest MoCRA guidance and anticipating when the FDA will release more guidance

• Creating a robust strategy to ensure compliance with the latest MoCRA provisions

• Identifying and procuring the necessary resources needed to implement the next phase of MoCRA requirements

• Identifying and minimizing the risk of litigation and consumer claims based on the new FDA requirements linkedin: FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs