PRE-CONFERENCE WORKSHOPS

Next Article

ACI’s 10th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products

Monday, March 27, 2023

Due to the hands-on nature of the workshops, they will only be available for in-person attendance.

The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

Microphone-alt Cynthia L. Meyer, Partner, Kleinfeld, Kaplan & Becker, LLP

Carrie Kovalerchik, Senior Legal Counsel, Unilever

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

A B

» Notification vs. Listing

» cGMPs

» Labeling

• 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 Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

As the biggest end of the year surprise, MoCRA 2022 was signed into law, bringing new federal standards in the cosmetics industry for registration, adverse event reporting product listing, recordkeeping, recalls, safety substantiation and more.

Our workshop leaders will provide an in-depth analysis of the new cosmetics regulatory framework and help you and your company prepare for the upcoming changes and requirements. Points of discussion will include:

• Analyzing how MoCRA will change how the FDA regulates cosmetics

• Determining the next steps for cosmetic brands in view of this legislation and examining what resources they need to implement and key provisions

• Developing a comprehensive plan of action in view of complying with the new provisions

• Identifying and minimizing the risk of litigation and consumer claims based on the new FDA requirements