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Course Details

Course Information
  • smart_display Format

    Live Online with Live Q&A

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Professional Skills

Date & Time
  • event Date

    Friday, January 10, 2025

  • schedule Time

    1:00 p.m. EST.

  • timer Program Length
Credit Information

  • An excellent opportunity to earn Ethics CLE credits. Note: BARBRI cannot guarantee that this course will be approved for ethics credits in all states. To confirm, please contact our CLE department at pdservice@barbri.com.

  • BARBRI is a NASBA CPE sponsor and this 110-minute webinar is accredited for 2.0 CPE credits.

  • BARBRI is an IRS-approved continuing education provider offering certified courses for Enrolled Agents (EA) and Tax Return Preparers (RTRP).

$401.00
CLE
CPE

This CLE course will examine consumer class actions targeting the cosmetics industry under the increased scrutiny by the FDA as it continues implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The panel will consider the possible impact of Loper Bright and how new FDA requirements already have and are expected to fuel class litigation. The panel will discuss theories of liability and strategies for defending and settling claims. The panel will also discuss proactive steps clients should take to minimize their exposure to class claims in light of increased FDA scrutiny and regulation.

Description

Enacted in 2022, MoCRA completely overhauled the way the FDA regulates cosmetics, adding many new requirements, including requiring adverse event reporting and record keeping, labeling requirements, safety substantiation, and records access. These new mandates mean that companies must change how they manage the entire manufacturing, marketing, and sale process. Attempts to comply with and implement MoCRA create opportunities for missteps and offer fertile ground for class action litigation.

Private litigants are increasingly using state laws to enforce alleged violations of the federal Food, Drug, and Cosmetics Act. As more states outlaw specific ingredients, this activity is expected to increase. A number of class lawsuits have sought damages for implied drug claims and misbranded drugs (unapproved drug) because products allegedly did not conform to an FDA monograph.

Whether pursuing or defending class actions against cosmetics manufacturers, counsel must understand common and emerging liability theories and be able to navigate issues of predominance, standing, causation, and more. Further, defense counsel will want to help their industry clients take proactive steps to minimize the likelihood of class claims.

Listen as our authoritative panel of class action attorneys discusses how MoCRA is impacting class actions against cosmetic companies and best practices for minimizing liability exposure.

Outline

  • History of cosmetics regulation in the U.S.
  • New requirements and FDA enforcement powers
  • Regulation of good manufacturing practices
  • Claims
  • Defenses
  • Strategies for plaintitff and defense

Benefits

  • How does adverse incident reporting (or failure to report) create risk of class litigation?
  • What is the difference between asserting that conduct violates the FDCA and attempting to enforce the FDCA?
  • What defenses may be available under MoCRA?

NASBA Details

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  • Field of Study: Business Law
  • Level of Knowledge: Basic
  • Advance Preparation: None
  • Teaching Method: Seminar/Lecture
  • Delivery Method: Group-Internet (via computer)
  • Attendance Monitoring Method: Attendance is monitored electronically via a participant's PIN and through a series of attendance verification prompts displayed throughout the program
  • Prerequisite: CPE Prereq text

Strafford Publications, Inc. is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of Accountancy have final authority on the acceptance of individual courses for CPE Credits. Complaints regarding registered sponsons may be submitted to NASBA through its website: www.nasbaregistry.org.

IRS Approved Provider

Strafford is an IRS-approved continuing education provider offering certified courses for Enrolled Agents (EA) and Tax Return Preparers (RTRP).