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Cosmetic Industry Class Actions: Navigating New Risks Under Modernization of Cosmetics Regulation Act

Unapproved Drug Claims, Product Performance, False and Misleading Advertising, Mislabeling

A live 90-minute CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Thursday, December 12, 2024 (in 5 days)

1:00pm-2:30pm EST, 10:00am-11:30am PST

(Alert: Event date has changed from 10/24/2024!)

or call 1-800-926-7926

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.

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Outline

  1. History of cosmetics regulation in the U.S.
  2. New requirements and FDA enforcement powers
  3. Regulation of good manufacturing practices
  4. Claims
  5. Defenses
  6. Strategies for plaintitff and defense

Benefits

The panel will review these and other important issues:

  • 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?

Faculty

Gottfried, Christopher
Christopher E. Gottfried

Of Counsel
Greenberg Traurig

Mr. Gottfried focuses his practice on health care, as well as administrative and regulatory matters. He represents...  |  Read More

Kolton, Eleanor
Eleanor A. (Miki) Kolton

Of Counsel
Greenberg Traurig

Ms. Kolton has wide-ranging legal, administrative and management experience in medical practice law; HIPAA, Stark,...  |  Read More

Miller, Gretchen
Gretchen N. Miller

Shareholder
Greenberg Traurig

Ms. Miller is the Co-Chair of the Products Liability & Mass Torts Practice and focuses her practice in toxic...  |  Read More

Pigott, Ginger
Ginger Heyman Pigott

Shareholder
Greenberg Traurig

Ms. Pigott provides critical product liability advice and litigation defense to emerging and established businesses. As...  |  Read More

Attend on December 12

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You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.

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