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New IRS Guidance on Basis Adjustments for Irrevocable Grantor Trusts: Key Issues for U.S. and Non-U.S. Persons
Unapproved Drug Claims, Product Performance, False and Misleading Advertising, Mislabeling
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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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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BARBRI is an IRS-approved continuing education provider offering certified courses for Enrolled Agents (EA) and Tax Return Preparers (RTRP).
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Live Online
On Demand
Date + Time
- event
Tuesday, April 1, 2025
- schedule
1:00 p.m. EST.
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?
- What defenses may be available under MoCRA?
- What defenses may be available under MoCRA?
- What defenses may be available under MoCRA?