Julian Klein

Sheppard Mullin Richter & Hampton LLP

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Texas Sues Johnson & Johnson and Kenvue Over Tylenol: Scientific Evidence, Regulatory Shifts, and the Future of OTC Drug Labeling

On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. (“Kenvue”)—formerly the consumer health division of Johnson & Johnson, and now in the process of being acquired by...more

11/5/2025 / Department of Health and Human Services (HHS) , False Advertising , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Product Labels , Regulatory Oversight , State Attorneys General , Texas , Unfair or Deceptive Trade Practices

FDA’s Wave of Untitled Letters Signals Stricter Scrutiny for DTC Pharma Ads

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued numerous untitled letters as part of the agency’s wider attack on direct to consumer (“DTC”)...more

10/2/2025 / Advertising , Direct to Consumer Sales , False Advertising , Food and Drug Administration (FDA) , OPDP , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements , Warning Letters

FDA Unleashes Wave of Enforcement: The Industry Faces a Crackdown on Drug Advertising

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down...more

9/19/2025 / Advertising , Artificial Intelligence , Drug Compounding , Enforcement Actions , Food and Drug Administration (FDA) , Misleading Statements , OPDP , Pharmaceutical Industry , Prescription Drugs , Warning Letters

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