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Labeling Commercial Speech

Shumaker, Loop & Kendrick, LLP

Summary of U.S. Advertising Laws and Regulations for Malt Beverages and Energy Drinks

WHAT IS, AND IS NOT, ADVERTISING? At the outset it is important to understand what is, and is not, considered to be advertising or an advertisement under U.S. law. Generally speaking, as applied to any product, be it beer,...more

Bilzin Sumberg

Mislabeling Claims Against Poland Spring Water Survive Dismissal

Bilzin Sumberg on

Water: two parts hydrogen, one part oxygen. It seems simple enough, but for companies selling bottled water, liability lurks below the surface. According to a recent lawsuit, consumers care not only about what is in their...more

Foley Hoag LLP

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

Foley Hoag LLP on

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Saul Ewing LLP

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

Saul Ewing LLP on

The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

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