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Warning Letters Product Labels Labeling

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

BakerHostetler

Bamboozling - Part I: Do Green Claims Require a Life Cycle Analysis?

BakerHostetler on

The title of this series is an homage to the great Lesley Fair, who launched and authors many of the best of the FTC’s business blogs and who coined this term in her blog reviewing 2013 cases on the same topic. But we are...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

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