News & Analysis as of

Warning Letters Advertising Federal Food Drug and Cosmetic Act (FFDCA)

Skadden, Arps, Slate, Meagher & Flom LLP

Joint FDA/HHS Initiative Targeting Direct-to-Consumer Pharmaceutical Advertising Garners Much Attention, but Legal Basis and...

On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a new initiative to close what the agencies describe as a “loophole” in requirements regarding the...more

Hogan Lovells

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

Hogan Lovells on

In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more

Neal, Gerber & Eisenberg LLP

Client Alert: FTC and FDA Team Up to Send Warning Letters About Social Media Influencer Posts

Recently, the Federal Trade Commission (“FTC”) and the U.S. Food & Drug Administration (“FDA”) issued joint warning letters to four sellers of e-liquids, the nicotine “juice” used in vaping regarding their use of social media...more

Cozen O'Connor

Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

Cozen O'Connor on

Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. ...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

Mintz - Health Care Viewpoints

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

Mintz - Consumer Product Safety Viewpoints

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

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