News & Analysis as of

Warning Letters Advertising 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

Womble Bond Dickinson

Can hashtags get you in trouble?

Womble Bond Dickinson on

They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same...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

Faegre Drinker Biddle & Reath LLP

FDA Scolds Company Claiming to Bake with Love

Where’s the love? Apparently, not at the FDA. On September 22 the FDA issued Warning Letter CMS# 532236 to Nashoba Brook Bakery, of Concord, Mass. Among several infractions cited in the letter was one for the misbranding...more

Cozen O'Connor

FTC Announces Red Light on Unqualified “Green Approved” Seals

Cozen O'Connor on

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental...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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