Unintentional Drug Claims on Cosmetics Not Actionable

Unintentional Drug Claims on Cosmetics Not Actionable

Last month, a long running case against Beiersdorf, Inc., makers of Nivea, was dismissed.  I would normally prepare a summary myself, but in this case, the first 3 paragraphs of the court's opinion provides a great summary: Five years ago, Ashley Franz purchased a $10 bottle of Nivea's Skin Firming Hydration Body Lotion from a [...]

FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption

FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption

On January 9, 2015, the FDA issued a warning letter to Derma Pen, LLC, claiming the company's micro-needle dermabrasion device is an adulterated and misbranded Class 1 medical device and challenging the marketing of the company's line of "cosmeceuticals" as misbranded drugs. FDA asserts that the automated micro-needling device, which uses a stamping action to [...]