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 CVS in San Diego. She spent an extra $4 on this Lotion because she believed the claim on the bottle: “Improves Skin’s Firmness in as little as 2 weeks.” When the Lotion didn’t firm her skin as advertised, she filed a class action against¬†Beiersdorf, Inc. (“Nivea”) for false advertising and for selling an unapproved drug.

About a year ago, the Court dismissed Franz’s false advertising claim, and found the FDA had primary jurisdiction to decide if the Lotion was a drug. The Court stayed the case to allow Franz to petition the FDA to take enforcement action against Nivea for making skin-firming claims that Franz maintains makes the Lotion a drug that requires FDA approval. The FDA declined to take any action.

Franz filed a second amended complaint based on a single claim: Nivea is engaged in unfair competition because it’s selling the Lotion as an unapproved drug. Nivea moved to dismiss. Because the Court lacks jurisdiction, it dismisses the complaint.

Continue reading “Unintentional Drug Claims on Cosmetics Not Actionable”

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. Continue reading “FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption”