Did Nivea’s claims for its Skin Firming Hydration Body Lotion push the product into the category of a drug requiring approval from the Food and Drug Administration (FDA)?

Possibly, a California federal court judge has ruled, denying the company’s motion to dismiss a putative class action.

Ashley Franz filed suit in 2014, alleging that Nivea’s labeling claims touting the skin-firming properties of its lotion tipped the product into the category of a drug. In addition to the product name, the plaintiff pointed to language on the front of the bottle claiming the product “Improves Skin’s Firmness in as little as 2 weeks” and, on the back, “Proven to firm and tighten skin’s surface in as little as two weeks” and “For softer, smoother, more toned skin.”

Since the company did not receive the necessary FDA approval for the claims, which “affect the structure or any function of the body,” the lotion was being sold in violation of the Federal Food, Drug and Cosmetic Act (FDCA) as well as the California Sherman Food, Drug and Cosmetic Law, Franz told the court. 

Nivea countered that the product label appropriately classified the lotion as a cosmetic moisturizer and not a drug. The company moved to dismiss the lawsuit, arguing that the court should look to an FDA guidance document, Wrinkle Treatments and Other Anti-Aging Products, where the agency states that “moisturizing is a cosmetic claim.”

In response, Franz submitted FDA warning letters to multiple cosmetic companies, expressing concern that their advertising crossed the line into drug claims. For example, in a 2012 letter to Avon Products regarding its face creams, the FDA objected to claims that the products would “fortify damaged tissue with new collagen. In just 3 days, see tighter, firmer, more lifted skin” and would “help tighten the connections between skin’s layers.”

Noting that FDA guidance, “as helpful as it may be, doesn’t necessarily determine what is and isn’t a drug under the FDCA,” U.S. District Court Judge Larry Alan Burns denied the motion, concluding that Franz had plausibly pled that the Nivea lotion was a drug.

“[T]he parties have not identified a provision of the FDCA or any applicable agency regulation that would exclude a product that ‘affects the structure or function of the body’ from the definition of ‘drug’ simply because it does so through moisturization,” the court wrote. “Nor have the parties identified the statutory or regulatory basis for the FDA’s Wrinkle Treatments and Other Anti-Aging Properties guidance, so the Court is unable at this juncture to determine whether the agency’s interpretation excluding moisturizing products from the definition of ‘drug’ is persuasive.”

Accepting the allegations in the complaint as true, “Franz has stated a plausible claim that the lotion is a drug and that it was sold unlawfully,” Judge Burns said.

To view the order in Franz v. Beiersdorf, Inc., click here.

Why it matters: Although the plaintiff’s lawsuit survived the motion to dismiss, the court was clear that it was issuing “a limited holding” and was “not deciding that the lotion is a drug.” Judge Burns found it “significant” that despite the multiple FDA warning letters supplied by the plaintiff, the agency “has declined to take any action with respect to the lotion in the seven-plus years it has been on the market,” despite its active policing of “drugs that are improperly sold as cosmetics.”