Nivea Lotion Not Subject to FDA’s Drug Rules, Company Argues

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The company that makes Nivea skin care products seeks dismissal of a class action lawsuit that claims one of its lotions is a misbranded and illegal drug.

In its motion for dismissal, defendant Beiersdorf Inc. says the purported Nivea class action lawsuit fails to plausibly allege that Nivea Skin Firming Hydration Body Lotion with CoQ10 Plus is a “drug” subject to FDA review and approval.

Plaintiff Ashley Franz originally filed this Nivea class action lawsuit in September 2014. After some back-and-forth over which claims are or are not well-grounded, she followed up in October 2016 with her current second amended complaint.

Franz now alleges only that Beiersdorf is illegally marketing a drug without having submitted it to the FDA’s New Drug Application process.

She argues the company’s representation that Nivea lotion can firm skin makes the product a “drug,” according to the FDA’s definition.

Products meeting that definition must go through the FDA’s New Drug Application process before they can be marketed, Franz claims. By failing to meet that requirement with Nivea lotion, Beiersdorf has violated the federal Food, Drug and Cosmetic Act, Franz argues.

She also claims violation of California’s Sherman Food, Drug and Cosmetic Act. Under that law, “drug” is defined as “any article other than food that is used or intended to affect the structure or any function of the body of human beings.”

Beiersdorf counters that the representations don’t even come close to making Nivea lotion a drug. The company cites FDA guidance saying that a product that purports only to moisturize or soften the skin is a cosmetic, not a drug.

Other FDA guidance says products intended to remove wrinkles or increase the production of collagen in the skin are considered “drugs.” But the labeling for Nivea lotion makes none of those claims, the company says.

Beiersdorf points out that the FDA has already declined to take action based on Franz’s complaint. Franz filed a petition with the FDA in September 2015, asking the agency to initiate enforcement action over the Nivea lotion.

The FDA responded in March 2016, saying it did not intend to pursue any action against Beiersdorf in response to Franz’s complaint.

In her earlier complaints, Franz claimed the company has no reliable scientific evidence to back up its claims that the Nivea lotion can actually firm skin. Without evidence, she argued, the company’s claims are misrepresentations that violate the California Consumer Legal Remedies Act.

Beiersdorf countered that Franz’s argument doesn’t support a claim for misrepresentation. She didn’t claim that the skin firming representations are actually false but only that they lack substantiation, the company said.

The judge tended to agree with Beiersdorf, noting that under California law there is no private right of action for claims that a representation is merely unsubstantiated. Franz dropped her misrepresentation claim in her current version of the complaint.

Franz is represented by Manfred Muecke, Patricia Syverson and Elaine Ryan of Bonnett Fairbourn Friedman & Balint PC and Max Stein and Stewart Weltman of Boodell & Domanskis LLC.

The Nivea Lotion Mislabeling Class Action Lawsuit is Franz v. Beiersdorf Inc., Case No. 3:14-cv-02241, in the U.S. District Court for the Southern District of California.

UPDATE: On Nov. 22, 2016, Franz urged a federal court to reject the company’s bid to dismiss this class action lawsuit by arguing that federal law states a cosmetic is a drug “when its intended use is to affect the structure or function of the body (here to firm and tighten the skin).”