Grande Cosmetics US$6.25 Million False Advertising Settlement Signals Litigant Focus on FDA Regulatory Compliance

Without admitting wrongdoing, Grande Cosmetics (Grande) recently settled a class action lawsuit for US$6.25 million regarding the formulation for its personal care eye brow and lash products. Relying heavily on statements by the U.S. Food and Drug Administration (FDA) regarding an ingredient in Grande’s products, the complainant alleged that the products contained “unapproved,” dangerous drugs, constituting violations of New Jersey consumer protection laws, fraud, negligent misrepresentation, breach of express and implied warranty, negligence, and unjust enrichment.

Central to the complaint was an allegation that Grande did not warn consumers that its GrandeLASH-MD, GrandeBROW, and GrandeHAIR products contain isopropyl cloprostenate (ICP), a drug used to treat glaucoma. In particular, the plaintiff alleged that because the products contained ICP, the products would be legally classified as “unapproved” and “misbranded” drugs by FDA, and therefore violated “the [New Jersey] state analogue to the federal Food, Drug, and Cosmetic Act… which prohibits the sale of any new drug or misbranded drug absent preapproval.” Referring to FDA statements regarding ICP, the plaintiff also alleged that ICP can cause eye inflammation and other side effects, which Grande did not disclose, and that Plaintiff herself developed a severe reaction, including swelling, pain, and blurred vision.

In defense of her position, the plaintiff cited a 2011 Warning Letter sent to Lifetech Resources LLC, regarding the use of ICP in lash and brow products. In pertinent part, the Warning Letter stated that ICP lash and brow products are not safe for use except under supervision of a licensed physician because of the potential of serious side effects.  

This case serves as an important reminder that private litigants are increasingly using state laws to enforce alleged violations of the federal Food, Drug, and Cosmetics Act and thus, it is prudent for personal care product companies, in particular, to fully vet the regulatory precedent and history related to all ingredients included in product formulations when assessing the risk associated with product innovation. Scrutiny of product formulas is expected to only increase with FDA’s implementation of the Modernization of Cosmetics Regulation Act of 2022, which in turn can increase the number of Warning Letters and other statements issued by FDA that may be integrated into private litigation strategies.

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