FDA Discovery of Methylene Chloride in Gel Nail Products

The U.S. Food and Drug Administration (FDA) recently issued a high-priority warning after identifying methylene chloride in several gel nail polish remover products. 

Although FDA has long prohibited methylene chloride in cosmetics, recent agency laboratory testing found concentrations ranging from 78% to 94% in multiple products, most of which were manufactured in China and marketed online.  

Regulatory Background: The Long-Standing Ban 

Methylene chloride is a volatile, colorless liquid with a sweet odor that has been used in multiple industrial applications, such as paint stripping, remover manufacturing, and metal cleaning and degreasing. FDA banned its use as an ingredient in cosmetic products in 1989, pursuant to 21 CFR 700.19, after determining that the substance posed a significant cancer risk to consumers. The regulation notes that methylene chloride produced significant increases in benign and malignant lung and liver tumors in animal studies and concludes that any cosmetic containing methylene chloride is adulterated under the Federal Food, Drug, and Cosmetic Act. More recently, in 2024, the U.S. Environmental Protection Agency finalized a rule under the Toxic Substances Control Act that effectively prohibits most consumer and commercial uses of methylene chloride based on unreasonable risks to human health. 

Recent Findings and Enforcement 

As of late April 2026, FDA’s surveillance program had identified 10 gel nail remover products containing high levels of methylene chloride. According to FDA, these products often either failed to disclose methylene chloride on their labels or used alternative terminology that may obscure the ingredient’s presence in online marketplaces. FDA’s announcement also follows the April 13, 2026, recall of Morovan Gel Nail Polish Remover, involving approximately 4,000 units after testing detected both methylene chloride and chloroform, each of which is prohibited in cosmetic formulations. 

These developments emphasize the immediate legal and regulatory risks for manufacturers, importers, distributors, and online sellers of cosmetics. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), companies must substantiate product safety, maintain appropriate records, and comply with applicable regulatory requirements. The presence of a banned substance in a cosmetic product may raise questions about supplier oversight, quality controls, and compliance with good manufacturing practice expectations. MoCRA also gives FDA mandatory recall authority when there is a reasonable probability that an adulterated cosmetic will cause serious adverse health consequences or death. In addition to regulatory risk, the discovery of a prohibited and potentially carcinogenic substance could create substantial civil litigation exposure. 

For further information or specific inquiries, please contact the firm’s Food & Consumer Packaged Goods Litigation team.