FDA Flags Prohibited Methylene Chloride in Certain Gel Nail Polish Removers: Industry Takeaways

On April 18, 2025, the FDA issued a public notice identifying several gel nail polish removers containing methylene chloride, a chemical banned in cosmetic products under 21 CFR 700.19. This action underscores the agency’s continued enforcement focus on prohibited substances in cosmetics and signals heightened scrutiny of non-compliant imports.

Key Findings

FDA testing revealed that four gel nail polish remover products—marketed under the names AL’IVER®, AIBRIT, and BesTby—contain 77% to 93% methylene chloride, despite labeling that either omits the ingredient or uses misleading synonyms (e.g., “dichloromethane”).

All products originated from China and were sold online to U.S. consumers. The agency emphasized that the inclusion of methylene chloride, whether disclosed or not, renders these products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA).

Implications for Industry

Distributors, retailers, and importers of cosmetic products should take immediate steps to:

• Review supply chains for gel polish removers and similar products that may contain or fail to disclose banned ingredients.
• Verify ingredient compliance through supplier certifications and independent testing, especially for imported goods or white-label products.
• Ensure proper labeling and ingredient transparency to avoid misbranding violations.

This enforcement action reinforces FDA’s position that cosmetic manufacturers and distributors bear primary responsibility for ensuring product compliance. Even unintentional violations involving restricted substances can trigger enforcement, recalls, or import refusal.

Action Items

• Audit your product portfolio for compliance with 21 CFR 700.19 and other applicable cosmetic ingredient restrictions.
• Engage legal or regulatory counsel to assess risk exposure and enhance compliance protocols.
• Consider reporting mechanisms and post-market surveillance to identify potential noncompliance early.

For additional guidance or regulatory support related to FDA cosmetic compliance, contact our office or visit FDA’s Cosmetics Regulatory Resources.