FDA Identifies New Nail Polish Removers with a Banned Ingredient

The US Food and Drug Administration (FDA) has once again focused on the safety of cosmetic products after detecting six new products marketed as "gel nail polish remover" that contain methylene chloride, a substance banned in cosmetics in the United States.

This detection is part of the agency's regular market surveillance programs, in which products available to consumers are analyzed to verify their regulatory compliance.

Table of contents

1. Why is this worrying?

2. What this reveals (and worries)

3. And in Europe?

4. Key for brands: trust is not enough

FDA Identifies New Nail Polish Removers with a Banned Ingredient

Why is this worrying?

Methylene chloride is not a "gray" or "under evaluation" cosmetic ingredient. It is clearly prohibited.

It is a substance used in industrial processes such as:

• Paint strippers

• Metal cleaning

• Industrial degreasing

Its use in cosmetics is prohibited due to its toxicological profile:

• Evidence of carcinogenic potential in animal studies

• Risks to human health from inhalation and dermal exposure

• Possible effects on the central nervous system

  
  

What this reveals (and worries)

These types of findings are not isolated, and reflect several current challenges in the sector:

1. Control problems in global supply chains Many of these products are marketed online or through marketplaces, where prior control is limited.

2. Gap between formulation and actual compliance There is not always adequate verification of the final composition against the applicable regulations.

3. Reputational risk for brands and distributors Even without manufacturing directly, marketing non-compliant products can have significant regulatory consequences.

And in Europe?

Although this news comes from the USA, the message is fully applicable to the European market.

Dichloromethane is also restricted under Regulation (EC) No 1223/2009, meaning that similar products would not be compliant in the EU.

Key for brands: trust is not enough

This type of case reinforces an idea that is already evident in regulation:

Responsibility does not end with the supplier.

To avoid similar situations, it is essential to:

• Verify formulations with reliable suppliers

• Review ingredients against updated regulatory lists

• Ensure adequate testing and technical documentation

• Implement additional controls on imported products

The FDA's action is not just a one-off alert: it is a clear reminder that market surveillance is real and constant.

And in an increasingly demanding environment, Compliance is no longer just a requirement — it's a competitive advantage.

Get in touch with our team of experts now.