The U.S. Food and Drug Administration has taken action against six companies marketing unauthorized and potentially dangerous topical pain relief products, primarily used in cosmetic procedures such as laser hair removal, tattooing, and piercing.
"These products pose unacceptable risks to consumers and should not be on the market," states Jill Furman, JD, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "We are committed to using all available tools to stop the sale of these illegal high-risk products."
Safety Concerns and Health Risks
The products in question contain lidocaine concentrations significantly higher than FDA-approved levels for over-the-counter use. When applied during cosmetic procedures, these high-concentration formulations can lead to dangerous levels of absorption, potentially causing:
- Irregular heartbeat
- Seizures
- Breathing difficulties
- Harmful interactions with medications or supplements
Risk factors are particularly elevated when these products are:
- Applied over large skin areas
- Used on irritated or broken skin
- Left on for extended periods
- Covered with plastic wrap or dressings
Regulatory Action and Company Response
The FDA has issued warning letters to companies including TKTX Company, SeeNext Venture Ltd, Tattoo Numbing Cream Co, Sky Bank Media LLC, Dermal Source Inc, and Indelicare. These companies have been marketing products with lidocaine concentrations ranging from 5% to 40%, far exceeding the FDA's 4% limit for OTC products.
The companies have been given a 15-day window to respond with their corrective action plans or provide evidence supporting their products' compliance with regulations. Failure to address these violations may result in legal actions, including product seizures and court-ordered manufacturing stops.
Consumer Safety Guidelines
The FDA has established clear guidelines for consumers regarding topical pain relief products:
- Use only OTC products containing no more than 4% lidocaine
- Avoid application on large skin areas
- Do not use on irritated or broken skin
- Never wrap treated areas in plastic or dressings
Import Restrictions
As part of its enforcement strategy, the FDA has placed several of the offending companies on import alert, effectively blocking their products from entering the United States. This measure aims to protect consumers from accessing these potentially dangerous products through various distribution channels.
The agency emphasizes that there is no evidence supporting the safety of these high-concentration lidocaine products, noting a decade-long history of warnings against similar products in the cosmetic procedure market.
