Upgraded Safety Standards for Tattoo Inks: FDA’s Final Guidance
The U.S. Food and Drug Administration (FDA) has taken a significant stride in consumer protection with the issuance of comprehensive final guidance on tattoo ink safety. This guidance, titled “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination”, was released in October 2024. It provides manufacturers and distributors with detailed recommendations to prevent dangerous bacterial contamination in tattoo inks.
Triggered by multiple reports of illnesses caused by microbially contaminated tattoo inks, the FDA’s action is a response to 18 voluntary recalls of contaminated products between 2003 and 2024. The guidance emphasizes on:
- Testing ink components for contamination
- Ensuring proper sterilization methods
- Maintaining sanitary manufacturing conditions
Key requirements include avoiding carpeted preparation areas, using sanitized containers, requiring appropriate protective equipment for personnel, and implementing proper hand hygiene facilities.
“This guidance is intended to help members of industry avoid the conditions that led to the production of contaminated inks and to protect consumers,” the FDA stated. The new standards encourage manufacturers to follow International Organization for Standardization (ISO) practices while the agency prepares to implement Good Manufacturing Practices under the Modernization of Cosmetics Regulation Act.
Source: FDA