Tattoo Ink Safety – A Reinvigorated Agency Concern

On June 12, 2023, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for tattoo ink manufacturers and distributors entitled, “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination,” to assist manufacturers and distributors of such products in recognizing when tattoo ink may pose contamination risk and/or cause potential injury.

The risks associated with contaminated tattoo ink are not new, but with the rise of tattooing and permanent ink usage (i.e., according to the Draft Guidance, 30% of all Americans and 40% of those 18-34, have at least one tattoo) creates additional hazards to consider. To illustrate, between 2003 and 2023, there were 18 recalls of tattoo inks due to contamination with a variety of microorganisms. In 2019, FDA issued a safety alert associated with certain tattoo inks.

This Draft Guidance is one additional step the agency is taking to protect consumers and assist those responsible for the safety of tattoo ink in recognizing when tattoo ink may be contaminated, or manufactured, or held under insanitary conditions, and, therefore, deemed “adulterated.”

The Draft Guidance offers “general considerations” (or factors) for evaluating tattoo ink, taking into account the diverse range of consumers who use it, the application of tattoo ink below the epidermis layer of dermal tissue (i.e., intradermally), and the elevated risk associated with tattoo ink as compared to a topical product. 

FDA additionally provides several examples of “insanitary conditions” that, if present during manufacturing or occurring during distribution, could render a tattoo or permanent ink product injurious to health, including – Unsuitable facilities for ink preparation, exposure of ink and components to airborne contaminants, contamination of ink with microorganisms, lack of proper cleaning and sanitization of ink holding containers, unhygienic or unclean mixing practices, inadequate garbing of personnel who handle inks, as well as certain other departures from basic hygiene practices such as lack of absence of soap and water in employee restrooms, improper disposal of used protective clothing, and storage of packaged products in contaminated areas.

Lastly, the FDA provides recommendations for manufacturers and distributors to address the risks associated with tattoo ink. Although we have added some additional context where appropriate, these recommendations are without limitation and generally include:

• Testing tattoo ink and components for microbial contamination or sourcing materials from reliable suppliers that routinely conduct such tests;
• Manufacturing processes should be conducted with proper cleaning, sanitization, and use of appropriate personal protective equipment designed to prevent contamination and enhance bioreduction practices;
• Appropriate validation of sterilization methods (a crucial element  for sterile products);
• Ensuring that cleaning, sanitization, and sterilization practices do not unintentionally adulterate a finished product;
• Taking corrective measures to prevent any final products that microbiological testing shows contain microorganisms that may harm consumers. Instead, manufacturers and distributors should determine where the microorganisms came from, including developing an understanding of the existing microflora in their respective environments and revise their processes to not only provide broad spectrum environment controls but also to specifically target those microorganisms identified during routine monitoring of their facilities; and
• Examining and establishing good manufacturing practices (GMPs) (or applying GMPs that pertain to cosmetics generally).

For next steps, FDA provides additional information regarding tattoos, temporary tattoos, and permanent makeup. In addition, there is an ongoing push for the National Center for Toxicological Research (NCTR) to conduct research into the toxicological impact that tattoo ink and permanent makeup can have. Notably, FDA closes the Draft Guidance stating that the agency intends to conduct rulemaking to establish cGMP regulations for tattoo ink and similar products as part of the implementation of the Modernization of Cosmetics Regulation Act of 2022.

If you are a manufacturer or distributor of tattoo ink or other permanently applied cosmetics and have questions about the Draft Guidance, would like to file comments regarding the Draft Guidance, or have other questions about how the Draft Guidance may impact your operations, please do not hesitate to contact us using the information below. OFW Law will continue to follow these developments and share relevant updates as they become available.

Please contact Andrew Harrison (aharrison@ofwlaw.com) and Kyla Kaplan (kkaplan@ofwlaw.com) if you have questions or would like assistance.