September 11, 2023
We appreciate the opportunity to comment and support FDA’s proposed rule regarding: “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance.”
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Due to the growing rate of Americans getting tattoos and increased reports of infections related to contaminated tattoo ink, NCHR agrees this is an important public health issue that needs to be addressed. Microbial contamination of tattoo inks can occur in nearly 50% of inks on the market in the United States, which can include organisms that are known to cause serious infection and are highly resistant to antibiotics.1 NCHR supports the FDA’s objectives of ensuring that ink products are unadulterated and holding manufacturers accountable for contaminated products.
While the act of tattooing is primarily regulated by state, local, and tribal public health authorities, the FDA has the authority to regulate tattoo ink. In addition to microbial contamination, pigments have been found to contain potentially toxic chemicals, heavy metals, degradants, printer toner, car paint, and other substances that were not intended to be used on the human body.2 We agree that the FDA needs to provide guidance that will better support state, local, and tribal public health agencies to help address the growing public health burden of unsafe tattoo ink. This is especially relevant as many local tattooing regulations have recently been found to be outdated as well as inconsistent.
Accordingly, NCHR recommends that the FDA provides explicit guidance regarding the labeling of tattoo inks. While tattoo ink manufacturers are required to include ingredient and safety risks as part of the labeling requirements under the Fair Packaging and Labeling Act, these labels are rarely seen by consumers since the ink is often purchased in bulk by tattoo studios.3 NCHR strongly urges the FDA to require that user-friendly labels for tattoo ink be made available online to consumers prior to getting tattoos; preferably, in a consumer checklist that they must sign, so that they have the information they need to make informed decisions on the risks of tattooing.
NCHR also recommends that the FDA include clear, understandable guidance regarding the water and dilution techniques that should be used to achieve color variation in tattoo studios. This is of particular importance as non-sterile dilution techniques were a primary cause of the nontuberculous mycobacterial skin infection outbreak that was referenced in FDA’s draft guidance. A common practice for tattoo studios is to use distilled or reverse osmosis water for dilution. However, these are non-sterile techniques, and the FDA should prohibit such techniques and instead require and explain the importance of sterile dilution techniques.
NCHR is also concerned about the voluntary reporting system of contaminated ink products, which primarily relies on consumers. This places the burden of contamination identification and reporting on the consumer rather than the manufacturer, and also undermines the responsibility of the manufacturer to ensure that their products are unadulterated. In addition, since consumers are rarely aware of existing reporting mechanisms, the FDA should require that tattoo studios educate consumers on how to report adverse events caused by contaminated ink. NCHR also agrees with the FDA’s recommendation that tattoo ink and ink components be tested for microbial contamination and that tattoo establishments be required to discard contaminated products. Although we are concerned that the lack of proposed manufacture accountability and enforcement mechanisms, traceability, and regulatory incentives will lead to noncompliance, having such requirements will increase the risk of lawsuits for noncompliance, and that will serve as an incentive to comply with FDA requirements.
It is estimated that nearly one-third of Americans have a tattoo with reports of microbial contamination at a staggering 49%1,4 Thus, there is a great need to better regulate tattoo ink and raise awareness among the public about the risks of unsafe tattoo ink. NCHR supports the objective of the FDA in helping manufacturers to identify and discard adulterated ink to better protect public health. However, NCHR recommends that ink labels be made readily available to consumers and sterile dilution techniques are included in the final guidance. We also strongly recommend that the FDA develop an information toolkit to increase consumer awareness regarding contamination reporting systems in tattoo studios, while working to build robust mechanisms for manufacturer reporting, traceability, and accountability.
As noted above, in addition to microbial contamination, pigments have been found to contain potentially toxic chemicals, heavy metals, degradants, printer toner, car paint, and other substances that were not intended to be used on the human body. The rate of ink contamination with unsafe substances that include but are not limited to microbial contamination has been reported as high as 67%.5 Therefore, we strongly urge the FDA to expand the regulation of all types of dangerous substances in this draft guidance or develop a similar draft guidance specifically to reduce the risks caused by these other dangerous substances.
References:
- Nho, SW et al. “Microbiological Survey of Commercial Tattoo and Permanent Makeup Inks Available in the United States.” Journal of Applied Microbiology, 124: 1294-1302 (2018).
- “NEHA Response to Request from FDA for Good Manufacturing Practices on Tattooing Inks and Pigments.” 2023.
- Association of Food and Drug Officials, Body Art Committee. “Tattoo Ink and Permanent Makeup Labeling Guide.” 2019.
- Pew Research Center. “32% of Americans have a tattoo, including 22% who have more than one.” 2023.
- Bonadonna, Lucia. “Survey of Studies on Contamination of Marketed Tattoo Inks.” Karger. 2015.