By Dr. RYAN P. SMITH
Tattooing represents one of the most ancient and universal forms of art in human history. According to a 2010 Pew Research Center report, nearly 4 in 10 millennials are getting inked, with approximately half of those individuals obtaining multiple tattoos. Tattoos may designate reverence to important life events or loved ones, serve as a means of self-expression, and foster healing from tragedy or medical illness.
In 2019, CNN Health and other media outlets cautioned consumers regarding the inconsistent and often absent oversight of tattoo parlors in the U.S. In addition, attention was drawn to the increasing regulation in Europe regarding tattoo ink chemical composition and consumer safety. Within the U.S., tattoo oversight is a window into the lack of regulation within the greater cosmetic industry. No laws or FDA regulations currently exist to require safety testing of individual cosmetic products or ingredients, leaving these entities innocent until proven guilty.
The European Chemicals Agency, the European Union equivalent to the U.S.' Food and Drug Administration, has publicly acknowledged that there are chemicals known to cause cancer, mutate DNA and carry reproductive toxicity in tattoo ink. While several EU nations already regulate the permissible chemicals within tattoo ink, there was a call for a universal legislative framework to protect all EU citizens.
The Joint Research Center, which provides independent scientific advisement to the European Commission, issued a report in 2016 citing that tattoo and permanent makeup products contain “the presence of polycyclic aromatic hydrocarbons, primary aromatic amines, microorganisms, heavy metals, and preservatives.” The chemical mixture of these agents is intended to stay in the body for life, increasing the risk of long-term exposure to the potentially harmful ingredients.
Tattoo ink is also known to migrate beyond the site of implantation. The surgical retrieval of ink-laden lymph nodes, mimicking cancerous enlargement, has been reported at the University of Virginia and other institutions. Scientific Reports published a study in 2017 demonstrating the presence of tattoo pigment, heavy metals and titanium dioxide within the lymph nodes of tattooed individuals examined postmortem. To date, the risk of cancers related to the chemical exposures in tattoo ink is ill-defined. Establishing causality or exclusion of their cancer-promoting potential in tattooed individuals would require complex, long-term studies, which are unlikely to be done.
The ECHA’s investigation ultimately has resulted in the adoption of proposed restrictions as a part of the EU’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations. This will establish concentration limits, abolish the use of some substances, and regulate the use of more than 4,000 chemicals found in body ink.
Despite their widespread prevalence, the FDA does not effectively regulate tattoo ink. Dr. Linda Katz states, “[The] FDA enforces existing U.S. laws and regulations based on the authority that Congress has given us, and, as such, we are not required to mandate manufacturers to declare ingredient statements or any substances of concern on the label of tattoo inks.” There are no known safe inks that have been FDA-approved for use in tattooing, and some inks may contain industrial-strength pigments formulated for printers and automobile paint.
As reflected in the actions of the ECHA, the composition of tattoo inks raises concerns for public health, the most significant being that “some of these substances might cause cancer, change DNA, or be harmful to human reproduction,” according to Mark Blainey, a senior scientific officer at the ECHA. Until the United States empowers the FDA to regulate the composition of tattoo ink, giving consumers the safety they deserve, the FDA rightly warns to "Think Before You Ink."