In research published on July 23, 2015, by The Lancet, authors Laux et al. discuss the potential toxicology of tattooing. According to the article abstract, tattoo-related health and safety regulations historically have focused on hygiene and the prevention of infections. However, tattooing has increased in popularity and "led to the development of many new colors, allowing tattoos to be more spectacular than ever before."
The authors add that little is known about the toxicological risks of these ingredients, and for risk assessment, the safe intradermal application of these pigments requires toxicity and biokinetic data, along with information about tattoo removal. Other concerns are for phototoxicity, substance migration and the possible metabolic conversion of tattoo ink ingredients into toxic substances.
In a related report from the Apex Tribune, Andreas Luch, M.D., senior author of the study and member of the German Federal Institute for Risk Assessment (Berlin), gave the statement: “Almost everybody these days has a tattoo, and nobody is talking about the side effects of ink deposits.” He added that no evidence has suggested these ink ingredients, when injected into the body, are safe. There simply is not enough data to reach a conclusion; this is due in part to tattoo inks being classified as cosmetic products in most countries.
FDA and Tattooing
What role does the U.S. Food and Drug Administration (FDA) play in regulating tattooing? According to the FDA website, ink and ink colorings (pigments) used in tattoos are "subject to FDA regulation as cosmetics and color additives." However, other public health concerns have held higher priorities, and there has been a lack of evidence of safety concerns—unlike other news reports over reactions to black henna; but that's another story. Therefore, the FDA has not traditionally regulated tattoo inks or the pigments used in them.
The agency notes it has received reports of bad reactions to tattoo inks just after tattooing or even years later, and some individuals report itchy or inflamed skin around their tattoos during the summer, when they have been exposed to the sun. The FDA also has warned against the use of certain inks found to be adulterated, and issued voluntary recalls, mainly due to microbial contamination.
Most notably, recent reports associated with permanent make-up inks have prompted the FDA to study tattoo ink safety. In the FDA's Arkansas-based National Center for Toxicological Research (NCTR), research chemist Paul Howard, Ph.D., and his team are currently investigating tattoo inks.
(continue to Part III)