The FDA has launched an investigation into the chemicals contained in tattoo and permanent makeup inks, as well as their potential health consequences.
Permanent makeup involves tattooing the face to create effects similar to those produced by more conventional makeups such as eye or lip liners.
News of the study was welcomed by many consumer advocates and health professionals.
"The FDA doesn't do anything. If you are concerned about public safety, we need rules and guidelines," said Charles Zwerling, an ophthalmologist and chairman of the American Academy of Micropigmentation.
The new investigation marks the first time the agency has chosen to exercise its authority to regulate the inks used in tattooing, an authority granted by the Federal Food, Drug & Cosmetic Act. Due to budget limitations and having more pressing priorities, the FDA has previously left the $2.3-billion tattoo industry to regulation by individual states, which have focused on basic sanitation.
It has long been known that using non-sterile tattoo needles can lead to skin infections or even more serious conditions including tetanus, hepatitis and HIV.
The FDA also plans to study how the chemicals contained in tattoo ink break down in the body, whether they pose long-term health risks, and whether some chemicals pose greater risks than others. The study is expected to take several years to complete.
According to FDA spokesperson Stephanie Kwisnek, the investigation was triggered by reports of adverse skin reactions to tattoo inks, the growing popularity of tattooing among the U.S. population, and "concerns raised by the scientific community."
Most adverse reactions to tattoo ink are similar to those caused by skin allergies. In 2005, 52,114 containers of tattoo ink were recalled after more than 150 cases of skin reactions including blistering, cracking, swelling, peeling and chronic inflammation were reported to the FDA. Consumers have also reported developing rashes after tattooing.
Rudy Saltzman, a tattoo shop owner from New Jersey, said he was unaware of any bad reactions in any of his customers, but acknowledged that any chemical could be potentially dangerous.
"I'm not a chemist, and I don't know what's in the inks and pigments," Saltzman said. "But you can have a reaction to a deodorant. There is no way of telling how a person will react to anything."
One of the chemicals known to be used in tattoo ink is thimerosal, also called thiomersal, an organic compound made with mercury. Thimerosal is commonly included in tattoo inks, vaccines, antivenins, and eye and ear products as a preservative. Due in part to mercury's toxic effects, thimerosal is very effective at killing off fungal and bacterial growth.
Mercury is a well-known neurotoxin, with effects that can be particularly severe in pregnant women, infants and children. Due to concern over mercury toxicity, the United States and European Union have removed thimerosal from all vaccines recommended for young children, with the exception of certain influenza vaccines. But vaccines recommended and often even required for older children, including those for diphtheria and tetanus, still contain the chemical. Thimerosal is also contained in several anti-venom treatments, and in most vaccines found outside of North America and Europe.
Alloys of mercury are also used in dental fillings, due in large part to their cheapness and durability. Like thimerosal, dental amalgams contain approximately 45 percent mercury by weight.
The FDA classifies dental amalgams as devices rather than substances, and has declined to impose more regulation on them, even while calling for more studies on their safety.
In 2001, a lawsuit forced dental offices in the state of California to display warnings that "dental amalgams, used in many dental fillings, causes exposure to mercury, a chemical known to the state of California to cause birth defects or other reproductive harm. Root canal treatments and restorations including fillings, crowns and bridges use chemicals known to the state of California to cause cancer."